Abstract
BackgroundChemotherapy-induced anemia (CIA) is responsive to treatment with erythropoiesis-stimulating agents (ESAs) such as darbepoetin alfa. Administration of ESAs on a synchronous schedule with chemotherapy administration could benefit patients by reducing clinic visits and potentially enhancing on-time chemotherapy delivery.MethodsThis phase 2, 25-week, open-label study evaluated the noninferiority of darbepoetin alfa administered weekly vs. as an extended dosing schedule (every 2 or 3 weeks) in patients with CIA. Patients were randomized 1:1 to an extended dosing schedule (EDS: darbepoetin alfa 300 μg Q2W if chemotherapy was QW, Q2W, or Q4W or darbepoetin alfa 500 μg Q3W if chemotherapy was Q3W) or weekly (150 μg QW regardless of chemotherapy schedule). Stratification factors included chemotherapy cycle length, screening hemoglobin (<10 g/dL vs. ≥10 g/dL), and tumor type (lung/gynecological vs. other nonmyeloid malignancies). The primary endpoint was change in hemoglobin from baseline to Week 13.ResultsSeven hundred fifty-two patients (374 QW patients; 378 EDS patients) received ≥1 dose of darbepoetin alfa and were included in the analysis. Demographics and disease state were similar between groups. Seventy-one percent of patients in the EDS group and 76% in the QW group achieved the target hemoglobin of ≥11.0 g/dL. There was a minimal difference in the primary endpoint of mean change in hemoglobin (baseline to Week 13) between the QW and the EDS groups (-0.04 g/dL; 95% confidence interval: -0.26, 0.17 g/dL). The upper limit of the 95% confidence interval was less than the prespecified limit of <0.75 g/dL, supporting noninferiority of the EDS dosing schedule. Reported adverse events were similar between groups. A slight increase in transfusions was reported in the QW group.ConclusionDarbepoetin alfa, when administered synchronously with chemotherapy, on an EDS appears to be similarly efficacious to darbepoetin alfa weekly dosing with no unexpected adverse events. This study provides prospective data on how multiple dosing regimens available with darbepoetin alfa can be synchronized with chemotherapy administered across a range of dosing schedules.Trial registrationClinicalTrials.gov Identifier NCT00144131.
Highlights
Chemotherapy-induced anemia (CIA) is responsive to treatment with erythropoiesis-stimulating agents (ESAs) such as darbepoetin alfa
Of patients randomized but not receiving study drug (8 for extended dosing schedule (EDS), 10 for QW), the most common reasons for not receiving study drug were that the patient either delayed or did not have chemotherapy (5 patients) or withdrew consent (4 patients), with a variety of reasons for the remaining 9 patients
Both EDS and QW dosing schedules were well tolerated, with similar safety profiles. These results suggest that darbepoetin alfa can be administered QW, Q2W, or Q3W for the treatment of CIA in patients with nonmyeloid malignancies, allowing synchronization with a variety of chemotherapy regimens
Summary
Chemotherapy-induced anemia (CIA) is responsive to treatment with erythropoiesis-stimulating agents (ESAs) such as darbepoetin alfa. Two US medication-use evaluation studies, utilizing retrospective chart analyses, have shown that an unindicated initial dose of 200 μg every two weeks (Q2W) was the most common dosing choice by physicians at hospital and community oncology centers in these two studies [7,8]. This alternate extended dosing regimen most likely arose because many common chemotherapy regimens progress on a similar Q2W schedule; this darbepoetin alfa regimen of 200 μg Q2W may provide greater patient convenience and enhance adherence to Q2W chemotherapy regimens by reducing the number of patient visits
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