Christopher Crane, MD Professor, Dept of Radiation Oncology

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Presentation transcript:

Christopher Crane, MD Professor, Dept of Radiation Oncology Short Course RT for Rectal Cancer: Safe, Effective, Cost Effective, and Efficient Christopher Crane, MD Professor, Dept of Radiation Oncology

Swedish Rectal Cancer Trial 1168 patients randomized to Surgery alone Preop RT (5 Gy X 5) + Surgery Median follow-up 13 yrs LR CSS OS Surgery alone 26 62 30 Pre-op RT + Surgery 9 72 38 P <.001 .03 .008 N+ patients: (23 v 43%, p<.001) P=NS >10cm from the AV Folkesson JCO 2005

Dutch TME Trial 5 x 5 Gy / TME vs TME 1861 patients randomized to TME alone Pre-op RT (5 Gy X 5) + TME Median follow-up 12 yrs RT decreased LR and overall recurrence 10 yr LR: 5% vs. 11% (P<0.001) R0/R1 resection (n=1652): Any recurrence: 26% vs 32% (p =0.03) OS p=NS Kapiteijn NEJM 2001 vanGijn Lancet Oncology2011

Dutch TME Trial Pre-planned subset analyses CRM negative (n=1382) LR: 3% vs 9% (P<0.0001) Any recurrence 20 vs 27% (p=0.01) DSS 83% vs 78% (p=0.04) Node+ with CRM negative (n=435) LR: 5% vs 17% (P<0.0001) OS: 50% vs 40% (p=0.032) No local control benefit >10cm from AV 1.3% vs 3.8%, p=ns Kapiteijn NEJM 2001 vanGijn Lancet Oncology2011

Late Side Effects: Dutch TME Trial Median F/U 5.1 yrs Peeters JCO 2005

MRC CR07 1350 pts randomized to Pre-op RT decreased LR Pre-op 5 Gy X 5 Post-op chemo-RT, only if CRM + (8%) Pre-op RT decreased LR 11% vs. 4%, P<0.0001 Pre-op RT improved DFS 72% vs. 78%, P=0.013 Sebag-Montefiore Lancet 2009

Late Side Effects: MRC CR07 Trial Bowel function Overall Fecal incontinence “Quite a bit and very much” differences were minimal Stephens JCO 2010

Short Course vs. Long Course: Randomized Trials Polish Trial TROG Trial Stockholm III

Polish Trial 316 patients randomized to 5 Gy X 5  Surgery in 1 wk 50.4 Gy + 5FU/LV  Surgery after 4-6 wks Increased path response with chemo-RT Path CR 16% vs 1% Lower T and N stage, lower rate of positive RM No diff in sphincter preservation No sig diff in LC, DFS, OS 4-yr LR 10.6% vs 15.6% (P=0.21) No sig diff in QoL, anorectal / sexual function Bujko Br J Surg 2006 Pietrzak Radiother Oncol 2007

TROG Trial 326 pts,T3Nx, randomized to 5 Gy X 5  Surgery in 1 wk  5-FU/LV X 6 50.4 Gy + CI 5-FU  Surgery in 4-6 wks  5-FU/LV X 4 Powered to detect 15% vs 5% difference in 3 yr LR 27 Australian and New Zealand centers Median follow-up 5.9 yrs Ngan ASCO 2010

TROG Trial: Results Short Course Long Course P 3-yr LR 7.5% 4.4% 0.24 5-yr DRFS 72% 69% 0.85 5-yr OS 74% 70% 0.56 G3-4 Late Tox 7.6% 8.8% 0.84 Ngan ASCO 2010

Stockholm III Patients randomized to Selective randomization 5 Gy X 5  Surgery in 1 wk 5 Gy X 5  Surgery after 4-8 wks 50 Gy  Surgery after 4-8 wks Selective randomization Accrual goal 840 Planned interim analysis on 303 pts Pettersson Br J Surg 2010

Complications Pettersson Br J Surg 2010

Surgical Complications Pettersson Br J Surg 2010

RT-Surgery Interval 5 X 5Gy pts only (39%) (65%) (33%) Pettersson Br J Surg 2010

Why no Short Course in the US? Is $$ the reason? People use 1 wk regimens SBRT: 5 fx/1 week (lung, liver) “SBRT” 32 Gy/5x is fashionable in PanCa Popular regimens (reimbursement 3x-$$) Answer is in the economics 5 x 5Gy to the whole pelvis is not “SBRT” Charges long course: 5x higher

Is 5 x5Gy the Future? Increased demand for care Contracted resources Efficiency will need to increase Bundled care plans

Summary Short Course RT 25Gy/5fx Effective Multiple randomized trials demonstrate role for short course RT Safe Late side effects not clearly a concern Cost effective Convenient