The influence of sex on efficacy, toxicity and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) non-small cell lung cancer (NSCLC) chemotherapy trials

8054 Background: Outcomes in lung cancer may differ by sex, with some studies reporting longer survival in women. Increased chemotherapy (CT) toxicity has been reported in women with small cell lung-cancer. We investigated the influence of sex on efficacy, toxicity, quality of life (QoL) and dose-delivery in NSCLC. Methods: This is a pooled analysis of three NCIC CTG phase III clinical trials: BR.10 (Stage I/II: adjuvant vinorelbine/cisplatin vs. observation), BR.14 (Stage IIIB/IV: vinorelbine/gemcitabine vs. gemcitabine/cisplatin or vinorelbine/cisplatin) and BR.18 (Stage IIIB/IV: carboplatin/paclitaxel plus BMS 275291 or placebo). Endpoints included overall survival (OS), progression free survival (PFS), response rate (BR.14 and BR.18 only), QoL, dose intensity (DI) and toxicity. Results: Of 1090 patients who received chemotherapy, 320 (29%) were women. At entry, women were more likely to have adenocarcinoma (70% vs. 44%, p<0.0001), be normal or underweight (60% vs. 49%, p<0.0001), and less likely to ha...