1、直腸癌放化療后等待觀察策略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第一頁，共二十六頁。直腸癌放化療后等待觀察策略v2004.10 ,Annals of Surgery,Habr-Gama.egv265 p

2、atients 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 Group第二頁，共二十六頁。直腸癌放化療后等待觀察策略Purposevoncological outcomes between watch and wait and surgical resection vthe safety of the wat

3、ch-and-wait 第三頁，共二十六頁。直腸癌放化療后等待觀察策略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 from the scar

4、, ulcer, or former tumor location v (5) no palpable tumor, when initially palpable with digital rectal examination 第四頁，共二十六頁。直腸癌放化療后等待觀察策略Methodsvone-to-one paired cohorts of watch and wait versus surgical resection using propensity-score matching（ T stage, age, and performance status）vprimary endpo

5、int was DFSvsecondary endpoints was OS and colostomy-free survival第五頁，共二十六頁。直腸癌放化療后等待觀察策略MethodsvCCR standard: after CRT 8 weeks or morevabsence of residual ulceration, stenosis, or mass within the rectum during digital rectal examination and endoscopic examination第六頁，共二十六頁。直腸癌放化療后等待觀察策略Methodsv259

6、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)第七頁，共二十六頁。直腸癌放化療后等待觀察策略Methodsv three neighbouring UK regional cancer centres(Lancashire and South Cumbria, Merseyside and Cheshire, and nort

7、h Wales) March 10, 2005, and Jan 21, 2015- wait-and-see policy group(98)第八頁，共二十六頁。直腸癌放化療后等待觀察策略Methodsv preoperative chemoradiotherapy:45 Gy in 25 daily fractions with concurrent fluoropyrimidine-based chemotherapy for 34 days第九頁，共二十六頁。直腸癌放化療后等待觀察策略MethodsvData include:v T and N stages (MRI)v Sex, a

8、ge, BMIv Smoking status, performance statusv Baseline CEAv Histological gradev Height from anal verge第十頁，共二十六頁。直腸癌放化療后等待觀察策略MethodsvStatistical analysisvcontinuous variables-Kruskal-Wallis and Wilcoxon signed-rank testsvcategorical variables- and McNamara testsvP value第十一頁，共二十六頁。直腸癌放化療后等待觀察策略第十二頁，共二

9、十六頁。直腸癌放化療后等待觀察策略第十三頁，共二十六頁。直腸癌放化療后等待觀察策略第十四頁，共二十六頁。直腸癌放化療后等待觀察策略ResultsvMedian 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)第十五頁，共二十六頁。直腸癌放化療后等待觀察策略Results第十六頁，共二十六頁。直腸癌放化療后等待觀察策略Resultsv 31 und

10、erwent subsequent salvage surgery T and N stages 5 ypT1, 10 ypT2, 16 ypT3 24 ypN0, 6 ypN1, 1 ypN2第十七頁，共二十六頁。直腸癌放化療后等待觀察策略Results第十八頁，共二十六頁。直腸癌放化療后等待觀察策略Results第十九頁，共二十六頁。直腸癌放化療后等待觀察策略Results第二十頁，共二十六頁。直腸癌放化療后等待觀察策略Discussionva new oncological endpoint-non-regrowth disease-free survivalvthe first tim

11、e- colostomy-free survival(1/4 CCR avoid colostomy)第二十一頁，共二十六頁。直腸癌放化療后等待觀察策略DiscussionvTwo additional findingvabout 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 第二十二頁，共二十六

12、頁。直腸癌放化療后等待觀察策略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 wait第二十三頁，共二十六頁。直腸癌放化療后等待觀察策略DiscussionvStrengths 1.largest reported cohort outside 2. from several treatmen

13、t centres 3. a standardised defi nitionCCR 第二十四頁，共二十六頁。直腸癌放化療后等待觀察策略Future 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第二十五頁，共二十六頁。直腸癌放化療后等待觀察策略