Quirt I, Robeson C, Lau C Y, Kovacs M, Burdette-Radoux S, Dolan S, Tang S C, McKenzie M, Couture F
Department of Medical Oncology and Hematology, Princess Margaret Hospital, Toronto, Canada.
J Clin Oncol. 2001 Nov 1;19(21):4126-34. doi: 10.1200/JCO.2001.19.21.4126.
To evaluate efficacy, safety, and quality of life (QOL) changes with epoetin alfa therapy for anemia in patients with nonmyeloid malignancies.
Anemic cancer patients were enrolled onto this prospective, open-label study from 34 centers across Canada. The trial had two cohorts: patients who were and were not receiving chemotherapy during the 16-week study. All patients initially received epoetin alfa 150 IU/kg subcutaneously three times per week. The dose was doubled after 4 weeks for patients who did not experience sufficient response.
Of the 183 patients enrolled in the nonchemotherapy cohort, statistically significant and clinically relevant improvements in QOL were observed with epoetin alfa therapy using both the FACT-An questionnaire and linear analog scale assessment. Hemoglobin levels increased significantly (P <.001; mean increase 2.5 g/dL from baseline to end of study) and these increases were positively correlated with improved QOL and change in Eastern Cooperative Oncology Group (ECOG) scores. There was a significant reduction in the percentage of patients who required blood transfusions. The 218 patients in the chemotherapy cohort also experienced significant improvements in QOL, decreased transfusion use, and increased hemoglobin levels that correlated with QOL improvements and change in ECOG scores. Epoetin alfa was well-tolerated in both cohorts.
Epoetin alfa administered to patients with cancer-related anemia for up to 16 weeks resulted in significantly improved QOL, increased hemoglobin levels, and decreased transfusion use. These benefits were observed in cancer patients who were not receiving chemotherapy as well as those who were.
评估促红细胞生成素α治疗非髓系恶性肿瘤患者贫血的疗效、安全性及生活质量(QOL)变化。
贫血癌症患者纳入了一项来自加拿大34个中心的前瞻性、开放标签研究。该试验有两个队列:在16周研究期间正在接受和未接受化疗的患者。所有患者最初每周皮下注射促红细胞生成素α 150 IU/kg,共三次。4周后,对未获得充分反应的患者,剂量加倍。
在未接受化疗队列的183例患者中,使用FACT-An问卷和线性模拟量表评估,促红细胞生成素α治疗使QOL有统计学显著且临床相关的改善。血红蛋白水平显著升高(P <.001;从基线到研究结束平均升高2.5 g/dL),且这些升高与QOL改善及东部肿瘤协作组(ECOG)评分变化呈正相关。需要输血的患者百分比显著降低。化疗队列中的218例患者在QOL方面也有显著改善,输血使用减少,血红蛋白水平升高,这与QOL改善及ECOG评分变化相关。促红细胞生成素α在两个队列中耐受性良好。
给癌症相关贫血患者使用促红细胞生成素α长达16周可使QOL显著改善、血红蛋白水平升高及输血使用减少。在未接受化疗的癌症患者以及接受化疗的患者中均观察到了这些益处。