1、.1Watch-and-wait approach versus surgical resection after chemoradiotherapy for patients with rectal cancer(the OnCoRe project):a propensity-score matched cohort analysis Lancet Oncol Published Online December 16,2015.2v2004.10,Annals of Surgery,Habr-Gama.egv265 patients with distal rectal were trea
2、ted by CRT with 5-FU,Leucovorin and 5040 cGyv Five-year OS and DFS rates were 88%and 83%in Resection Group,100%and 92%in Observation Group.3Purposevoncological outcomes between watch and wait and surgical resection vthe safety of the watch-and-wait.4The definition of a cCR v(1)substantial downsizing
3、 with no residual tumor or residual fibrosis only v(2)no suspicious lymph nodes on MRI v(3)no residual tumor at endoscopy or only a small residual erythematous ulcer or scar v(4)negative biopsies from the scar,ulcer,or former tumor location v(5)no palpable tumor,when initially palpable with digital
4、rectal examination.5Methodsvone-to-one paired cohorts of watch and wait versus surgical resection using propensity-score matching（T stage,age,and performance status）vprimary endpoint was DFSvsecondary endpoints was OS and colostomy-free survival.6MethodsvCCR standard:after CRT 8 weeks or morevabsenc
5、e of residual ulceration,stenosis,or mass within the rectum during digital rectal examination and endoscopic examination.7Methodsv259 patients from a tertiary cancer centre in Manchester,UK between Jan 14,2011 and April 15,2013vCCR-wait-and-see policy group(31)vNCCR-surgical resection(228).8Methodsv
6、 three neighbouring UK regional cancer centres(Lancashire and South Cumbria,Merseyside and Cheshire,and north Wales)March 10,2005,and Jan 21,2015-wait-and-see policy group(98).9Methodsv preoperative chemoradiotherapy:45 Gy in 25 daily fractions with concurrent fluoropyrimidine-based chemotherapy for
7、 34 days.10MethodsvData include:v T and N stages (MRI)v Sex,age,BMIv Smoking status,performance statusv Baseline CEAv Histological gradev Height from anal verge.11MethodsvStatistical analysisvcontinuous variables-Kruskal-Wallis and Wilcoxon signed-rank testsvcategorical variables-and McNamara testsv
8、P value.12.13.14.15ResultsvMedian follow-up of 33 months(IQR 1943)v44/129 patients had local regrowths(42 patients had mucosal lesions,2 patient had submucosal or mesorectal lesions).16Results.17Resultsv 31 underwent subsequent salvage surgery T and N stages 5 ypT1,10 ypT2,16 ypT3 24 ypN0,6 ypN1,1 y
9、pN2.18Results.19Results.20Results.21Discussionva new oncological endpoint-non-regrowth disease-free survivalvthe first time-colostomy-free survival(1/4 CCR avoid colostomy).22DiscussionvTwo additional findingvabout 2/3 node positive assessed by MRI,but did not affect subsequent endpoints v9%(CCR)did
10、 not receive preoperative chemotherapy and its absence did not affect study endpoints.23Discussionv limitations 1.follow-up was relatively short 2.not representative of real-world off -trial clinical practice 3.is a risk in patients with CCR managed by watch and wait.24DiscussionvStrengths 1.largest
11、 reported cohort outside 2.from several treatment centres 3.a standardised defi nitionCCR .25Future PerspectivesvNeed a prospective randomized controlled trialvuniform standards for the definition of a cCRv The proposed selection criteria and follow-up can be used in future trials aimed at providing more evidence on the wait-and-see policy
