Efficacy of darbepoetin alfa in colorectal cancer patients: Data from the CHOICE study.

Abstract

552 Background: To evaluate adherence to hemoglobin (Hb) values recommended by the updated European (EU) product label for darbepoetin alfa (DA) and describe hematological response in patients (pts) receiving DA for the treatment of chemotherapy-induced anemia in clinical practice. Data of colorectal cancer (CRC) pts are reported. Methods: A prospective, multicenter, observational study assessed DA use in CRC, breast, ovarian and lung cancer pts in 11 EU countries. Data (such as Hb levels and need for red blood cell (RBC) transfusions) were extracted from medical records on an electronic case report form. Results: This interim analysis included 1,290 pts. 192 pts had CRC: 1% had stage I, 6% stage II, 18% stage III and 75% stage IV cancer. The most-used chemotherapy regimens were 5-fluoruracil or capecitabine (33%), ironotecan- (27%) and oxaliplatin-based (24%). Baseline (BL) Hb values were available for 189 pts; the mean (standard deviation, SD) Hb value at BL was 9.8 (0.8) g/dL; 60% of CRC pts had BL Hb values of <10 g/dL and 90% values of <11 g/dL. Of the 119 pts still on study at week (wk) 9, 60% (95% CI: 51, 68) achieved a Hb level of 10-12 g/dL at wk 9 (primary outcome measure). With increasing BL Hb values, more pts achieved Hb ≥10 g/dL (see table). The mean (SD) Hb at the end of treatment period (EOTP) was 11.0 (1.5) g/dL. The Kaplan-Meier (K-M) % of pts with Hb levels ≥10 g/dL at EOTP was 91% (only pts with BL Hb <10 g/dL included). The K-M % of pts with Hb levels >13 g/dL at EOTP was 10% for pts with BL Hb <10 g/dL. Of pts in the study for ≥29 days after start of DA, the K-M % of pts needing RBC transfusions after wk 5 was 21% at EOTP. No treatment-related adverse drug reactions were reported. Conclusions: Most CRC pts were treated in accordance with the EU product label. The high K-M % of pts with Hb values ≥10 g/dL suggests DA is effective. Hb levels >13 g/dL were rare for pts with BL Hb <10 g/dL. Sponsored by Amgen (Europe) GmbH. [Table: see text] [Table: see text]