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Efficacy and Safety Analysis of Epoetin Alfa in Patients With Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial

From the Forsyth Regional Cancer Center, Winston-Salem, NC; Private practice, Birmingham, AL; Ochsner Cancer Institute, New Orleans, LA; Dial Research Associates, Brentwood, TN; Trinitas Hospital, Elizabeth, NJ; Joan Karnell Cancer Center, PA Hospital, Philadelphia, PA; Berkshire Hematology Oncology, Pittsfield, MA; Eisenhower Army Medical Center, Gordon, GA; and Johnson & Johnson Pharmaceutical Research & Development LLC, Raritan, NJ.

Address reprint requests to Thomas Grote, MD, Forsyth Regional Cancer Center, 1010 Bethesda Court, Winston-Salem, NC 27103; e-mail: tgrote{at}phoa.org

PURPOSE: This randomized, double-blind, placebo-controlled trial (N93-004) evaluated the effects of epoetin alfa on tumor response to chemotherapy and survival in patients with small-cell lung cancer (SCLC).

PATIENTS AND METHODS: Adult patients with hemoglobin 14.5 g/dL starting chemotherapy received epoetin alfa 150 U/kg or placebo subcutaneously 3 times weekly until 3 weeks after completion of chemotherapy. Survival was assessed for 3 years. The primary end point was the proportion of patients with complete or partial response after three chemotherapy cycles.

RESULTS: The trial was terminated prematurely after 224 of a projected 400 patients were accrued. Baseline characteristics were similar between groups. Epoetin alfa and placebo patients (n = 109 and n = 115, respectively) had mean baseline hemoglobin of 12.8 g/dL and 13.0 g/dL, respectively. Overall tumor response was similar between the epoetin alfa and placebo groups after three chemotherapy cycles (72% and 67%, respectively; 95% CI of difference, –6% to 18%) and after completion of chemotherapy (60% and 56%, respectively; 95% CI of difference, –9% to 17%). Epoetin alfa and placebo groups had similar median overall survival (10.5 and 10.4 months, respectively) and overall mortality (91.7% and 87.8%, respectively; hazard ratio, 1.172; 95% CI, 0.887 to 1.549; P = .264). Hemoglobin was maintained in the prechemotherapy range in epoetin alfa patients, but decreased substantially in placebo patients. Fewer epoetin alfa patients than placebo patients required transfusion.

CONCLUSION: These results suggest that in newly diagnosed patients with SCLC epoetin alfa does not affect tumor response to chemotherapy or survival. However, the early trial closure makes these conclusions preliminary.

Supported by Johnson & Johnson LLC.

Presented in part in Grote T, Castillo R, Fishkin E, et al: Effects of early intervention with epoetin alfa in patients with small cell lung cancer (SCLC). Lung Cancer 41:S74,2003 (suppl 2; abstr O-252).

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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