Phase II trial comparing darbepoetin alfa every 3-week versus weekly epoetin alfa for the treatment of chemotherapy-induced anemia

Abstract

e20724 Background: Anemia is common in patients receiving chemotherapy and may adversely affect health-related quality of life. Erthyrpiotic factors darbepoetin alfa (DA) and epoetin alfa (EA) are currently approved for the treatment of anemia in patients with nonmyeloid malignancies who receive chemotherapy. Methods: Forty patients with a diagnosis of nonmyeloid malignancy with 8 weeks of planned chemotherapy, age 18 years, and anemia (hemoglobin 10 g/dL). 20 patients received DA 500 μg every three weeks (Q3W) and the others 20 patients received EA 40,000 units every week (QW) for up to 18 weeks. Treatment was hold at week 6 for nonresponse, which was defined as failure to achieve a hemoglobin increment of at least 2 g/dL above the baseline measurement. Efficacy was assessed by the incidence of RBC transfusion. Results: Forty patients with a diagnosis of nonmyeloid malignancy, the median age was 49 years and 52 years for DA and EA groups respectively, The majority of patients had solid tumors: Common cancer types for (DA - EA) groups were gastrointestinal (8 -5), breast (3–6), lung (3–3), soft tissue sarcoma (2–1), genitourinary (2–1), non-Hodgkin's lymphoma (1–1), multiple myeloma (1–1), Hodgkin's lymphoma (0–1), and metastatic with unknown primary in (1–0) respectively . 75% 0f the patients in both group achieved the target hemoglobin level. Transfusion incidence from week 6 to the end of the treatment phase (the primary end point) was required in 5 patients (25%) in both groups. The side effects reported in this study were thromboembolic in two patients in both groups 10%. Nausea, diarrhea and neutropnia were 25%, 15% and 10% for DA group respectively compare to 20%, 10%, and 15% in AE group respectively. Conclusions: This study demonstrates comparable efficacy and safety of DA 500 μg every three weeks (Q3W) and EA40, 000 units every week (QW). No significant financial relationships to disclose.