The primary objective of this study was to compare the effectiveness of darbopoetin alfa to placebo in the treatment of anemia in adults with lung cancer receiving multicycle platinum-containing chemotherapy, by assessing the percentage of participants who received red blood cell (RBC) transfusions during weeks 5-12 inclusive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
320
Administered by subcutaneous injection once a week
Placebo matching to darbopoetin alfa administered by subcutaneous injection once a week.
Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12
Time frame: Weeks 5 to 12
Time to First Red Blood Cell Transfusion During Weeks 5 to 12
The number of days from the first day of study week 5 (day 29) to the first administration of a RBC transfusion during the Treatment Phase that occurs on or after day 29.
Time frame: Week 5 to week 12
Percentage of Participants with a Hemoglobin Response by Week 12
Hemoglobin Response was defined as an increase in hemoglobin of ≥ 2.0 g/dL over baseline hemoglobin in the absence of any RBC transfusions during the preceding 28 days.
Time frame: 12 weeks
Time to Hemoglobin Response
The number of days from the first administration of study drug to the first occurrence of a hemoglobin response.
Time frame: 12 weeks
Percentage of Participants who Achieved a Sustained Hemoglobin Response by Week 12
Sustained hemoglobin response was defined as in increase in hemoglobin of ≥ 2.0 g/dL over baseline hemoglobin sustained for at least 28 days or until the end of the Treatment Phase. This increase must have occurred in the absence of RBC transfusions during the period of sustained response and the preceding 28 days.
Time frame: 12 weeks
Time to Sustained Hemoglobin Response
The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin response.
Time frame: 12 weeks
Percentage of Participants who Achieved a Hemoglobin Correction by Week 12
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Hemoglobin correction was defined as a hemoglobin value of ≥ 12.0 g/dL that occurred in the absence of RBC transfusions during the preceding 28 days.
Time frame: 12 weeks
Percentage of Participants who Achieved a Sustained Hemoglobin Correction by Week 12
Sustained hemoglobin correction was defined as a hemoglobin value of ≥ 12.0 g/dL that was sustained for at least 28 days or until the end of the Treatment Phase. This must have occurred in the absence of RBC transfusions during the period of sustained correction and the preceding 28 days.
Time frame: 12 weeks
Time to Hemoglobin Correction
The number of days from the first administration of study drug to the first occurrence of a hemoglobin correction.
Time frame: 12 weeks
Time to Sustained Hemoglobin Correction
The number of days from the first administration of study drug to the first occurrence of a sustained hemoglobin correction.
Time frame: 12 weeks
Change from Baseline in Hemoglobin at Week 12
Time frame: Baseline and week 12
Percentage of Participants who Received a Red Blood Cell Transfusion During Weeks 1 to 4, 5 to 8, and 9 to 12
Time frame: Weeks 1 to 4, 5 to 8, and 9 to 12
Number of Standard Units of RBCs Transfused During Weeks 5 to 12
Time frame: Weeks 5 to 12
Number of Days with RBC Transfusions During Weeks 5 to 12
Time frame: Weeks 5 to 12
Change from Baseline in the Functional Assessment of Cancer Therapy (FACT)-Anemia Subscales at Week 12
The FACT-anemia is a 47-item questionnaire to assess specific quality of life concerns related to anemia and fatigue in cancer patients.
Time frame: Baseline and week 12
Number of Participants with Adverse Events
Time frame: 16 weeks