Comparing local excision with watch and wait for the management of rectal cancer patients responding to neoadjuvant chemoradiotherapy: Composite endpoint analysis using the win ratio
Giulia Capelli, Giulia Lorenzoni, Maria Vittoria Chiaruttini, Paolo Delrio, Mario Guerrieri, Monica Ortenzi, Nicola Cillara, Angelo Restivo, Simona Deidda, Antonino Spinelli, Carmela Romano, Francesco Bianco, Giacomo Sarzo, Dajana Glavas, Emilio Morpurgo, Claudio Belluco, Elisa Palazzari, Giuditta Chiloiro, Elisa Meldolesi, Claudio Coco, Donato Paolo Pafundi, Cosimo Feleppa, Carlo Aschele, Michele Bonomo, Andrea Muratore, Alfredo Mellano, Germana Chiaulon, Francesca Bergamo, Maria Antonietta Gambacorta, Daniela Rega, Dario Gregori, Gaya Spolverato, Salvatore Pucciarelli
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引用次数: 0
Abstract
Aim
The aim of this work was to apply the ‘win ratio’ to compare the outcomes of rectal-sparing approaches [watch and wait (WW) and local excision (LE)] in the management of locally advanced rectal cancer responding to neoadjuvant chemoradiotherapy.
Method
Patients enrolled in the ReSARCh study (NCT02710812) between 2016 and 2021 were divided into two cohorts (WW vs. LE). The win ratio was calculated by dividing the number of successes (or wins) in the WW group by the number of successes in the LE group on matched pairs. Oncological outcomes (overall survival, distant and local recurrence), presence of a stoma and rectum not preserved were considered as outcomes of interest.
Results
Overall, 108 (62.1%) patients underwent LE and 66 (37.9%) WW. Patients who underwent WW were more likely to have a complete clinical response (cCR) at restaging [i.e. ycT = 0: n = 51 (80%) for WW vs. n = 45 (42%) for LE, p < 0.001]. After matching for age, sex, distance from the anal verge and T stage at restaging, i.e. ycT, 57 pairs of patients were identified. The overall win ratio considering only oncological outcomes was 0.4 (95% CI 0.02–0.94). The disadvantage of WW was mainly due to a higher rate of local recurrences. The overall win ratio considering oncological outcomes, presence of a stoma and rectum not preserved was 0.6 (95% CI 0.04–1.38), indicating a potential disadvantage for WW, but with wide confidence intervals suggesting uncertainty.
Conclusions
LE may have an advantage in terms of local recurrence rates compared with WW, potentially conferring a survival benefit. These results should be confirmed in further prospective randomized trials.
期刊介绍:
Diseases of the colon and rectum are common and offer a number of exciting challenges. Clinical, diagnostic and basic science research is expanding rapidly. There is increasing demand from purchasers of health care and patients for clinicians to keep abreast of the latest research and developments, and to translate these into routine practice. Technological advances in diagnosis, surgical technique, new pharmaceuticals, molecular genetics and other basic sciences have transformed many aspects of how these diseases are managed. Such progress will accelerate.
Colorectal Disease offers a real benefit to subscribers and authors. It is first and foremost a vehicle for publishing original research relating to the demanding, rapidly expanding field of colorectal diseases.
Essential for surgeons, pathologists, oncologists, gastroenterologists and health professionals caring for patients with a disease of the lower GI tract, Colorectal Disease furthers education and inter-professional development by including regular review articles and discussions of current controversies.
Note that the journal does not usually accept paediatric surgical papers.