A randomized trial comparing immediate versus delayed treatment of anemia with once-weekly epoetin alfa in patients with non-small cell lung cancer scheduled to receive first-line chemotherapy.

Abstract

INTRODUCTION:

This study evaluated the safety/efficacy of once-weekly (QW) epoetin alfa measured by quality of life (QOL), hemoglobin (Hb), transfusion incidence, tumor response, and survival in patients with chemotherapy-naïve, advanced non-small cell lung cancer (NSCLC).

METHODS:

Stage IIIB/IV NSCLC patients with Hb > or = 11 to < 15 g/dl scheduled for at least 8 weeks of first-line chemotherapy were randomized to subcutaneously receive 40,000 U of epoetin alfa QW at chemotherapy initiation (immediate) or no epoetin alfa unless Hb decreased to < or = 10 g/dl (delayed). The primary efficacy variable was change in QOL for immediate versus delayed intervention. Target accrual was 320 patients.

RESULTS:

The study was terminated early because of slow accrual; of 216 patients enrolled, 211 were evaluable for efficacy. Hb was maintained in the immediate group, but it decreased in the delayed group (12.9 versus 11.6 g/dl final values, respectively). Numerically, fewer immediate patients required transfusions versus delayed patients. Mean QOL scores, modestly declining in both groups from baseline to final measurement, were not significantly different between groups. Tumor response and median overall survival were similar between groups. Epoetin alfa was well tolerated, with a similar thrombovascular event rate between groups.

CONCLUSION:

Epoetin alfa in subcutaneous doses of 40,000 U QW, given immediately at chemotherapy initiation for advanced NSCLC, was well tolerated, and it effectively maintained Hb, leading to a reduced transfusion incidence versus delayed epoetin alfa. Overall QOL scores were higher than typical in this population, decreasing slightly during treatment in both groups. Overall survival was similar between groups, with no evidence of a negative effect by early epoetin alfa intervention.

• Authors: Jeffrey Crawford, Francisco Robert, Michael C Perry, Chandra Belani, Denise Williams, Anemia Prevention in NSCLC Group
• Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer (J Thorac Oncol) Vol. 2 Issue 3 Pg. 210-20 (Mar 2007) ISSN: 1556-1380 [Electronic] United States
• PMID: 17410044 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Hematinics
• Recombinant Proteins
• Erythropoietin
• Epoetin Alfa

Topics

• Aged
• Anemia (drug therapy, etiology)
• Antineoplastic Agents (therapeutic use)
• Carcinoma, Non-Small-Cell Lung (complications, drug therapy, pathology)
• Epoetin Alfa
• Erythropoietin (administration & dosage)
• Female
• Hematinics (administration & dosage)
• Humans
• Lung Neoplasms (complications, drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Staging
• Recombinant Proteins
• Survival Analysis
• Time Factors