title: Survival of stage IIIB/IV non-small cell lung cancer patients who received chemotherapy but did not participate in clinical trials.
abstract: 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.
authors.affiliation: Department of Oncology, National Taiwan University Hospital and National Taiwan University College of Medicine, No. 7, Chung-Shan South Rd, Taipei, Taiwan.
authors.forename: Sung-Hsin
authors.initials: SH
authors.lastname: Kuo
authors.forename: Chih-Hsin
authors.initials: CH
authors.lastname: Yang
authors.forename: Chong-Jen
authors.initials: CJ
authors.lastname: Yu
authors.forename: Chiun
authors.initials: C
authors.lastname: Hsu
authors.forename: Ann-Lii
authors.initials: AL
authors.lastname: Cheng
authors.forename: Pan-Chyr
authors.initials: PC
authors.lastname: Yang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology*; D002986:Clinical Trials as Topic; D018450:Disease Progression; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012189:Retrospective Studies; D016019:Survival Analysis