FINAL_Reinacher_Abstract 4030_formatiert - Medizin-telegramm.com

Title:
Activity of the combination of bevacizumab (Bev) with capecitabine/irinotecan
(CapIri/Bev) or capecitabine/oxaliplatin (CapOx/Bev) in advanced colorectal cancer
(ACRC): A randomized phase II study of the AIO Colorectal Study Group (AIO trial 0604).
Citation:
J Clin Oncol 26: 2008 (May 20 suppl; abstr 4030)
Author(s):
A. C. Reinacher-Schick, S. Kubicka, W. Freier, D. Arnold, G. Dietrich, M. Geissler,
S. Hegewisch-Becker, U. Graeven, H. Schmoll, W. Schmiegel. Ruhr University Bochum,
Bochum, Germany
Background:
The combination of Bev with 5-FU/FA and irinotecan or oxaliplatin is highly active in
ACRC. A recent phase III trial demonstrated that infusional 5-FU and capecitabine (cape)
have comparable efficacy when combined with oxaliplatin and Bev (Cassidy et al. 2007).
In contrast, data are heterogeneous for cape/irinotecan combinations. This randomized
phase II trial compared safety and efficacy of Bev with either CapOx or CapIri as first line
therapy in ACRC.
Methods:
Prerequisites were: untreated ACRC, ECOG PS

Results:
From July 2005 to Oct 2006, 255 patients (pts) were randomised. Patient characteristics
(arm A/B): Median age 64/65 yrs, male 67%/68%, ECOG 0/1/2 52/45/3% and 52/45/2%,
colon 60%/64%, rectum 40%/36%, respectively. Data are available for 244 (124/120) pts.
Treatment characteristics (arm A/B): A total of 965/1069 cycles (median 8/9 cycles) have
been administered. For 198 pts the end of treatment has been documented: 34%
(30%/38%) due to progression, 29% (41%/18%) due to toxicity, 20% (16%/24%) because
of pts' decision. Most common CTC gr. 3/4 toxicities of pts, arm A/B: Diarrhea 19%/15%,
hand-foot-syndrome 10%/7%, peripheral neuropathy 23%/0% Tumor response rates
(CR+PR) were 54%/55%, tumor control rates (incl. SD) were 79%/80%. PFS rate at 6 mos
were 78%/84%, median PFS 9.9/12.5 mos.
Conclusions:
Both regimen are highly active and safe. The absence of neuropathy favours the
CapIri/Bev combination. Interestingly, the dose reduction of CapIri seemingly improves
tolerability without compromising efficacy.