直肠癌放化疗后等待观察策略

1、直肠癌放化疗后等待观察策略v2004.10 ,Annals of Surgery,Habr-Gama.egv265 patients with distal rectal were treated 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 GroupPurposevoncological outcomes between watch and wait and surgi

2、cal resection vthe safety of the watch-and-wait The definition of a cCR v (1) substantial downsizing 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

3、from the scar, ulcer, or former tumor location v (5) no palpable tumor, when initially palpable with digital rectal examination Methodsvone-to-one paired cohorts of watch and wait versus surgical resection using propensity-score matching（ T stage, age, and performance status）vprimary endpoint was DF

4、Svsecondary endpoints was OS and colostomy-free survivalMethodsvCCR standard: after CRT 8 weeks or morevabsence of residual ulceration, stenosis, or mass within the rectum during digital rectal examination and endoscopic examinationMethodsv259 patients from a tertiary cancer centre in Manchester, UK

5、 between Jan 14, 2011 and April 15, 2013vCCR-wait-and-see policy group(31)vNCCR-surgical resection(228)Methodsv 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)Methods

6、v preoperative chemoradiotherapy:45 Gy in 25 daily fractions with concurrent fluoropyrimidine-based chemotherapy for 34 daysMethodsvData include:v T and N stages (MRI)v Sex, age, BMIv Smoking status, performance statusv Baseline CEAv Histological gradev Height from anal vergeMethodsvStatistical anal

7、ysisvcontinuous variables-Kruskal-Wallis and Wilcoxon signed-rank testsvcategorical variables- and McNamara testsvP valueResultsvMedian 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)ResultsResults

8、v 31 underwent subsequent salvage surgery T and N stages 5 ypT1, 10 ypT2, 16 ypT3 24 ypN0, 6 ypN1, 1 ypN2ResultsResultsResultsDiscussionva new oncological endpoint-non-regrowth disease-free survivalvthe first time- colostomy-free survival(1/4 CCR avoid colostomy)DiscussionvTwo additional findingvabo

9、ut 2/3 node positive assessed by MRI, but did not affect subsequent endpoints v9% (CCR) did not receive preoperative chemotherapy and its absence did not affect study endpoints Discussionv 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 waitDiscussionvStrengths 1.largest reported cohort outside 2. from several treatment centres 3. a standardised defi nitionCCR Future PerspectivesvNeed a prospective randomized controlled trialvuniform standards for the de