Abstract
Data on efficacy and safety of darbepoetin alfa (DA) administered at hemoglobin (Hb) ≤10 g/dL are limited. In this analysis, we examined DA's efficacy and safety in patients with Stage IV cancers and chemotherapy‐induced anemia (CIA) initiated on DA at Hb ≤10 g/dL. Data for patients with Stage IV cancers and CIA and who initiated DA at Hb ≤10 g/dL were extracted from three phase 3 trials identified in a central database of Amgen‐sponsored DA studies in CIA. Efficacy outcomes were assessed by achievement of Hb increases of ≥1 g/dL and ≥2 g/dL and red blood cell (RBC) or whole blood transfusion requirements. Data were analyzed for all patients with baseline Hb ≤10 g/dL, and by the subgroups of patients with baseline Hb ≥9 to ≤10 g/dL versus <9 g/dL. Crude and Kaplan–Meier proportions of patients who experienced each outcome and time (days) to each outcome were summarized by treatment. Meta‐analysis (fixed‐effects inverse‐variance model) was performed to compare outcomes for DA versus placebo. Safety was assessed by occurrence of adverse events. Data from 213 patients were analyzed: DA, n = 115; placebo, n = 98. More patients in the DA versus the placebo subgroup achieved Hb increase of ≥1 g/dL (72% vs. 36%; HR: 2.92, 95% CI: 1.95, 4.39) and ≥2 g/dL (44% vs. 18%; HR: 2.98, 95% CI: 1.71, 5.21) during the first 12 treatment weeks. Median times to Hb increase of ≥1 g/dL and ≥2 g/dL were 36 days and 78 days for DA, respectively. RBC or whole blood transfusions were less common in patients in the DA versus the placebo subgroup (24% vs. 45%; HR: 0.44, 95% CI: 0.27, 0.73). No new safety issues were reported. Our results confirm that DA use in patients with Stage IV cancer and CIA is more effective than placebo at increasing Hb levels and at reducing transfusion needs when DA treatment is initiated at Hb ≤10 g/dL.
Highlights
Patients with cancer who are treated with myelosuppressive chemotherapy often develop chemotherapy-induced anemia (CIA) [1, 2]
CIA often leads to the need for blood transfusion, which is associated with a range of challenges that include ensuring safety of the blood supply, limited availability of suitable blood, inconvenience to both patients and healthcare professionals, and associated costs [3]
No studies have evaluated the efficacy of darbepoetin alfa (DA) when initiated at Hb ≤10 g/dL in patients with advanced disease and CIA, to meet the limitations of use for DA in the US; that DA is not for use in patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure [4]. In this retrospective subgroup analysis of clinical trial data, we examined the efficacy and safety of DA when administered at baseline Hb ≤10 g/dL in patients with Stage IV cancer
Summary
Patients with cancer who are treated with myelosuppressive chemotherapy often develop chemotherapy-induced anemia (CIA) [1, 2]. Erythropoiesis- stimulating agents (ESAs) such as darbepoetin alfa (DA) are among treatments that can increase serum hemoglobin (Hb) concentrations and thereby reduce the need for blood transfusions [3], providing benefit to patients and healthcare systems. The US FDA updated DA’s prescribing information, decreasing the Hb treatment initiation threshold to 12 g/dL, respectively [5]
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