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

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 (...

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Vydáno v:	Journal of clinical oncology Ročník 28; číslo 20; s. 3239
Hlavní autoři:	Miles, David W, Chan, Arlene, Dirix, Luc Y, Cortés, Javier, Pivot, Xavier, Tomczak, Piotr, Delozier, Thierry, Sohn, Joo Hyuk, Provencher, Louise, Puglisi, Fabio, Harbeck, Nadia, Steger, Guenther G, Schneeweiss, Andreas, Wardley, Andrew M, Chlistalla, Andreas, Romieu, Gilles
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States 10.07.2010
Témata:	Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Bevacizumab Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Breast Neoplasms - pathology Drug Administration Schedule Female Humans Middle Aged Neoplasm Metastasis Neoplasm Recurrence, Local - drug therapy Placebos - administration & dosage Receptor, Epidermal Growth Factor - metabolism Taxoids - administration & dosage
ISSN:	1527-7755, 1527-7755
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Popis
Shrnutí:	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 (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. 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. 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.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3
ISSN:	1527-7755 1527-7755
DOI:	10.1200/JCO.2008.21.6457