PMID- 19402889 OWN - NLM STAT- MEDLINE DCOM- 20090918 LR - 20211020 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 9 DP - 2009 Apr 29 TI - Eligibility of patients with advanced non-small cell lung cancer for phase III chemotherapy trials. PG - 130 LID - 10.1186/1471-2407-9-130 [doi] AB - BACKGROUND: Evidence that chemotherapy improves survival and quality of life in patients with stage IIIB & IV non small cell lung cancer (NSCLC) is based on large randomized controlled trials. The purpose of this study was to determine eligibility of patients with advanced NSCLC for major chemotherapy trials. METHODS: Physicians treating stage IIIB/IV NSCLC at Sydney Cancer Centre assessed patient eligibility for the E1594, SWOG9509 and TAX326 trials for patients presenting from October 2001 to December 2002. A review of the centre's registry was used to obtain missing data. RESULTS: 199 patients with advanced NSCLC were registered during the 14-month period. Characteristics of 100 patients were defined prospectively, 85 retrospectively: 77% males, median age 68 (range 32-88), 64% stage IV disease. Only 35% met trial eligibility for E1594 and 28% for SWOG9509 and TAX326. Common reasons for ineligibility were: co-morbidities 75(40%); ECOG Performance Status >or=2 72(39%); symptomatic brain metastasis 15(8%); and previous cancers 21(11%). Many patients were ineligible by more than one criterion. CONCLUSION: The majority of patients with advanced NSCLC were ineligible for the large chemotherapy trials. The applicability of trial results to advanced lung cancer populations may be limited. Future trials should be conducted in a more representative population. FAU - Vardy, Janette AU - Vardy J AD - Sydney Cancer Centre, Concord Repatriation General Hospital and Royal Prince Alfred Hospital, Sydney, NSW, Australia. jvardy@med.usyd.edu.au FAU - Dadasovich, Ryan AU - Dadasovich R FAU - Beale, Philip AU - Beale P FAU - Boyer, Michael AU - Boyer M FAU - Clarke, Stephen J AU - Clarke SJ LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20090429 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Carcinoma, Non-Small-Cell Lung/*drug therapy MH - Clinical Trials, Phase III as Topic MH - Eligibility Determination/*standards/statistics & numerical data MH - Female MH - Humans MH - Lung Neoplasms/*drug therapy MH - Male MH - Middle Aged MH - Neoplasm Staging MH - *Patient Selection MH - Prospective Studies MH - Randomized Controlled Trials as Topic MH - Registries/statistics & numerical data MH - Retrospective Studies MH - Surveys and Questionnaires PMC - PMC2683856 EDAT- 2009/05/01 09:00 MHDA- 2009/09/19 06:00 PMCR- 2009/04/29 CRDT- 2009/05/01 09:00 PHST- 2008/12/05 00:00 [received] PHST- 2009/04/29 00:00 [accepted] PHST- 2009/05/01 09:00 [entrez] PHST- 2009/05/01 09:00 [pubmed] PHST- 2009/09/19 06:00 [medline] PHST- 2009/04/29 00:00 [pmc-release] AID - 1471-2407-9-130 [pii] AID - 10.1186/1471-2407-9-130 [doi] PST - epublish SO - BMC Cancer. 2009 Apr 29;9:130. doi: 10.1186/1471-2407-9-130.