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Annals of Oncology Advance Access originally published online on April 23, 2008
Annals of Oncology 2008 19(9):1547-1552; doi:10.1093/annonc/mdn171
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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

A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients

X. Pivot1,*, P. Koralewski2, J. L. Hidalgo3, A. Chan4, A. Gonçalves5, G. Schwartsmann6, S. Assadourian7 and J. P. Lotz8

1 Department of Medical Oncology, University Hospital Jean Minjoz, Besançon; Institut National de la Santé et de la Recherche Médicale, Unit 645, Besançon, France
2 Rydygier Memorial Hospital, 31-826 Krakow, os. Zlotej Jesieni 1, Poland
3 Clinical Oncology Institution and Research, Mendoza, Argentina
4 Department of Medical Oncology, Mount Hospital, Perth, Australia
5 Department of Medical Oncology, Institut Paoli Calmettes, UMR599 Inserm, Université de la Méditerranée Marseille, France
6 Department of Medical Oncology, Federal Univ, Porto Alegre, Brazil
7 Department of Oncology development, Sanofi-Aventis, Antony
8 Department of Medical Oncology, Hopital Tenon, Paris, France

* Correspondence to: Prof. X. Pivot, Service d'Oncologie Médicale, Centre Hospitalier Universitaire de Besançon, 25030 BESANCON cedex, France. Tel: +33-3-81-66-88-58; Fax: +33-2-81-66-88-58; E-mail: Xavier.pivot{at}univ-fcomte.fr

Background: XRP6258 is a novel taxoid with a low affinity for P-glycoprotein. This multicenter phase II study assessed the activity of XRP6258 in the treatment of taxane-resistant metastatic breast cancer (MBC).

Patients and methods: XRP6258 was administered as a 1-h i.v. infusion every 3 weeks at 20 mg/m2 (then, in the absence of severe toxicity, at 25 mg/m2 from cycle 2). The primary end point was the objective response rate (ORR) assessed according to response evaluation criteria in solid tumours (RECIST) guidelines.

Results: Seventy-one patients were enrolled. The median relative dose intensity was 0.98. The ORR was 14% (two complete, eight partial responses). Eighteen patients (25%) had stable disease of >3 months duration. At a median follow-up of 20.0 months, the median time to progression was 2.7 months, and the median overall survival 12.3 months. The most common grade 3/4 adverse events (AEs) were neutropenia (73%) and leucopenia (55%), with a low febrile neutropenia rate (3%) and infrequent grade 3/4, treatment-related, non-hematological AEs (<5% patients for any AE). Two deaths were reported, one related to study drug and one to unknown cause.

Conclusions: XRP6258 was active and well tolerated in this group of MBC patients with taxane-resistant disease. These results support the further clinical development of this agent.

Key words: chemotherapy, metastatic breast cancer, resistance, taxane, taxoid, XRP6258

Received for publication February 14, 2008. Revision received March 19, 2008. Accepted for publication March 20, 2008.


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