Crawford Jeffrey, Robert Francisco, Perry Michael C, Belani Chandra, Williams Denise
Duke Medical Center, Durham, NC 27710, USA.
J Thorac Oncol. 2007 Mar;2(3):210-20. doi: 10.1097/JTO.0b013e318031cd9a.
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).
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.
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.
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.
本研究通过生活质量（QOL）、血红蛋白（Hb）、输血发生率、肿瘤反应和生存率，评估了初治的晚期非小细胞肺癌（NSCLC）患者每周一次（QW）使用促红细胞生成素α的安全性/疗效。
计划接受至少8周一线化疗、Hb≥11至＜15g/dl的IIIB/IV期NSCLC患者被随机分为两组，一组在化疗开始时皮下注射40000U促红细胞生成素α（立即给药组），另一组除非Hb降至≤10g/dl否则不使用促红细胞生成素α（延迟给药组）。主要疗效变量是立即干预组与延迟干预组生活质量的变化。目标入组人数为320例患者。
由于入组缓慢，研究提前终止；在入组的216例患者中，211例可进行疗效评估。立即给药组的Hb得以维持，而延迟给药组的Hb下降（最终值分别为12.9g/dl和11.6g/dl）。从数量上看，立即给药组需要输血的患者比延迟给药组少。两组的平均生活质量评分从基线到最终测量均略有下降，组间差异无统计学意义。两组的肿瘤反应和中位总生存期相似。促红细胞生成素α耐受性良好，两组的血栓血管事件发生率相似。
对于晚期NSCLC患者，在化疗开始时立即皮下注射40000U QW的促红细胞生成素α耐受性良好，能有效维持Hb水平，与延迟使用促红细胞生成素α相比，输血发生率降低。总体生活质量评分高于该人群的典型水平，两组在治疗期间均略有下降。两组的总生存期相似，没有证据表明早期使用促红细胞生成素α干预有负面影响。
