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CR07 results and informed patient consent

CR07 results and informed patient consent. David Sebag-Montefiore Leeds Cancer Centre. PRE. Pre-operative RT 25Gy / 5F. Surgery. Pathology. Surgery. CRM-ve. CRM+ve. Pathology. No RT. Trial Design. Clinically operable adenocarcinoma of the rectum

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CR07 results and informed patient consent

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  1. CR07 results and informed patient consent David Sebag-Montefiore Leeds Cancer Centre

  2. PRE Pre-operative RT 25Gy / 5F Surgery Pathology Surgery CRM-ve CRM+ve Pathology No RT Trial Design Clinically operable adenocarcinoma of the rectum <15cm from anal verge; no metastases N=1350 POST Post-op CRT 45Gy / 25F + concurrent 5FU Adjuvant chemotherapy given as per local policy

  3. N Events 3yr LR 5yr LR PRE 674 27 4% 5% POST 676 71 10% 15% HR(95%CI)=2.50(1.66, 3.72) p<0.0001 90 80 70 60 LR rate (%) 50 40 30 20 10 0 0 1 2 3 4 5 Time (years) At risk: 674 587 475 338 236 134 PRE LR by treatment (ITT) 100 676 594 457 333 214 115 POST

  4. 100 90 80 70 60 DFS Rate (%) 50 N Events 3yr 5yr PRE 674 147 77% 73% POST 676 188 73% 65% HR(95%CI)=1.30 (1.05, 1.61) p=0.0154 40 30 20 10 0 0 1 2 3 4 5 Time (years) At risk: 674 556 436 312 219 126 PRE DFS by treatment (ITT) 676 557 414 309 196 109 POST

  5. 90 80 70 60 Survival (%) 50 N Events 3yr OS 5yr OS PRE 674 153 81% 71% POST 676 173 80% 66% HR(95%CI)=1.12(0.90, 1.40) p=0.2886 40 30 20 10 0 0 1 2 3 4 5 Time (years) 674 593 484 343 239 136 PRE Survival by treatment arm (ITT) 100 676 608 484 359 232 121 POST

  6. 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

  7. Worse Better Bowel problems

  8. Worse Better Sexual problems

  9. 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

  10. 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

  11. 100 90 80 70 60 LR rate (%) 50 40 30 20 10 0 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 Time (years) LR by stage III

  12. LR for node +ve CRM -ve

  13. T3++/T4 CRM +ve T1/2 N0 CRM -ve Which patients not to treat? X NNT= 18

  14. Which patients to treat? T3/4 Tany N0 N+ CRM -ve T3++/T4 CRM +ve T1/2 N0 CRM -ve NNT= 9

  15. Which patients to treat? Tany N+ve CRM -ve T3++/T4 CRM +ve T1/2 N0 CRM -ve NNT= 6

  16. >5mm T3/N+ CRM-ve >2mm T3/N+ CRM-ve SCPRT Different scenarios T3++/T4 CRM +ve T1/2 N0 CRM -ve S CRT

  17. 41% 59% 32% 68% LN+ rate by extramural spread of T 3 tumours (YCN data) n=4731 N=1279 N=1948 N=786 N=718

  18. Use of radiotherapy according to selection criteria used for T3 tumours

  19. Use of radiotherapy according to selection criteria used for T3 tumours

  20. Use of radiotherapy according to selection criteria used for T3 tumours

  21. 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

  22. Conclusion • Identify patients without threatened margins at significant risk of LR • There is not a definitive answer! • Share practice • Prospective audit

  23. Its chemorads or nothing! Some need 5x5 in the middle!

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