Sebag-Montefiore et al., ASCO 2006

@ 3yPreop. RT

+ OP(n=674)

OP + RCT in CRM +(n=676)

Hazard-Ratio

(95%CI)

Local recurence 4.7% 11.1%2.5

(1.61-3.79)

Disease free survival

79.5% 74.9%1.31

(1.02-1.67)

Overall survival 80.8% 78.7%1.25

(0.98-1.59)

MRC CR07: 5x5 TME vs. TME RCT in CRM+

CAO/ARO/AIO-94

TMETME

TMETME

RR

Sauer et al. N Eng J Med 2004

823 patients

Primary endpoint: overall survival

(4 cycles)

(4 cycles)

Local recurrence rate

FFCD 9203

SS

SS

RR(4 Zyklen)

(4 Zyklen)

Gerard et al. J Clin Oncol 2006, ASCO 2005

Primary endpoint: overall survival

733 patients

TME not routine

Local recurrence rate

EORTC 22921

Bosset et al. N Eng J Med 2006Primary endpoint: overall survival

SS

SS

RR

(4 cycles)

(4 cycles)

1011 patients

SS

SS

(years)0 2 4 6 8 10 12

0

10

20

30

40

50

60

70

80

90

100

Adj. CT vs no Adj CT: p=0.1187

No Adj CT

Adj CT

5-year OS (95%CI)

63.2 (58.3, 68.1)

67.2 (62.7, 71.8)

Disease free survival @ 5 yrs. Overall survival @ 5 yrs.

Bosset et al., NEJM 2006

EORTC Study: Role of adjuvant Chemotherapy

EORTC 22921

Bosset et al. N Eng J Med 2006

Lokal recurrence rate

SS

SS

RR

(4 cycles)

(4 cycles)

1011 patients

SS

SS

TME in 37%

Collette, J Clin Oncol 2007

EORTC-Studie 22921 Rolle der adjuvanten Chemotherapie

local failurevs.

distant mets. vs.

5y OSvs.

FFCD JCO 2006

RT vs. RChT

16% 8% 36% 38% 66% 67%

EORTC NEJM 2006

RT vs. RChT

17% 9% 32% 35% 65% 65%

AIO/CAO/ARO NEJM 2004

Pre vs. post

13% 6% 36% 38% 74% 76%*

Marijnen ASCO GI 2005

5x5 11% 6% n.a. 63% 64%

PreOP trials: Patterns of failure

Despite significant reduction of local relapse, no influence on distant mets. and survival observed

Improvement of chemorad ?

Improvement of adjuvant Chemotherapy!