Researchers involved in Amgen’s Aranesp pharmacovigilance program (the 145 Study) have reported that Aranesp® (darbepoetin alfa) has no adverse effect on outcomes of patients with extensive-stage small cell lung cancer (SCLC) receiving platinum-based chemotherapy. The details of this randomized Phase III study were published in the May 10, 2008 issue of the Journal of Clinical Oncology.¹

Chemotherapy-induced anemia can be corrected by the administration of Procrit® or Eprex® (both epoetin alfa) or long-acting Aranesp. Both are approved by the U.S. Food and Drug Administration for this indication. However, there has been concern about the potential for erythropoietins to increase relapse rates due to the presence of erythropoietin receptors on some cancer cells.

The current study involved 600 patients with extensive-stage SCLC who were receiving initial platinum-based chemotherapy. Patients were randomly allocated to receive Aranesp or placebo to correct chemotherapy-induced anemia. The target hemoglobin level was 13 gm/%, and doses were withheld if the hemoglobin was 14 gm/%. Patients receiving Aranesp had consistently higher hemoglobin levels than the control group. In the Aranesp group, 17% received a blood transfusion compared with 39% in the control group.

There were no differences in overall or progression-free survival between the Aranesp and control groups. Embolism/thrombosis occurred in 9% of Aranesp treated patients and 5% of the control patients.

Comments: This reasonably large randomized trial does not show an adverse effect of Aranesp on progression-free survival of patients with extensive-stage SCLC receiving chemotherapy. These data would suggest that Aranesp did not stimulate cancer growth in this setting. However, this study did confirm the increased incidence of thromboembolic events, which did not affect survival.

Related News:

Aranesp® for Chemotherapy Induced Anemia has no Adverse Effect on Survival or Relapse (09/27/2007)

Aranesp® Has No Adverse Effect on Survival or Progression-free Survival when Used to Treat Chemotherapy-induced Anemia in SCLC (9/17/2007)

Reference:

¹ Pirker R, Ramiau RA, Schuette W, et al. Safety and Efficacy of darbepoetin alfa in previously untreated extensive-stage small-cell lung cancer treated with platinum plus etoposide. Journal of Clinical Oncology. 2008;26:2342-2349.