Purpose This systematic review and meta-analysis compared the outcomes of the watch-and-wait (WW) approach versus radical surgery (RS) in rectal cancers with clinical complete response (cCR) after neoadjuvant chemoradiotherapy.
Methods This study followed the PRISMA guidelines. Major databases were searched to identify relevant articles. WW and RS were compared through meta-analyses of pooled proportions. Primary outcomes included overall survival (OS), disease-free survival (DFS), local recurrence, and distant metastasis rates. Pooled salvage surgery rates and outcomes were also collected. The Newcastle-Ottawa scale was employed to assess the risk of bias.
Results Eleven studies including 1,112 rectal cancer patients showing cCR after neoadjuvant chemoradiation were included. Of these patients, 378 were treated nonoperatively with WW, 663 underwent RS, and 71 underwent local excision. The 2-year OS (risk ratio [RR], 0.95; P = 0.94), 5-year OS (RR, 2.59; P = 0.25), and distant metastasis rates (RR, 1.05; P = 0.80) showed no significant differences between WW and RS. Local recurrence was more frequent in the WW group (RR, 6.93; P < 0.001), and 78.4% of patients later underwent salvage surgery (R0 resection rate, 97.5%). The 2-year DFS (RR, 1.58; P = 0.05) and 5-year DFS (RR, 2.07; P = 0.02) were higher among RS cases. However, after adjustment for R0 salvage surgery, DFS showed no significant between-group difference (RR, 0.82; P = 0.41).
Conclusion Local recurrence rates are higher for WW than RS, but complete salvage surgery is often possible with similar long-term outcomes. WW is a viable strategy for rectal cancer with cCR after neoadjuvant chemoradiation, but further research is required to improve patient selection.
Citations
Citations to this article as recorded by
Watch‐and‐Wait Approach Following Neoadjuvant Chemo‐Radiotherapy for Locally Advanced Rectal Cancer: A Retrospective Single‐Center Cohort Study Georgi Kalev, Sylvia Buettner, Tianzuo Zhan, Ralf‐Dieter Hofheinz, Judit Boda‐Heggemann, Christoph Reissfelder, Steffen Seyfried, Georgi Vassilev, Julia Hardt Journal of Surgical Oncology.2025; 131(4): 658. CrossRef
Phase 2, Multicenter, Open-label, Nonrandomized Study of Neoadjuvant Chemotherapy Liposomal Irinotecan With 5-Fluorouracil, Leucovorin, and Oxaliplatin, Followed by Chemoradiotherapy in Patients With Rectal Cancer in a Watch-and-Wait Program César Muñoz, María-C. Riesco Martinez, Lisardo Ugidos, Pilar García-Alfonso, Rafael Alvarez-Gallego, Paloma Peinado, Carmen Toledano, Luka Mihic-Góngora, Justo Gabriel Ortega Anselmi, Enrique Sanz Garcia, Emilio Vicente, Yolanda Quijano, Hipólito J. Durán American Journal of Clinical Oncology.2025; 48(3): 142. CrossRef
Therapeutic Management of Locally Advanced Rectal Cancer: Existing and Prospective Approaches Horia-Dan Lișcu, Nicolae Verga, Dimitrie-Ionuț Atasiei, Andreea-Teodora Ilie, Maria Vrabie, Laura Roșu, Alexandra Poștaru, Stefania Glăvan, Adriana Lucaș, Maria Dinulescu, Andreea Delea, Andreea-Iuliana Ionescu Journal of Clinical Medicine.2025; 14(3): 912. CrossRef
A management of patients achieving clinical complete response after neoadjuvant therapy and perspectives: on locally advanced rectal cancer Yu-Xin Liu, Xin-Rong Yang, Lan-Qing Peng, Zhuo-Hong Li Frontiers in Oncology.2025;[Epub] CrossRef
ACCORD study: a national multi‐centre study of the watch and wait approach in patients with rectal cancer in Aotearoa New Zealand
Watch and wait in early onset rectal cancer patients: A review of the literature Melissa K Drezdzon, Carrie Y Peterson Seminars in Colon and Rectal Surgery.2025; : 101117. CrossRef
Non-operative management of locally advanced rectal cancer with an emphasis on outcomes and quality of life: a narrative review In Ja Park Ewha Medical Journal.2025; 48(3): e40. CrossRef
Non-Operative Management (NOM) in Rectal Cancer: Current Evidence and Future Directions Vincenzo Schiavone, Gabriella Teresa Capolupo, Gianluca Mascianà, Filippo Carannante, Gianluca Costa, Valentina Miacci, Marco Caricato Encyclopedia.2025; 5(4): 165. CrossRef
Advancing Personalized Medicine in the Treatment of Locally Advanced Rectal Cancer Francesco Giulio Sullo, Alessandro Passardi, Chiara Gallio, Chiara Molinari, Giorgia Marisi, Eleonora Pozzi, Leonardo Solaini, Alessandro Bittoni Journal of Clinical Medicine.2024; 13(9): 2562. CrossRef
Tailoring rectal cancer surgery: Surgical approaches and anatomical insights during deep pelvic dissection for optimal outcomes in low‐lying rectal cancer Youn Young Park, Nam Kyu Kim Annals of Gastroenterological Surgery.2024; 8(5): 761. CrossRef
Combined Transanal and Laparoscopic Approach for Full-Thickness Local Excision of Locally Advanced Rectal Cancer Following Near-Complete Response after Chemotherapy Joshua S. H. Lim, Si-Lin Koo, Iain Beehuat Tan, Isaac Seow-En World Journal of Colorectal Surgery.2024; 13(3): 95. CrossRef
Sungwoo Jung, Anuj Parajuli, Chang Sik Yu, Seong Ho Park, Jong Seok Lee, Ah Young Kim, Jong Lyul Lee, Chan Wook Kim, Yong Sik Yoon, In Ja Park, Seok-Byung Lim, Jin Cheon Kim
Ann Coloproctol. 2019;35(5):275-281. Published online October 31, 2019
Purpose We investigated the sensitivity of various evaluating modalities in predicting a pathologic complete response (pCR) after preoperative chemoradiation therapy (PCRT) for locally advanced rectal cancer (LARC).
Methods From a population of 2,247 LARC patients who underwent PCRT followed by surgery at Asan Medical Center, Seoul, Korea from January 2007 to June 2016, we retrospectively analyzed 313 patients (14.1%) who showed a pCR after surgery. Transrectal ultrasound (TRUS), high-resolution magnetic resonance imaging (MRI), abdominopelvic computed tomography (AP-CT), and endoscopy were performed within 2 weeks prior to surgery.
Results Of the 313 patients analyzed, 256 (81.8%) had a pCR after radical surgery and 57 (18.2%) showed total regression after local excision. Preoperative TRUS, MRI, and AP-CT were performed in 283, 305, and 139 patients, respectively. Among these 3 groups, a prediction of a pCR of the primary tumor was made in 41 (14.5%), 51 (16.7%), and 27 patients (19.4%), respectively, before surgery. A prediction of a clinical N0 stage was made in 204 patients (88.3%) using TRUS, 130 (52.2%) using MRI, and 78 (65.5%) using AP-CT. Of the 211 patients who underwent endoscopy, 87 (41.2%) had a mention of clinical CR in their records. A prediction of a pathologic CR was made for 124 patients (39.6%) through at least one diagnostic modality.
Conclusion The various evaluation methods for predicting a pCR after PCRT show a predictive sensitivity of 0.15–0.41 for primary tumors and 0.52–0.88 for lymph nodes. Endoscopy is a relatively superior modality for predicting the pCR of the primary tumor of LARC patients.
Citations
Citations to this article as recorded by
Comparison between Local Excision and Radical Resection for the Treatment of Rectal Cancer in ypT0-1 Patients: An Analysis of the Clinicopathological Factors and Survival Rates Soo Young Oh, In Ja Park, Young IL Kim, Jong-Lyul Lee, Chan Wook Kim, Yong Sik Yoon, Seok-Byung Lim, Chang Sik Yu, Jin Cheon Kim Cancers.2021; 13(19): 4823. CrossRef
Predicting Neoadjuvant Chemoradiotherapy Response in Locally Advanced Rectal Cancer Using Tumor-Infiltrating Lymphocytes Density Yao Xu, Xiaoying Lou, Yanting Liang, Shenyan Zhang, Shangqing Yang, Qicong Chen, Zeyan Xu, Minning Zhao, Zhenhui Li, Ke Zhao, Zaiyi Liu Journal of Inflammation Research.2021; Volume 14: 5891. CrossRef
A Nine-Gene Signature for Predicting the Response to Preoperative Chemoradiotherapy in Patients with Locally Advanced Rectal Cancer In Ja Park, Yun Suk Yu, Bilal Mustafa, Jin Young Park, Yong Bae Seo, Gun-Do Kim, Jinpyo Kim, Chang Min Kim, Hyun Deok Noh, Seung-Mo Hong, Yeon Wook Kim, Mi-Ju Kim, Adnan Ahmad Ansari, Luigi Buonaguro, Sung-Min Ahn, Chang-Sik Yu Cancers.2020; 12(4): 800. CrossRef