AustralieFrV1, PascalFrancis, Checkpoint, bibRecord, 003459

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 : 003459 ( PascalFrancis/Checkpoint ); précédent : 003458; suivant : 003460

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

Auteurs : X. Pivot [France] ; P. Koralewski [Pologne] ; J. L. Hidalgo [Argentine] ; A. Chan [Australie] ; A. Goncalves [France] ; G. Schwartsmann [Brésil] ; S. Assadourian [France] ; J. P. Lotz [France]

Source :

Annals of oncology [ 0923-7534 ] ; 2008.

RBID : Pascal:08-0479465

Descripteurs français

Pascal (Inist)
- Etude multicentrique, Homme, Essai clinique phase II, Traitement, Perfusion, Dérivé du taxane, Résistance, Stade avancé, Métastase, Cancer du sein, Chimiothérapie.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Breast cancer, Chemotherapy, Human, Metastasis, Multicenter study, Perfusion, Phase II trial, Resistance, Taxane derivatives, Treatment.

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.

Affiliations:

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<front><div type="abstract" xml:lang="en">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/m<sup>2</sup>
 (then, in the absence of severe toxicity, at 25 mg/m<sup>2</sup>
 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>
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<fC01 i1="01" l="ENG"><s0>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/m<sup>2</sup>
 (then, in the absence of severe toxicity, at 25 mg/m<sup>2</sup>
 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.</s0>
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<fC03 i1="06" i2="X" l="SPA"><s0>Taxane derivado</s0>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Résistance</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Resistance</s0>
<s5>07</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Resistencia</s0>
<s5>07</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Stade avancé</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Advanced stage</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Estadio avanzado</s0>
<s5>08</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Métastase</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Metastasis</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Metástasis</s0>
<s5>09</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Cancer du sein</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Breast cancer</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Cáncer del pecho</s0>
<s2>NM</s2>
<s5>10</s5>
</fC03>
<fC03 i1="11" i2="X" l="FRE"><s0>Chimiothérapie</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="ENG"><s0>Chemotherapy</s0>
<s5>11</s5>
</fC03>
<fC03 i1="11" i2="X" l="SPA"><s0>Quimioterapia</s0>
<s5>11</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Pathologie de la glande mammaire</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Mammary gland diseases</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Glándula mamaria patología</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Pathologie du sein</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Breast disease</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Seno patología</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fN21><s1>308</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<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>Antony</li>
<li>Besançon</li>
<li>Paris</li>
<li>Porto Alegre</li>
</settlement>
</list>
<tree><country name="France"><region name="Bourgogne-Franche-Comté"><name sortKey="Pivot, X" sort="Pivot, X" uniqKey="Pivot X" first="X." last="Pivot">X. Pivot</name>
</region>
<name sortKey="Assadourian, S" sort="Assadourian, S" uniqKey="Assadourian S" first="S." last="Assadourian">S. Assadourian</name>
<name sortKey="Goncalves, A" sort="Goncalves, A" uniqKey="Goncalves A" first="A." last="Goncalves">A. Goncalves</name>
<name sortKey="Lotz, J P" sort="Lotz, J P" uniqKey="Lotz J" first="J. P." last="Lotz">J. P. Lotz</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Koralewski, P" sort="Koralewski, P" uniqKey="Koralewski P" first="P." last="Koralewski">P. Koralewski</name>
</noRegion>
</country>
<country name="Argentine"><noRegion><name sortKey="Hidalgo, J L" sort="Hidalgo, J L" uniqKey="Hidalgo J" first="J. L." last="Hidalgo">J. L. Hidalgo</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Chan, A" sort="Chan, A" uniqKey="Chan A" first="A." last="Chan">A. Chan</name>
</noRegion>
</country>
<country name="Brésil"><region name="Rio Grande do Sul"><name sortKey="Schwartsmann, G" sort="Schwartsmann, G" uniqKey="Schwartsmann G" first="G." last="Schwartsmann">G. Schwartsmann</name>
</region>
</country>
</tree>
</affiliations>
</record>

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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

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

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