PMID- 20354457 OWN - NLM STAT- MEDLINE DCOM- 20100812 LR - 20100427 IS - 1556-1380 (Electronic) IS - 1556-0864 (Linking) VI - 5 IP - 5 DP - 2010 May TI - The influence of sex on efficacy, adverse events, quality of life, and delivery of treatment in National Cancer Institute of Canada Clinical Trials Group non-small cell lung cancer chemotherapy trials. PG - 640-8 LID - 10.1097/JTO.0b013e3181d40a1b [doi] AB - BACKGROUND: Female sex is a favorable prognostic factor in lung cancer. In small-cell lung cancer, women have been shown to experience greater toxicity from chemotherapy, but there are few studies of sex-related toxicity in non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: This retrospective analysis evaluated the effect of sex on efficacy, adverse events (AEs), dose intensity (DI), and quality of life (QoL) in three phase III NSCLC trials conducted by the National Cancer Institute of Canada Clinical Trials Group; BR.10 (adjuvant chemotherapy), BR.14, and BR.18 (first-line advanced disease). Only patients with National Cancer Institute of Canada Clinical Trials Group data were included, and patients in the BR.10 observation arm were excluded. RESULTS: Of 1,108 patients analyzed, 29% were female. On study entry, women were less likely to be overweight or obese (40% versus 51%, p < 0.0001), more likely to have adenocarcinoma (70% versus 44%, p < 0.0001), and less likely to be anemic at baseline (29% versus 55%, p < 0.0001) or have medical comorbidities. There were no significant differences in response rate to chemotherapy (27% versus 31%, p = 0.44 [excluding BR.10]), grade 3 or 4 AEs, DI, or QoL between sexes, although women reported more nausea and vomiting of any grade (77% versus 66%, p = 0.0004). In multivariate analysis, women had longer progression-free survival than men (hazard ratio 0.83, 95% confidence interval 0.71-0.97, p = 0.02) but not overall survival (hazard ratio 0.89, 95% confidence interval 0.75-1.05, p = 0.17). CONCLUSION: Women demonstrate modestly longer progression-free survival than men in chemotherapy-treated NSCLC, with no differences observed in response rates, serious AEs, or QoL. FAU - Wheatley-Price, Paul AU - Wheatley-Price P AD - Princess Margaret Hospital/University Health Network, University of Toronto, Toronto, Canada. pwheatleyprice@toh.on.ca FAU - Le Maitre, Aurelie AU - Le Maitre A FAU - Ding, Keyue AU - Ding K FAU - Leighl, Natasha AU - Leighl N FAU - Hirsh, Vera AU - Hirsh V FAU - Seymour, Lesley AU - Seymour L FAU - Bezjak, Andrea AU - Bezjak A FAU - Shepherd, Frances A AU - Shepherd FA CN - NCIC Clinical Trials Group LA - eng PT - Journal Article PL - United States TA - J Thorac Oncol JT - Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer JID - 101274235 SB - IM MH - Adenocarcinoma/drug therapy/*mortality/pathology MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Canada MH - Carcinoma, Non-Small-Cell Lung/drug therapy/*mortality/pathology MH - Carcinoma, Squamous Cell/drug therapy/*mortality/pathology MH - Chemotherapy, Adjuvant MH - Clinical Trials, Phase III as Topic MH - Female MH - Humans MH - Lung Neoplasms/*mortality/pathology/therapy MH - Male MH - Neoplasm Staging MH - *Quality of Life MH - Randomized Controlled Trials as Topic MH - Retrospective Studies MH - Sex Factors MH - Treatment Outcome EDAT- 2010/04/01 06:00 MHDA- 2010/08/13 06:00 CRDT- 2010/04/01 06:00 PHST- 2010/04/01 06:00 [entrez] PHST- 2010/04/01 06:00 [pubmed] PHST- 2010/08/13 06:00 [medline] AID - S1556-0864(15)32137-7 [pii] AID - 10.1097/JTO.0b013e3181d40a1b [doi] PST - ppublish SO - J Thorac Oncol. 2010 May;5(5):640-8. doi: 10.1097/JTO.0b013e3181d40a1b.