Combination of bevacizumab and 2-weekly pegylated liposomal doxorubicin as first-line therapy for locally recurrent or metastatic breast cancer. A multicenter, single-arm phase II trial (SAKK 24/06).

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Serval ID
serval:BIB_C1E1D436CEC3
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Combination of bevacizumab and 2-weekly pegylated liposomal doxorubicin as first-line therapy for locally recurrent or metastatic breast cancer. A multicenter, single-arm phase II trial (SAKK 24/06).
Journal
Annals of Oncology
Author(s)
Rochlitz C., Ruhstaller T., Lerch S., Spirig C., Huober J., Suter T., Bühlmann M., Fehr M., Schönenberger A., von Moos R., Winterhalder R., Rauch D., Müller A., Mannhart-Harms M., Herrmann R., Cliffe B., Mayer M., Zaman K.
Working group(s)
Swiss Group for Clinical Cancer Research (SAKK)
ISSN
1569-8041 (Electronic)
ISSN-L
0923-7534
Publication state
Published
Issued date
2011
Volume
22
Number
1
Pages
80-85
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Abstract
BACKGROUND: Pegylated liposomal doxorubicin (PLD) and bevacizumab are active agents in the treatment of metastatic breast cancer (MBC). We carried out a multicenter, single-arm phase II trial to evaluate the toxicity and efficacy of PLD and bevacizumab as first-line treatment in MBC patients. METHODS: Bevacizumab (10 mg/kg) and PLD (20 mg/m(2)) were infused on days 1 and 15 of a 4-week cycle for a maximum of six cycles. Thereafter, bevacizumab monotherapy was continued at the same dose until progression or toxicity. The primary objective was safety and tolerability, and the secondary objective was to evaluate efficacy of the combination. RESULTS: Thirty-nine of 43 patients were assessable for the primary end point. Eighteen of 39 patients (46%, 95% confidence interval 30% to 63%) had a grade 3 toxicity. Sixteen (41%) had grade 3 palmar-plantar erythrodysesthesia, one had grade 3 mucositis, and one severe cardiotoxicity. Secondary end point of overall response rate among 43 assessable patients was 21%. CONCLUSIONS: In this nonrandomized single-arm trial, the combination of bimonthly PLD and bevacizumab in locally recurrent and MBC patients demonstrated higher than anticipated toxicity while exhibiting only modest activity. Based on these results, we would not consider this combination for further investigation in this setting.
Pubmed
Web of science
Open Access
Yes
Create date
25/08/2010 12:49
Last modification date
25/09/2019 6:10
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