Chemoradiation, surgery and adjuvant chemotherapy versus induction chemotherapy followed by chemoradiation and surgery : Long-term results of the Spanish GCR-3 phase II randomized trial
Mené sur 108 patients atteints d'un adénocarcinome dans la partie distale ou dans le tiers moyen du rectum (durée médiane de suivi : 69,5 mois), cet essai de phase II évalue, du point de vue de la toxicité et des taux actuariels de survie sans maladie et de survie globale à 5 ans, l'intérêt d'une chimiothérapie par capécitabine-oxaliplatine avant ou après un traitement comportant une chimioradiothérapie suivie d'une intervention chirurgicale
Background : The primary results of our phase II randomized trial suggested that compared with conventional preoperative chemoradiation (CRT), the addition of chemotherapy (CT) prior to CRT and surgery allows most patients receive their planned treatment with a better toxicity profile without compromising the pathological complete response and complete resection rates. We now report the 5-year outcomes. Patients and methods : Patients with distal or middle third, T3-T4 and/or N+ rectal adenocarcinoma selected by MRI, were randomly assigned to arm A— preoperative CRT followed by surgery and four cycles of postoperative adjuvant capecitabine and oxaliplatin (CAPOX)—or arm B— four cycles of CAPOX followed by CRT and surgery. The following five-year actuarial outcomes were assessed: the cumulative incidence of local relapse (LR) and distant metastases (DM), disease-free (DFS) and overall survival (OS). Results : 108 eligible patients were randomly assigned to arm A (n=52) or arm B (n=56). With a median follow-up of 69.5 months, 5-year DFS was 64% in arm A and 62% in arm B (P=0.85) and 5-year OS was 78% in arm A and 75% in arm B (P=0.64). The 5-year cumulative incidence of LR was 2% and 5% (P= 0.61) and 5-year cumulative incidence of DM was 21% and 23%; (P =0.79) in A and B arms respectively. Conclusion : Both treatment approaches yield similar outcomes. Given the lower acute toxicity and improved compliance with induction CT compared with adjuvant CT, integrating effective systemic therapy prior to CRT and surgery is a promising strategy and should be examined in phase III trials.
Annals of Oncology 2015