The safety and efficacy of total mesorectal excision (TME) surgery following dose-escalation: Surgical outcomes from the organ preservation in early rectal adenocarcinoma (OPERA) trial, a European multicentre phase 3 randomised trial (NCT02505750).

Autor: Sun Myint A; Clatterbridge Cancer Centre, Liverpool, UK., Rao C; Department of Surgery and Cancer, Imperial College London, London, UK.; Department of Colorectal Surgery, The Cumberland Infirmary, Carlisle, UK., Barbet N; ORLAM Lyon-Villeurbanne-Mâcon, Villeurbanne, France., Thamphya B; Departement of Epidemiology, Biostatistic, and Health Data, Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France., Pace-Loscos T; Departement of Epidemiology, Biostatistic, and Health Data, Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France., Schiappa R; Departement of Epidemiology, Biostatistic, and Health Data, Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France., Magné N; Department of Radiation Oncology, Saint-Priest-en-Jarez, France., Martel-Lafay I; Léon Bérard Cancer Center, Lyon, France., Mineur L; Department of Radiation Oncology, Institute Sainte Catherine, Avignon, France., Deberne M; Centre Hospitalier Lyon-Sud, Lyon, France., Zilli T; Department of Oncology, University of Genève, Genève, Switzerland., Dhadda A; Queen's Centre for Oncology, Castle Hill Hospital, Hull, UK., Gerard JP; Departement of Epidemiology, Biostatistic, and Health Data, Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France.
Jazyk: angličtina
Zdroj: Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland [Colorectal Dis] 2023 Nov; Vol. 25 (11), pp. 2160-2169. Date of Electronic Publication: 2023 Oct 13.
DOI: 10.1111/codi.16773
Abstrakt: Aim: 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-ray 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 months.
Methods: OPERA is a European multicentre phase 3 trial (NCT02505750) which randomises patients with cT2-3a-b, cN0-1, M0 to EBCRT (45 Gy in 25 fractions over 5 weeks with oral capecitabine 825 mg/m 2 ) followed by EBRT boost (9 Gy in 5 fractions over 5 days) versus EBCRT followed by CXB boost (90 Gy in 3 fractions over 4 weeks). Patients were assessed at 14, 20 and 24 weeks from the start of treatment. Watch and wait management was adopted for patients who achieved a clinical complete response (cCR) at 24 weeks 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.
Results: Between July 2015 and June 2020, 148 patients were randomised of which 141 were evaluable in March 2022. At median follow-up of 38.2 months (range: 34.2-42.5), 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-Dindo IIIb complications. Whilst there was a statistically significant decrease in the TME rate following CXB boost (HR 0.38, 95% CI: 0.19-0.74, p = 0.00419) there was no difference in surgical outcomes between patients who received EBRT and CXB boost.
Conclusion: Dose escalation can facilitate nonsurgical treatment for cT2-3 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.
(© 2023 Crown copyright and The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland. This article is published with the permission of the Controller of HMSO and the King’s Printer for Scotland.)
Databáze: MEDLINE
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