CHOICE, an international, observational study to examine current practice use of darbepoetin alfa in the management of chemotherapy-induced anaemia

Abstract

Introduction In February 2008, the European product label for darbepoetin alfa (DA) in the treatment of chemotherapy-induced anaemia (CIA) was changed to stipulate target haemoglobin (Hb) values between 10 and 12 g/dL. EORTC guidelines on ESA use state similar Hb target levels. The primary aim of this study is to assess adherence to the recommended Hb target range in patients (pts) receiving DA in routine clinical practice. Methods This prospective, multicenter, observational study evaluated the routine clinical practice use of DA in 11 European countries in pts with various non-myeloid malignancies (breast, colorectal, ovarian and lung cancer) at any time during chemotherapy treatment. Key outcome measures were Hb levels and the requirement for red blood cell (RBC) transfusions. Results 336 (mean±SD age 61.8±10.9 years) out of 1300 pts were included in this interim analysis. 80 pts had breast, 57 colorectal, 131 lung (33 small cell lung and 98 non-small cell lung cancer) and 68 ovarian cancer. 25% and 61% of pts had stage 3 and 4 disease at baseline, respectively. At baseline, 60% of all pts (53% of breast cancer and 62% of lung cancer pts) had a baseline Hb value of At week 9, Hb values for 243 pts (72%) were available. Of these, 136 pts (56%) had Hb levels between 10 and 12 g/dL, 59 pts (24%) had a Hb value > 12 g/dL and for 48 pts (20%), a Hb value below 10 g/dL was reported. The Kaplan-Meier percentage of pts with Hb levels ⩾10 g/dL was 89% (see table). The Kaplan-Meier percentage of pts requiring RBC transfusions from week 5 to end of treatment period was 17% (see table). A median DA dose of 500 μg was administered 3 times (median). Additional efficacy outcomes are presented in the table below. A treatment related non-serious adverse drug reaction (back pain) was reported for one patient only. Table 1Efficacy outcomes Total Breast cancer Lung cancer n (%) 336 (100) 80 (24) 131 (39) Hb (g/dL )at baseline, mean (SD) 9.8 (0.8) 9.9 (0.7) 9.7 (0.9) Hb (g/dL)at EOTP, mean (SD) 10.8 (1.6) 11.2 (1.4) 10.5 (1.7) K-M Hb⩾10 (g/dL) from wk 1 to EOTP, % (95% CI), na 89 (84, 95), 202 91 (82,101), 42 94 (85,102), 81 K-M RBC transfusions from wk 1 to EOTP, % (95% CI), n 26 (20, 31), 336 19 (8, 29), 80 37 (27, 46), 131 K-M RBC transfusions from wk 5 to EOTP, % (95% CI), nb 17 (12, 23), 208 12 (2, 22), 50 24 (14, 35), 72 CI, confidence interval; Hb, haemoglobin; EOTP, end of treatment period; K-M, Kaplan-Meier; RBC, red blood cell; wk, week.aOnly patients with Hb Conclusions This interim analysis suggests that the majority of pts were treated according to the European product label for DA and EORTC guidelines and did not surpass Hb levels of 12 g/dL. Furthermore, only 17% needed RBC transfusions from week 5 to end of treatment period. These data further support the effectiveness of DA for the treatment of pts with CIA. Sponsored by Amgen GmbH.