| Title: |
Rectal Sparing Approach after preoperative Radio- and/or Chemo-therapy (ReSARCh): a prospective, multicenter, observational study |
| Authors: |
Spolverato G.; Bao Q. R.; Delrio P.; Guerrieri M.; Ortenzi M.; Cillara N.; Restivo A.; Deidda S.; Spinelli A.; Romano C.; Bianco F.; Sarzo G.; Morpurgo E.; Belluco C.; Palazzari E.; Chiloiro G.; Meldolesi E.; Coco C.; Pafundi D. P.; Feleppa C.; Aschele C.; Bonomo M.; Muratore A.; Mellano A.; Chiaulon G.; Crimi F.; Maretto I.; Perin A.; Urso E. D. L.; Scarpa M.; Bigon M.; Scognamiglio F.; Bergamo F.; Del Bianco P.; Gambacorta M. A.; Rega D.; Pucciarelli S. |
| Contributors: |
Spolverato, G.; Bao, Q. R.; Delrio, P.; Guerrieri, M.; Ortenzi, M.; Cillara, N.; Restivo, A.; Deidda, S.; Spinelli, A.; Romano, C.; Bianco, F.; Sarzo, G.; Morpurgo, E.; Belluco, C.; Palazzari, E.; Chiloiro, G.; Meldolesi, E.; Coco, C.; Pafundi, D. P.; Feleppa, C.; Aschele, C.; Bonomo, M.; Muratore, A.; Mellano, A.; Chiaulon, G.; Crimi, F.; Maretto, I.; Perin, A.; Urso, E. D. L.; Scarpa, M.; Bigon, M.; Scognamiglio, F.; Bergamo, F.; Del Bianco, P.; Gambacorta, M. A.; Rega, D.; Pucciarelli, S. |
| Publisher Information: |
LIPPINCOTT WILLIAMS & WILKINS |
| Publication Year: |
2024 |
| Collection: |
Padua Research Archive (IRIS - Università degli Studi di Padova) |
| Subject Terms: |
local excision; locally advance rectal cancer; neoadjuvant chemoradiotherapy; neoadjuvant treatment; rectal-sparing approach; wait and see; watch-and-wait |
| Description: |
BACKGROUND: Rectal-sparing approaches for patients with rectal cancer who achieved a complete or major response following neoadjuvant therapy constitute a paradigm of a potential shift in the management of patients with rectal cancer; however, their role remains controversial. The aim of this study was to investigate the feasibility of rectal-sparing approaches to preserve the rectum without impairing the outcomes. METHODS: This prospective, multicenter, observational study investigated the outcomes of patients with clinical stage II-III mid-low rectal adenocarcinoma treated with any neoadjuvant therapy, and either transanal local excision or watch-and-wait approach, based on tumor response (major or complete) and patient/surgeon choice. The primary endpoint of the study was rectum preservation at a minimum follow-up of 2 years. Secondary endpoints were overall, disease-free, local and distant recurrence-free, and stoma-free survival at 3 years. RESULTS: Of the 178 patients enrolled in 16 centers, 112 (62.9%) were managed with local excision and 66 (37.1%) with watch-and-wait. At a median (interquartile range) follow-up of 36.1 (30.6-45.6) months, the rectum was preserved in 144 (80.9%) patients. The 3-year rectum-sparing, overall survival, disease-free survival, local recurrence-free survival, and distant recurrence-free survival was 80.6% (95% CI 73.9-85.8), 97.6% (95% CI 93.6-99.1), 90.0% (95% CI 84.3-93.7), 94.7% (95% CI 90.1-97.2), and 94.6% (95% CI 89.9-97.2), respectively. The 3-year stoma-free survival was 95.0% (95% CI 89.5-97.6). The 3-year regrowth-free survival in the watch-and-wait group was 71.8% (95% CI 59.9-81.2). CONCLUSIONS: In rectal cancer patients with major or complete clinical response after neoadjuvant therapy, the rectum can be preserved in about 80% of cases, without compromising the outcomes. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/38518084; info:eu-repo/semantics/altIdentifier/wos/WOS:001291410700002; volume:110; issue:8; firstpage:4736; lastpage:4745; numberofpages:10; journal:INTERNATIONAL JOURNAL OF SURGERY; https://hdl.handle.net/11577/3528104 |
| DOI: |
10.1097/JS9.0000000000001322 |
| Availability: |
https://hdl.handle.net/11577/3528104; https://doi.org/10.1097/JS9.0000000000001322 |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Creative commons ; license uri:http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Accession Number: |
edsbas.EA05FDAD |
| Database: |
BASE |