Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Department of Surgery, Leiden University Medical Centre, Leiden, the Netherlands.
Br J Surg. 2023 May 16;110(6):676-684. doi: 10.1093/bjs/znad051.
BACKGROUND: In rectal cancer, watch and wait for patients with a cCR after neoadjuvant treatment has an established evidence base. However, there is a lack of consensus on the definition and management of a near-cCR. This study aimed to compare outcomes in patients who achieved a cCR at first reassessment versus later reassessment. METHODS: This registry study included patients from the International Watch & Wait Database. Patients were categorized as having a cCR at first reassessment or at later reassessment (that is near-cCR at first reassessment) based on MRI and endoscopy. Organ preservation, distant metastasis-free survival, and overall survival rates were calculated. Subgroup analyses were done for near-cCR groups based on the response evaluation according to modality. RESULTS: A total of 1010 patients were identified. At first reassessment, 608 patients had a cCR; 402 had a cCR at later reassessment. Median follow-up was 2.6 years for patients with a cCR at first reassessment and 2.9 years for those with a cCR at later reassessment. The 2-year organ preservation rate was 77.8 (95 per cent c.i. 74.2 to 81.5) and 79.3 (75.1 to 83.7) per cent respectively (P = 0.499). Similarly, no differences were found between groups in distant metastasis-free survival or overall survival rate. Subgroup analyses showed a higher organ preservation rate in the group with a near-cCR categorized exclusively by MRI. CONCLUSION: Oncological outcomes for patients with a cCR at later reassessment are no worse than those of patients with a cCR at first reassessment.
背景:在新辅助治疗后达到 cCR 的直肠癌患者,观察与等待策略已具有充分的证据支持。然而,对于接近 cCR 的定义和处理,目前尚未达成共识。本研究旨在比较首次和再次评估时达到 cCR 的患者的结局。
方法:本研究为国际观察与等待数据库的注册研究,基于 MRI 和内镜,将患者分为首次评估时达到 cCR 和再次评估时达到 cCR(即首次评估时为接近 cCR)。计算保肛率、无远处转移生存率和总生存率。根据不同的评估方式,对接近 cCR 组进行亚组分析。
结果:共纳入 1010 例患者,其中 608 例患者在首次评估时达到 cCR,402 例患者在再次评估时达到 cCR。首次评估时达到 cCR 患者的中位随访时间为 2.6 年,再次评估时达到 cCR 患者的中位随访时间为 2.9 年。首次评估时达到 cCR 患者的 2 年保肛率为 77.8%(95%可信区间 74.2%至 81.5%),再次评估时达到 cCR 患者的 2 年保肛率为 79.3%(75.1%至 83.7%)(P=0.499)。同样,两组在无远处转移生存率或总生存率方面也无差异。亚组分析显示,仅通过 MRI 评估为接近 cCR 的患者保肛率更高。
结论:再次评估时达到 cCR 的患者的肿瘤学结局并不比首次评估时达到 cCR 的患者差。
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