Artikel
Incidence of gastrointestinal perforations (GI perf) and bleeding in patients starting bevacizumab treatment in first-line metastatic Colorectal cancer (mCRC) without primary tumour resection – Preliminary results from the First BEATrial
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Autoren
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Albrecht Kretzschmar
- HELIOS-Klinikum, Charité, Campus Berlin-Buch, Deutschland
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Erika Kettner
- Städt. Klinikum, Magdeburg
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Joachim Preiss
- Caritas Kliniken, Saarbrücken
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Werner Freier
- Praxis, Hildesheim
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Tanja Trarbach
- Westdeutsches Tumorzentrum, Essen
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Peter Thuss-Patience
- Charité, Campus Virchow-Klinikum, Berlin
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Peter Reichardt
- HELIOS-Klinikum, Charité, Campus Berlin-Buch
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Eric Van Cutsem
- University Hospital Gasthuisberg, Leuven, Belgien
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Beatrix Lutiger
- Hoffmann-La Roche Ltd., Basel, Switzerland
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David Cunningham
- Royal Marsden Hospital, Surrey, UK
| Veröffentlicht: | 20. März 2006 |
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Gliederung
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Background: In a phase III pivotal trial in patients (pts) with mCRC, bevacizumab (BEV) increased overall survival by 30% when added to first-line irinotecan, 5FU (bolus) and leucovorin (IFL). In this study, there was no significant difference in the incidence of grade 3/4 bleeding between IFL plus BEV (3.1%) as compared to the IFL plus placebo (2.5%). 1,5 % of pts in the BEV-arm suffered GI perf. However, no data was reported on the subset of pts with primary tumours left in situ (PTIS). First BEAT was opened to evaluate safety events of BEV in a broader pt population using a variety of CT regimens.
Methods: First BEAT started in June 2004 and aims to enrol up to 2000 mCRC pts. Eligible patients starting with first-line CT are treated until progression with BEV (5mg/kg q2w (5FU based CT) or 7.5mg/kg q2w (Capecitabine (CAP) based CT). At protocol visits, bleeding and gastrointestinal (GI) perforation data was collected according to CTC AE grading (v3.0). In addition, serious adverse events were to be collected within 24 hours of occurrence. Incidence af GI perf and bleeding in all pts and in pts with PTIS is to be compared.
Results: In Fall 2005 1198 pts (male 58%; median age 60 years [30% were > 65 years]; PS 0-1 99%) had baseline data available for analyses. 14% had no surgical resection. In these 164 pts, primary disease was in 57% colon only, 36% rectum only, 7% rectum and colon. Median time from diagnosis to first BEV was 1.7 months. Single organ metastases were reported in 48% (35% liver, 3% lung, 4% loco-regional, 5% other). 3% had surgical resection of metastatic disease and 12% had a stoma in place. The most common first-line CT regimens used with BEV were FOLFOX (23%), CAPOX (23%), FOLFIRI (23%).The 1198 / 164 pts had a median follow-up of 5.6 / 4.6 months, respectively. In 1% of all pts and 1/164 with PTIS serious GI bleeding was reported . GI perf. were reported in 1% of all pts, and in 3% (5/164) of PTIS of those 2 perforations were at the site of the PTIS. Updated safety data will be available in early 2006 and circumstances and locations of perforations as well as response of PTIS to CT plus BEV will be reviewed.
Conclusions: Preliminary analyses of BEV treatment in a the subgroup of 164 pts without resection of the primary tumour suggest no added risk so far.
