Rydbeck Daniel, Azhar Najia, Blomqvist Lennart, Chabok Abbas, Folkesson Joakim, Gerdin Anders, Hermus Linda, Matthiessen Peter, Martling Anna, Nilsson Per J, Angenete Eva
Department of Surgery, SSORG-Scandinavian Surgical Outcomes Research Group, Institute of Clinical Sciences, Sahlgrenska Academy University of Gothenburg, Gothenburg, Sweden.
Department of Surgery, Region Västra Götaland, Sahlgrenska Universitetssjukhuset, Gothenburg, Sweden.
BJS Open. 2024 Dec 30;9(1). doi: 10.1093/bjsopen/zrae151.
Despite absence of level 1 evidence on the long-term oncological safety of non-operative management for rectal cancer (watch and wait), increased implementation has occurred globally over the past decades. In Sweden, a pan-national prospective non-randomized study was initiated in 2017 to assess its implementation.
Patients with biopsy-proven rectal cancer receiving neoadjuvant therapy according to national guidelines in whom a clinical complete response was detected at reassessment were eligible for inclusion following informed consent. Only patients with an opportunistic watch-and-wait approach were included. Inclusion and follow-up, according to the study protocol, was managed at the participating study centres. The primary outcome measure of the study is 3-year disease-free survival. Here, the secondary short-term outcomes local regrowth rate, distant metastasis rate and outcomes after surgery for regrowth, at 6 months follow-up, are reported.
Between January 2017 and February 2023, 211 patients with a clinical complete response were included in the study. Thirty-three (16%) patients developed suspicious regrowth within 6 months of inclusion. Thirty-two of 33 patients had abdominal resectional surgery for regrowth. The curative intention rate was 94% for patients with regrowth. Three patients (1.4%) developed distant metastases within 6 months of inclusion.
This Swedish national study on watch and wait reports regrowth rates after 6 months are in line with previous reports in the literature. Nearly all patients with early regrowth could be treated with salvage surgery and curative intent.
尽管缺乏关于直肠癌非手术治疗（观察等待）长期肿瘤学安全性的一级证据，但在过去几十年中，全球范围内对其的应用有所增加。在瑞典，2017年启动了一项全国性前瞻性非随机研究以评估其应用情况。
根据国家指南接受新辅助治疗且在重新评估时检测到临床完全缓解的经活检证实的直肠癌患者，在获得知情同意后符合纳入标准。仅纳入采用机会性观察等待方法的患者。根据研究方案，纳入和随访在参与研究的中心进行管理。该研究的主要结局指标是3年无病生存率。在此，报告次要短期结局，即6个月随访时的局部复发率、远处转移率以及复发后手术的结局。
2017年1月至2023年2月期间，211例临床完全缓解的患者被纳入该研究。33例（16%）患者在纳入后6个月内出现可疑复发。33例患者中有32例因复发接受了腹部切除手术。复发患者的根治性手术意向率为94%。3例（1.4%）患者在纳入后6个月内出现远处转移。
这项瑞典关于观察等待的全国性研究报告称，6个月后的复发率与文献中先前的报告一致。几乎所有早期复发的患者都可以接受挽救性手术并具有根治性意向。
