Wakelee Heather A, Wang Wei, Schiller Joan H, Langer Corey J, Sandler Alan B, Belani Chandra P, Johnson David H
Department of Medicine, Division of Oncology, Stanford University, Stanford, CA 94305-5826, USA.
J Thorac Oncol. 2006 Jun;1(5):441-6.
Previous data suggest that women may live longer with advanced non-small cell lung cancer (NSCLC) than men. We evaluated whether sex affected survival in the Eastern Cooperative Oncology Group (ECOG) E1594 trial. E1594 randomized patients with advanced NSCLC to one of four platinum doublets and found that all four regimens had comparable efficacy.
Patients in the E1594 database were divided into male and female cohorts; response and survival were calculated separately for each cohort. Known prognostic factors and differences in toxicity profiles were compared between the two cohorts.
All 1157 eligible patients (431 women, 726 men) from E1594 were included in this analysis. There was no statistically significant difference in performance status, weight loss of >10%, stage, or incidence of brain metastases between women and men. Response rates were similar (19% for both; P = 0.15). The median survival time for women, however, was significantly longer at 9.2 months (95% CI, 8.1-10.4 months) versus only 7.3 months for men (95% CI, 6.8-8.0 months) (P = 0.004 log-rank test). Toxicity was generally greater in women than in men.
Women in ECOG 1594 had a 1.9-month statistically significant improvement in median survival compared with men, despite similar response rates and greater toxicity and no difference in other known prognostic factors. These data strongly support the significance of sex as a separate prognostic factor in advanced NSCLC and emphasize the importance of sex as a stratification factor in future phase III NSCLC trials.
既往数据表明，患有晚期非小细胞肺癌（NSCLC）的女性可能比男性存活时间更长。我们在东部肿瘤协作组（ECOG）E1594试验中评估了性别是否会影响生存情况。E1594试验将晚期NSCLC患者随机分为四种含铂双药联合方案之一，发现所有四种方案疗效相当。
将E1594数据库中的患者分为男性和女性队列；分别计算每个队列的缓解率和生存率。比较两个队列之间已知的预后因素和毒性特征差异。
E1594试验的所有1157例符合条件的患者（431例女性，726例男性）均纳入本分析。女性和男性在体能状态、体重减轻>10%、分期或脑转移发生率方面无统计学显著差异。缓解率相似（均为19%；P = 0.15）。然而，女性的中位生存时间显著更长，为9.2个月（95%CI，8.1 - 10.4个月），而男性仅为7.3个月（95%CI，6.8 - 8.0个月）（对数秩检验P = 0.004）。女性的毒性一般比男性更大。
在ECOG 1594试验中，尽管缓解率相似、毒性更大且其他已知预后因素无差异，但女性的中位生存时间比男性有1.9个月的统计学显著改善。这些数据有力地支持了性别作为晚期NSCLC独立预后因素的重要性，并强调了性别作为未来III期NSCLC试验分层因素的重要性。
