title: Wait-and-see or radical surgery for rectal cancer patients with a clinical complete response after neoadjuvant chemoradiotherapy: a cohort study.
abstract: A wait-and-see policy might be considered instead of surgery for rectal cancer patients with no residual tumor or involved lymph nodes on imaging or endoscopy after neoadjuvant chemoradiotherapy (clinical complete response, cCR). In this cohort study, we compared the oncologic outcomes of rectal cancer patients with a cCR who were managed according to a wait-and-see policy (observation group) or with surgery (surgery group). In the observation group, follow-up was performed every 3 months for the first year and consisted of MRI, endoscopy with biopsy, computed tomography and transrectal ultrasonography. In the surgery group, patients received radical surgery. Long-term oncologic outcomes were estimated using Kaplan-Meier curves. Thirty patients were enrolled in the observation group (median follow-up, 60 months; range, 18-100 months), and 92 patients were enrolled in the surgery group (median follow-up, 58 months; range, 18-109 months). The 5-year disease free survival and overall survival rates were similar in the two groups: 90.0% vs. 94.3% (P = 0.932) and 100.0% vs. 95.6% (P = 0.912), respectively. We conclude that for rectal cancer patients with a cCR after neoadjuvant chemoradiotherapy, a wait-and-see policy with strict selection criteria, follow-up and salvage treatments achieves outcomes at least as good as radical surgery. Additionally, we declare that the pCR (pathologic complete regression) and non-pCR subgroups of patients with a cCR have similar long-term failure (local recurrence and/or distant metastasis) rate.
authors.affiliation: General Surgery Department, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China.
authors.forename: Jun
authors.initials: J
authors.lastname: Li
authors.affiliation: 2nd Affiliated Hospital of Jilin University, Changchun, People's Republic of China.
authors.forename: Hao
authors.initials: H
authors.lastname: Liu
authors.affiliation: Xuzhou Central Hospital, Xuzhou, People's Republic of China.
authors.forename: Jie
authors.initials: J
authors.lastname: Yin
authors.affiliation: Beijing Youan Hospital, Capital Medical University, Beijing, People's Republic of China.
authors.forename: Sai
authors.initials: S
authors.lastname: Liu
authors.affiliation: Hubei Cancer Hospital, Wuhan, People's Republic of China.
authors.forename: Junjie
authors.initials: J
authors.lastname: Hu
authors.affiliation: Cancer Institute/Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, People's Republic of China.
authors.forename: Feng
authors.initials: F
authors.lastname: Du
authors.affiliation: General Surgery Department, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China.
authors.forename: Jiatian
authors.initials: J
authors.lastname: Yuan
authors.affiliation: General Surgery Department, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China.
authors.forename: Bo
authors.initials: B
authors.lastname: Lv
authors.affiliation: General Surgery Department, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China.
authors.forename: Jun
authors.initials: J
authors.lastname: Fan
authors.affiliation: General Surgery Department, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China.
authors.forename: Shusheng
authors.initials: S
authors.lastname: Leng
authors.affiliation: General Surgery Department, Affiliated Hospital/Clinical Medical College of Chengdu University, Chengdu, People's Republic of China.
authors.forename: Xin
authors.initials: X
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059248:Chemoradiotherapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D017063:Outcome Assessment, Health Care; D012004:Rectal Neoplasms / Q000601:surgery* / Q000628:therapy*; D012074:Remission Induction; D016879:Salvage Therapy / Q000379:methods*; D013997:Time Factors; D057832:Watchful Waiting
keywords: complete clinical response; neoadjuvant chemoradiotherapy; rectal cancer