AustralieFrV1, Main, Exploration, bibRecord, 005A07

Phase II study of single-agent bosutinib, a Src/Abl tyrosine kinase inhibitor, in patients with locally advanced or metastatic breast cancer pretreated with chemotherapy

Identifieur interne : 005A07 ( Main/Exploration ); précédent : 005A06; suivant : 005A08

Phase II study of single-agent bosutinib, a Src/Abl tyrosine kinase inhibitor, in patients with locally advanced or metastatic breast cancer pretreated with chemotherapy

Auteurs : M. Campone [France] ; I. Bondarenko [Ukraine] ; S. Brincat [Malte] ; Y. Hotko [Ukraine] ; P. N. Munster [États-Unis] ; E. Chmielowska [Pologne] ; P. Fumoleau [France] ; R. Ward [Australie] ; N. Bardy-Bouxin [France] ; E. Leip [États-Unis] ; K. Turnbul [États-Unis] ; C. Zacharchuk [États-Unis] ; R. J. Epstein [Hong Kong]

Source :

Annals of oncology [ 0923-7534 ] ; 2012.

RBID : Pascal:12-0154866

Descripteurs français

Pascal (Inist)
- Homme, Essai clinique phase II, Traitement, Bosutinib, Gène onc cellulaire, Protooncogène, Inhibiteur enzyme, Protein-tyrosine kinase, Inhibiteur de la tyrosine kinase, Malade, Stade avancé, Métastase, Cancer du sein, Chimiothérapie, Src protein kinase, Gène abl, Gène src, Stade localement avancé, Tumeur sein.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Bosutinib, Breast cancer, Breast tumor, C-Onc gene, Chemotherapy, Enzyme inhibitor, Human, Locally advanced stage, Metastasis, Patient, Phase II trial, Protein-tyrosine kinase, Protooncogene, Treatment, Tyrosine kinase inhibitor.

Abstract

Background: This phase II study evaluated single-agent bosutinib in pretreated patients with locally advanced or metastatic breast cancer. Patients and methods: Patients received oral bosutinib 400 mg/day. The primary end point was the progression-free survival (PFS) rate at 16 weeks. Secondary end points included objective response rate, clinical benefit rate, 2-year overall survival rate, safety, and changes in levels of bone resorption/formation biomarkers. Results: Seventy-three patients were enrolled and treated. Median time from diagnosis of metastatic disease to initiation of bosutinib treatment was 24.5 months. For the intent-to-treat population, the PFS rate at 16 weeks was 39.6%. Unexpectedly, all responding patients (n = 4) were hormone receptor positive. The clinical benefit rate was 27.4%. The 2-year overall survival rate was 26.4%. The main toxic effects were diarrhea (66%), nausea (55%), and vomiting (47%). Grade 3-4 laboratory aminotransferase elevations occurred in 14 (19%) patients. Myelosuppression was minimal. No consistent changes in the levels of bone resorption/formation biomarkers were seen. Conclusions: Bosutinib showed promising efficacy in prolonging time to progression in chemotherapy-pretreated patients with locally advanced or metastatic breast cancer. Bosutinib was generally well tolerated, with a safety profile different from that of the Src/Abl tyrosine kinase inhibitor dasatinib in a similar patient population.

Affiliations:

Australie, France, Hong Kong, Malte, Pologne, Ukraine, États-Unis
Bourgogne, Bourgogne-Franche-Comté, Pays de la Loire, Île-de-France
Dijon, Nantes, Paris

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Bosutinib</term>
<term>Breast cancer</term>
<term>Breast tumor</term>
<term>C-Onc gene</term>
<term>Chemotherapy</term>
<term>Enzyme inhibitor</term>
<term>Human</term>
<term>Locally advanced stage</term>
<term>Metastasis</term>
<term>Patient</term>
<term>Phase II trial</term>
<term>Protein-tyrosine kinase</term>
<term>Protooncogene</term>
<term>Treatment</term>
<term>Tyrosine kinase inhibitor</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Homme</term>
<term>Essai clinique phase II</term>
<term>Traitement</term>
<term>Bosutinib</term>
<term>Gène onc cellulaire</term>
<term>Protooncogène</term>
<term>Inhibiteur enzyme</term>
<term>Protein-tyrosine kinase</term>
<term>Inhibiteur de la tyrosine kinase</term>
<term>Malade</term>
<term>Stade avancé</term>
<term>Métastase</term>
<term>Cancer du sein</term>
<term>Chimiothérapie</term>
<term>Src protein kinase</term>
<term>Gène abl</term>
<term>Gène src</term>
<term>Stade localement avancé</term>
<term>Tumeur sein</term>
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<front><div type="abstract" xml:lang="en">Background: This phase II study evaluated single-agent bosutinib in pretreated patients with locally advanced or metastatic breast cancer. Patients and methods: Patients received oral bosutinib 400 mg/day. The primary end point was the progression-free survival (PFS) rate at 16 weeks. Secondary end points included objective response rate, clinical benefit rate, 2-year overall survival rate, safety, and changes in levels of bone resorption/formation biomarkers. Results: Seventy-three patients were enrolled and treated. Median time from diagnosis of metastatic disease to initiation of bosutinib treatment was 24.5 months. For the intent-to-treat population, the PFS rate at 16 weeks was 39.6%. Unexpectedly, all responding patients (n = 4) were hormone receptor positive. The clinical benefit rate was 27.4%. The 2-year overall survival rate was 26.4%. The main toxic effects were diarrhea (66%), nausea (55%), and vomiting (47%). Grade 3-4 laboratory aminotransferase elevations occurred in 14 (19%) patients. Myelosuppression was minimal. No consistent changes in the levels of bone resorption/formation biomarkers were seen. Conclusions: Bosutinib showed promising efficacy in prolonging time to progression in chemotherapy-pretreated patients with locally advanced or metastatic breast cancer. Bosutinib was generally well tolerated, with a safety profile different from that of the Src/Abl tyrosine kinase inhibitor dasatinib in a similar patient population.</div>
</front>
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<li>France</li>
<li>Hong Kong</li>
<li>Malte</li>
<li>Pologne</li>
<li>Ukraine</li>
<li>États-Unis</li>
</country>
<region><li>Bourgogne</li>
<li>Bourgogne-Franche-Comté</li>
<li>Pays de la Loire</li>
<li>Île-de-France</li>
</region>
<settlement><li>Dijon</li>
<li>Nantes</li>
<li>Paris</li>
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<name sortKey="Bardy Bouxin, N" sort="Bardy Bouxin, N" uniqKey="Bardy Bouxin N" first="N." last="Bardy-Bouxin">N. Bardy-Bouxin</name>
<name sortKey="Campone, M" sort="Campone, M" uniqKey="Campone M" first="M." last="Campone">M. Campone</name>
<name sortKey="Fumoleau, P" sort="Fumoleau, P" uniqKey="Fumoleau P" first="P." last="Fumoleau">P. Fumoleau</name>
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<country name="Ukraine"><noRegion><name sortKey="Bondarenko, I" sort="Bondarenko, I" uniqKey="Bondarenko I" first="I." last="Bondarenko">I. Bondarenko</name>
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<name sortKey="Hotko, Y" sort="Hotko, Y" uniqKey="Hotko Y" first="Y." last="Hotko">Y. Hotko</name>
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<country name="Malte"><noRegion><name sortKey="Brincat, S" sort="Brincat, S" uniqKey="Brincat S" first="S." last="Brincat">S. Brincat</name>
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<country name="États-Unis"><noRegion><name sortKey="Munster, P N" sort="Munster, P N" uniqKey="Munster P" first="P. N." last="Munster">P. N. Munster</name>
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<country name="Pologne"><noRegion><name sortKey="Chmielowska, E" sort="Chmielowska, E" uniqKey="Chmielowska E" first="E." last="Chmielowska">E. Chmielowska</name>
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<country name="Australie"><noRegion><name sortKey="Ward, R" sort="Ward, R" uniqKey="Ward R" first="R." last="Ward">R. Ward</name>
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<country name="Hong Kong"><noRegion><name sortKey="Epstein, R J" sort="Epstein, R J" uniqKey="Epstein R" first="R. J." last="Epstein">R. J. Epstein</name>
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   |wiki=    Wicri/Asie
   |area=    AustralieFrV1
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   |clé=     Pascal:12-0154866
   |texte=   Phase II study of single-agent bosutinib, a Src/Abl tyrosine kinase inhibitor, in patients with locally advanced or metastatic breast cancer pretreated with chemotherapy
}}

This area was generated with Dilib version V0.6.33.
Data generation: Tue Dec 5 10:43:12 2017. Site generation: Tue Mar 5 14:07:20 2024

	Serveur d'exploration sur les relations entre la France et l'Australie
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Serveur d'exploration sur les relations entre la France et l'Australie

Phase II study of single-agent bosutinib, a Src/Abl tyrosine kinase inhibitor, in patients with locally advanced or metastatic breast cancer pretreated with chemotherapy

Phase II study of single-agent bosutinib, a Src/Abl tyrosine kinase inhibitor, in patients with locally advanced or metastatic breast cancer pretreated with chemotherapy

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