In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 15_suppl ( 2009-05-20), p. e15057-e15057
Abstract:
e15057 Background: BV prolongs overall survival (OS) and progression-free survival (PFS) when added to standard CT for patients (pts) with mCRC. After approval of BV in Germany in 01/05, this observational cohort study was initiated in pts receiving BV with various first-line CT regimens to evaluate safety events and effectiveness. Methods: To facilitate and evaluate enrollment of a typical mCRC population, eligibility criteria were minimized. Choice of the CT regimen was at physician´s discretion, but influenced by the current registration status. Predefined endpoints were treatment characteristics, response rate (RR), PFS, OS, and adverse events assessed as potentially related to the treatment (AERT) or as severe (SAE). Pts are followed for up to 4 years, and clinical data were updated every cycle (2–4 weeks). Results: 1,300 pts were enrolled at 261 sites from 01/05 through 06/08; abstract data cutoff date was 11/24/08. Median age: 64 (range 19–100) years, 〉 70 years.: 25%; male 63%; ECOG PS status 0–1/2/ 〉 2 88%/11%/1%. CT choice was fluoropyrimidine (FU)/BV alone (any 5-FU or capecitabine) 12%; FU/BV/oxaliplatin 18%; FU/BV/irinotecan 69%; other 1%. Median treatment duration with BV was 7.4 (range 0–28) months; duration 〉 10 months 21%. 60-day mortality was 4.0%. In total, 183 AERT were reported in 10% of pts., most commonly diarrhea (34 AERT), nausea (26) and hypertension (18). Reported SAE were deep venous TE in 0.8% of pts, bleeding 1.2%, pulmonary embolism 0.5%, arterial TE 0.4%. Best investigator- assessed RR was 59% (CR 10%, PR 49%; all pts) with 64% for FU/BV/oxaliplatin, 59% for FU/BV/irinotecan and 53% for FU/BV alone. Conclusions: The safety profile of BV in this population of mCRC pts with different CT regimens appears consistent with that observed in the other reports like BRiTE or first BEATrial. RR in this preliminary dataset are higher than that reported in the randomized controlled trials, but likely biased by the methodology of evaluation. However, activity with FU/BV alone was surprisingly high. Updated efficacy data including PFS will be presented. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2009.27.15_suppl.e15057
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2009
detail.hit.zdb_id:
2005181-5
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