在接受全新辅助治疗的局部晚期直肠癌患者中，采用观望策略实现器官保存的疗效方面的前瞻性数据有限。

在这项前瞻性、随机的II期试验中，我们根据肿瘤反应评估了324例II期或III期直肠腺癌患者接受诱导化疗后放化疗(INCT-CRT)或放化疗后巩固化疗(CRT-CNCT)以及全直肠系膜切除术(TME)或观望治疗的结果。两组患者均在放疗期间接受了4个月的氟尿嘧啶-亚叶酸钙-奥沙利铂或卡培他滨-奥沙利铂输注以及5，000至5，600 cGy的放疗联合氟尿嘧啶或卡培他滨持续输注。本试验设计为两项独立研究，以无病生存期(DFS)作为两组的主要终点，并根据历史数据与无效假设进行比较。次要终点是无TME生存期。

中位随访时间为3年。INCT-CRT组三年DFS为76% (95% CI，69-84)，CRT-CNCT组为76% (95% CI，69-83)，与历史观察到的三年DFS率(75%)一致。INCT-CRT组的三年无TME生存率为41% (95% CI，33-50)，CRT-CNCT组为53% (95% CI，45-62)。在局部无复发生存期、远处无转移生存期或总生存期方面，各组之间未发现差异。复发后接受TME治疗的患者和再生后接受TME治疗的患者的DFS率相似。与接受放化疗、TME和术后化疗的历史对照相比，在接受全新辅助治疗的直肠癌患者中，有一半的患者可以实现器官保存，而生存率没有明显的损害。

Abstract

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, distant metastasis-free survival, or overall survival. Patients who underwent TME after restaging and patients who underwent TME after regrowth had similar DFS rates.

Conclusion: Organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME, and postoperative chemotherapy.

原文链接

https://ascopubs.org/doi/full/10.1200/JCO.22.00032

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