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Phase II multicenter study of larotaxel (XRP9881), a novel taxoid, in patients with metastatic breast cancer who previously received taxane-based therapy.
Diéras, V; Limentani, S; Romieu, G; Tubiana-Hulin, M; Lortholary, A; Kaufman, P; Girre, V; Besenval, M; Valero, V.
Afiliación
  • Diéras V; Department of Medical Oncology, Institut Curie, Paris, France. Electronic address: veronique.dieras@curie.net.
  • Limentani S; Carolinas Hematology-Oncology Associates, Charlotte, NC, USA.
  • Romieu G; Centre Val d'Aurelle, Montpellier.
  • Tubiana-Hulin M; Centre René Huguenin, Saint Cloud.
  • Lortholary A; Centre Catherine de Sienne, Nantes, France.
  • Kaufman P; Hematology/Oncology, Dartmouth/Hitchcock Medical Center, Lebanon, NH, USA.
  • Girre V; Department of Medical Oncology, Institut Curie, Paris, France.
  • Besenval M; Sanofi-aventis, Bagneux, France.
  • Valero V; MD Anderson Cancer Center, Houston, TX, USA.
Ann Oncol ; 19(7): 1255-1260, 2008 Jul.
Article en En | MEDLINE | ID: mdl-18381372
BACKGROUND: Treatment options are limited for patients with refractory metastatic breast cancer (MBC). Larotaxel (XRP9881) is a novel taxoid with preclinical activity against taxane-resistant breast cancer. The current phase II trial of larotaxel was conducted in women with taxane-treated MBC. PATIENTS AND METHODS: Patients were stratified by response to prior taxane therapy (resistant or nonresistant). Larotaxel 90 mg/m(2) was administered as a 1-h infusion every 3 weeks. Patients were evaluated for tumor response every two cycles. A blinded external response review committee determined the overall response rate (ORR), duration of response (DOR), and time to progression (TtP) of the disease. Median survival time (MST) and safety were also evaluated. RESULTS: One hundred and thirty patients were treated. In the nonresistant group, the ORR was 42%; median DOR 5.3 months; median TtP 5.4 months; and MST 22.6 months. In the resistant group, the ORR was 19%; median DOR 5.0 months; median TtP 1.6 months; and MST 9.8 months. The most common grade 3/4 adverse events were neutropenia (82%), fatigue (15%), diarrhea (12%), febrile neutropenia (9%), neutropenic infection (8%), and sensory neuropathy (7%). CONCLUSIONS: Larotaxel has good activity, manageable toxicity, and a favorable therapeutic index in women with taxane-pretreated MBC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Hidrocarburos Aromáticos con Puentes / Taxoides / Antineoplásicos Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2008 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Hidrocarburos Aromáticos con Puentes / Taxoides / Antineoplásicos Tipo de estudio: Clinical_trials / Etiology_studies / Incidence_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Ann Oncol Asunto de la revista: NEOPLASIAS Año: 2008 Tipo del documento: Article Pais de publicación: Reino Unido