Titre
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).
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Rochlitz, C.
Auteure/Auteur
Ruhstaller, T.
Auteure/Auteur
Lerch, S.
Auteure/Auteur
Spirig, C.
Auteure/Auteur
Huober, J.
Auteure/Auteur
Suter, T.
Auteure/Auteur
Bühlmann, M.
Auteure/Auteur
Fehr, M.
Auteure/Auteur
Schönenberger, A.
Auteure/Auteur
von Moos, R.
Auteure/Auteur
Winterhalder, R.
Auteure/Auteur
Rauch, D.
Auteure/Auteur
Müller, A.
Auteure/Auteur
Mannhart-Harms, M.
Auteure/Auteur
Herrmann, R.
Auteure/Auteur
Cliffe, B.
Auteure/Auteur
Mayer, M.
Auteure/Auteur
Zaman, K.
Auteure/Auteur
Groupes de travail
Swiss Group for Clinical Cancer Research (SAKK)
Liens vers les personnes
Liens vers les unités
ISSN
1569-8041
Statut éditorial
Publié
Date de publication
2011
Volume
22
Numéro
1
Première page
80
Dernière page/numéro d’article
85
Langue
anglais
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Résumé
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.
PID Serval
serval:BIB_C1E1D436CEC3
PMID
Open Access
Oui
Date de création
2010-08-25T11:49:34.450Z
Date de création dans IRIS
2025-05-20T23:52:24Z
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Nom
REF.pdf
Version du manuscrit
published
Taille
101.91 KB
Format
Adobe PDF
PID Serval
serval:BIB_C1E1D436CEC3.P001
URN
urn:nbn:ch:serval-BIB_C1E1D436CEC39
Somme de contrôle
(MD5):2b29977a1802a4d345ad06dc50bd14d0