Effects of epoetin alfa on hematologic parameters and quality of life in cancer patients receiving nonplatinum chemotherapy: Results of a randomized,double-blind, placebo-controlled trial

Purpose: This randomized, double-blind, placebo-controlled clinical trial a ssessed the effects of epoetin alfa on transfusion requirements, hematopoie tic parameters, quality of life (QOL), and safety in anemic cancer patients receiving nonplatinum chemotherapy, The study also explored a possible rel ationship between increased hemoglobin and survival. Patients and Methods: Three hundred seventy-five patients with solid or non myeloid hematologic malignancies and hemoglobin levels less than or equal t o 10.5 g/dL, or greater than 10.5 g/dL but less than or equal to 12.0 g/dL after a hemoglobin decrease of greater than or equal to 1.5 g/dL per cycle since starting chemotherapy, were randomized 2:1 to epoetin alfa 150 to 300 IU/kg (n = 251) or placebo (n = 124) three times per week subcutaneously f or 12 to 24 weeks. The primary end point was proportion of patients transfu sed; secondary end points were change in hemoglobin and QOL, The protocol w as amended before unblinding to prospectively collect and assess survival d ata 12 months after the last patient completed the study. Results: Epoetin alfa, compared with placebo, significantly decreased trans fusion requirements (P = .0057) and increased hemoglobin (P < .001), Improv ement of all primary cancer- and anemia-specific QOL domains, including ene rgy level, ability to do daily activities, and fatigue, was significantly ( P <less than> .01) greater for epoetin alfa versus placebo patients. Althou gh the study was not powered for survival as an end point, Kaplan-Meier est imates showed a trend in overall survival favoring epoetin alfa (P = .13, l og-rank test), and Cox regression analysis showed an estimated hazards rati o of 1.309 (P = .052) favoring epoetin alfa, Adverse events were comparable between groups. Conclusion: Epoetin alfa safely and effectively ameliorates anemia and sign ificantly improves QOL in cancer patients receiving nonplatinum chemotherap y, Encouraging results regarding increased survival warrant another trial d esigned to confirm these findings.