{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T19:45:25Z","timestamp":1782330325692,"version":"3.54.5"},"reference-count":29,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2023,10,13]],"date-time":"2023-10-13T00:00:00Z","timestamp":1697155200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Colorectal Disease"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>Nonsurgical treatment with chemoradiotherapy for rectal cancer is gaining interest as it avoids total mesorectal excision (TME) surgery and stoma. The OPERA trial aims to evaluate whether dose escalation with contact X\u2010ray brachytherapy (CXB) boost improves organ preservation compared to external beam radiotherapy (EBRT) boost. It has been suggested that dose escalation adversely affects surgical outcomes and therefore we report outcomes following TME in OPERA at 36\u2009months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>OPERA is a European multicentre phase 3 trial (NCT02505750) which randomises patients with cT2\u20103a\u2010b, cN0\u20101, M0 to EBCRT (45\u2009Gy in 25 fractions over 5\u2009weeks with oral capecitabine 825\u2009mg\/m<jats:sup>2<\/jats:sup>) followed by EBRT boost (9\u2009Gy in 5 fractions over 5\u2009days) versus EBCRT followed by CXB boost (90\u2009Gy in 3 fractions over 4\u2009weeks). Patients were assessed at 14, 20 and 24\u2009weeks from the start of treatment. Watch and wait management was adopted for patients who achieved a clinical complete response (cCR) at 24\u2009weeks following treatment. Either local excision (LE) or TME surgery was offered for residual disease or local regrowth, according to patient and surgeon preference. Surgical morbidity and mortality were recorded prospectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between July 2015 and June 2020, 148 patients were randomised of which 141 were evaluable in March 2022. At median follow\u2010up of 38.2\u2009months (range: 34.2\u201342.5), surgery was performed for 66 (47%) patients. A total of 27 (20%) patients had local excision and 39 (29%) had TME surgery, 22\/39 (56%) underwent anterior resection and 17\/39 (44%) underwent abdominoperineal excision of the rectum. The R0 resection rate was 87%. There were no deaths, and six patients (15%) had Clavien\u2010Dindo IIIb complications. Whilst there was a statistically significant decrease in the TME rate following CXB boost (HR 0.38, 95% CI: 0.19\u20130.74, <jats:italic>p<\/jats:italic>\u2009=\u20090.00419) there was no difference in surgical outcomes between patients who received EBRT and CXB boost.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Dose escalation can facilitate nonsurgical treatment for cT2\u20103 rectal cancer patients who are fit but wish to avoid TME surgery and stoma. If TME surgery is required, then it can be performed safely and effectively.<\/jats:p><\/jats:sec>","DOI":"10.1111\/codi.16773","type":"journal-article","created":{"date-parts":[[2023,10,14]],"date-time":"2023-10-14T06:24:57Z","timestamp":1697264697000},"page":"2160-2169","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["The safety and efficacy of total mesorectal excision (<scp>TME<\/scp>) surgery following dose\u2010escalation: Surgical outcomes from the organ preservation in early rectal adenocarcinoma (<scp>OPERA<\/scp>) trial, a European multicentre phase 3 randomised trial (<scp>NCT02505750<\/scp>)"],"prefix":"10.1111","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5323-5696","authenticated-orcid":false,"given":"Arthur","family":"Sun\u00a0Myint","sequence":"first","affiliation":[{"name":"Clatterbridge Cancer Centre  Liverpool 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Lacassagne Universit\u00e9 C\u00f4te d'Azur  Nice France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renaud","family":"Schiappa","sequence":"additional","affiliation":[{"name":"Departement of Epidemiology, Biostatistic, and Health Data, Centre Antoine Lacassagne Universit\u00e9 C\u00f4te d'Azur  Nice France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Magn\u00e9","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology  Saint\u2010Priest\u2010en\u2010Jarez France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Martel\u2010Lafay","sequence":"additional","affiliation":[{"name":"L\u00e9on B\u00e9rard Cancer Center  Lyon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Mineur","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Institute Sainte Catherine  Avignon 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