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PublishChester Flynn Modified over 9 years ago
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CR07 results and informed patient consent David Sebag-Montefiore Leeds Cancer Centre
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N=1350 Clinically operable adenocarcinoma of the rectum <15cm from anal verge; no metastases Adjuvant chemotherapy given as per local policy POST Post-op CRT 45Gy / 25F + concurrent 5FU PRE Pre-operative RT 25Gy / 5F Surgery Pathology Surgery Pathology CRM-ve CRM+ve No RT Trial Design
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LR by treatment (ITT) 100 676594457333214115 POST 0 10 20 30 40 50 60 70 80 90 012345 Time (years) LR rate (%) At risk: 674587475338236134 PRE N Events3yr LR 5yr LR PRE67427 4% 5% POST6767110% 15% HR(95%CI)=2.50(1.66, 3.72) p<0.0001
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676557414309196109 POST DFS Rate (%) 0 10 20 30 40 50 60 70 80 90 100 Time (years) 012345 At risk: 674556436312219126 PRE N Events 3yr 5yr PRE674147 77% 73% POST676188 73% 65% HR(95%CI)=1.30 (1.05, 1.61) p=0.0154 DFS by treatment (ITT)
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100 676608484359232121 POST 0 10 20 30 40 50 60 70 80 90 012345 Time (years) Survival (%) 674593484343239136 PRE N Events 3yr OS 5yr OS PRE674153 81% 71% POST676173 80% 66% HR(95%CI)=1.12(0.90, 1.40) p=0.2886 Survival by treatment arm (ITT)
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Subset analyses Treatment effect for:- Low mid and upper rectum Anterior resection and APER By stage (increased difference with higher stage Irrespective of plane of surgery achieved
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Bowel problems Worse Better
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Sexual problems Worse Better
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Informed patient consent Clinical oncologist required! Planned operation important Perineal wound re APER Bowel funnction re AR Erectile dysfunction Sterility Small bowel stricture Pelvic insufficiency fractures
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Three key issues Pre-operative radiotherapy works – the question is where to define the threshold where radiotherapy is considered If surgery first and node positive (irrespective of margin status), post- operative chemoradiation should be considered Radiation causes late toxicity
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LR by stage III N3 yr5 yr PRE2529.0%10.2% POST27117.4%25.6% p=0.008
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LR for node +ve CRM -ve N3 yr5 yr PRE2146.7%8.2% POST22117.1%24.5% p=0.0039
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Which patients not to treat? T1/2 N0 CRM -ve T3++/T4 CRM +ve NNT= 18 X
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Which patients to treat? T1/2 N0 CRM -ve T3++/T4 CRM +ve T3/4 Tany N0 N+ CRM -ve NNT= 9
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Which patients to treat? T1/2 N0 CRM -ve T3++/T4 CRM +ve Tany N+ve CRM -ve NNT= 6
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Different scenarios T1/2 N0 CRM -ve T3++/T4 CRM +ve CRT S SCPRT >2mm T3/N+ CRM-ve>5mm T3/N+ CRM-ve
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LN+ rate by extramural spread of T 3 tumours (YCN data) n=4731 N=1948 N=1279 N=786N=718 41%59% 32% 68%
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Use of radiotherapy according to selection criteria used for T3 tumours >2mm cut off>5mm cut off PrePostPrePost SCPRT5932 Receive SCPRT5630
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Use of radiotherapy according to selection criteria used for T3 tumours >2mm cut off>5mm cut off PrePostPrePost SCPRT5932 Receive SCPRT5630 Surgery first4168 LN+ve1323 Receive post-op CRT916
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Use of radiotherapy according to selection criteria used for T3 tumours >2mm cut off>5mm cut off PrePostPrePost SCPRT5932 Receive SCPRT5630 Surgery first4168 LN+ve1323 Receive post-op CRT916 RT courses6548 RT fractions505400
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Yorkshire audit Network agreed MRI reporting proforma Includes the MRI T stage and N stage SCPRT criteria to agree (predicted CRM-ve) >2mm or 5mm (unit policy) N+ Document if SCPRT given or reasons why not given Histopathology
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Conclusion Identify patients without threatened margins at significant risk of LR There is not a definitive answer! Share practice Prospective audit
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Some need 5x5 in the middle! Its chemorads or nothing!
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