Titre
Phase I trial combining temozolomide plus lapatinib for the treatment of brain metastases in patients with HER2-positive metastatic breast cancer: the LAPTEM trial.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
de Azambuja, E.
Auteure/Auteur
Zardavas, D.
Auteure/Auteur
Lemort, M.
Auteure/Auteur
Rossari, J.
Auteure/Auteur
Moulin, C.
Auteure/Auteur
Buttice, A.
Auteure/Auteur
D'Hondt, V.
Auteure/Auteur
Lebrun, F.
Auteure/Auteur
Lalami, Y.
Auteure/Auteur
Cardoso, F.
Auteure/Auteur
Sotiriou, C.
Auteure/Auteur
Gil, T.
Auteure/Auteur
Devriendt, D.
Auteure/Auteur
Paesmans, M.
Auteure/Auteur
Piccart-Gebhart, M.
Auteure/Auteur
Awada, A.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
1569-8041
Statut éditorial
Publié
Date de publication
2013
Volume
24
Numéro
12
Première page
2985
Dernière page/numéro d’article
2989
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Journal ArticlePublication Status: ppublish
Résumé
BACKGROUND: Brain metastases (BMs) pose a clinical challenge in breast cancer (BC). Lapatinib or temozolomide showed activity in BM. Our study assessed the combination of both drugs as treatment for patients with HER2-positive BC and BM.
METHODS: Eighteen patients were enrolled, with sixteen of them having recurrent or progressive BM. Any type of previous therapy was allowed, and disease was assessed by gadolinium (Gd)-enhanced magnetic resonance imaging (MRI). The primary end points were the evaluation of the dose-limiting toxicities (DLTs) and the determination of the maximum-tolerated dose (MTD). The secondary end points included objective response rate, clinical benefit and duration of response.
RESULTS: The lapatinib-temozolomide regimen showed a favorable toxicity profile because the MTD could not be reached. The most common adverse events (AEs) were fatigue, diarrhea and constipation. Disease stabilization was achieved in 10 out of 15 assessable patients. The estimated median survival time for the 16 patients with BM reached 10.94 months (95% CI: 1.09-20.79), whereas the median progression-free survival time was 2.60 months [95% confidence interval (CI): 1.82-3.37].
CONCLUSIONS: The lapatinib-temozolomide combination is well tolerated. Preliminary evidence of clinical activity was observed in a heavily pretreated population, as indicated by the volumetric reductions occurring in brain lesions.
METHODS: Eighteen patients were enrolled, with sixteen of them having recurrent or progressive BM. Any type of previous therapy was allowed, and disease was assessed by gadolinium (Gd)-enhanced magnetic resonance imaging (MRI). The primary end points were the evaluation of the dose-limiting toxicities (DLTs) and the determination of the maximum-tolerated dose (MTD). The secondary end points included objective response rate, clinical benefit and duration of response.
RESULTS: The lapatinib-temozolomide regimen showed a favorable toxicity profile because the MTD could not be reached. The most common adverse events (AEs) were fatigue, diarrhea and constipation. Disease stabilization was achieved in 10 out of 15 assessable patients. The estimated median survival time for the 16 patients with BM reached 10.94 months (95% CI: 1.09-20.79), whereas the median progression-free survival time was 2.60 months [95% confidence interval (CI): 1.82-3.37].
CONCLUSIONS: The lapatinib-temozolomide combination is well tolerated. Preliminary evidence of clinical activity was observed in a heavily pretreated population, as indicated by the volumetric reductions occurring in brain lesions.
PID Serval
serval:BIB_C1B203640C6D
PMID
Open Access
Oui
Date de création
2014-01-03T08:35:46.456Z
Date de création dans IRIS
2025-05-21T01:19:49Z
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Nom
REF.pdf
Version du manuscrit
published
Taille
171.92 KB
Format
Adobe PDF
PID Serval
serval:BIB_C1B203640C6D.P001
URN
urn:nbn:ch:serval-BIB_C1B203640C6D6
Somme de contrôle
(MD5):5b1aaf932eecc560560f8eb5e064e0ac