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Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer

PURPOSE: The efficacy and safety of combining bevacizumab (7.5 and 15 mg/kg) with docetaxel as first-line therapy for human epidermal growth factor receptor 2 (HER2) -negative, locally recurrent or metastatic breast cancer (MBC) was investigated in a three-arm, placebo-controlled, phase III trial. -...

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Main Authors: Miles, David W. (Author) , Chan, Arlene (Author) , Dirix, Luc Y. (Author) , Cortés, Javier (Author) , Pivot, Xavier (Author) , Tomczak, Piotr (Author) , Delozier, Thierry (Author) , Sohn, Joo Hyuk (Author) , Provencher, Louise (Author) , Puglisi, Fabio (Author) , Harbeck, Nadia (Author) , Steger, Guenther G. (Author) , Schneeweiss, Andreas (Author) , Wardley, Andrew M. (Author) , Chlistalla, Andreas (Author) , Romieu, Gilles (Author)
Format: Article (Journal)
Language:English
Published: July 10 2010
In: Journal of clinical oncology
Year: 2010, Volume: 28, Issue: 20, Pages: 3239-3247
ISSN:1527-7755
Online Access:Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2008.21.6457
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Author Notes:David W. Miles, Arlene Chan, Luc Y. Dirix, Javier Cortés, Xavier Pivot, Piotr Tomczak, Thierry Delozier, Joo Hyuk Sohn, Louise Provencher, Fabio Puglisi, Nadia Harbeck, Guenther G. Steger, Andreas Schneeweiss, Andrew M. Wardley, Andreas Chlistalla, and Gilles Romieu
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Summary:PURPOSE: The efficacy and safety of combining bevacizumab (7.5 and 15 mg/kg) with docetaxel as first-line therapy for human epidermal growth factor receptor 2 (HER2) -negative, locally recurrent or metastatic breast cancer (MBC) was investigated in a three-arm, placebo-controlled, phase III trial. - PATIENTS AND METHODS: Patients (N = 736) were randomly assigned to docetaxel 100 mg/m(2) plus either placebo or bevacizumab 7.5 or 15 mg/kg every 3 weeks. The primary end point was progression-free survival (PFS); secondary end points included best overall response, duration of response, time to treatment failure, overall survival, and safety. - RESULTS: Combination of bevacizumab 15 mg/kg, but not 7.5 mg/kg, with docetaxel showed superior median PFS (mPFS) to placebo plus docetaxel in unstratified analysis (placebo mPFS, 8.2 months; 7.5 mg/kg mPFS, 9.0 months [hazard ratio (HR), 0.86; P = .12]; 15 mg/kg mPFS, 10.1 months [HR, 0.77; P = .006]) and stratified analysis (placebo mPFS, 8.1 months; 7.5 mg/kg mPFS, 9.0 months [HR, 0.80; P = .045]; 15 mg/kg mPFS, 10.0 months [HR, 0.67; P < .001]). Response rates in patients with measurable disease at baseline also increased with bevacizumab 15 mg/kg (46% [placebo] v 55% [7.5 mg/kg; P = .07] and 64% [15 mg/kg; P < .001]). Combination with bevacizumab had limited impact on the known toxicity profile of docetaxel. - CONCLUSION: Combination of bevacizumab with docetaxel did not significantly impact on the safety profile of docetaxel. Bevacizumab 15 mg/kg every 3 weeks significantly increased PFS when combined with docetaxel as first-line therapy for MBC compared with docetaxel plus placebo.
Item Description:Gesehen am 26.04.2023
Physical Description:Online Resource
ISSN:1527-7755

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