Researchers involved in Amgen’s Aranesp pharmacovigilance program (the 145 Study) have reported that Aranesp (darbepoetin alfa) has no adverse effect on the outcomes of patients with extensive stage small cell lung cancer (SCLC) receiving platinum-based chemotherapy. The details of this randomized Phase III study were reported at the 2007 World Conference on Lung Cancer.[1]  

Chemotherapy-induced anemia can be corrected by the administration of Procrit® or Eprex® 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. In a European study involving 351 patients with head and neck cancer, NeoRecormon® (epoetin beta) was found to increase both relapse and death rates.[2] That study involved a different form of erythropoietin and the results have not been confirmed in other studies. A Radiation Therapy Oncology Group study of Procrit in patients with head and neck cancer receiving chemoradiotherapy did not show an increase in relapse rates in epoetin alfa recipients.[3] However, researchers affiliated with the Ontario Oncology Group have reported that anemic patients with NSCLC randomly allocated to receive Eprex or Procrit for disease-related anemia had a shorter median survival than patients receiving a placebo.[4] Recently, there has been concern that erythropoetins could stimulate the growth of breast cancer; one randomized breast cancer study of Eprex vs. placebo was terminated early due to a 6% lower one-year survival in the Eprex group.[5]  

The current study involved 596 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/%.  In the Aranesp group, 17% received a blood transfusion compared with 39% in the control group. Eighty-one percent of Aranesp-treated patients died compared with 84% of control patients. The median survival was 40 weeks for both groups. Thromboembolic events occurred in 22% of Aranesp-treated patients compared with 15% in the control group. 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.

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Related News:

Medicare and Medicaid Guidelines for Epoetin and Darbepoetin for Non-Renal Indications (8/3/2007)

Aranesp® and Epoetin Alfa Do Not Increase Blood Clots in Ovarian Cancer (05/02/2007)

Aranesp® Does Not Increase Relapses in Patients with Lung Cancer or Lymphoproliferative Malignancies (10/19/2005)

Epoetin Alfa May Improve Survival After Chemoradiotherapy for Esophageal Cancer (5/10/2006)

Epoetin Alfa May Decrease Survival in Anemic Patients with NSCLC (3/26/2007)