Trial Outcomes & Findings for S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer (NCT NCT00004124)
NCT ID: NCT00004124
Last Updated: 2022-12-30
Results Overview
Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
983 participants
Primary outcome timeframe
at 10 Years
Results posted on
2022-12-30
Participant Flow
983 patients consented and were enrolled to the trial. 22 patients were found to be ineligible per eligibility criteria, and were thus excluded from final analysis.
Participant milestones
| Measure |
Arm I: Bicalutamide + Goserelin
Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
|
|---|---|---|
|
Overall Study
STARTED
|
481
|
480
|
|
Overall Study
COMPLETED
|
469
|
460
|
|
Overall Study
NOT COMPLETED
|
12
|
20
|
Reasons for withdrawal
| Measure |
Arm I: Bicalutamide + Goserelin
Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
|
|---|---|---|
|
Overall Study
Received no protocol therapy
|
12
|
20
|
Baseline Characteristics
S9921, Hormone Therapy With or Without Mitoxantrone and Prednisone in Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm I: Bicalutamide + Goserelin
n=481 Participants
Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
n=480 Participants
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
|
Total
n=961 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
60 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
481 Participants
n=5 Participants
|
480 Participants
n=7 Participants
|
961 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
399 Participants
n=5 Participants
|
411 Participants
n=7 Participants
|
810 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
66 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
PSA at Prostatectomy
|
7.9 ng/mL
n=5 Participants
|
7.4 ng/mL
n=7 Participants
|
7.7 ng/mL
n=5 Participants
|
|
Hispanic
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Disease Extent
N1
|
79 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Disease Extent
>= T3 but N0
|
293 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
599 Participants
n=5 Participants
|
|
Disease Extent
Organ Confined
|
109 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Positive Margins from Prostatectomy
|
316 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
609 Participants
n=5 Participants
|
|
Intent to Receive Adjuvant RT
|
130 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
257 Participants
n=5 Participants
|
|
Gleason Score
<= 6
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Gleason Score
7
|
215 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
435 Participants
n=5 Participants
|
|
Gleason Score
8 - 10
|
256 Participants
n=5 Participants
|
248 Participants
n=7 Participants
|
504 Participants
n=5 Participants
|
|
Risk Groups
Node Positive
|
79 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Risk Groups
Gleason Score >= 8 or pT3b
|
276 Participants
n=5 Participants
|
296 Participants
n=7 Participants
|
572 Participants
n=5 Participants
|
|
Risk Groups
Gleason Score<8 w/Positive Margins or PSA>10 ng/mL
|
126 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 10 YearsMeasured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.
Outcome measures
| Measure |
Arm I: Bicalutamide + Goserelin
n=481 Participants
Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
n=480 Participants
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
|
|---|---|---|
|
Overall Survival
|
87 percentage of probability of survival
|
86 percentage of probability of survival
|
PRIMARY outcome
Timeframe: at 10 YearsPopulation: Intent-to-treat
Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact.
Outcome measures
| Measure |
Arm I: Bicalutamide + Goserelin
n=480 Participants
Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
n=481 Participants
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
|
|---|---|---|
|
Disease Free Survival
|
72 percentage of probability of survival
|
72 percentage of probability of survival
|
SECONDARY outcome
Timeframe: Up to 22 months from registrationPopulation: All eligible patients who received protocol therapy
Number of patients with adverse events that are related to study drug
Outcome measures
| Measure |
Arm I: Bicalutamide + Goserelin
n=469 Participants
Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
n=460 Participants
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
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|---|---|---|
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Skin-other
|
11 Participants
|
11 Participants
|
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Surgery-wound infection
|
0 Participants
|
1 Participants
|
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Sweating
|
138 Participants
|
129 Participants
|
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Syncope
|
0 Participants
|
3 Participants
|
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Taste disturbance
|
1 Participants
|
46 Participants
|
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Tearing
|
0 Participants
|
6 Participants
|
|
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Thrombocytopenia
|
3 Participants
|
35 Participants
|
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Thrombosis/embolism
|
2 Participants
|
5 Participants
|
|
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Speech impairment
|
0 Participants
|
1 Participants
|
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Stomatitis/pharyngitis
|
5 Participants
|
49 Participants
|
|
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Supraventricular arrhythmia
|
0 Participants
|
2 Participants
|
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Tremor
|
0 Participants
|
2 Participants
|
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Troponin T (cTnT) increase
|
0 Participants
|
1 Participants
|
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Urinary frequency/urgency
|
86 Participants
|
101 Participants
|
|
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Urinary retention
|
13 Participants
|
7 Participants
|
|
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Urinary tr infect w/ neutrop
|
0 Participants
|
1 Participants
|
|
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Urinary tr infect w/o neutrop
|
1 Participants
|
2 Participants
|
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Urinary tr infection, unk ANC
|
3 Participants
|
2 Participants
|
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Urine color change
|
3 Participants
|
44 Participants
|
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Urticaria
|
3 Participants
|
4 Participants
|
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Ventricular arrhythmia
|
1 Participants
|
0 Participants
|
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Weakness (motor neuropathy)
|
3 Participants
|
6 Participants
|
|
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Sexual/reproductive-other
|
2 Participants
|
1 Participants
|
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Sinus bradycardia
|
0 Participants
|
4 Participants
|
|
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Gastritis/ulcer, NOS
|
0 Participants
|
1 Participants
|
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Glaucoma
|
2 Participants
|
0 Participants
|
|
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Gynecomastia
|
140 Participants
|
100 Participants
|
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Headache
|
37 Participants
|
82 Participants
|
|
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Hematologic-other
|
1 Participants
|
1 Participants
|
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Hematuria
|
9 Participants
|
13 Participants
|
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Hemolysis
|
0 Participants
|
1 Participants
|
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Hemoptysis
|
0 Participants
|
1 Participants
|
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Hemorrhage-other
|
1 Participants
|
4 Participants
|
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Hiccoughs
|
0 Participants
|
4 Participants
|
|
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Hot flashes
|
439 Participants
|
422 Participants
|
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Hypercalcemia
|
4 Participants
|
5 Participants
|
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Hypercholesterolemia
|
5 Participants
|
2 Participants
|
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Hyperglycemia
|
44 Participants
|
78 Participants
|
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Hyperkalemia
|
0 Participants
|
4 Participants
|
|
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Hypermagnesemia
|
0 Participants
|
1 Participants
|
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Hypernatremia
|
0 Participants
|
4 Participants
|
|
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Hypertension
|
38 Participants
|
38 Participants
|
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Hypertriglyceridemia
|
2 Participants
|
0 Participants
|
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Hypoalbuminemia
|
1 Participants
|
6 Participants
|
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Hypocalcemia
|
1 Participants
|
7 Participants
|
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Hypoglycemia
|
0 Participants
|
1 Participants
|
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Hypokalemia
|
8 Participants
|
11 Participants
|
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Hypomagnesemia
|
1 Participants
|
1 Participants
|
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Hyponatremia
|
3 Participants
|
2 Participants
|
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Hypotension
|
3 Participants
|
11 Participants
|
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Hypothyroidism
|
2 Participants
|
0 Participants
|
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Hypoxia
|
0 Participants
|
4 Participants
|
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Incontinence
|
88 Participants
|
71 Participants
|
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Infection w/o 3-4 neutropenia
|
5 Participants
|
10 Participants
|
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Infection with 3-4 neutropenia
|
0 Participants
|
2 Participants
|
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Infection, unk ANC
|
1 Participants
|
4 Participants
|
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Inner ear-hearing loss
|
3 Participants
|
2 Participants
|
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Insomnia
|
79 Participants
|
92 Participants
|
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Invol. movement/restlessness
|
2 Participants
|
2 Participants
|
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Joint,muscle,bone-other
|
11 Participants
|
27 Participants
|
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LVEF decrease/CHF
|
0 Participants
|
8 Participants
|
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Leukopenia
|
14 Participants
|
317 Participants
|
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Libido loss
|
163 Participants
|
133 Participants
|
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Local injection site reaction
|
11 Participants
|
17 Participants
|
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Lung-other
|
0 Participants
|
2 Participants
|
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Lymphopenia
|
4 Participants
|
49 Participants
|
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Male infertility
|
2 Participants
|
3 Participants
|
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Melena/ GI bleeding
|
0 Participants
|
2 Participants
|
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Memory loss
|
15 Participants
|
12 Participants
|
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Metabolic-other
|
0 Participants
|
1 Participants
|
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Middle ear-hearing loss/otitis
|
0 Participants
|
1 Participants
|
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Mood/consciousness change, NOS
|
2 Participants
|
3 Participants
|
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Mouth dryness
|
10 Participants
|
13 Participants
|
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Muscle weakness (not neuro)
|
55 Participants
|
77 Participants
|
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Myalgia
|
26 Participants
|
45 Participants
|
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Myalgia/arthralgia, NOS
|
1 Participants
|
12 Participants
|
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Myocarditis
|
0 Participants
|
1 Participants
|
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Nail changes
|
4 Participants
|
57 Participants
|
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Nausea
|
26 Participants
|
205 Participants
|
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Neuro-other
|
5 Participants
|
4 Participants
|
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Neuropathic pain
|
0 Participants
|
1 Participants
|
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Neutropenia/granulocytopenia
|
11 Participants
|
239 Participants
|
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PRBC transfusion
|
0 Participants
|
3 Participants
|
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Pain-other
|
112 Participants
|
127 Participants
|
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Palpitations
|
1 Participants
|
6 Participants
|
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Pelvic pain
|
9 Participants
|
11 Participants
|
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Pericar. effusion/pericarditis
|
0 Participants
|
1 Participants
|
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Personality/behavioral change
|
12 Participants
|
11 Participants
|
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Phlebitis
|
0 Participants
|
5 Participants
|
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Pigmentation changes/yellowing
|
0 Participants
|
3 Participants
|
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Pleural effusions
|
0 Participants
|
1 Participants
|
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Pneumonitis/infiltrates
|
0 Participants
|
1 Participants
|
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Proctitis
|
4 Participants
|
4 Participants
|
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Proteinuria
|
3 Participants
|
1 Participants
|
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Pruritus
|
13 Participants
|
23 Participants
|
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RT-GI mucositis, NOS
|
0 Participants
|
1 Participants
|
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RT-focal dermatitis, NOS
|
3 Participants
|
1 Participants
|
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RT-late bladder morbidity
|
1 Participants
|
0 Participants
|
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RT-late intestinal morbidity
|
2 Participants
|
1 Participants
|
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RT-pain
|
1 Participants
|
0 Participants
|
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Rash/desquamation
|
46 Participants
|
63 Participants
|
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Rectal bleeding/hematochezia
|
12 Participants
|
10 Participants
|
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Rectal/perirectal pain
|
7 Participants
|
5 Participants
|
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Respiratory infect w/o neutrop
|
1 Participants
|
7 Participants
|
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Respiratory infection, unk ANC
|
1 Participants
|
8 Participants
|
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Rigors/chills
|
7 Participants
|
24 Participants
|
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SGOT (AST) increase
|
42 Participants
|
42 Participants
|
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SGPT (ALT) increase
|
22 Participants
|
26 Participants
|
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Salivary change, NOS
|
0 Participants
|
1 Participants
|
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Second primary
|
0 Participants
|
6 Participants
|
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Seizures
|
1 Participants
|
1 Participants
|
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Sensory neuropathy
|
37 Participants
|
57 Participants
|
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Vertigo
|
1 Participants
|
1 Participants
|
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Vision,NOS
|
0 Participants
|
1 Participants
|
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Voice change/stridor/larynx
|
0 Participants
|
6 Participants
|
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Vomiting
|
10 Participants
|
51 Participants
|
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Weight gain
|
179 Participants
|
151 Participants
|
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Weight loss
|
12 Participants
|
29 Participants
|
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Abdominal pain/cramping
|
19 Participants
|
41 Participants
|
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Abscess
|
0 Participants
|
1 Participants
|
|
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Alkaline phosphatase increase
|
11 Participants
|
11 Participants
|
|
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Allergic reaction
|
1 Participants
|
5 Participants
|
|
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Allergic rhinitis
|
2 Participants
|
16 Participants
|
|
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Alopecia
|
91 Participants
|
131 Participants
|
|
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Anal incontinence
|
2 Participants
|
2 Participants
|
|
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Anemia
|
52 Participants
|
141 Participants
|
|
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Anorexia
|
7 Participants
|
41 Participants
|
|
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Anxiety/agitation
|
52 Participants
|
62 Participants
|
|
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Apnea
|
1 Participants
|
1 Participants
|
|
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Arrhythmia, NOS
|
0 Participants
|
1 Participants
|
|
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Arthralgia
|
43 Participants
|
64 Participants
|
|
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Arthritis
|
17 Participants
|
17 Participants
|
|
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Ataxia (incoordination)
|
1 Participants
|
1 Participants
|
|
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Bilirubin increase
|
5 Participants
|
20 Participants
|
|
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Blurred vision
|
3 Participants
|
6 Participants
|
|
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Bone pain
|
19 Participants
|
34 Participants
|
|
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Bruising
|
1 Participants
|
14 Participants
|
|
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CPK increase
|
0 Participants
|
2 Participants
|
|
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Cardiac ischemia/infarction
|
1 Participants
|
1 Participants
|
|
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Cardiovascular-other
|
0 Participants
|
5 Participants
|
|
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Cataract
|
5 Participants
|
6 Participants
|
|
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Cerebrovascular ischemia
|
1 Participants
|
0 Participants
|
|
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Chest pain,not cardio or pleur
|
11 Participants
|
19 Participants
|
|
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Conduction abnormality/block
|
1 Participants
|
0 Participants
|
|
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Confusion
|
6 Participants
|
14 Participants
|
|
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Conjunctivitis
|
0 Participants
|
4 Participants
|
|
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Constipation/bowel obstruction
|
57 Participants
|
117 Participants
|
|
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Cough
|
10 Participants
|
34 Participants
|
|
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Creatinine increase
|
7 Participants
|
17 Participants
|
|
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Cushingoid appearance
|
0 Participants
|
8 Participants
|
|
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Dehydration
|
0 Participants
|
6 Participants
|
|
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Depression
|
80 Participants
|
85 Participants
|
|
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Diarrhea without colostomy
|
55 Participants
|
75 Participants
|
|
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Dizziness/light headedness
|
33 Participants
|
71 Participants
|
|
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Dry eye
|
1 Participants
|
5 Participants
|
|
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Dry skin
|
11 Participants
|
28 Participants
|
|
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Dysmenorrhea
|
0 Participants
|
1 Participants
|
|
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Dyspepsia/heartburn
|
7 Participants
|
44 Participants
|
|
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Dyspnea
|
21 Participants
|
49 Participants
|
|
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Dysuria
|
14 Participants
|
11 Participants
|
|
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Ear-other
|
0 Participants
|
2 Participants
|
|
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Edema
|
40 Participants
|
56 Participants
|
|
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Endocrine-other
|
3 Participants
|
2 Participants
|
|
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Epistaxis
|
0 Participants
|
2 Participants
|
|
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Erectile impotence
|
181 Participants
|
146 Participants
|
|
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Eryth/rash/eruption/desq, NOS
|
0 Participants
|
2 Participants
|
|
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Esophagitis/dysphagia
|
2 Participants
|
13 Participants
|
|
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Eye-other
|
1 Participants
|
6 Participants
|
|
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Fatigue/malaise/lethargy
|
258 Participants
|
357 Participants
|
|
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Febrile neutropenia
|
0 Participants
|
2 Participants
|
|
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Feminization of male
|
1 Participants
|
0 Participants
|
|
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Fever without neutropenia
|
0 Participants
|
9 Participants
|
|
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Fever, NOS
|
1 Participants
|
6 Participants
|
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Flatulence
|
2 Participants
|
3 Participants
|
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Flu-like symptoms-other
|
2 Participants
|
6 Participants
|
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Flushing
|
5 Participants
|
4 Participants
|
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GGT increase
|
1 Participants
|
0 Participants
|
|
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GI Mucositis, NOS
|
0 Participants
|
10 Participants
|
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GI-other
|
12 Participants
|
20 Participants
|
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GU-other
|
9 Participants
|
9 Participants
|
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Gastritis
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 10 YearsPopulation: Data for trial not collected for analysis.
Measured from date of randomization to date of PSA progression or death due to any cause. PSA progression is defined as a serum PSA level of \> 0.2 ng/mL measured on 3 consecutive occasions or in the absence of increasing PSA, a positive bone scan result or other radiographic or histologic evidence of progression will be used. Date of progression will be the date that the first measure of increasing PSA is noted in the series of 3.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 10 YearsPopulation: Data not collected for analysis.
Outcome measures
Outcome data not reported
Adverse Events
Arm I: Bicalutamide + Goserelin
Serious events: 3 serious events
Other events: 461 other events
Deaths: 85 deaths
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
Serious events: 11 serious events
Other events: 457 other events
Deaths: 91 deaths
Serious adverse events
| Measure |
Arm I: Bicalutamide + Goserelin
n=469 participants at risk
Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
n=460 participants at risk
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
|
|---|---|---|
|
General disorders
Reportable adverse event, NOS
|
0.21%
1/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
0.00%
0/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
0.22%
1/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Vascular disorders
Thrombosis/embolism
|
0.00%
0/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
0.22%
1/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
General disorders
Flu-like symptoms-other
|
0.21%
1/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
0.43%
2/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Infections and infestations
Infection with 3-4 neutropenia
|
0.00%
0/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
0.43%
2/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
0.22%
1/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
General disorders
Pain-other
|
0.00%
0/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
0.22%
1/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary
|
0.21%
1/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
1.1%
5/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
Other adverse events
| Measure |
Arm I: Bicalutamide + Goserelin
n=469 participants at risk
Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity.
|
Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin
n=460 participants at risk
Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.3%
6/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
5.0%
23/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Blood and lymphatic system disorders
Anemia
|
15.1%
71/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
33.0%
152/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
Leukopenia
|
4.3%
20/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
69.3%
319/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
Lymphopenia
|
1.7%
8/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
11.1%
51/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
Neutropenia/granulocytopenia
|
2.8%
13/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
52.2%
240/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
Thrombocytopenia
|
1.5%
7/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
7.8%
36/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Cardiac disorders
Edema
|
10.7%
50/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
14.1%
65/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Cardiac disorders
Hypertension
|
12.4%
58/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
11.1%
51/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
General disorders
Fatigue/malaise/lethargy
|
57.1%
268/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
79.3%
365/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
General disorders
Rigors/chills
|
1.9%
9/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
5.2%
24/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
General disorders
Sweating
|
29.6%
139/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
28.9%
133/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
Weight gain
|
39.7%
186/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
33.3%
153/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
Weight loss
|
3.6%
17/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
6.5%
30/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.8%
93/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
28.9%
133/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.6%
17/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
7.0%
32/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.85%
4/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
12.8%
59/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
19/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
5.9%
27/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
12.6%
59/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
15.9%
73/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Endocrine disorders
Gynecomastia
|
29.9%
140/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
21.7%
100/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Endocrine disorders
Hot flashes
|
93.8%
440/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
91.7%
422/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.9%
9/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
9.6%
44/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
Constipation/bowel obstruction
|
14.7%
69/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
28.9%
133/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
13.2%
62/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
18.9%
87/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
2.3%
11/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
9.6%
44/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
GI-other
|
3.6%
17/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
5.4%
25/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
Nausea
|
6.6%
31/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
45.7%
210/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
1.5%
7/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
10.7%
49/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
Taste disturbance
|
0.21%
1/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
10.0%
46/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
16/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
11.7%
54/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
SGOT (AST) increase
|
9.2%
43/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
11.1%
51/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
SGPT (ALT) increase
|
5.1%
24/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
7.2%
33/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.0%
61/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
22.2%
102/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.4%
30/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
7.0%
32/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Musculoskeletal and connective tissue disorders
Joint,muscle,bone-other
|
3.6%
17/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
7.4%
34/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not neuro)
|
12.4%
58/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
18.0%
83/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Psychiatric disorders
Anxiety/agitation
|
12.6%
59/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
15.2%
70/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Psychiatric disorders
Depression
|
20.3%
95/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
21.5%
99/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Nervous system disorders
Dizziness/light headedness
|
9.0%
42/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
17.0%
78/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Psychiatric disorders
Insomnia
|
19.8%
93/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
22.8%
105/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Nervous system disorders
Sensory neuropathy
|
12.6%
59/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
15.7%
72/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
6.4%
30/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
11.5%
53/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
57/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
16.7%
77/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.1%
24/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
7.4%
34/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
General disorders
Chest pain,not cardio or pleur
|
3.4%
16/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
5.0%
23/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Nervous system disorders
Headache
|
9.6%
45/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
19.1%
88/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
29/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
10.7%
49/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
General disorders
Pain-other
|
34.5%
162/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
37.6%
173/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.1%
24/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
10.0%
46/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
35/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
12.8%
59/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Investigations
Creatinine increase
|
2.1%
10/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
5.2%
24/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Renal and urinary disorders
Incontinence
|
29.2%
137/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
25.4%
117/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
27.9%
131/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
28.3%
130/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Renal and urinary disorders
Urine color change
|
0.85%
4/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
9.6%
44/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Reproductive system and breast disorders
Erectile impotence
|
46.3%
217/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
37.2%
171/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
|
Reproductive system and breast disorders
Libido loss
|
35.8%
168/469 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
29.1%
134/460 • Arm 1 assessed every 3 months up through 22 months; Arm 2 assessed every 21 days through first four months, and then every 3 months through 22 months
Patients on Arm 1 were monitored for toxicity every 3 months while on hormonal therapy. Patients on Arm 2 were monitored every 21 days while receiving chemotherapy in first 4 months of study, and then every 3 months through hormonal therapy. Patients on either arm maybe have had more frequent monitoring at discretion of the treating physician.
|
Additional Information
Catherine Tangen, Genitourinary Committee Statistician
SWOG Statistics and Data Management Center
Phone: (206) 667-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place