Survival of stage IIIB/IV non-small cell lung cancer patients who received chemotherapy but did not participate in clinical trials

This study was designed to compare the outcome of stage IIIB/IV non-small cell lung cancer patients who were treated with chemotherapy but did not participate in clinical trials of first-line chemotherapy with patients that had been treated with three clinical trials during this period. From October 1997 through October 1999, 132 patients (stage IIIB, 31 patients; stage IV, 101 patients) who received at least one dose of chemotherapy but did not participate in first-line chemotherapy trials were included. Response was evaluated in 132 patients. Six (4.5%) achieved a complete response and 32 (24.3%) achieved a partial response, resulting in an overall response rate of 28.8% (95% CI, 21.0-36.6). The median overall survival for all 132 patients was 11 months (95% CI, 9.5-12.5), and the median progression-free survival was 4.2 months (95% CI, 3.4-5.0). The median overall and progression-free survival for patients (N = 129) who participated in one of three clinical trials during the study period was 13.5 months (95% CI, 11.2-15.8) and 5.6 months (95% CI, 4.9-6.0), respectively. There was no significant difference in overall and progression-free survival between patients who did or did not participate in clinical trials (overall survival: P = 0.36; progression-free survival: P = 0.57). Our data suggest that the survival of patients who received chemotherapy but did not participate in clinical trials was similar to patients participated in clinical trials. (c) 2004 Elsevier Ireland Ltd. All rights reserved.