Avastin - Abstract 602: Preliminary safety of bevacizumab with first-line FOLFOX, CAPOX, FOLFIRI and Capecitabine for mCRC - First BEATrial
Citation: European Journal of Cancer Supplements Volume 3, No. 2, October 2005, Page 168
V. Georgoulias1, S. Berry2, M. Di Bartolomeo3, A. Kretzschmar4, M. Michael5, F. Rivera6, M.A. Mazier7, B. Lutiger8, E. VanCutsem9, D. Cunningham10
1University General Hospital of Heraklion, Department of Medical Oncology, Heraklion, Crete, Greece
2Toronto-Sunnybrook Regional Cancer Centre, Medical Oncology, Toronto, Canada
3Istituto Nazionale per lo Studio e la Cura dei Tumori, Division of Medical Oncology Unit 2, Milano, Italy
4HELIOS-Klinikum Berlin, Robert Rössle Klinik der Charité, Berlin, Germany
5Peter MacCallum Cancer Institute, Dept Haematology and Medical Oncology, Melbourne, Australia
6Hospital "M. Valdecilla", Sv Oncología Médica, Santander, Spain
7Parexel, Statistics Department, Paris, France
8F. Hoffmann-La Roche, Basel, Switzerland
9University Hospital Gasthuisberg, Digestive Oncology Unit, Leuven, Belgium
10Royal Marsden Hospital, Sutton, UK
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).
Safety data from controlled BEV trials have been described, and indicate that certain serious adverse events (SAE), primarily gastrointestinal (GI) perforations and arterial thromboembolic events (TE) occurred more often in pts who received CT with BEV than those who received CT alone.
First BEAT was opened to evaluate safety events of BEV in a broader pt population using a variety of CT regimens.
Methods and material:
First BEAT started in June 2004 and aims to enrol up to 2000 mCRC pts globally.
Eligible pts starting with first-line CT (choice of CT is at the physician's discretion) are 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]).
SAEs include deaths, new and prolonged hospitalizations, life-threatening as well as medically significant events.
BEV-related (investigators' assessment) SAE's and survival are reported as information becomes available (24 hours).
Results:
By May 17, 2005, 951 pts had been enrolled in 32 countries.
606/951 pts (male 58%; median age 60 years [31% were >65 years]; PS 0–1 99%) had data for baseline analyses.
Median follow-up was 4.1 months (mean 4.4); 522 pts had been followed-up for >60 days.
The most common first-line CT regimens used with BEV were FOLFOX (27%), CAPOX (20%), FOLFIRI (18%) and capecitabine (7%).
Among the 942 pts that had started treatment with BEV,
257 SAEs were reported in 161 pts including 31 deaths.
60-day mortality was 2.1%.
67 BEV related SAEs, including 8 deaths (†), were reported in 57 (6%) pts.
The related SAE included 13 venous TE, 7 (2†) pulmonary embolism, 6 (1†) GI perforation, 6 (1†) bleeding, 6 diarrhea, 5 abdominal pain, 5 arterial TE, 3 fever, 2 hypertension, 1 GI inflammation, 1 peptic oesophagitis, 1 (1†) mucositis with peritonitis/sepsis, 1 (1†) ileus, 1 (1†) sudden death, 1 (1†) cardiac arrest, 1 abscess, 1 cardiac palpitation, 1 dyspnea, 1 allergic reaction, 1 surgery and 1 rigors.
Conclusions:
In this ongoing, large community-based study, the safety profile of BEV in first line mCRC pts receiving a variety of CT regimens, namely FOLFOX, CAPOX, FOLFIRI and capecitabine, appears consistent with that observed in the pivotal trial.
Updated safety data (including additional SAEs) will be presented.
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