Demetri G D, Kris M, Wade J, Degos L, Cella D
Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.
J Clin Oncol. 1998 Oct;16(10):3412-25. doi: 10.1200/JCO.1998.16.10.3412.
To evaluate prospectively the effectiveness of epoetin alfa as an adjunct to chemotherapy in patients with cancer based on changes in quality-of-life parameters and hemoglobin levels, and to correlate these changes with antitumor response.
Two thousand three hundred seventy patients with nonmyeloid malignancies who received chemotherapy were enrolled onto this study from 621 US community-based practices. Patients received epoetin alfa 10,000 U three times weekly, which could be increased to 20,000 U three times weekly depending on the hemoglobin response at 4 weeks. Treatment continued for a maximum of 16 weeks in patients who showed evidence of hematologic response.
Two thousand two hundred eighty-nine patients (97%) were eligible for efficacy analyses. Epoetin alfa therapy was associated with improved quality-of-life parameters; these improvements correlated significantly with hemoglobin levels and were independent of tumor response. Provider-reported Karnofsky performance scores did not correlate with the improved quality-of-life changes. Epoetin alfa therapy was also associated with a significant increase in hemoglobin levels and decrease in transfusion use. Tumor type, chemotherapy agent/regimen, prior chemotherapy, baseline hemoglobin level, and baseline erythropoietin level were not predictive of a positive response to treatment. Epoetin alfa was well tolerated.
Epoetin alfa appears to have a beneficial impact on patient-reported functional capacity and quality of life in patients with cancer who received chemotherapy independent of tumor response. Concordantly, epoetin alfa appeared to increase hemoglobin levels and decrease transfusion use. Patients responded across all tumor types. The results suggest that epoetin alfa effectively improves functional outcomes in patients with cancer who receive chemotherapy.
基于生活质量参数和血红蛋白水平的变化,前瞻性评估促红细胞生成素α作为癌症患者化疗辅助药物的有效性,并将这些变化与抗肿瘤反应相关联。
从美国621个社区医疗机构招募了2370例接受化疗的非髓性恶性肿瘤患者参与本研究。患者每周三次接受10,000 U促红细胞生成素α治疗,根据4周时的血红蛋白反应情况,剂量可增至每周三次20,000 U。对有血液学反应证据的患者,治疗最长持续16周。
2289例患者(97%)符合疗效分析条件。促红细胞生成素α治疗与生活质量参数改善相关;这些改善与血红蛋白水平显著相关且独立于肿瘤反应。医生报告的卡氏评分与生活质量改善变化无关。促红细胞生成素α治疗还与血红蛋白水平显著升高及输血使用减少相关。肿瘤类型、化疗药物/方案、既往化疗、基线血红蛋白水平和基线促红细胞生成素水平均不能预测对治疗的阳性反应。促红细胞生成素α耐受性良好。
促红细胞生成素α似乎对接受化疗的癌症患者的患者报告的功能能力和生活质量有有益影响,且独立于肿瘤反应。相应地,促红细胞生成素α似乎能提高血红蛋白水平并减少输血使用。所有肿瘤类型的患者均有反应。结果表明,促红细胞生成素α能有效改善接受化疗的癌症患者的功能结局。