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
Identifieur interne : 008705 ( Main/Exploration ); précédent : 008704; suivant : 008706A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients
Auteurs : X. Pivot [France] ; P. Koralewski [Pologne] ; J. L. Hidalgo [Argentine] ; A. Chan [Australie] ; A. Gonçalves [France] ; G. Schwartsmann [Brésil] ; S. Assadourian ; J. P. Lotz [France]Source :
- Annals of Oncology [ 0923-7534 ] ; 2008-04-23.
Descripteurs français
- Pascal (Inist)
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- topic : Homme.
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Abstract
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.
Url:
DOI: 10.1093/annonc/mdn171
Affiliations:
- Argentine, Australie, Brésil, France, Pologne
- Bourgogne-Franche-Comté, Franche-Comté, Rio Grande do Sul, Île-de-France
- Besançon, Paris, Porto Alegre
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Zlotej Jesieni 1</wicri:regionArea><wicri:noRegion>os. Zlotej Jesieni 1</wicri:noRegion></affiliation></author><author><name sortKey="Hidalgo, J L" sort="Hidalgo, J L" uniqKey="Hidalgo J" first="J. L." last="Hidalgo">J. L. Hidalgo</name><affiliation wicri:level="1"><country xml:lang="fr">Argentine</country><wicri:regionArea>Clinical Oncology Institution and Research, Mendoza</wicri:regionArea><wicri:noRegion>Mendoza</wicri:noRegion></affiliation></author><author><name sortKey="Chan, A" sort="Chan, A" uniqKey="Chan A" first="A." last="Chan">A. Chan</name><affiliation wicri:level="1"><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Medical Oncology, Mount Hospital, Perth</wicri:regionArea><wicri:noRegion>Perth</wicri:noRegion></affiliation></author><author><name sortKey="Goncalves, A" sort="Goncalves, A" uniqKey="Goncalves A" first="A." last="Gonçalves">A. 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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.</div></front></TEI><affiliations><list><country><li>Argentine</li><li>Australie</li><li>Brésil</li><li>France</li><li>Pologne</li></country><region><li>Bourgogne-Franche-Comté</li><li>Franche-Comté</li><li>Rio Grande do Sul</li><li>Île-de-France</li></region><settlement><li>Besançon</li><li>Paris</li><li>Porto Alegre</li></settlement></list><tree><noCountry><name sortKey="Assadourian, S" sort="Assadourian, S" uniqKey="Assadourian S" first="S." last="Assadourian">S. 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