Surgery and adjuvant chemotherapy (CT) compared to surgery alone in non-small cell lung cancer (NSCLC): A meta-analysis using individual patient data (IPD) from randomized clinical trials (RCT)

Abstract

7552 Background: A previous IPD meta-analysis (BMJ 1995;311:899) that suggested CT may have a role in the treatment of NSCLC has been updated. This includes RCTs, regimens and outcomes that were not available in 1995. The meta-analysis examines the role of CT in 7 treatment comparisons. Here we report on the effectiveness of surgery plus adjuvant CT compared with surgery alone. Methods: We conducted a systematic search for RCTs followed by the central collection, checking and re-analysis of updated IPD. Results from RCTs were combined using the stratified (by trial) log rank test to calculate individual and pooled hazard ratios (HRs). Previously included RCTs using long-term alkylating agents were excluded from this analysis due to their antiquity. Results: IPD were obtained on 8147 patients from 30 RCTs. 15 RCTs used a cisplatin combination without Tegafur/Tegafur+Uracil (UFT), 8 RCTs used Tegafur/UFT without cisplatin and 7 RCTs used Tegafur/UFT and cisplatin. This represents 95% of all known randomised patients and adds 18 trials and 5835 patients to the 1995 analyses. The results show a highly significant benefit of CT on survival (HR=0.86 95% CI 0.81–0.93, p<0.000001), with an absolute benefit of 4% (from 60% to 64%) at 5 years. Results were similar for recurrence-free survival and time to distant recurrence, but there was a larger effect on time to local recurrence ( Table ). There was no clear difference in effect by type of CT given. There was no clear evidence that any patient subgroup defined by age, sex or histology benefited more or less from CT. There was a suggestion of a trend in effect by stage (p=0.047), this will be explored further. Conclusion: The results demonstrate conclusively and consistently a benefit of adjuvant CT in resected NSCLC, irrespective of the regimen used, the patient subgroup treated or the endpoint assessed, thus providing reliable estimates on which to base future policy and research. [Table: see text] [Table: see text]