Avastin - Abstract 629: Starting bevacizumab shortly after venous access device implantation appears not to increase wound healing/bleeding complications nor catheter related thromboses - preliminary results from First BEAT
Citation: European Journal of Cancer Supplements Volume 3, No. 2, October 2005, Page 177
A. Kretzschmar1, S. Berry2, D. Cunningham3, M. Di Bartolomeo4, P.A. Kosmidis5, M. Michael6, M.E. Vegas-Villegas7, B. Lutiger8, M.A. Mazier9, E. Van Cutsem10
1HELIOS-Klinikum Berlin, Robert Rössle Klinik der Charité, Berlin, Germany
2Toronto-Sunnybrook Regional Cancer Centre, Medical Oncology, Toronto, Canada
3Royal Marsden Hospital, Sutton, UK
4Istituto Nazionale per lo Studio e la Cura dei Tumori, Division of Medical Oncology Unit 2, Milano, Italy
5Hygeia Hospital, Department of Medical Oncology, Athens, Greece
6Peter MacCallum Cancer Institute, Dept Haematology and Medical Oncology, Melbourne, Australia
7Hospital "M. Valdecilla", Sv Oncología Médica, Santander, Spain
8F. Hoffmann-La Roche, Basel, Switzerland
9Parexel, Statistics Department, Paris, France
10University Hospital Gasthuisberg, Digestive Oncology Unit, Leuven, Belgium
Background:
In a phase III pivotal trial in patients (pts) with metastatic colorectal cancer (mCRC), bevacizumab (BEV, Avastin®) increased overall survival by 30% when added to first-line IFL chemotherapy (CT).
First BEAT evaluates the safety of BEV in a broader pt population with mCRC using a variety of CT regimens.
Pts with major surgery within 28 days of first BEV dose are excluded from clinical trials.
We report here the outcome of minor surgery such as venous access device (VAD) implantation.
VADs in cancer pt are associated with a 4–6% risk of catheter related thrombosis (CRT) in the affected vein.
Material and methods:
Up to 2000 eligible pts starting with first-line mCRC CT will be treated until progression with BEV (5 mg/kg every 2 weeks [5FU based CT] or 7.5 mg/kg every 3 weeks [Capecitabine based CT]).
Formal protocol visits are scheduled every 3 months, followed by a final visit 30 days after the last BEV dose.
At these visits all wound healing (any) and bleeding complications (at VAD), as well as CRT are assessed (CTCAE, v3.0).
Results:
By May 17, 2005, 606/951 pts (male 58%; median age 60 years [31% were >65 years]; PS 0–1 99%) had data available for baseline analyses.
286/606 (47%) pts had a VAD implanted including 215 (36%) with an indwelling venous catheter and 47 (8%) with a peripheral catheter.
CT regimens used with BEV included FOLFOX (47%) and FOLFIRI (27%).
80 (13%) pts had their VAD placed 7 days prior to first BEV dose, and 36 (6%) pts 2 days prior to first BEV dose. 39/286 (14%) pts received anticoagulants/antiplatelet therapy (8% low dose aspirin, 2% warfarin, 3% LMW heparin, <1% unfractioned heparin, <1% other), which was stopped in 10 pts prior to BEV initiation.
118/286 pts have follow up data.
Wound healing complications were reported for 3 (2.5%) pts (all CTC AE grade 1; none in pts with VAD implantation within 7 days).
No bleeding at VAD wound was reported.
CRT was reported in 3 (2.5%) pts (1 CTC AE grade 2, 2 CTC AE grade 3; all in pts with VAD implantation within 7 days).
Follow-up of >300 pts is expected to be available by October 2005.
Conclusions:
BEV treatment in combination with continuous infusion CT appears safe.
CRT and bleeding at insertion site of VAD were not increased in this series.
The implantation of VAD shortly before starting BEV treatment did not result in an increased risk of wound healing complications.
The addition of BEV should not lead to delays in starting treatment after implantation of VAD.
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