Doxorubicin-based adjuvant chemotherapy in soft tissue sarcoma: pooled analysis of two STBSG-EORTC phase III clinical trials
A partir de données portant sur un total de 819 patients atteints d'un sarcome des tissus mous de haut grade et inclus dans deux essais évaluant la doxorubicine en traitement adjuvant (durée médiane de suivi : 8,2 ans), cette étude analyse la survie globale pour différents sous-groupes de patients
Background : The EORTC-STBSG coordinated two large trials of adjuvant chemotherapy(CT) in localized high grade soft tissue sarcoma(STS). Both studies failed to demonstrate any benefit on OS. The aim of the analysis of these two trials was to identify subgroups of patients who may benefit from adjuvant CT. Patients and Methods : Individual patient data from two EORTC trials comparing doxorubicin-based CT to observation only in completely resected STS (large resection, R0/marginal resection, R1) were pooled. Prognostic factors were assessed by univariate and multivariate analysis. Patient outcomes were subsequently compared between the two groups of patients according to each analysed factor. Results : A total of 819 patients had been enrolled with a median follow-up of 8.2 years. Tumor size, high histological grade and R1 resection emerged as independent adverse prognostic factors for RFS and OS. Adjuvant CT is an independent favourable prognostic factor for RFS but not for OS. A significant interaction between benefit of adjuvant CT and age, gender and R1 resection was observed for RFS and OS. Males and patients >40years had a significantly better RFS in the treatment arms, while adjuvant CT was associated with a marginally worse OS in females and patients <40years. Patients with R1 resection had a significantly better RFS and OS favouring adjuvant CT arms. Conclusion : Adjuvant CT is not associated with a better overall survival in young patients or in any pathology subgroup. Poor quality of initial surgery is the most important prognostic and predictive factor for utility of adjuvant CT in STS. Based on these data, we conclude that adjuvant CT for STS remains an investigational procedure and is not a routine standard of care