ADJUVANT CHEMOTHERAPY FOR LOCALIZED RESECTABLE SOFT-TISSUE SARCOMA OFADULTS - METAANALYSIS OF INDIVIDUAL DATA

Background Individually, randomised trials have not shown conclusively whether adjuvant chemotherapy benefits adult patients with localised resectable soft-tissue sarcoma. Methods A quantitative meta-analysis o f updated data from individual patients from all available randomised trials was carried out to assess whether adjuvant chemotherapy improve s overall survival, recurrence-free survival, and local and distant re currence-free intervals (RFI) and whether chemotherapy is differential ly effective in patients defined by age, sex, disease status at random isation, disease site, histology, grade, tumour size, extent of resect ion, and use of radiotherapy. Findings 1568 patients from 14 trials of doxorubicin-based adjuvant chemotherapy were included (median follow- up 9.4 years). Hazard ratios of 0.73 (95% CI 0.56-0.94, p=0.016) for l ocal RFI, 0.70 (0.57-0.85, p=0.0003) for distant RFI, and 0.75 (0.64-0 .87, p=0.0001) for overall recurrence-free survival, correspond to abs olute benefits from adjuvant chemotherapy of 6% (95% CI 1-10), 10% (5- 15), and 10% (5-15), respectively, at 10 years. For overall survival, the hazard ratio of 0.89 (0.76-1.03) was not significant (p=0.12), but represents an absolute benefit of 4% (1-9) at 10 years. These results were not affected by prespecified changes in the groups of patients a nalysed. There was no consistent evidence that the relative effect of adjuvant chemotherapy differed for any subgroup of patients for any en dpoint. However, the best evidence of an effect of adjuvant chemothera py for survival was seen in patients with sarcomas of the extremities. Interpretation The meta-analysis provides evidence that adjuvant doxo rubicin-based chemotherapy significantly improves the time to local an d distant recurrence and overall recurrence-free survival. There is a trend towards improved overall survival.