1. 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

2. 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

3. 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

4. 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

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

6. 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

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

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

9. 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

10. 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

11. 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

12. 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

13. Complications
Pettersson Br J Surg 2010

14. Surgical Complications
Pettersson Br J Surg 2010

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

16. 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

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

18. 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