Organ Preservation and Survival by Clinical Response Grade in Patients With Rectal Cancer Treated With Total Neoadjuvant Therapy

作者：Hannah M. Thompson, Dana M. Omer, Sabrina T. Lin, Jin K. Kim, Jonathan B. Yuval, Floris S. Veheij, Li‐Xuan Qin, Marc J. Gollub, Abraham J. Wu, Meghan Lee, Sujata Patil, Aram F. Hezel, 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, Julio García‐Aguilar · 发表于：JAMA Network Open · 年份：2024 · DOI：10.1001/jamanetworkopen.2023.50903 · 被引用次数：136 · 研究领域：Colorectal Cancer Surgical Treatments、Colorectal and Anal Carcinomas、Bladder and Urothelial Cancer Treatments

Importance: Assessing clinical tumor response following completion of total neoadjuvant therapy (TNT) in patients with locally advanced rectal cancer is paramount to select patients for watch-and-wait treatment. Objective: To assess organ preservation (OP) and oncologic outcomes according to clinical tumor response grade. Design, Setting, and Participants: This was secondary analysis of the Organ Preservation in Patients with Rectal Adenocarcinoma trial, a phase 2, nonblinded, multicenter, randomized clinical trial. Randomization occurred between April 2014 and March 2020. Eligible participants included patients with stage II or III rectal adenocarcinoma. Data analysis occurred from March 2022 to July 2023. Intervention: Patients were randomized to induction chemotherapy followed by chemoradiation or chemoradiation followed by consolidation chemotherapy. Tumor response was assessed 8 (±4) weeks after TNT by digital rectal examination and endoscopy and categorized by clinical tumor response grade. A 3-tier grading schema that stratifies clinical tumor response into clinical complete response (CCR), near complete response (NCR), and incomplete clinical response (ICR) was devised to maximize patient eligibility for OP. Main Outcomes and Measures: OP and survival rates by clinical tumor response grade were analyzed using the Kaplan-Meier method and log-rank test. Results: There were 304 eligible patients, including 125 patients with a CCR (median [IQR] age, 60.6 [50.4-68.0] years...