Titre
First-line temozolomide combined with bevacizumab in metastatic melanoma: a multicentre phase II trial (SAKK 50/07).
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
von Moos, R.
Auteure/Auteur
Seifert, B.
Auteure/Auteur
Simcock, M.
Auteure/Auteur
Goldinger, S.M.
Auteure/Auteur
Gillessen, S.
Auteure/Auteur
Ochsenbein, A.
Auteure/Auteur
Michielin, O.
Auteure/Auteur
Cathomas, R.
Auteure/Auteur
Schläppi, M.
Auteure/Auteur
Moch, H.
Auteure/Auteur
Schraml, P.H.
Auteure/Auteur
Mjhic-Probst, D.
Auteure/Auteur
Mamot, C.
Auteure/Auteur
Schönewolf, N.
Auteure/Auteur
Dummer, R.
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
2012
Volume
23
Numéro
2
Première page
531
Dernière page/numéro d’article
6
Langue
anglais
Résumé
BACKGROUND: Oral temozolomide has shown similar efficacy to dacarbazine in phase III trials with median progression-free survival (PFS) of 2.1 months. Bevacizumab has an inhibitory effect on the proliferation of melanoma and sprouting endothelial cells. We evaluated the addition of bevacizumab to temozolomide to improve efficacy in stage IV melanoma. PATIENTS AND METHODS: Previously untreated metastatic melanoma patients with Eastern Cooperative Oncology Group performance status of two or more were treated with temozolomide 150 mg/m(2) days 1-7 orally and bevacizumab 10 mg/kg body weight i.v. day 1 every 2 weeks until disease progression or unacceptable toxicity. The primary end point was disease stabilisation rate [complete response (CR), partial response (PR) or stable disease (SD)] at week 12 (DSR12); secondary end points were best overall response, PFS, overall survival (OS) and adverse events. RESULTS: Sixty-two patients (median age 59 years) enrolled at nine Swiss centres. DSR12 was 52% (PR: 10 patients and SD: 22 patients). Confirmed overall response rate was 16.1% (CR: 1 patient and PR: 9 patients). Median PFS and OS were 4.2 and 9.6 months. OS (12.0 versus 9.2 months; P = 0.014) was higher in BRAF V600E wild-type patients. CONCLUSIONS: The primary end point was surpassed showing promising activity of this bevacizumab/temozolomide combination with a favourable toxicity profile. Response and OS were significantly higher in BRAF wild-type patients.
PID Serval
serval:BIB_1D509D2A35CB
PMID
Open Access
Oui
Date de création
2011-10-25T07:35:54.540Z
Date de création dans IRIS
2025-05-20T14:53:33Z
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Nom
REF.pdf
Version du manuscrit
published
Taille
124.32 KB
Format
Adobe PDF
PID Serval
serval:BIB_1D509D2A35CB.P001
URN
urn:nbn:ch:serval-BIB_1D509D2A35CB2
Somme de contrôle
(MD5):f79eff28ccebf84e0b8474cbb3372c0c