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1/03/2016
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BV in (neo-)adjuvant setting: overview
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A review of trials of bevacizumab in CRT schedules
showed a pooled pCR rate of 19.6% with up to 36%
post-op wound complications
•
No definitive signal of improved efficacy (lack of
phase III)
•
Long-term outcomes (DFS, OS) might be better
influenced by intensification of adjuvant thx
39
Glynne-Jones J Gastrointest Oncol 2013
AXEBeam study
•
Study design
40
PRIMARY ENDPOINT
•
Pathological complete response rate (pCR) > 20% (8/40) in
Arm A
Eligible
Patients
(n=84)
Randomization
ARM A
A 5 mg/kg q2wk
E 50 mg/m2 qwk
X 825 mg/m2 bid qd5d
RT 1.8 Gy qd5d
ARM B
A 5 mg/kg q2wk
X 825 mg/m2 bid qd5d
RT 1.8 Gy qd5d
TME surgery
4-8 wks of safety FU
then regular FU
Baseline
max 3 wks
2+5 wks
6-8 wks
Study ends 30 days
after TME
FU 5 yrs for disease
and survival status
SECONDARY ENDPOINTS
•
R0 and negative CRM resection rate
•
Surgical complication rate at 1 mth
•
Toxicity (CTCAE version 3.0)
•
Recurrence rates at 3 and 5 yrs
•
DFS and OS at 3 and 5 yrs