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
| Autor: | Timothy Littlewood, Johan W. R. Nortier, E. Bajetta, E. Vercammen, Bernardo Leon Rapoport |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Adolescent Darbepoetin alfa Anemia Placebo-controlled study Antineoplastic Agents Placebo law.invention Placebos Hemoglobins Double-Blind Method Randomized controlled trial law Neoplasms Internal medicine Activities of Daily Living medicine Clinical endpoint Humans Blood Transfusion Erythropoietin Fatigue Aged Aged 80 and over Epoetin beta business.industry Epoetin alfa Middle Aged medicine.disease Survival Analysis Recombinant Proteins Surgery Epoetin Alfa Treatment Outcome Oncology Hematinics Quality of Life Female business medicine.drug |
| Zdroj: | Scopus-Elsevier |
| ISSN: | 1527-7755 0732-183X |
| Popis: | PURPOSE: This randomized, double-blind, placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements, hematopoietic parameters, quality of life (QOL), and safety in anemic cancer patients receiving nonplatinum chemotherapy. The study also explored a possible relationship between increased hemoglobin and survival. PATIENTS AND METHODS: Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels ≤ 10.5 g/dL, or greater than 10.5 g/dL but ≤ 12.0 g/dL after a hemoglobin decrease of ≥ 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 for 12 to 24 weeks. The primary end point was proportion of patients transfused; secondary end points were change in hemoglobin and QOL. The protocol was amended before unblinding to prospectively collect and assess survival data 12 months after the last patient completed the study. RESULTS: Epoetin alfa, compared with placebo, significantly decreased transfusion requirements (P = .0057) and increased hemoglobin (P < .001). Improvement of all primary cancer- and anemia-specific QOL domains, including energy level, ability to do daily activities, and fatigue, was significantly (P < .01) greater for epoetin alfa versus placebo patients. Although the study was not powered for survival as an end point, Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa (P = .13, log-rank test), and Cox regression analysis showed an estimated hazards ratio of 1.309 (P = .052) favoring epoetin alfa. Adverse events were comparable between groups. CONCLUSION: Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy. Encouraging results regarding increased survival warrant another trial designed to confirm these findings. |
| Databáze: | OpenAIRE |
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