Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy

作者：Julio García‐Aguilar, Sujata Patil, Marc J. Gollub, Jin K. Kim, Jonathan B. Yuval, Hannah M. Thompson, Floris S. Verheij, Dana M. Omer, Meghan Lee, Richard F. Dunne, Jorge Marcet, Peter A. Cataldo, Blasé N. Polite, Daniel O. Herzig, David Liska, Samuel Oommen, Charles M. Friel, Charles A. Ternent, Andrew L. Coveler, Steven R. Hunt, Anita Gregory, Madhulika G. Varma, Brian L. Bello, Joseph C. Carmichael, John C. Krauss, Ana Gleisner, Philip B. Paty, Martin R. Weiser, Garrett M. Nash, Emmanouil P. Pappou, José G. Guillem, Larissa K. Temple, Iris H. Wei, Maria Widmar, Sabrina T. Lin, Neil H. Segal, Andrea Cercek, Rona Yaeger, J. Joshua Smith, Karyn A. Goodman, Abraham J. Wu, Leonard B. Saltz · 发表于：Journal of Clinical Oncology · 年份：2022 · 被引用次数：977 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Stoma care and complications

PURPOSE: Prospective data on the efficacy of a watch-and-wait strategy to achieve organ preservation in patients with locally advanced rectal cancer treated with total neoadjuvant therapy are limited. METHODS: In this prospective, randomized phase II trial, we assessed the outcomes of 324 patients with stage II or III rectal adenocarcinoma treated with induction chemotherapy followed by chemoradiotherapy (INCT-CRT) or chemoradiotherapy followed by consolidation chemotherapy (CRT-CNCT) and either total mesorectal excision (TME) or watch-and-wait on the basis of tumor response. Patients in both groups received 4 months of infusional fluorouracil-leucovorin-oxaliplatin or capecitabine-oxaliplatin and 5,000 to 5,600 cGy of radiation combined with either continuous infusion fluorouracil or capecitabine during radiotherapy. The trial was designed as two stand-alone studies with disease-free survival (DFS) as the primary end point for both groups, with a comparison to a null hypothesis on the basis of historical data. The secondary end point was TME-free survival. RESULTS: Median follow-up was 3 years. Three-year DFS was 76% (95% CI, 69 to 84) for the INCT-CRT group and 76% (95% CI, 69 to 83) for the CRT-CNCT group, in line with the 3-year DFS rate (75%) observed historically. Three-year TME-free survival was 41% (95% CI, 33 to 50) in the INCT-CRT group and 53% (95% CI, 45 to 62) in the CRT-CNCT group. No differences were found between groups in local recurrence-free survival, dista...