AustralieFrV1, PascalFrancis, Corpus, bibRecord, 001500

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 : 001500 ( PascalFrancis/Corpus ); précédent : 001499; suivant : 001501

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 ; I. Bondarenko ; S. Brincat ; Y. Hotko ; P. N. Munster ; E. Chmielowska ; P. Fumoleau ; R. Ward ; N. Bardy-Bouxin ; E. Leip ; K. Turnbul ; C. Zacharchuk ; R. J. Epstein

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.

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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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C01	`01`		`ENG`	@0 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.
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Format Inist (serveur)

NO :	PASCAL 12-0154866 INIST
ET :	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
AU :	CAMPONE (M.); BONDARENKO (I.); BRINCAT (S.); HOTKO (Y.); MUNSTER (P. N.); CHMIELOWSKA (E.); FUMOLEAU (P.); WARD (R.); BARDY-BOUXIN (N.); LEIP (E.); TURNBUL (K.); ZACHARCHUK (C.); EPSTEIN (R. J.)
AF :	Department of Medical Oncology, Centre René Gauducheau/Nantes Saint-Herblain/France (1 aut.); UMR 892 INSERM/Nantes/France (1 aut.); Department of Oncology and Medical Radiology, Dnepropetrovsk State Medical Academy/Dnepropetrovsk/Ukraine (2 aut.); Radiotherapy and Oncology Department, Sir Paul Boffa Hospital/Floriana/Malte (3 aut.); Transcarpathian Regional Clinical Oncology Dispensary, Uzhgorod National University/Uzhgorod/Ukraine (4 aut.); Departments of Breast and Experimental Therapeutics, H. Lee Moffitt Cancer Center/Tampa/Etats-Unis (5 aut.); Multi-Med Salata i Wsp sp. Jawna/Lodz/Pologne (6 aut.); Department of Oncology, Centre Georges-François Leclerc/Dijon/France (7 aut.); Department of Medical Oncology, Vincent's Hospital/Darlinghurst/Australie (8 aut.); Pfizer Inc/Paris/France (9 aut.); Pfizer Inc/Cambridge/Etats-Unis (10 aut., 11 aut., 12 aut.); Department of Medicine, The University of Hong Kong, Queen Mary Hospital/Hong-Kong (13 aut.)
DT :	Publication en série; Niveau analytique
SO :	Annals of oncology; ISSN 0923-7534; Royaume-Uni; Da. 2012; Vol. 23; No. 3; Pp. 610-617; Bibl. 24 ref.
LA :	Anglais
EA :	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.
CC :	002B02R; 002B20E02
FD :	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
FG :	Transferases; Enzyme; Tumeur maligne; Cancer; Pathologie de la glande mammaire; Pathologie du sein
ED :	Human; Phase II trial; Treatment; Bosutinib; C-Onc gene; Protooncogene; Enzyme inhibitor; Protein-tyrosine kinase; Tyrosine kinase inhibitor; Patient; Advanced stage; Metastasis; Breast cancer; Chemotherapy; Locally advanced stage; Breast tumor
EG :	Transferases; Enzyme; Malignant tumor; Cancer; Mammary gland diseases; Breast disease
SD :	Hombre; Ensayo clínico fase II; Tratamiento; Bosutinib; Gen onc celular; Protooncogen; Inhibidor enzima; Protein-tyrosine kinase; Inhibidor tyrosine kinase; Enfermo; Estadio avanzado; Metástasis; Cáncer del pecho; Quimioterapia; Estadio localmente avanzado; Tumor pecho
LO :	INIST-22429.354000509725210110
ID :	12-0154866

Links to Exploration step

Pascal:12-0154866

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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</title>
<author><name sortKey="Campone, M" sort="Campone, M" uniqKey="Campone M" first="M." last="Campone">M. Campone</name>
<affiliation><inist:fA14 i1="01"><s1>Department of Medical Oncology, Centre René Gauducheau</s1>
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<author><name sortKey="Bondarenko, I" sort="Bondarenko, I" uniqKey="Bondarenko I" first="I." last="Bondarenko">I. Bondarenko</name>
<affiliation><inist:fA14 i1="03"><s1>Department of Oncology and Medical Radiology, Dnepropetrovsk State Medical Academy</s1>
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<s3>UKR</s3>
<sZ>2 aut.</sZ>
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<author><name sortKey="Brincat, S" sort="Brincat, S" uniqKey="Brincat S" first="S." last="Brincat">S. Brincat</name>
<affiliation><inist:fA14 i1="04"><s1>Radiotherapy and Oncology Department, Sir Paul Boffa Hospital</s1>
<s2>Floriana</s2>
<s3>MLT</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Hotko, Y" sort="Hotko, Y" uniqKey="Hotko Y" first="Y." last="Hotko">Y. Hotko</name>
<affiliation><inist:fA14 i1="05"><s1>Transcarpathian Regional Clinical Oncology Dispensary, Uzhgorod National University</s1>
<s2>Uzhgorod</s2>
<s3>UKR</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Munster, P N" sort="Munster, P N" uniqKey="Munster P" first="P. N." last="Munster">P. N. Munster</name>
<affiliation><inist:fA14 i1="06"><s1>Departments of Breast and Experimental Therapeutics, H. Lee Moffitt Cancer Center</s1>
<s2>Tampa</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Chmielowska, E" sort="Chmielowska, E" uniqKey="Chmielowska E" first="E." last="Chmielowska">E. Chmielowska</name>
<affiliation><inist:fA14 i1="07"><s1>Multi-Med Salata i Wsp sp. Jawna</s1>
<s2>Lodz</s2>
<s3>POL</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Fumoleau, P" sort="Fumoleau, P" uniqKey="Fumoleau P" first="P." last="Fumoleau">P. Fumoleau</name>
<affiliation><inist:fA14 i1="08"><s1>Department of Oncology, Centre Georges-François Leclerc</s1>
<s2>Dijon</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Ward, R" sort="Ward, R" uniqKey="Ward R" first="R." last="Ward">R. Ward</name>
<affiliation><inist:fA14 i1="09"><s1>Department of Medical Oncology, Vincent's Hospital</s1>
<s2>Darlinghurst</s2>
<s3>AUS</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Bardy Bouxin, N" sort="Bardy Bouxin, N" uniqKey="Bardy Bouxin N" first="N." last="Bardy-Bouxin">N. Bardy-Bouxin</name>
<affiliation><inist:fA14 i1="10"><s1>Pfizer Inc</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Leip, E" sort="Leip, E" uniqKey="Leip E" first="E." last="Leip">E. Leip</name>
<affiliation><inist:fA14 i1="11"><s1>Pfizer Inc</s1>
<s2>Cambridge</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Turnbul, K" sort="Turnbul, K" uniqKey="Turnbul K" first="K." last="Turnbul">K. Turnbul</name>
<affiliation><inist:fA14 i1="11"><s1>Pfizer Inc</s1>
<s2>Cambridge</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Zacharchuk, C" sort="Zacharchuk, C" uniqKey="Zacharchuk C" first="C." last="Zacharchuk">C. Zacharchuk</name>
<affiliation><inist:fA14 i1="11"><s1>Pfizer Inc</s1>
<s2>Cambridge</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Epstein, R J" sort="Epstein, R J" uniqKey="Epstein R" first="R. J." last="Epstein">R. J. Epstein</name>
<affiliation><inist:fA14 i1="12"><s1>Department of Medicine, The University of Hong Kong, Queen Mary Hospital</s1>
<s3>HKG</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
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<series><title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
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<seriesStmt><title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
</seriesStmt>
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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>
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<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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<fA03 i2="1"><s0>Ann. oncol.</s0>
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<fA05><s2>23</s2>
</fA05>
<fA06><s2>3</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>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</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>CAMPONE (M.)</s1>
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<fA11 i1="06" i2="1"><s1>CHMIELOWSKA (E.)</s1>
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<fA11 i1="07" i2="1"><s1>FUMOLEAU (P.)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>WARD (R.)</s1>
</fA11>
<fA11 i1="09" i2="1"><s1>BARDY-BOUXIN (N.)</s1>
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<fA11 i1="10" i2="1"><s1>LEIP (E.)</s1>
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<fA11 i1="11" i2="1"><s1>TURNBUL (K.)</s1>
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<fA11 i1="12" i2="1"><s1>ZACHARCHUK (C.)</s1>
</fA11>
<fA11 i1="13" i2="1"><s1>EPSTEIN (R. J.)</s1>
</fA11>
<fA14 i1="01"><s1>Department of Medical Oncology, Centre René Gauducheau</s1>
<s2>Nantes Saint-Herblain</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>UMR 892 INSERM</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Department of Oncology and Medical Radiology, Dnepropetrovsk State Medical Academy</s1>
<s2>Dnepropetrovsk</s2>
<s3>UKR</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Radiotherapy and Oncology Department, Sir Paul Boffa Hospital</s1>
<s2>Floriana</s2>
<s3>MLT</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Transcarpathian Regional Clinical Oncology Dispensary, Uzhgorod National University</s1>
<s2>Uzhgorod</s2>
<s3>UKR</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Departments of Breast and Experimental Therapeutics, H. Lee Moffitt Cancer Center</s1>
<s2>Tampa</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Multi-Med Salata i Wsp sp. Jawna</s1>
<s2>Lodz</s2>
<s3>POL</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Department of Oncology, Centre Georges-François Leclerc</s1>
<s2>Dijon</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Department of Medical Oncology, Vincent's Hospital</s1>
<s2>Darlinghurst</s2>
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<fA14 i1="10"><s1>Pfizer Inc</s1>
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<fA14 i1="11"><s1>Pfizer Inc</s1>
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<sZ>10 aut.</sZ>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="12"><s1>Department of Medicine, The University of Hong Kong, Queen Mary Hospital</s1>
<s3>HKG</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA20><s1>610-617</s1>
</fA20>
<fA21><s1>2012</s1>
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<fA23 i1="01"><s0>ENG</s0>
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<fA43 i1="01"><s1>INIST</s1>
<s2>22429</s2>
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<fA47 i1="01" i2="1"><s0>12-0154866</s0>
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<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
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<fA64 i1="01" i2="1"><s0>Annals of oncology</s0>
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<fA66 i1="01"><s0>GBR</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B02R</s0>
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<fC02 i1="02" i2="X"><s0>002B20E02</s0>
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<fC07 i1="03" i2="X" l="ENG"><s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>37</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Pathologie de la glande mammaire</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Mammary gland diseases</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Glándula mamaria patología</s0>
<s2>NM</s2>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Pathologie du sein</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Breast disease</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Seno patología</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fN21><s1>114</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
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<server><NO>PASCAL 12-0154866 INIST</NO>
<ET>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</ET>
<AU>CAMPONE (M.); BONDARENKO (I.); BRINCAT (S.); HOTKO (Y.); MUNSTER (P. N.); CHMIELOWSKA (E.); FUMOLEAU (P.); WARD (R.); BARDY-BOUXIN (N.); LEIP (E.); TURNBUL (K.); ZACHARCHUK (C.); EPSTEIN (R. J.)</AU>
<AF>Department of Medical Oncology, Centre René Gauducheau/Nantes Saint-Herblain/France (1 aut.); UMR 892 INSERM/Nantes/France (1 aut.); Department of Oncology and Medical Radiology, Dnepropetrovsk State Medical Academy/Dnepropetrovsk/Ukraine (2 aut.); Radiotherapy and Oncology Department, Sir Paul Boffa Hospital/Floriana/Malte (3 aut.); Transcarpathian Regional Clinical Oncology Dispensary, Uzhgorod National University/Uzhgorod/Ukraine (4 aut.); Departments of Breast and Experimental Therapeutics, H. Lee Moffitt Cancer Center/Tampa/Etats-Unis (5 aut.); Multi-Med Salata i Wsp sp. Jawna/Lodz/Pologne (6 aut.); Department of Oncology, Centre Georges-François Leclerc/Dijon/France (7 aut.); Department of Medical Oncology, Vincent's Hospital/Darlinghurst/Australie (8 aut.); Pfizer Inc/Paris/France (9 aut.); Pfizer Inc/Cambridge/Etats-Unis (10 aut., 11 aut., 12 aut.); Department of Medicine, The University of Hong Kong, Queen Mary Hospital/Hong-Kong (13 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Annals of oncology; ISSN 0923-7534; Royaume-Uni; Da. 2012; Vol. 23; No. 3; Pp. 610-617; Bibl. 24 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B02R; 002B20E02</CC>
<FD>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</FD>
<FG>Transferases; Enzyme; Tumeur maligne; Cancer; Pathologie de la glande mammaire; Pathologie du sein</FG>
<ED>Human; Phase II trial; Treatment; Bosutinib; C-Onc gene; Protooncogene; Enzyme inhibitor; Protein-tyrosine kinase; Tyrosine kinase inhibitor; Patient; Advanced stage; Metastasis; Breast cancer; Chemotherapy; Locally advanced stage; Breast tumor</ED>
<EG>Transferases; Enzyme; Malignant tumor; Cancer; Mammary gland diseases; Breast disease</EG>
<SD>Hombre; Ensayo clínico fase II; Tratamiento; Bosutinib; Gen onc celular; Protooncogen; Inhibidor enzima; Protein-tyrosine kinase; Inhibidor tyrosine kinase; Enfermo; Estadio avanzado; Metástasis; Cáncer del pecho; Quimioterapia; Estadio localmente avanzado; Tumor pecho</SD>
<LO>INIST-22429.354000509725210110</LO>
<ID>12-0154866</ID>
</server>
</inist>
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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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