A higher rate of distant metastasis was observed among patients in the WW group who had local regrowth vs those who did not have local regrowth (36% vs 1%, P < .001).Ĭonclusions and Relevance A WW strategy for select rectal cancer patients who had a clinical complete response after neoadjuvant therapy resulted in excellent rectal preservation and pelvic tumor control however, in the WW group, worse survival was noted along with a higher incidence of distant progression in patients with local regrowth vs those without local regrowth. At 5 years, overall survival was 73% (95% CI, 60%-89%) in the WW group and 94% (95% CI, 90%-99%) in the pCR group disease-free survival was 75% (95% CI, 62%-90%) in the WW group and 92% (95% CI, 87%-98%) in the pCR group and disease-specific survival was 90% (95% CI, 81%-99%) in the WW group and 98% (95% CI, 95%-100%) in the pCR group.
#PCR COMPLETE RESPONSE PLUS#
Rectal preservation was achieved in 93 of 113 patients (82%) in the WW group (91 patients with no local regrowths plus 2 patients with local regrowths salvaged with transanal excision). No pelvic recurrences occurred in the pCR group. Pelvic control after salvage surgery was maintained in 20 of 22 patients (91%). All 22 local regrowths in the WW group were detected on routine surveillance and treated by salvage surgery (20 total mesorectal excisions plus 2 transanal excisions). Results Compared with the 136 patients in the pCR group, the 113 patients in the WW group were older (median, 67.2 vs 57.3 years, P < .001) with cancers closer to the anal verge (median height from anal verge, 5.5 vs 7.0 cm). Main Outcomes and Measures Kaplan-Meier estimates were used for analyses of local regrowth and 5-year rates of overall survival, disease-free survival, and disease-specific survival. Data analyses were conducted from June 1, 2016, to October 1, 2018.Įxposures Patients had a clinical complete response after completing neoadjuvant therapy and agreed to a WW strategy of active surveillance and possible salvage surgery (n = 113), or patients underwent total mesorectal excision and were found to have a pathologic complete response (pCR) at resection (n = 136).
#PCR COMPLETE RESPONSE SERIES#
Objective To analyze the outcomes of WW among patients with rectal cancer who had a clinical complete response to neoadjuvant therapy.ĭesign, Setting, and Participants This retrospective case series analysis conducted at a comprehensive cancer center in New York included patients who received a diagnosis of rectal adenocarcinoma between January 1, 2006, and January 31, 2015. Importance The watch-and-wait (WW) strategy aims to spare patients with rectal cancer unnecessary resection.
Meaning A watch-and-wait strategy may be safe for most patients, but better risk stratification is needed for more precise patient selection to identify those at high risk of local regrowth who are not optimal candidates. However, worse survival was observed compared with 136 patients undergoing total mesorectal excision who had a pathologic complete response a higher incidence of distant progression was also noted among patients managed by the watch-and-wait strategy who developed local regrowth vs those who did not develop local regrowth. Question What are the rates of local regrowth, pelvic control, and survival when using a watch-and-wait approach for patients with rectal cancer after a clinical complete response to neoadjuvant therapy?įindings A watchful waiting strategy for 113 patients with rectal cancer achieving a clinical complete response after neoadjuvant therapy resulted in excellent rectal preservation (82%) and pelvic tumor control (91%) in this case series study. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.
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