用全新辅助治疗(TNT)治疗的局部晚期直肠癌患者可能在不损害肿瘤学结果的情况下实现器官保留。然而，关于患者对TNT的依从性和治疗相关毒性的报道有限。OPRA试验评估了临床分期II/III直肠腺癌患者的器官保留率和肿瘤学结果，将其随机分为诱导化疗后化疗放疗(INCT-CRT)组和化疗放疗后巩固化疗(CRT-CNCT)组。系统化疗包括8个周期（16周）的氟尿嘧啶、亚叶酸和奥沙利铂（FOLFOX）或5个周期（15周）的卡培他滨和奥沙利铂（CAPEOX）。患者接受了>4500厘格雷（cGy）的放射治疗，配合敏化的卡培他滨或氟尿嘧啶。在本研究中，我们比较了接受INCT-CRT和CRT-CNCT的患者的依从性和治疗相关毒性。此外，我们评估了化疗依从性、化疗放疗依从性和毒性与器官保留和无病生存（DFS）的关联。在324名随机分配的患者中，与CRT-CNCT组相比，INCT-CRT组开始接受化疗放疗的患者较少(93% vs 98%, P = .03)，CRT-CNCT组开始接受全身化疗的患者较少(94% vs 99%, P = .04)。TNT的顺序不影响完成所有预期周期FOLFOX (86% INCT-CRT vs 83% CRT-CNCT, P = .60)或CAPEOX(74% INCT-CRT vs 77% CRT-CNCT, P = .80) 的能力。INCT和CRT-CNCT患者中，97%接受了>4500 cGy的放疗(P = .93)。64名（41%）接受INCT-CRT治疗的患者和57名CRT-CNCT患者（34%）经历了3级以上的不良事件（P = .30）。依从性和毒性与器官保留或DFS无关。我们发现接受INCT-CRT和CRT-CNCT治疗的患者之间的治疗依从性只有轻微差异。各组之间不观察到不良事件的差异。治疗依从性和毒性与器官保留率和DFS无相关性。版权所有 © 2023. 由Elsevier Inc.出版。

Patients with locally advanced rectal cancer treated with total neoadjuvant therapy (TNT) may achieve organ preservation without a compromise to oncologic outcomes. However, reports on patient compliance with TNT and with treatment-related toxicities are limited.The OPRA trial assessed organ preservation rates and oncologic outcomes in patients with clinical stage II/III rectal adenocarcinoma randomized to induction chemotherapy followed by chemoradiation (INCT-CRT) or chemoradiation followed by consolidation chemotherapy (CRT-CNCT). Systemic chemotherapy consisted of 8 cycles (16 weeks) of fluorouracil, leucovorin and oxaliplatin (FOLFOX) or 5 cycles (15 weeks) of capecitabine and oxaliplatin (CAPEOX). Patients received >4500 centi-gray (cGy) of radiation with sensitizing capecitabine or fluorouracil. In this report we compared compliance and treatment-related toxicity in patients receiving INCT-CRT versus CRT-CNCT. Additionally, we evaluated the association of compliance to chemotherapy, compliance to chemoradiation, and toxicity with organ preservation and disease-free survival (DFS).Of the 324 patients randomized, fewer patients started chemoradiation in the INCT-CRT group compared to the CRT-CNCT group (93% vs 98%, P = .03), and fewer patients started systemic chemotherapy in the CRT-CNCT group compared to the INCT-CRT group (94% vs 99%, P = .04). Order of TNT did not impact the ability to complete all intended cycles of FOLFOX (86% INCT-CRT vs 83% CRT-CNCT, P = .60) or CAPEOX (74% INCT-CRT vs 77% CRT-CNCT, P = .80). A total of 97% of INCT and 98% of CRT-CNCT patients received >4500 cGy radiation (P = .93). Sixty-four patients (41%) treated with INCT-CRT and 57 CRT-CNCT patients (34%) experienced a grade 3+ adverse event (P = .30). Compliance and toxicity were not associated with organ preservation or DFS.We identified only minor differences in treatment compliance between patients treated with INCT-CRT and CRT-CNCT. No difference in adverse events was observed between groups. Treatment compliance and toxicity did not correlate with organ preservation rates or DFS.Copyright © 2023. Published by Elsevier Inc.