BMC Cancer 2009, 9:130 http://www.biomedcentral.com/1471-2407/9/130 Table 2: Eligibility for E1594 and SWOG9509 Prospective Data N = 100 (%) 61 (61%) 39 (39%) 0 (0%) 66 (66%) 34 (34%) 0 (0%) E1594: Ineligible Eligible Not assessable SWOG 9509 Ineligible Eligible Not assessable ria and would have excluded 50 (27%) patients based on their co-morbidities. (Table 4) Across all studies 21 (11%) patients were excluded due to second malignancies. Fifteen patients were not eligible because of unstable brain metastasis. Some of these patients might have subsequently qualified for inclusion in E1594 after cerebral radiotherapy. Eleven patients would have been excluded from SWOG 9509 on the basis of abnormal blood test results: most commonly elevated creatinine and raised bilirubin. In 16 patients, blood results were not available, as they either hadn't been performed (generally because patients were too unwell to consider chemotherapy) or they were done in private laboratories and not available. For the purposes of determining eligibility these were regarded as being normal. Ten patients were ineligible due to non-measurable dis- ease and twelve patients because they had received prior chemotherapy. Discussion The last decade has seen a shift from studies comparing BSC with chemotherapy in patients with advanced NSCLC, to studies comparing different chemotherapy combina- tions, administered either alone or in combination with molecular targeted agents, most commonly targeted against the epidermal growth factor receptor (EGFR) or vas- cular endothelial growth factor (VEGF). This has resulted in Table 3: Number (%) of Criteria Resulting in Ineligibility for Trials Retrospective Data N = 85 (%) 60 (70.5%) 22 (26%) 3 (3.5%) 66 (78%) 16 (19%) 3 (3.5%) Entire Cohort N = 185 (%) 121 (65%) 61 (33%) 3 (2%) 132 (71%) 50 (27%) 3 (2%) increasingly complex and expensive treatment regimens, and it is important that such therapies be evaluated in the target population. Consequently, we determined whether the patients enrolled in large chemotherapy trials were typ- ical of the lung cancer patients presenting to cancer centres. Eligibility for the newer molecular targeted therapy trials were not included as these were not widely available at our centre at the time of this study; however a second study is in progress to assess this. Of the 3 trials whose inclusion/exclusion criteria were evalu- ated, the ECOG-1594 study had the least restrictive criteria and would have excluded 121 (65%) of our NSCLC patients, whilst a further 3 had insufficient data available to determine their eligibility. Of the 61 (33%) that would have met E1594 eligibility criteria, 7 patients were estimated to have a life expectancy of less than 12 weeks, 4 had severe concomitant pulmonary disease and eight had weight loss of greater than 10% in the 6 weeks prior to assessment. Life expectancy was estimated to be less than 12 weeks in 54 (29%) of patients. This is likely a conservative estimate, as physicians are known to consistently overestimate life expectancy in people with advanced cancer[7], and where life expectancy was not documented we assumed it was greater than 12 weeks. Physicians estimated a life expect- ancy of <12 weeks in 6 patients who met all eligibility crite- ria for E1594, SWOG 9509 and TAX 326. Weight loss is a poor prognostic factor for patients with advanced NSCLC[8,9] Fifty two (28%) patients had docu- No of Criteria Resulting in Ineligibility 1 2 3 4 Prospective Data N = 100 (%) 32 (32%) 22 (22%) 6 (6%) 1 (1%) No of Patients E1594 Retrospective Data N = 85 (%) 38 (45%) 11 (13%) 9 (11%) 2 (2%) Entire Cohort N = 185(%) 71 (38%) 33 (18%) 15 (8%) 3 (2%) * Eligibility for TAX326 is almost identical to SWOG9509 and so is not listed separately No of Patients SWOG9509 Prospective Data Retrospective Data N = 100 (%) N = 85 (%) 34 (34%) 23 (23%) 7 (7%) 2 (2%) 41 (48%) 12 (14%) 11 (13%) 2 (2%) Entire Cohort N = 185 (%) 75 (40.5%) 35 (19%) 18 (10%) 4 (2%) Page 4 of 6 (page number not for citation purposes)