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Annals of Oncology Advance Access originally published online on April 1, 2008
Annals of Oncology 2008 19(7):1255-1260; doi:10.1093/annonc/mdn060
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

breast cancer

Phase II multicenter study of larotaxel (XRP9881), a novel taxoid, in patients with metastatic breast cancer who previously received taxane-based therapy

V. Diéras1,*, S. Limentani2, G. Romieu3, M. Tubiana-Hulin4, A. Lortholary5, P. Kaufman6, V. Girre1, M. Besenval7 and V. Valero8

1 Department of Medical Oncology, Institut Curie, Paris, France
2 Carolinas Hematology-Oncology Associates, Charlotte, NC, USA
3 Centre Val d'Aurelle, Montpellier
4 Centre René Huguenin, Saint Cloud
5 Centre Catherine de Sienne, Nantes, France
6 Hematology/Oncology, Dartmouth/Hitchcock Medical Center, Lebanon, NH, USA
7 Sanofi-aventis, Bagneux, France
8 MD Anderson Cancer Center, Houston, TX, USA

* Correspondence to: Dr V. Diéras, Department of Medical Oncology, Institut Curie, 26 rue d'Ulm, 75005 Paris, France. Tel: +33-144324675; Fax: +33-144324671; E-mail: veronique.dieras{at}curie.net

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/m2 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.

Key words: breast cancer, larotaxel, metastatic breast cancer, taxanes, XRP9881

Received for publication December 5, 2007. Revision received February 11, 2008. Revision received February 12, 2008.
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