BMC Cancer Research article Eligibility of patients with advanced non-small cell lung cancer for phase III chemotherapy trials Janette Vardy*1,2,3, Ryan Dadasovich1,2,3, Philip Beale1,2,3, Michael Boyer1,2,3 and Stephen J Clarke1,2,3 BioMed Central Open Access Address: 1Sydney Cancer Centre, Concord Repatriation General Hospital and Royal Prince Alfred Hospital, Sydney, NSW, Australia, 2Sydney Cancer Centre, Concord Repatriation General Hospital, Hospital Rd, Concord, NSW, 2139 Australia and 3Sydney Cancer Centre, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, 2050, NSW, Australia Email: Janette Vardy* - jvardy@med.usyd.edu.au; Ryan Dadasovich - ryan.dadasovitch@gmp.med.usyd.edu.au; Philip Beale - Philip.beale@sswahs.nsw.gov.au; Michael Boyer - Michael.boyer@sswahs.nsw.gov.au; Stephen J Clarke - sclarke@med.usyd.edu.au * Corresponding author Published: 29 April 2009 BMC Cancer 2009, 9:130 doi:10.1186/1471-2407-9-130 This article is available from: http://www.biomedcentral.com/1471-2407/9/130 Received: 5 December 2008 Accepted: 29 April 2009 © 2009 Vardy et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract 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 ≥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. Background There is level one evidence that patients with stage IIIB and IV non-small cell lung cancer (NSCLC) and good per- formance status benefit from chemotherapy, both in terms of survival and improved quality of life. A meta- analysis by the Non-Small Cell Lung Cancer Collaborative Group, comparing best supportive care (BSC) with BSC and chemotherapy reported a 27% reduction in the risk of death (p < 0.0001), with an increase in median survival of 1.5 months, in patients receiving cisplatin-based chemo- therapy[1]. A phase III study randomising patients with stage IIIB (pleural effusion) or IV NSCLC to BSC or BSC and chemotherapy with mitomycin C, ifosfamide and cis- platin (MIC2), found a median survival of 6.7 months in Page 1 of 6 (page number not for citation purposes)