Trial Outcomes & Findings for Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes (NCT NCT00003138)
NCT ID: NCT00003138
Last Updated: 2023-06-29
Results Overview
Whether a patient required transfusion or not at 4 months was recorded.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
118 participants
Primary outcome timeframe
Assessed at 4 months
Results posted on
2023-06-29
Participant Flow
This study was activated on December 9, 1997, accrued its first patient on March 4, 1998, and closed on June 1, 2004. A total of 118 patients were enrolled (110 ECOG patients and 8 Canadian Leukemia Study Group \[CLSG\] patients).
Participant milestones
| Measure |
Supportive Care
Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
|
Erythropoietin
Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
|
|---|---|---|
|
Step 1
STARTED
|
61
|
57
|
|
Step 1
Patients With Complete Data
|
57
|
53
|
|
Step 1
Treated
|
56
|
53
|
|
Step 1
Eligible and Treated
|
52
|
50
|
|
Step 1
Patients With QOL Data at 4 Months
|
42
|
42
|
|
Step 1
Patients With Transfusion Data
|
37
|
42
|
|
Step 1
COMPLETED
|
0
|
0
|
|
Step 1
NOT COMPLETED
|
61
|
57
|
|
Step 2 (Cross Over)
STARTED
|
26
|
0
|
|
Step 2 (Cross Over)
COMPLETED
|
0
|
0
|
|
Step 2 (Cross Over)
NOT COMPLETED
|
26
|
0
|
|
Step 3 (EPO 150 Units/kg and G-CSF)
STARTED
|
12
|
20
|
|
Step 3 (EPO 150 Units/kg and G-CSF)
Treated
|
12
|
19
|
|
Step 3 (EPO 150 Units/kg and G-CSF)
COMPLETED
|
0
|
0
|
|
Step 3 (EPO 150 Units/kg and G-CSF)
NOT COMPLETED
|
12
|
20
|
|
Step 4 (EPO 300 Units/kg and G-CSF)
STARTED
|
6
|
7
|
|
Step 4 (EPO 300 Units/kg and G-CSF)
COMPLETED
|
0
|
0
|
|
Step 4 (EPO 300 Units/kg and G-CSF)
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Supportive Care
Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
|
Erythropoietin
Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
|
|---|---|---|
|
Step 1
Reasons off treatment not documented
|
60
|
57
|
|
Step 1
Never started treatment
|
1
|
0
|
|
Step 2 (Cross Over)
Reasons off treatment not documented
|
26
|
0
|
|
Step 3 (EPO 150 Units/kg and G-CSF)
Off treatment reasons not documented
|
12
|
19
|
|
Step 3 (EPO 150 Units/kg and G-CSF)
Never started treatment
|
0
|
1
|
|
Step 4 (EPO 300 Units/kg and G-CSF)
Off treatment reasons not documented
|
6
|
7
|
Baseline Characteristics
Erythropoietin (EPO)+/- Filgrastim (G-CSF) vs. Supportive Therapy Alone for Patients With Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Supportive Care
n=57 Participants
Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
|
Erythropoietin
n=53 Participants
Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at 4 monthsPopulation: Only patients with transfusion data were included in this analysis.
Whether a patient required transfusion or not at 4 months was recorded.
Outcome measures
| Measure |
Supportive Care
n=37 Participants
Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
|
Erythropoietin
n=42 Participants
Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
|
|---|---|---|
|
Proportion of Patients Free of Transfusion at 4 Months
|
0.459 Proportion of patients
Interval 0.295 to 0.631
|
0.714 Proportion of patients
Interval 0.554 to 0.843
|
SECONDARY outcome
Timeframe: Assessed every 3 months for 2 years, every 6 months for 3 subsequent years, and annually thereafterPopulation: All patients with complete data were included in this analysis.
Time from randomization to death from any cause. Patients alive at the time of analysis were censored at the date of last contact.
Outcome measures
| Measure |
Supportive Care
n=57 Participants
Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
|
Erythropoietin
n=53 Participants
Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
|
|---|---|---|
|
Overall Survival
|
31 Months
Interval 23.5 to 48.0
|
37 Months
Interval 24.4 to 40.8
|
SECONDARY outcome
Timeframe: Assessed at 4 monthsPopulation: Only patients who completed quality of life assessment at 4 months were included in this analysis.
The FACT-G scale has 4 dimensions, including physical well-being, social/family well-being, emotional well-being, and functional well-being. The score for each subscale was added together to obtain the total FACT-G score that was evaluated on this study. The total FACT-G score ranges from 0 to 108 with higher scores reflecting better quality of life. It was administered at the time of study entry, every 4 months for the first year, and at the time patient went off treatment. Due to limited data after 4 months on treatment, the analysis was restricted to the four-month time point.
Outcome measures
| Measure |
Supportive Care
n=42 Participants
Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
|
Erythropoietin
n=42 Participants
Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
|
|---|---|---|
|
Quality of Life- Total Functional Assessment of Cancer Therapy - General (FACT-G) Score at 4 Months
|
84.1 Scores on a scale
Standard Deviation 15.77
|
84.33 Scores on a scale
Standard Deviation 14.75
|
Adverse Events
Supportive Care (Step 1)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Erythropoietin (Step 1)
Serious events: 16 serious events
Other events: 28 other events
Deaths: 0 deaths
Erythropoietin (Cross-over; Step 2)
Serious events: 7 serious events
Other events: 13 other events
Deaths: 0 deaths
Erythropoietin (150 Units/kg) and Filgrastim (Step 3)
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Erythropoietin (300 Units/kg) and Filgrastim (Step 4)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Supportive Care (Step 1)
n=56 participants at risk
Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
|
Erythropoietin (Step 1)
n=53 participants at risk
Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
|
Erythropoietin (Cross-over; Step 2)
n=26 participants at risk
Patients in the supportive care arm who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm. Erythropoietin was administered at 150 units/kg subcutaneously every day.
|
Erythropoietin (150 Units/kg) and Filgrastim (Step 3)
n=31 participants at risk
All patients received erythropoietin alone treatment may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, add filgrastim.
|
Erythropoietin (300 Units/kg) and Filgrastim (Step 4)
n=13 participants at risk
All patients received erythropoietin (150 units/kg) and filgrastim may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, increased their dose of erythropoietin to 300 units/kg.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
5.7%
3/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
2/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
9.7%
3/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
2/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
11.5%
3/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever w/o infection
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
GU adverse event
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Liver
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
15.1%
8/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
2/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac adverse event
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Metabolic
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Coagulation
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
1/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Reproductive system and breast disorders
Impotence
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Other toxicities
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
Other adverse events
| Measure |
Supportive Care (Step 1)
n=56 participants at risk
Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
|
Erythropoietin (Step 1)
n=53 participants at risk
Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
|
Erythropoietin (Cross-over; Step 2)
n=26 participants at risk
Patients in the supportive care arm who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of \>= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm. Erythropoietin was administered at 150 units/kg subcutaneously every day.
|
Erythropoietin (150 Units/kg) and Filgrastim (Step 3)
n=31 participants at risk
All patients received erythropoietin alone treatment may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, add filgrastim.
|
Erythropoietin (300 Units/kg) and Filgrastim (Step 4)
n=13 participants at risk
All patients received erythropoietin (150 units/kg) and filgrastim may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, increased their dose of erythropoietin to 300 units/kg.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
5.7%
3/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
2/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
15.1%
8/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
15.4%
2/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Renal and urinary disorders
GU adverse event
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
11.3%
6/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
1/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
17.0%
9/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
19.2%
5/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.5%
4/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
2/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
1.8%
1/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
18.9%
10/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
11.5%
3/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
5.7%
3/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
1/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Liver
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
9.4%
5/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
19.4%
6/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.8%
1/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.5%
4/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
2/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
9.7%
3/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
23.1%
3/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Skin and subcutaneous tissue disorders
Skin
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
18.9%
10/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
11.5%
3/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Investigations
Weight loss
|
1.8%
1/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
5.7%
3/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
11.5%
3/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
5.7%
3/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-clinical
|
1.8%
1/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
20.8%
11/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
1/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
11.3%
6/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
11.5%
3/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Epigastric distress
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
9.4%
5/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Edema
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
11.3%
6/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
2/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.5%
4/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
1/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
5.7%
3/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
1/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.2%
1/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fatigue
|
7.1%
4/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
22.6%
12/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
30.8%
8/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
32.3%
10/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
30.8%
4/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Cardiac disorders
Cardiac adverse event
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
15.4%
4/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
2/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
General disorders
Fever w/o infection
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
1/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Nervous system disorders
Neuropathy-psych
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
1.9%
1/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
3.8%
1/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
6.5%
2/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Abdominal cramps
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/56 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/53 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/26 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
0.00%
0/31 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
7.7%
1/13 • Adverse events were reported within 10 days of any reportable events specified in the protocol while on treatment and for 30 days after the end of treatment.
|
Additional Information
Study Statistician
ECOG Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place