Early Efficacy End Points in Neoadjuvant Rectal Cancer Trials: Surrogacy Revisited
Cet article examine les conditions pour lesquelles s'avère pertinente l'utilisation de certains critères de jugement de substitution dans les essais cliniques évaluant des traitements néo-adjuvants pour le cancer du rectum
Rectal cancer constitutes one of the prime examples for the success of multimodal treatment. Preoperative fluorouracil (5-FU)-based chemoradiotherapy (CRT) or short-course radiotherapy (SCRT) followed by total mesorectal excision (TME) has substantially reduced locoregional recurrence and, partly, increased disease-free survival (DFS) and overall survival (OS).1,2 Multiple potential combinations of radiotherapy platforms (SCRT, CRT); induction, concurrent, and consolidation chemotherapy (as part of total neoadjuvant treatment [TNT]); neoadjuvant chemotherapy with selected use of SCRT/CRT, as demonstrated in the recently presented PROSPECT trial; adjuvant cytotoxic chemotherapy, different molecular targeted agents, immunotherapeutic agents, and the spectrum of nonoperative management (NOM) to a range of minimal/radical surgical resections; and all their varying combinations, sequences, and intervals have emerged and provide a challenge for research in multimodal rectal cancer treatment.
Journal of Clinical Oncology , article en libre accès, 2022