Trial Outcomes & Findings for Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer (NCT NCT00004888)
NCT ID: NCT00004888
Last Updated: 2014-05-23
Results Overview
This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) \>=10% but \<20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF \>=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
84 participants
Primary outcome timeframe
Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy
Results posted on
2014-05-23
Participant Flow
The study was activated on Oct 19, 2000 and closed on Sept 7, 2004. Accrual to Arm II was suspended on April 23, 2002 for a pre-planned interim analysis regarding cardiac safety and resumed on Nov 6, 2002. Study participants all came from ECOG institutions.
Entry on the study requires determination by the Eastern Cooperative Group Pathology Coordinating Office of HER2 expression status in primary breast tissue or site of metastasis. Patients with PS 2 were excluded from further enrollment in both arms as they were found to experience more severe toxicities and more frequent dose reductions.
Participant milestones
| Measure |
Arm I: Doxorubicin and Taxotere
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
46
|
|
Overall Study
COMPLETED
|
27
|
22
|
|
Overall Study
NOT COMPLETED
|
11
|
24
|
Reasons for withdrawal
| Measure |
Arm I: Doxorubicin and Taxotere
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Progressive Disease
|
4
|
9
|
|
Overall Study
Death without progressive disease
|
0
|
1
|
|
Overall Study
Toxic death
|
1
|
0
|
Baseline Characteristics
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I: Doxorubicin and Taxotere
n=38 Participants
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=46 Participants
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
53 years
n=7 Participants
|
53 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
38 participants
n=5 Participants
|
46 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapyPopulation: Treated patients who had a cardiotoxicity event
This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) \>=10% but \<20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF \>=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.
Outcome measures
| Measure |
Arm I: Doxorubicin and Taxotere
n=16 Participants
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=37 Participants
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 1 After Cycle 4 (approx. 84 days)
|
2 participants
|
12 participants
|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 1 After Cycle 8 (approx. 168 days)
|
4 participants
|
8 participants
|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 1 After 30 days or more after last cycle
|
1 participants
|
10 participants
|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 2 After Cycle 4 (approx 84 days)
|
3 participants
|
0 participants
|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 2 After Cycle 8 (approx 168 days)
|
4 participants
|
2 participants
|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 2 After 30 days or more after last cycle
|
1 participants
|
5 participants
|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 3 After Cycle 4 (approx 84 days)
|
1 participants
|
0 participants
|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 3 After Cycle 8 (approx 168 days)
|
0 participants
|
0 participants
|
|
Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event
Grade 3 After 30 days or more after last cycle
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline, after cycle 4, after cycle 8, and 30 or more days after last cycle of induction therapy.Population: All treated patients
This table summarizes the LVEF information at baseline, post Cycle 4, post Cycle 8, and 30 or more days after Cycle 8 on all treated patients and on the eligible subset. LVEF drops reported are absolute (not relative) drops.
Outcome measures
| Measure |
Arm I: Doxorubicin and Taxotere
n=41 Participants
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=48 Participants
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
Summary of Left Ventricular Ejection Fraction Values
Baseline
|
64.8 LVEF percent
Standard Deviation 8.3
|
62.9 LVEF percent
Standard Deviation 7.2
|
|
Summary of Left Ventricular Ejection Fraction Values
Post Cycle 4
|
63 LVEF percent
Standard Deviation 7.9
|
61.7 LVEF percent
Standard Deviation 7.2
|
|
Summary of Left Ventricular Ejection Fraction Values
Post Cycle 8
|
60.8 LVEF percent
Standard Deviation 8.2
|
58.9 LVEF percent
Standard Deviation 7.4
|
|
Summary of Left Ventricular Ejection Fraction Values
greater than or equal to 30 days after cycle 8
|
62.6 LVEF percent
Standard Deviation 6.4
|
59.1 LVEF percent
Standard Deviation 7.5
|
|
Summary of Left Ventricular Ejection Fraction Values
Baseline minus post cycle 4
|
2.3 LVEF percent
Standard Deviation 7.5
|
1.6 LVEF percent
Standard Deviation 8.0
|
|
Summary of Left Ventricular Ejection Fraction Values
Baseline minus post cycle 8
|
4.2 LVEF percent
Standard Deviation 8.8
|
4.9 LVEF percent
Standard Deviation 6.7
|
|
Summary of Left Ventricular Ejection Fraction Values
Baseline minus 30 days or more after cycle 8
|
0.9 LVEF percent
Standard Deviation 7.1
|
6.2 LVEF percent
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of Nov 21, 2007 is used for this report. Please note that best overall response is reported in the table.Population: Eligible Patients
Please note that overall response includes CR and PR. CR is defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. PR is greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. No change is defined as no significant change in measurable or evaluable disease for at least 4 weeks. Progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.
Outcome measures
| Measure |
Arm I: Doxorubicin and Taxotere
n=38 Participants
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=46 Participants
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.
Unevaluable
|
3 participants
|
5 participants
|
|
Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.
Complete Response
|
1 participants
|
4 participants
|
|
Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.
Partial Response
|
17 participants
|
17 participants
|
|
Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.
No Change
|
11 participants
|
11 participants
|
|
Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.
Progression
|
6 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.Population: All eligible patients were included in this analysis.
Outcome measures
| Measure |
Arm I: Doxorubicin and Taxotere
n=38 Participants
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=46 Participants
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
Overall Survival
|
24.6 months
Interval 14.7 to 37.3
|
31.8 months
Interval 23.7 to 44.9
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.Population: All eligible patients were included in this analysis. Please note that 2 patients on Arm B died without documentation of progression. Also, 4 patients died or were taken off treatment before follow-up evaluations, and PFS was censored at zero.
Progression-Free Survival was defined as time from study entry to progression or to death without documentation of progression. A progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.
Outcome measures
| Measure |
Arm I: Doxorubicin and Taxotere
n=38 Participants
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=46 Participants
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
Progression-Free Survival
|
11 months
Interval 8.6 to 12.8
|
10.6 months
Interval 5.6 to 15.7
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.Population: Responders
Defined as time from onset of PR or CR, whichever occurred first, until objective evidence of progression.
Outcome measures
| Measure |
Arm I: Doxorubicin and Taxotere
n=18 Participants
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=21 Participants
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
Duration of Response
|
10.1 Months
Interval 6.7 to 15.4
|
14.7 Months
Interval 7.8 to 23.7
|
Adverse Events
Arm I: Doxorubicin and Taxotere
Serious events: 41 serious events
Other events: 41 other events
Deaths: 0 deaths
Arm II: Doxorubicin, Taxotere, and Herceptin
Serious events: 48 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I: Doxorubicin and Taxotere
n=41 participants at risk
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=48 participants at risk
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
General disorders
abdominal pain
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Creatinine Increased
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
22.0%
9/41 • Number of events 9 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
37.5%
18/48 • Number of events 26 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
12.2%
5/41 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
10.4%
5/48 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Leukopenia
|
53.7%
22/41 • Number of events 83 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
58.3%
28/48 • Number of events 82 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Neutropenia
|
58.5%
24/41 • Number of events 88 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
66.7%
32/48 • Number of events 120 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.9%
2/41 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Cardiac disorders
Hypertension
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
2.1%
1/48 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Infections and infestations
Infection with Grade 3 or 4 neutropenia
|
12.2%
5/41 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
12.5%
6/48 • Number of events 6 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.3%
3/41 • Number of events 3 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
4.2%
2/48 • Number of events 2 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Anemia
|
12.2%
5/41 • Number of events 8 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
12.5%
6/48 • Number of events 10 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Thrombosis/embolism
|
9.8%
4/41 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/Pulmonary Infiltrates
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
2.1%
1/48 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Infections and infestations
Infection with Unknown ANC
|
7.3%
3/41 • Number of events 3 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
6.2%
3/48 • Number of events 3 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Cardiac disorders
Hypotension
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
2.1%
1/48 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Fatigue
|
4.9%
2/41 • Number of events 9 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
16.7%
8/48 • Number of events 9 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
DIC
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Dehydration
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
10.4%
5/48 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
6.2%
3/48 • Number of events 3 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Stomatitis
|
17.1%
7/41 • Number of events 7 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
22.9%
11/48 • Number of events 13 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Gastrointestinal disorders
Diarrhea without prior colostomy
|
4.9%
2/41 • Number of events 2 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
2.1%
1/48 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
4.2%
2/48 • Number of events 2 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Hepatobiliary disorders
Bilirubin Increased
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
AST Increased
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
2.1%
1/48 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
2.1%
1/48 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Endocrine disorders
Hyperglycemia
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Infections and infestations
Conjunctivitis
|
2.4%
1/41 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Eye disorders
Tearing
|
4.9%
2/41 • Number of events 2 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
0.00%
0/48 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
Other adverse events
| Measure |
Arm I: Doxorubicin and Taxotere
n=41 participants at risk
Patients received PLD 30 mg/m\^2 IV followed by docetaxel 60 mg/m\^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m\^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
|
Arm II: Doxorubicin, Taxotere, and Herceptin
n=48 participants at risk
Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
|
|---|---|---|
|
General disorders
Allergic Reaction
|
7.3%
3/41 • Number of events 3 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
16.7%
8/48 • Number of events 11 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Anemia
|
73.2%
30/41 • Number of events 331 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
81.2%
39/48 • Number of events 586 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Leukopenia
|
75.6%
31/41 • Number of events 204 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
89.6%
43/48 • Number of events 267 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Neutropenia
|
53.7%
22/41 • Number of events 72 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
75.0%
36/48 • Number of events 109 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
24.4%
10/41 • Number of events 56 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
12.5%
6/48 • Number of events 22 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Cardiac disorders
Cardiac-left ventric
|
22.0%
9/41 • Number of events 10 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
22.9%
11/48 • Number of events 15 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Skin and subcutaneous tissue disorders
Edema
|
14.6%
6/41 • Number of events 13 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
10.4%
5/48 • Number of events 15 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Fatigue
|
70.7%
29/41 • Number of events 128 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
68.8%
33/48 • Number of events 68 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Fever
|
12.2%
5/41 • Number of events 7 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
12.5%
6/48 • Number of events 8 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Rigors/Chills
|
12.2%
5/41 • Number of events 8 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
12.5%
6/48 • Number of events 10 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Weight Loss
|
7.3%
3/41 • Number of events 6 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
16.7%
8/48 • Number of events 11 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Alopecia
|
75.6%
31/41 • Number of events 225 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
79.2%
38/48 • Number of events 220 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
48.8%
20/41 • Number of events 58 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
62.5%
30/48 • Number of events 96 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Nail Changes
|
41.5%
17/41 • Number of events 51 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
37.5%
18/48 • Number of events 80 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Pigmentation
|
9.8%
4/41 • Number of events 16 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
10.4%
5/48 • Number of events 11 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
14.6%
6/41 • Number of events 13 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
20.8%
10/48 • Number of events 18 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Hot Flashes
|
4.9%
2/41 • Number of events 4 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
18.8%
9/48 • Number of events 23 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.8%
4/41 • Number of events 4 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
22.9%
11/48 • Number of events 22 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Gastrointestinal disorders
Constipation
|
22.0%
9/41 • Number of events 13 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
33.3%
16/48 • Number of events 37 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.2%
5/41 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
14.6%
7/48 • Number of events 26 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Nausea
|
53.7%
22/41 • Number of events 53 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
64.6%
31/48 • Number of events 104 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Stomatitis
|
68.3%
28/41 • Number of events 98 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
79.2%
38/48 • Number of events 108 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Taste Disturbance
|
14.6%
6/41 • Number of events 53 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
12.5%
6/48 • Number of events 21 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Gastrointestinal disorders
Vomiting
|
26.8%
11/41 • Number of events 16 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
37.5%
18/48 • Number of events 33 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Gastrointestinal disorders
Diarrhea
|
31.7%
13/41 • Number of events 20 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
43.8%
21/48 • Number of events 42 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Hepatobiliary disorders
Bilirubin Increased
|
4.9%
2/41 • Number of events 4 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
4.2%
2/48 • Number of events 3 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
4.9%
2/41 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
2.1%
1/48 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Blood and lymphatic system disorders
AST Increased
|
51.2%
21/41 • Number of events 60 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
50.0%
24/48 • Number of events 59 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Infections and infestations
Infection with neutro
|
7.3%
3/41 • Number of events 6 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
22.9%
11/48 • Number of events 22 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Dizziness/lightheaded
|
19.5%
8/41 • Number of events 9 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
4.2%
2/48 • Number of events 3 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
General disorders
Insomnia
|
9.8%
4/41 • Number of events 13 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
8.3%
4/48 • Number of events 8 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Nervous system disorders
Neuropathy Sensory
|
39.0%
16/41 • Number of events 33 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
35.4%
17/48 • Number of events 39 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Eye disorders
Conjunctivitis
|
7.3%
3/41 • Number of events 5 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
2.1%
1/48 • Number of events 1 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Eye disorders
Dry Eye
|
9.8%
4/41 • Number of events 4 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
4.2%
2/48 • Number of events 12 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Eye disorders
Tearing
|
36.6%
15/41 • Number of events 46 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
31.2%
15/48 • Number of events 41 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.0%
9/41 • Number of events 22 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
16.7%
8/48 • Number of events 22 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
34.1%
14/41 • Number of events 31 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
25.0%
12/48 • Number of events 25 • Information about toxicities was collected during treatment for all treated patients and the table shows toxicities experienced by patients. These are limited to toxicities reported on case report forms. The average time period was 5-6 months.
Please note that all of these toxicities are considered at least possibly treatment related by the study chair.
|
Additional Information
Study Statistician
Eastern Cooperative Oncology Group Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60