Chemoradiotherapy versus triplet chemotherapy as initial therapy for T4b esophageal cancer: survival results from a multicenter randomized Phase 2 trial
Mené sur des patients atteints d'un cancer de l'oesophage de stade T4b (durée médiane de suivi : 43,8 mois), cet essai randomisé multicentrique de phase II évalue la non-infériorité, du point de vue de la survie globale à 2 ans, d'une chimioradiothérapie par rapport à un triplet de chimiothérapie en traitement d'induction avant une chirurgie de conversion
Résumé en anglais
Background: We report the long-term results as primary endpoint in a multicentre randomized prospective Phase 2 trial which compared chemoradiotherapy (CRT) and triplet chemotherapy (CT) as the initial therapy for conversion surgery (CS) in T4b esophageal cancer (EC).
Methods: Patients with T4b EC were randomly assigned to the CRT group or CT group as initial treatment. CS was performed if resectable after initial or secondary treatment. The primary endpoint was 2-year overall survival, analysed by intention-to-treat.
Results: The median follow-up period was 43.8 months. The 2-year survival rate was higher in the CRT group (55.1%; 95% CI: 41.1–68.3%) compared to the CT group (34.7%; 95% CI: 22.8–48.9%), although the difference was not significant (P = 0.11). Local and regional lymph node recurrence in patients undergoing R0 resection was significantly higher in the CT group compared to the CRT group (local: 30% versus 8%, respectively, P = 0.03; regional: 37% versus 8%, respectively, P = 0.002).
Conclusions: Upfront CT was not superior to upfront CRT as induction therapy for T4b EC in terms of 2-year survival and was significantly inferior to upfront CRT in terms of local and regional control.
