1. AUDIT OF DOWN-STAGING CHEMORADIATION FOR LOCALLY ADVANCED RECTAL CANCER DR J J NICOLL NORTH CUMBRIA UNIVERSITY HOSPITALS SEPTEMBER 2012

2. STANDARD Aim is to achieve complete surgical resection with Circumferential Resection Margin (CRM) >1mm Success measured as number of CRM –ve resections and number of complete pathological responses (pCR) No nationally or internationally agreed standards. Meta-analysis of trials of pre-op CRT 2524 pts – pCR 10% Retrospective data on 677 pts from 6 UK centres – CRM –ve 70%; pCR 13% Denominator uncertain, different criteria for treatment. Aim to compare with data published in 2005 from Mount Vernon & “pooled series” from 7 UK centres.

3. METHODS RT database searched for patients receiving DXT (>23 fractions) and chemotherapy first registered 2006-2010. 76 pts identified as having radical chemoradiation (CRT) for rectal cancer. Database records examined – 12 patients were excluded because treatment was post-op, palliative or given for local recurrence. Remaining 64 pts. analysed for results of down-staging CRT.

4. TREATMENT 45GY/25# to Isocentre Capecitabine 825 mg/sq.m b.d throughout DXT weekends included. Restage (CT CAP & MRI) 6-10 weeks later.

5. RESULTS 41/64 (64%) underwent attempted resection. 23/64 (36%) had no surgery.

6. REASONS FOR NO RESECTION Metastatic disease on restaging CT scan 9 ( 5 were operable by MRI criteria) Not fit for surgery 3 Records not found 4 Patient refused surgery 2 Judged still inoperable on restaging MRI scan 4 Surgery attempted but failed 1 TOTAL 23

7. RESULTS OF RESECTION (resected patients only) CRM >1-10mm 19 CRM >10 mm 11 pCR 5 (12%) Total CRM -ve 35 (85%) Total CRM involved 6 (15%) CRM +ve – no recurrence 2 CRM +ve – local recurrence 4

8. RESULTS OR TREATMENT (ALL 64 PATIENTS) OPERATED41 (64%) R0 RESECTION35 (55%) pCR5 (8%)

9. COMPARISONS- OPERATED MOUNT VERNON 200581% POOLED RESULTS 7 CENTRES 2005 80% (RANGE 61-78%) NCUH64% (72% IF NO RESTAGING)

10. COMPARISONS – RO RESECTIONS MOUNT VERNON 200580% (OF OPERATED) 65% (OF TOTAL) POOLED RESULTS 7 CENTRES 2005 79% (OF OPERATED 63% (OF TOTAL RANGE 42- 77%) NCUH85% (OF OPERATED) 55% (OF TOTAL)

11. COMPARISONS - pCR MOUNT VERNON 200512% (OF OPERATED) 10% (OF TOTAL) POOLED RESULTS 7 CENTRES 2005 2-12% (NO FURTHER DETAILS) NCUH12% (OF OPERATED) 8% (OF TOTAL)

12. NOTES Mount Vernon series (150 pts) did not repeat CT scan after CRT. 5 NCUH pts had mets on post-CRT CT scan and didn’t have surgery. No details of re-staging for “pooled series” (680 pts) MV series includes “borderline resectable” – no clear definition “Pooled series” included “locally advanced” – no definition given. We are not necessarily comparing like with like. Published series used FU/FA, not capecitabine. 4 records not found – treated as not having surgery.

13. CONCLUSIONS NCUH results are similar to two large UK series. Populations treated are similar but not strictly identical. NCUH standards are in line with other published results

14. ACTIONS Continue to offer down-staging CRT to patients identified at MDT to have threatened margins by MRI criteria. Offer suitable patients chance to participate in ARISTOTLE trial in the hope of improving results through the use of better chemotherapy.