Francesco Marchegiani1, Valeria Palatucci1, Giulia Capelli1, Mario Guerrieri2, Claudio Belluco3, Daniela Rega4, Emilio Morpurgo5, Claudio Coco6, Angelo Restivo7, Silvia De Franciscis4, Carlo Aschele8, Alessandro Perin1, Michele Bonomo9, Andrea Muratore10, Antonino Spinelli11, Salvatore Ramuscello12, Francesca Bergamo13, Giampaolo Montesi14, Gaya Spolverato15, Paola Del Bianco13, Maria Antonietta Gambacorta16, Paolo Delrio4, Salvatore Pucciarelli1. 1. Department of Surgical, Oncological and Gastroenterological Sciences, First Surgical Clinic, University of Padova, Padua, Italy. 2. Surgery Clinic, Marche Polytechnic University, Ancona, Italy. 3. Oncological Surgery Department, Centro di Riferimento Oncologico, National Cancer Institute, Aviano, Italy. 4. National Cancer Institute, IRCCS Fondazione "G.Pascale", Naples, Italy. 5. Department of Surgery, Regional Center for Laparoscopic and Robotic Surgery, Camposampiero Hospital, Padua, Italy. 6. Department of Surgical Sciences, Catholic University of Rome, Rome, Italy. 7. Department of Surgery, Colorectal Surgery Center, University of Cagliari, Cagliari, Italy. 8. Sant'Andrea Hospital, La Spezia, Italy. 9. San Bortolo Hospital, Vicenza, Italy. 10. Division of General Surgery, E. Agnelli Hospital, Pinerolo, Turin, Italy. 11. Colon and Rectal Surgery Unit, Humanitas Clinical and Research Center, Rozzano, Milan, Italy. 12. Surgical Department, Chioggia Hospital, Venice, Italy. 13. Istituto Oncologico Veneto - IRCCS, Padua, Italy. 14. Radiation Oncology Unit, Santa Maria della Misericordia Hospital, Rovigo, Italy. 15. Department of Surgical, Oncological and Gastroenterological Sciences, First Surgical Clinic, University of Padova, Padua, Italy. gaya.spolverato@unipd.it. 16. Agostino Gemelli Hospital, Rome, Italy.
Abstract
BACKGROUND: Rectum-preservation for locally advanced rectal cancer has been proposed as an alternative to total mesorectal excision (TME) in patients with major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The purpose of this study was to report on the short-term outcomes of ReSARCh (Rectal Sparing Approach after preoperative Radio- and/or Chemotherapy) trial, which is a prospective, multicenter, observational trial that investigated the role of transanal local excision (LE) and watch-and-wait (WW) as integrated approaches after neoadjuvant therapy for rectal cancer. METHODS: Patients with mid-low rectal cancer who achieved mCR or cCR after neoadjuvant therapy and were fit for major surgery were enrolled. Clinical response was evaluated at 8 and 12 weeks after completion of chemoradiotherapy. Treatment approach, incidence, and reasons for subsequent TME were recorded. RESULTS: From 2016 to 2019, 160 patients were enrolled; mCR or cCR at 12 weeks was achieved in 64 and 96 of patients, respectively. Overall, 98 patients were managed with LE and 62 with WW. In the LE group, Clavien-Dindo 3+ complications occurred in three patients. The rate of cCR increased from 8- to 12-week restaging. Thirty-three (94.3%) of 35 patients with cCR had ypT0-1 tumor. At a median 24 months follow-up, a tumor regrowth was found in 15 (24.2%) patients undergoing WW. CONCLUSIONS: LE for patients achieving cCR or mCR is safe. A 12-week interval from chemoradiotherapy completion to LE is correlated with an increased cCR rate. The risk of ypT > is reduced when LE is performed after cCR.
BACKGROUND: Rectum-preservation for locally advanced rectal cancer has been proposed as an alternative to total mesorectal excision (TME) in patients with major (mCR) or complete clinical response (cCR) after neoadjuvant therapy. The purpose of this study was to report on the short-term outcomes of ReSARCh (Rectal Sparing Approach after preoperative Radio- and/or Chemotherapy) trial, which is a prospective, multicenter, observational trial that investigated the role of transanal local excision (LE) and watch-and-wait (WW) as integrated approaches after neoadjuvant therapy for rectal cancer. METHODS: Patients with mid-low rectal cancer who achieved mCR or cCR after neoadjuvant therapy and were fit for major surgery were enrolled. Clinical response was evaluated at 8 and 12 weeks after completion of chemoradiotherapy. Treatment approach, incidence, and reasons for subsequent TME were recorded. RESULTS: From 2016 to 2019, 160 patients were enrolled; mCR or cCR at 12 weeks was achieved in 64 and 96 of patients, respectively. Overall, 98 patients were managed with LE and 62 with WW. In the LE group, Clavien-Dindo 3+ complications occurred in three patients. The rate of cCR increased from 8- to 12-week restaging. Thirty-three (94.3%) of 35 patients with cCR had ypT0-1 tumor. At a median 24 months follow-up, a tumor regrowth was found in 15 (24.2%) patients undergoing WW. CONCLUSIONS: LE for patients achieving cCR or mCR is safe. A 12-week interval from chemoradiotherapy completion to LE is correlated with an increased cCR rate. The risk of ypT > is reduced when LE is performed after cCR.
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