Abstracts of the 17th MASCC International Symposium Geneva, Switzerland, - June 30 - July 2, 2005

Abstract

Anemia is common in cancer patients with chemotherapyinduced anemia (CIA) and contributes significantly to a reduced health-related quality of life. Since chemotherapy is typically administered every 3 weeks (Q3W), administration of darbepoetin alfa (DA) Q3W may enable the synchronization of anemia therapy with chemotherapy. This multicenter, 16 week study of patients with CIA evaluated the effectiveness of DA 300 mcg Q3W in achieving and maintaining hemoglobin (Hb) levels within the range recommended by evidence-based guidelines (11-13 g/dL). This interim analysis includes 634 patients who could have completed 16 weeks of treatment and received at least one dose of DA. Most patients were female (61%) and white (81%) with a median age of 64 years. The mean (95% CL) change in Hb for patients with baseline Hb < 10 g/dL (mean [SD] = 9.3 407 Receiving Multicycle Chemotherapy: Results of a Randomized, Double-Blind, Active-Controlled Trial.Chemotherapy-induced anemia (CIA) is associated with a significant risk of transfusions and debilitating fatigue. Darbepoetin alfa (Aranesp ® ; DA) is licensed in Europe for the treatment of CIA using either once weekly (QW) or Q3W administration. The Q3W schedule is convenient because it can be synchronized with many chemotherapy regimens, resulting in fewer visits and reduced burden to patients. This study evaluated the comparability (non-inferiority) of a fixed starting dose of 500 mcg Q3W with 2.25 mcg/kg QW DA, with respect to efficacy and safety. This was a randomized, double-blind, double-dummy, active-controlled phase 3 study in 110 European centers. Eligible subjects were ≥18 years of age, anemic (hemoglobin [Hb]<11g/dL), and had a nonmyeloid malignancy with ≥12 weeks of planned chemotherapy. Patients were randomized 1:1 to Q3W or QW DA for 15 weeks. The primary endpoint was incidence of transfusions from week 5 to end of treatment phase. Noninferiority was determined if the 95% confidence limit (CL) of the difference in transfusions between groups did not exceed a pre-specified margin based on studies of DA 2.25 mcg/kg. Secondary endpoints included change in Hb and FACT-Fatigue, and achievement of Hb ≥11g/dL. Analyses were based on the set of patients who received ≥1 dose of study medication. 705 patients were randomized; 672 were analyzed for the primary endpoint. Demographic characteristics were similar between groups. Adjusting for stratification factors, transfusion incidence rates were 19% (Q3W) and 28% (QW) (difference -6.7% [95% CL: -13.2, -0.2]). Changes in Hb and FACTFatigue were similar for both groups. Proportions of patients achieving Hb ≥11g/dL were 73% (Q3W) and 72% (QW). Median numbers of doses were five (Q3W) and 14 (QW). DA 500 mcg Q3W was well tolerated with no differences in toxicities or thrombotic events between groups. The Q3W regimen was comparable (non-inferior) to QW. These data demonstrate effective anemia management with less frequent injections of DA. 02-005A Comparative, Randomized, Open-Label Study to Evaluate the Effectiveness of Every-2-Week...