Are we already in the era of total neoadjuvant treatment for rectal cancer?
Mené en France entre 2012 et 2017 sur 461 patients atteints d'un adénocarcinome rectal de stade cT3 ou cT4 M0 (âge : 18-75 ans ; durée médiane de suivi : 46,5 mois), cet essai randomisé multicentrique de phase III évalue l'intérêt, du point de vue de la survie sans maladie à 3 ans, d'ajouter une chimiothérapie néoadjuvante avant la chimioradiothérapie préopératoire
The pace of change in rectal cancer treatment has accelerated. In the past 5 years, a watch-and-wait strategy in patients with complete clinical response after radiotherapy has been accepted by many as a breakthrough, and currently it is believed by some experts that the total neoadjuvant treatment era has begun. In this issue of The Lancet Oncology, Thierry Conroy and colleagues 1 provide evidence supporting this belief. In their UNICANCER-PRODIGE-23 phase 3 randomised, controlled trial (n=461), total neoadjuvant treatment (neoadjuvant chemotherapy consisting of oxaliplatin, irinotecan, leucovorin, and fluorouracil given for 3 months followed by chemoradiotherapy) combined with surgery and adjuvant chemotherapy given for 3 months was compared with standard-of-care treatment (neoadjuvant chemoradiotherapy combined with surgery and adjuvant chemoradiotherapy given for 6 months). At a median follow-up of about 4 years, 3-year disease-free survival rates were significantly higher in the neoadjuvant chemotherapy group (76%) than in the standard-of-care group (69%; hazard ratio 0·69, 95% CI 0·49–0·97; p=0·034), attributed to a decreased rate of distant metastases. However, this benefit did not translate to a significant gain in overall survival (p=0·077). Pathological complete response rate was also significantly higher in the neoadjuvant chemotherapy group (p<0·0001). Grade 3–4 acute toxic effects occurred in 46% of patients during neoadjuvant chemotherapy. Neoadjuvant chemotherapy was better tolerated than adjuvant chemotherapy.
The Lancet Oncology , commentaire, 2020