BMC Cancer 2009, 9:130 http://www.biomedcentral.com/1471-2407/9/130 Table 4: Number (%) of Ineligible Patients Based on Trials Exclusion Criteria* E1594 SWOG 9509 Prospective Data Retro-spective Data Entire Cohort Prospective Data Retro-spective Data Entire Cohort N = 100 (%) N = 85 (%) N = 185 (%) N = 100 (%) N = 85 (%) N = 185 (%) * Does not equal 100% due to many patients being excluded on more than one criterion – see Table 3 Performance Status Co-morbidities Previous History of Cancer 12 (12%) Brain Metastases Non Evaluable or Non Measurable Disease Abnormal Blood Parameter Previous Chemotherapy Unable to give Informed Consent 37 (37%) 19 (19%) 14 (14%) 9 (9%) 2 (2%) 2 (2%) 1 (1%) 35 (41%) 31 (36%) 9 (11%) 1 (1%) 1 (1%) 6 (7%) 10 (12%) 3 (3.5%) mented weight loss of greater than 10% within the preced- ing six weeks: of these patients 12 (6%) were eligible for the E1594 trial and 13 (7%) met eligibility criteria for both the SWOG 9509 and TAX 326 trials. Excluding patients with ECOG PS of 2–4 immediately excluded 72 (39%) of our patients with advanced NSCLC. Of those with a performance status of 2, only 15/39 (38%) would have met all the other eligibility criteria for SWOG 9509 or TAX326. Co-morbidities were a major cause of trial ineligibility: 40.5% in SWOG 9509 and 27% in E1594. With approxi- mately 86% of lung cancers in men and 49% in women being current smokers, or having a significant past history of smoking[10], it is not surprising that there is a high rate of co-morbidities, particularly pulmonary (e.g. chronic obstructive pulmonary disease) and cardiovascular dis- ease. In addition 11% of our patients had a past history of a previous malignancy, excluding non-melanoma skin lesions and cervical cancer in situ. A total of 35 (19%) patients were excluded for having non-measurable dis- ease, previous malignancy and/or prior receipt of chemo- therapy. Of these, 24 (69%) remained ineligible on other grounds, and 11 patients were rendered ineligible on these criteria only, and would not necessarily have been restricted from receiving chemotherapy off trial. The major limitation of this study is that it is not popula- tion based. Due to failure of physicians to complete the questionnaire on every new patient presenting to the Syd- ney Cancer Centre with advanced NSCLC, we were not 72 (39%) 50 (27%) 21 (11%) 15 (8%) 10 (5%) 8 (4%) 12 (6.5%) 4 (2%) 37 (37%) 34 (34%) 12 (12%) 14 (14%) 9 (9%) 2 (2%) 2 (2%) 1 (1%) 35 (41%) 41 (48%) 9 (10.5%) 1 (1%) 1 (1%) 7 (8%) 10 (12%) 3 (3.5%) 72 (39%) 75 (40%) 21 (11%) 15 (8%) 10 (5%) 9 (5%) 12 (6.5%) 4 (2%) able to prospectively survey consecutive patients. Exami- nation of our lung cancer data base reveals that it is likely that our study obtained data on 93% of patients who had presented to the Sydney Cancer Centre with advanced NSCLC during the study period; although almost half of the data were obtained retrospectively. However, our study likely underestimates the number of patients that would be excluded from advanced NSCLC trials, as the sickest patients and patients with other co-morbidities are often not referred to a Cancer Centre, but instead are man- aged by their family physician, geriatrician or palliative care services with symptomatic treatment only. It is likely that a true population based study would result in an even smaller percent of patients meeting inclusion criteria. Whilst cisplatin-based chemotherapy regimens have been shown to increase survival and quality of life in patients who are eligible for large clinical trials compared to those treated with best supportive care, we need to recognise limitations in generalisability of results of those trials to the broader population with advanced lung cancer. The median age of our cohort was 68 years, consistent with the median age of presentation of patients with advanced NSCLC, whereas the median age in E1594, SWOG9509 and TAX326 was 61–63 years. It is only recently that we have seen the emergence of studies investigating the effects of chemotherapy in the elderly[11,12], as well as ongoing studies in those with poorer performance status. Conclusion Our study demonstrates that 65–71% of ANSCLC patients presenting to Sydney Cancer Centre, would not have been Page 5 of 6 (page number not for citation purposes)