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1、Watch 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 1 v2004 10 Annals of Surgery Habr Gama eg v265 patients with distal rectal were treat
2、ed by CRT with 5 FU Leucovorin and 5040 cGy v Five year OS and DFS rates were 88 and 83 in Resection Group 100 and 92 in Observation Group 2 Purpose voncological outcomes between watch and wait and surgical resection vthe safety of the watch and wait 3 The definition of a cCR v 1 substantial downsiz
3、ing 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 digit
4、al rectal examination 4 Methods vone to one paired cohorts of watch and wait versus surgical resection using propensity score matching T stage age and performance status vprimary endpoint was DFS vsecondary endpoints was OS and colostomy free survival 5 Methods vCCR standard after CRT 8 weeks or mor
5、e vabsence of residual ulceration stenosis or mass within the rectum during digital rectal examination and endoscopic examination 6 Methods v259 patients from a tertiary cancer centre in Manchester UK between Jan 14 2011 and April 15 2013 vCCR wait and see policy group 31 vNCCR surgical resection 22
6、8 7 Methods v 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 8 Methods v preoperative chemoradiotherapy 45 Gy in 25 daily fractions with concurrent fluoropyrimidine based ch
7、emotherapy for 34 days 9 Methods vData include v T and N stages MRI v Sex age BMI v Smoking status performance status v Baseline CEA v Histological grade v Height from anal verge 10 Methods vStatistical analysis vcontinuous variables Kruskal Wallis and Wilcoxon signed rank tests vcategorical variabl
8、es and McNamara tests vP value 11 12 13 14 Results vMedian follow up of 33 months IQR 19 43 v44 129 patients had local regrowths 42 patients had mucosal lesions 2 patient had submucosal or mesorectal lesions 15 Results 16 Results v 31 underwent subsequent salvage surgery T and N stages 5 ypT1 10 ypT
9、2 16 ypT3 24 ypN0 6 ypN1 1 ypN2 17 Results 18 Results 19 Results 20 Discussion va new oncological endpoint non regrowth disease free survival vthe first time colostomy free survival 1 4 CCR avoid colostomy 21 Discussion vTwo additional finding vabout 2 3 node positive assessed by MRI but did not aff
10、ect subsequent endpoints v9 CCR did not receive preoperative chemotherapy and its absence did not affect study endpoints 22 Discussion v 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 w
11、ait 23 Discussion vStrengths 1 largest reported cohort outside 2 from several treatment centres 3 a standardised defi nition CCR 24 Future Perspectives vNeed a prospective randomized controlled trial vuniform standards for the definition of a cCR v The proposed selection criteria and follow up can be used in future trials aimed at providing more evidence on the wait and see policy 25 26
