AustralieFrV1, Main, Exploration, bibRecord, 006907

Multicenter Phase III Randomized Trial Comparing Docetaxel and Trastuzumab With Docetaxel, Carboplatin, and Trastuzumab As First-Line Chemotherapy for Patients With HER2-Gene-Amplified Metastatic Breast Cancer (BCIRG 007 Study): Two Highly Active Therapeutic Regimens

Identifieur interne : 006907 ( Main/Exploration ); précédent : 006906; suivant : 006908

Multicenter Phase III Randomized Trial Comparing Docetaxel and Trastuzumab With Docetaxel, Carboplatin, and Trastuzumab As First-Line Chemotherapy for Patients With HER2-Gene-Amplified Metastatic Breast Cancer (BCIRG 007 Study): Two Highly Active Therapeutic Regimens

Auteurs : Vicente Valero [États-Unis, Australie, Pologne, Allemagne, France] ; John Forbes ; Mark D. Pegram ; Tadeusz Pienkowski ; Wolfgang Eiermann ; Gunter Von Minckwitz ; Henri Roche ; Miguel Martin ; John Crown ; John R. Mackey ; Pierre Fumoleau ; Janusz Rolski ; Zrinka Mrsic-Krmpotic ; Agnieszka Jagiello-Gruszfeld ; Alessandro Riva ; Marc Buyse ; Henry Taupin ; Guido Sauter ; Michael F. Press ; Dennis J. Slamon

Source :

Journal of clinical oncology [ 0732-183X ] ; 2011.

RBID : Pascal:11-0097624

Descripteurs français

Pascal (Inist)
- Essai clinique phase III, Etude multicentrique, Randomisation, Docétaxel, Etude comparative, Trastuzumab, Chimiothérapie, Homme, Gène erbB2, Carboplatine, Amplification génique, Stade avancé, Traitement de première intention, Métastase, Cancer du sein, Protocole thérapeutique, Cancérologie, Anticancéreux.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Antineoplastic agent, Breast cancer, Cancerology, Carboplatin, Chemotherapy, Comparative study, Docetaxel, First line treatment, Gene amplification, Human, Metastasis, Multicenter study, Phase III trial, Randomization, Therapeutic protocol, Trastuzumab, erbB2 Gene.

Abstract

Purpose Docetaxel-trastuzumab (TH) is effective therapy for HER2-amplified metastatic breast cancer (MBC). Preclinical findings of synergy between docetaxel, carboplatin, and trastuzumab (TCH) prompted a phase III randomized trial comparing TCH with TH in patients with HER2-amplified MBC. Patients and Methods Two hundred sixty-three patients were randomly assigned to receive eight 3-week cycles of TH (trastuzumab plus docetaxel 100 mg/m²) or TCH (trastuzumab plus carboplatin at area under the serum concentration-time curve 6 and docetaxel 75 mg/m²). Trastuzumab was given at 4 mg/kg loading dose followed by a 2 mg/kg dose once per week during chemotherapy, and then 6 mg/kg once every 3 weeks until progression. Results Patient characteristics were balanced between groups. There was no significant difference between TH and TCH in terms of the primary end point, time to progression (medians of 11.1 and 10.4 months, respectively; hazard ratio, 0.914; 95% CI, 0.694 to 1.203; P = .57), response rate (72% for both groups), or overall survival (medians of 37.1 and 37.4 months, respectively; P = .99). Rates of grades 3 or 4 adverse effects for TH and TCH, respectively, were neutropenic-related complications, 29% and 23%; thrombocytopenia, 2% and 15%; anemia, 5% and 11 %; sensory neuropathy, 3% and 0.8%; fatigue, 5% and 12%; peripheral edema, 3.8% and 1.5%; and diarrhea, 2% and 10%. Two patients given TCH died of sepsis, and one patient given TH experienced sudden cardiac death. Absolute left ventricular ejection fraction decline > 15% was seen in 5.5% of patients on the TH arm and 6.7% of patients on the TCH arm. Conclusion Adding carboplatin did not enhance TH antitumor activity.TH (docetaxel, 100 mg/m²) and TCH (docetaxel, 75 mg/m²) demonstrated efficacy with acceptable toxicity in women with HER2-amplified MBC.

Affiliations:

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

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Le document en format XML

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<author><name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
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<author><name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
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<affiliation wicri:level="3"><inist:fA14 i1="03"><s1>University of California</s1>
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<country>Allemagne</country>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
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<s2>Toulouse</s2>
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</inist:fA14>
<country>France</country>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Midi-Pyrénées</region>
<settlement type="city">Toulouse</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Forbes, John" sort="Forbes, John" uniqKey="Forbes J" first="John" last="Forbes">John Forbes</name>
</author>
<author><name sortKey="Pegram, Mark D" sort="Pegram, Mark D" uniqKey="Pegram M" first="Mark D." last="Pegram">Mark D. Pegram</name>
</author>
<author><name sortKey="Pienkowski, Tadeusz" sort="Pienkowski, Tadeusz" uniqKey="Pienkowski T" first="Tadeusz" last="Pienkowski">Tadeusz Pienkowski</name>
</author>
<author><name sortKey="Eiermann, Wolfgang" sort="Eiermann, Wolfgang" uniqKey="Eiermann W" first="Wolfgang" last="Eiermann">Wolfgang Eiermann</name>
</author>
<author><name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
</author>
<author><name sortKey="Roche, Henri" sort="Roche, Henri" uniqKey="Roche H" first="Henri" last="Roche">Henri Roche</name>
</author>
<author><name sortKey="Martin, Miguel" sort="Martin, Miguel" uniqKey="Martin M" first="Miguel" last="Martin">Miguel Martin</name>
</author>
<author><name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name>
</author>
<author><name sortKey="Mackey, John R" sort="Mackey, John R" uniqKey="Mackey J" first="John R." last="Mackey">John R. Mackey</name>
</author>
<author><name sortKey="Fumoleau, Pierre" sort="Fumoleau, Pierre" uniqKey="Fumoleau P" first="Pierre" last="Fumoleau">Pierre Fumoleau</name>
</author>
<author><name sortKey="Rolski, Janusz" sort="Rolski, Janusz" uniqKey="Rolski J" first="Janusz" last="Rolski">Janusz Rolski</name>
</author>
<author><name sortKey="Mrsic Krmpotic, Zrinka" sort="Mrsic Krmpotic, Zrinka" uniqKey="Mrsic Krmpotic Z" first="Zrinka" last="Mrsic-Krmpotic">Zrinka Mrsic-Krmpotic</name>
</author>
<author><name sortKey="Jagiello Gruszfeld, Agnieszka" sort="Jagiello Gruszfeld, Agnieszka" uniqKey="Jagiello Gruszfeld A" first="Agnieszka" last="Jagiello-Gruszfeld">Agnieszka Jagiello-Gruszfeld</name>
</author>
<author><name sortKey="Riva, Alessandro" sort="Riva, Alessandro" uniqKey="Riva A" first="Alessandro" last="Riva">Alessandro Riva</name>
</author>
<author><name sortKey="Buyse, Marc" sort="Buyse, Marc" uniqKey="Buyse M" first="Marc" last="Buyse">Marc Buyse</name>
</author>
<author><name sortKey="Taupin, Henry" sort="Taupin, Henry" uniqKey="Taupin H" first="Henry" last="Taupin">Henry Taupin</name>
</author>
<author><name sortKey="Sauter, Guido" sort="Sauter, Guido" uniqKey="Sauter G" first="Guido" last="Sauter">Guido Sauter</name>
</author>
<author><name sortKey="Press, Michael F" sort="Press, Michael F" uniqKey="Press M" first="Michael F." last="Press">Michael F. Press</name>
</author>
<author><name sortKey="Slamon, Dennis J" sort="Slamon, Dennis J" uniqKey="Slamon D" first="Dennis J." last="Slamon">Dennis J. Slamon</name>
</author>
</analytic>
<series><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
<imprint><date when="2011">2011</date>
</imprint>
</series>
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</sourceDesc>
<seriesStmt><title level="j" type="main">Journal of clinical oncology</title>
<title level="j" type="abbreviated">J. clin. oncol.</title>
<idno type="ISSN">0732-183X</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Antineoplastic agent</term>
<term>Breast cancer</term>
<term>Cancerology</term>
<term>Carboplatin</term>
<term>Chemotherapy</term>
<term>Comparative study</term>
<term>Docetaxel</term>
<term>First line treatment</term>
<term>Gene amplification</term>
<term>Human</term>
<term>Metastasis</term>
<term>Multicenter study</term>
<term>Phase III trial</term>
<term>Randomization</term>
<term>Therapeutic protocol</term>
<term>Trastuzumab</term>
<term>erbB2 Gene</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term>
<term>Etude multicentrique</term>
<term>Randomisation</term>
<term>Docétaxel</term>
<term>Etude comparative</term>
<term>Trastuzumab</term>
<term>Chimiothérapie</term>
<term>Homme</term>
<term>Gène erbB2</term>
<term>Carboplatine</term>
<term>Amplification génique</term>
<term>Stade avancé</term>
<term>Traitement de première intention</term>
<term>Métastase</term>
<term>Cancer du sein</term>
<term>Protocole thérapeutique</term>
<term>Cancérologie</term>
<term>Anticancéreux</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">Purpose Docetaxel-trastuzumab (TH) is effective therapy for HER2-amplified metastatic breast cancer (MBC). Preclinical findings of synergy between docetaxel, carboplatin, and trastuzumab (TCH) prompted a phase III randomized trial comparing TCH with TH in patients with HER2-amplified MBC. Patients and Methods Two hundred sixty-three patients were randomly assigned to receive eight 3-week cycles of TH (trastuzumab plus docetaxel 100 mg/m<sup>2</sup>
) or TCH (trastuzumab plus carboplatin at area under the serum concentration-time curve 6 and docetaxel 75 mg/m<sup>2</sup>
). Trastuzumab was given at 4 mg/kg loading dose followed by a 2 mg/kg dose once per week during chemotherapy, and then 6 mg/kg once every 3 weeks until progression. Results Patient characteristics were balanced between groups. There was no significant difference between TH and TCH in terms of the primary end point, time to progression (medians of 11.1 and 10.4 months, respectively; hazard ratio, 0.914; 95% CI, 0.694 to 1.203; P = .57), response rate (72% for both groups), or overall survival (medians of 37.1 and 37.4 months, respectively; P = .99). Rates of grades 3 or 4 adverse effects for TH and TCH, respectively, were neutropenic-related complications, 29% and 23%; thrombocytopenia, 2% and 15%; anemia, 5% and 11 %; sensory neuropathy, 3% and 0.8%; fatigue, 5% and 12%; peripheral edema, 3.8% and 1.5%; and diarrhea, 2% and 10%. Two patients given TCH died of sepsis, and one patient given TH experienced sudden cardiac death. Absolute left ventricular ejection fraction decline > 15% was seen in 5.5% of patients on the TH arm and 6.7% of patients on the TCH arm. Conclusion Adding carboplatin did not enhance TH antitumor activity.TH (docetaxel, 100 mg/m<sup>2</sup>
) and TCH (docetaxel, 75 mg/m<sup>2</sup>
) demonstrated efficacy with acceptable toxicity in women with HER2-amplified MBC.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Pologne</li>
<li>États-Unis</li>
</country>
<region><li>Bavière</li>
<li>Californie</li>
<li>District de Darmstadt</li>
<li>District de Haute-Bavière</li>
<li>Hesse (Land)</li>
<li>Midi-Pyrénées</li>
<li>Occitanie (région administrative)</li>
</region>
<settlement><li>Francfort-sur-le-Main</li>
<li>Los Angeles</li>
<li>Munich</li>
<li>Toulouse</li>
</settlement>
<orgName><li>Université de Californie du Sud</li>
</orgName>
</list>
<tree><noCountry><name sortKey="Buyse, Marc" sort="Buyse, Marc" uniqKey="Buyse M" first="Marc" last="Buyse">Marc Buyse</name>
<name sortKey="Crown, John" sort="Crown, John" uniqKey="Crown J" first="John" last="Crown">John Crown</name>
<name sortKey="Eiermann, Wolfgang" sort="Eiermann, Wolfgang" uniqKey="Eiermann W" first="Wolfgang" last="Eiermann">Wolfgang Eiermann</name>
<name sortKey="Forbes, John" sort="Forbes, John" uniqKey="Forbes J" first="John" last="Forbes">John Forbes</name>
<name sortKey="Fumoleau, Pierre" sort="Fumoleau, Pierre" uniqKey="Fumoleau P" first="Pierre" last="Fumoleau">Pierre Fumoleau</name>
<name sortKey="Jagiello Gruszfeld, Agnieszka" sort="Jagiello Gruszfeld, Agnieszka" uniqKey="Jagiello Gruszfeld A" first="Agnieszka" last="Jagiello-Gruszfeld">Agnieszka Jagiello-Gruszfeld</name>
<name sortKey="Mackey, John R" sort="Mackey, John R" uniqKey="Mackey J" first="John R." last="Mackey">John R. Mackey</name>
<name sortKey="Martin, Miguel" sort="Martin, Miguel" uniqKey="Martin M" first="Miguel" last="Martin">Miguel Martin</name>
<name sortKey="Mrsic Krmpotic, Zrinka" sort="Mrsic Krmpotic, Zrinka" uniqKey="Mrsic Krmpotic Z" first="Zrinka" last="Mrsic-Krmpotic">Zrinka Mrsic-Krmpotic</name>
<name sortKey="Pegram, Mark D" sort="Pegram, Mark D" uniqKey="Pegram M" first="Mark D." last="Pegram">Mark D. Pegram</name>
<name sortKey="Pienkowski, Tadeusz" sort="Pienkowski, Tadeusz" uniqKey="Pienkowski T" first="Tadeusz" last="Pienkowski">Tadeusz Pienkowski</name>
<name sortKey="Press, Michael F" sort="Press, Michael F" uniqKey="Press M" first="Michael F." last="Press">Michael F. Press</name>
<name sortKey="Riva, Alessandro" sort="Riva, Alessandro" uniqKey="Riva A" first="Alessandro" last="Riva">Alessandro Riva</name>
<name sortKey="Roche, Henri" sort="Roche, Henri" uniqKey="Roche H" first="Henri" last="Roche">Henri Roche</name>
<name sortKey="Rolski, Janusz" sort="Rolski, Janusz" uniqKey="Rolski J" first="Janusz" last="Rolski">Janusz Rolski</name>
<name sortKey="Sauter, Guido" sort="Sauter, Guido" uniqKey="Sauter G" first="Guido" last="Sauter">Guido Sauter</name>
<name sortKey="Slamon, Dennis J" sort="Slamon, Dennis J" uniqKey="Slamon D" first="Dennis J." last="Slamon">Dennis J. Slamon</name>
<name sortKey="Taupin, Henry" sort="Taupin, Henry" uniqKey="Taupin H" first="Henry" last="Taupin">Henry Taupin</name>
<name sortKey="Von Minckwitz, Gunter" sort="Von Minckwitz, Gunter" uniqKey="Von Minckwitz G" first="Gunter" last="Von Minckwitz">Gunter Von Minckwitz</name>
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<country name="États-Unis"><noRegion><name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
</noRegion>
<name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
<name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
</country>
<country name="Australie"><noRegion><name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
</noRegion>
</country>
<country name="Pologne"><noRegion><name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
</noRegion>
<name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
</country>
<country name="Allemagne"><region name="Bavière"><name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
</region>
<name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
</country>
<country name="France"><region name="Occitanie (région administrative)"><name sortKey="Valero, Vicente" sort="Valero, Vicente" uniqKey="Valero V" first="Vicente" last="Valero">Vicente Valero</name>
</region>
</country>
</tree>
</affiliations>
</record>

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   |wiki=    Wicri/Asie
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   |texte=   Multicenter Phase III Randomized Trial Comparing Docetaxel and Trastuzumab With Docetaxel, Carboplatin, and Trastuzumab As First-Line Chemotherapy for Patients With HER2-Gene-Amplified Metastatic Breast Cancer (BCIRG 007 Study): Two Highly Active Therapeutic Regimens
}}

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

Multicenter Phase III Randomized Trial Comparing Docetaxel and Trastuzumab With Docetaxel, Carboplatin, and Trastuzumab As First-Line Chemotherapy for Patients With HER2-Gene-Amplified Metastatic Breast Cancer (BCIRG 007 Study): Two Highly Active Therapeutic Regimens

Multicenter Phase III Randomized Trial Comparing Docetaxel and Trastuzumab With Docetaxel, Carboplatin, and Trastuzumab As First-Line Chemotherapy for Patients With HER2-Gene-Amplified Metastatic Breast Cancer (BCIRG 007 Study): Two Highly Active Therapeutic Regimens

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