title: Survival differences by sex for patients with advanced non-small cell lung cancer on Eastern Cooperative Oncology Group trial 1594.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine, Division of Oncology, Stanford University, Stanford, CA 94305-5826, USA. hwakelee@stanford.edu
authors.forename: Heather A
authors.initials: HA
authors.lastname: Wakelee
authors.forename: Wei
authors.initials: W
authors.lastname: Wang
authors.forename: Joan H
authors.initials: JH
authors.lastname: Schiller
authors.forename: Corey J
authors.initials: CJ
authors.lastname: Langer
authors.forename: Alan B
authors.initials: AB
authors.lastname: Sandler
authors.forename: Chandra P
authors.initials: CP
authors.lastname: Belani
authors.forename: David H
authors.initials: DH
authors.lastname: Johnson
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000401:mortality*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012727:Sex Characteristics; D015431:Weight Loss