Darbepoetin Alfa (DA) - Pattern of Use and Outcomes in Adult Patients with Non-Myeloid Malignancies and Chemotherapy-Induced Anemia: A French Observational Study.

INTRODUCTION: DA is widely used to treat anemia in patients undergoing chemotherapy (CT) for non-myeloid malignancies. Three years after the commercialization of DA in France, a study of the pattern of DA use in daily practice was conducted in this population.

METHODS: A nationwide, retrospective observational study of DA use and patient outcomes was conducted in 239 centers between September 2004 and May 2005. Adult patients with non-myeloid malignancies, who had received DA for CT-induced anemia for at least three 3- or 4-weekly or at least five 2-weekly CT cycles (min. 9–12 weeks) were studied. Response was defined as hemoglobin (Hb) ≥ 12g/dL or a Hb increase of at least 2 g/dL from baseline to week 6/8. In addition, the proportion of patients achieving a Hb level of ≥ 11 g/dL as suggested by NCCN guidelines was assessed. Hb levels were evaluated at baseline, week 3 and week 6 (CT cycles of 21 days) or week 4 and week 8 (CT cycles of 15 or 28 days).

RESULTS: Of 2017 patients recruited, 1865 (92.5%) were evaluable at week 6 or 8. Analyses were conducted on the evaluable patient population. A total of 51% were female and the mean age was 62.5 years [range: 18–96 years]. The most common tumor types were non-myeloid hematological malignancies (25%), lung cancer (21%), breast cancer (16%) and gastrointestinal tumors (14%). A total of 37% of centers were University hospitals, 30% public hospitals, 21% private hospitals and 11% specialized cancer centers. Baseline mean Hb level was 10g/dL [range 5–16.6 g/dL]. A total of 843 patients at week 0 (45.4%) had a Hb <10g/dL. The first DA dose was administered to 40% of patients at the first CT cycle and to 60% of patients at subsequent cycles. At week 6/8, 707 patients (38%) had a Hb ≥ 12 g/dL and 1096 patients (58.8%) had a Hb ≥ 11 g/dL. During the study period, between week 0 and week 6/8, 272 pts (15.9%) received RBC transfusions.

CONCLUSIONS: Despite the very short follow-up of 6/8 weeks, almost 40% of the patients achieved a Hb ≥ 12 g/dL. More importantly, the proportion of patients reaching a Hb level within the range recommended by NCCN guidelines (≥ 11 g/dL) at this short follow-up was around 60%, which is comparable to results published in other trials of DA.