AustralieFrV1, Main, Exploration, bibRecord, 00A477

Randomized phase ii trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment : The M77001 study group

Identifieur interne : 00A477 ( Main/Exploration ); précédent : 00A476; suivant : 00A478

Randomized phase ii trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment : The M77001 study group

Auteurs : Michel Marty [France, Italie, Australie, Royaume-Uni, Espagne, Irlande (pays), Suisse] ; Francesco Cognetti ; Dominique Maraninchi ; Ray Snyder ; Louis Mauriac ; Michèle Tubiana-Hulin ; Stephen Chan ; David Grimes ; Antonio Anton ; Ana Lluch ; John Kennedy ; Kenneth O'Byrne ; Pier Franco Conte ; Michael Green ; Carol Ward ; Karen Mayne ; Jean-Marc Extra

Source :

Journal of clinical oncology [ 0732-183X ] ; 2005.

RBID : Pascal:05-0319825

Descripteurs français

Pascal (Inist)
- Essai clinique phase II, Essai clinique, Efficacité traitement, Docétaxel, Toxicité, Trastuzumab, Métastase, Anticorps monoclonal, Homme, Glande mammaire pathologie, Stade avancé, Cancérologie, Tumeur maligne, Anticancéreux, Récepteur HER2, Cancer sein, Traitement première intention.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Antineoplastic agent, Breast cancer, Cancerology, Clinical trial, Docetaxel, First line treatment, Human, Human Epidermal growth factor Receptor 2, Malignant tumor, Mammary gland diseases, Metastasis, Monoclonal antibody, Phase II trial, Toxicity, Trastuzumab, Treatment efficiency.

Abstract

Purpose This randomized, multicenter trial compared first-line trastuzumab plus docetaxel versus docetaxel alone in patients with human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer (MBC). Patients and Methods Patients were randomly assigned to six cycles of docetaxel 100 mg/m² every 3 weeks, with or without trastuzumab 4 mg/kg loading dose followed by 2 mg/kg weekly until disease progression. Results A total of 186 patients received at least one dose of the study drug. Trastuzumab plus docetaxel was significantly superior to docetaxel alone in terms of overall response rate (61% v 34%; P = .0002), overall survival (median, 31.2 v 22.7 months; P = .0325), time to disease progression (median, 11.7 v 6.1 months; P = .0001), time to treatment failure (median, 9.8 v 5.3 months; P = .0001), and duration of response (median, 11.7 v 5.7 months; P = .009). There was little difference in the number and severity of adverse events between the arms. Grade 3 to 4 neutropenia was seen more commonly with the combination (32%) than with docetaxel alone (22%), and there was a slightly higher incidence of febrile neutropenia in the combination arm (23% v 17%). One patient in the combination arm experienced symptomatic heart failure (1%). Another patient experienced symptomatic heart failure 5 months after discontinuation of trastuzumab because of disease progression, while being treated with an investigational anthracycline for 4 months. Conclusion Trastuzumab combined with docetaxel is superior to docetaxel alone as first-line treatment of patients with HER2-positive MBC in terms of overall survival, response rate, response duration, time to progression, and time to treatment failure, with little additional toxicity.

Affiliations:

Australie, Espagne, France, Irlande (pays), Italie, Royaume-Uni, Suisse
Aquitaine, Latium, Nouvelle-Aquitaine, Provence-Alpes-Côte d'Azur, Victoria (État), Île-de-France
Bordeaux, Marseille, Melbourne, Paris, Rome

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

to stream PascalFrancis, to step Corpus: 004864
to stream PascalFrancis, to step Curation: 001839
to stream PascalFrancis, to step Checkpoint: 004422
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to stream Main, to step Curation: 00A477

Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Antineoplastic agent</term>
<term>Breast cancer</term>
<term>Cancerology</term>
<term>Clinical trial</term>
<term>Docetaxel</term>
<term>First line treatment</term>
<term>Human</term>
<term>Human Epidermal growth factor Receptor 2</term>
<term>Malignant tumor</term>
<term>Mammary gland diseases</term>
<term>Metastasis</term>
<term>Monoclonal antibody</term>
<term>Phase II trial</term>
<term>Toxicity</term>
<term>Trastuzumab</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase II</term>
<term>Essai clinique</term>
<term>Efficacité traitement</term>
<term>Docétaxel</term>
<term>Toxicité</term>
<term>Trastuzumab</term>
<term>Métastase</term>
<term>Anticorps monoclonal</term>
<term>Homme</term>
<term>Glande mammaire pathologie</term>
<term>Stade avancé</term>
<term>Cancérologie</term>
<term>Tumeur maligne</term>
<term>Anticancéreux</term>
<term>Récepteur HER2</term>
<term>Cancer sein</term>
<term>Traitement première intention</term>
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<front><div type="abstract" xml:lang="en">Purpose This randomized, multicenter trial compared first-line trastuzumab plus docetaxel versus docetaxel alone in patients with human epidermal growth factor receptor 2 (HER2) -positive metastatic breast cancer (MBC). Patients and Methods Patients were randomly assigned to six cycles of docetaxel 100 mg/m<sup>2</sup>
 every 3 weeks, with or without trastuzumab 4 mg/kg loading dose followed by 2 mg/kg weekly until disease progression. Results A total of 186 patients received at least one dose of the study drug. Trastuzumab plus docetaxel was significantly superior to docetaxel alone in terms of overall response rate (61% v 34%; P = .0002), overall survival (median, 31.2 v 22.7 months; P = .0325), time to disease progression (median, 11.7 v 6.1 months; P = .0001), time to treatment failure (median, 9.8 v 5.3 months; P = .0001), and duration of response (median, 11.7 v 5.7 months; P = .009). There was little difference in the number and severity of adverse events between the arms. Grade 3 to 4 neutropenia was seen more commonly with the combination (32%) than with docetaxel alone (22%), and there was a slightly higher incidence of febrile neutropenia in the combination arm (23% v 17%). One patient in the combination arm experienced symptomatic heart failure (1%). Another patient experienced symptomatic heart failure 5 months after discontinuation of trastuzumab because of disease progression, while being treated with an investigational anthracycline for 4 months. Conclusion Trastuzumab combined with docetaxel is superior to docetaxel alone as first-line treatment of patients with HER2-positive MBC in terms of overall survival, response rate, response duration, time to progression, and time to treatment failure, with little additional toxicity.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Espagne</li>
<li>France</li>
<li>Irlande (pays)</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
</country>
<region><li>Aquitaine</li>
<li>Latium</li>
<li>Nouvelle-Aquitaine</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Victoria (État)</li>
<li>Île-de-France</li>
</region>
<settlement><li>Bordeaux</li>
<li>Marseille</li>
<li>Melbourne</li>
<li>Paris</li>
<li>Rome</li>
</settlement>
</list>
<tree><noCountry><name sortKey="Anton, Antonio" sort="Anton, Antonio" uniqKey="Anton A" first="Antonio" last="Anton">Antonio Anton</name>
<name sortKey="Chan, Stephen" sort="Chan, Stephen" uniqKey="Chan S" first="Stephen" last="Chan">Stephen Chan</name>
<name sortKey="Cognetti, Francesco" sort="Cognetti, Francesco" uniqKey="Cognetti F" first="Francesco" last="Cognetti">Francesco Cognetti</name>
<name sortKey="Conte, Pier Franco" sort="Conte, Pier Franco" uniqKey="Conte P" first="Pier Franco" last="Conte">Pier Franco Conte</name>
<name sortKey="Extra, Jean Marc" sort="Extra, Jean Marc" uniqKey="Extra J" first="Jean-Marc" last="Extra">Jean-Marc Extra</name>
<name sortKey="Green, Michael" sort="Green, Michael" uniqKey="Green M" first="Michael" last="Green">Michael Green</name>
<name sortKey="Grimes, David" sort="Grimes, David" uniqKey="Grimes D" first="David" last="Grimes">David Grimes</name>
<name sortKey="Kennedy, John" sort="Kennedy, John" uniqKey="Kennedy J" first="John" last="Kennedy">John Kennedy</name>
<name sortKey="Lluch, Ana" sort="Lluch, Ana" uniqKey="Lluch A" first="Ana" last="Lluch">Ana Lluch</name>
<name sortKey="Maraninchi, Dominique" sort="Maraninchi, Dominique" uniqKey="Maraninchi D" first="Dominique" last="Maraninchi">Dominique Maraninchi</name>
<name sortKey="Mauriac, Louis" sort="Mauriac, Louis" uniqKey="Mauriac L" first="Louis" last="Mauriac">Louis Mauriac</name>
<name sortKey="Mayne, Karen" sort="Mayne, Karen" uniqKey="Mayne K" first="Karen" last="Mayne">Karen Mayne</name>
<name sortKey="O Byrne, Kenneth" sort="O Byrne, Kenneth" uniqKey="O Byrne K" first="Kenneth" last="O'Byrne">Kenneth O'Byrne</name>
<name sortKey="Snyder, Ray" sort="Snyder, Ray" uniqKey="Snyder R" first="Ray" last="Snyder">Ray Snyder</name>
<name sortKey="Tubiana Hulin, Michele" sort="Tubiana Hulin, Michele" uniqKey="Tubiana Hulin M" first="Michèle" last="Tubiana-Hulin">Michèle Tubiana-Hulin</name>
<name sortKey="Ward, Carol" sort="Ward, Carol" uniqKey="Ward C" first="Carol" last="Ward">Carol Ward</name>
</noCountry>
<country name="France"><noRegion><name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</noRegion>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</country>
<country name="Italie"><region name="Latium"><name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</region>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</country>
<country name="Australie"><noRegion><name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</noRegion>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</noRegion>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</country>
<country name="Espagne"><noRegion><name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</noRegion>
<name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</country>
<country name="Irlande (pays)"><noRegion><name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</noRegion>
</country>
<country name="Suisse"><noRegion><name sortKey="Marty, Michel" sort="Marty, Michel" uniqKey="Marty M" first="Michel" last="Marty">Michel Marty</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Randomized phase ii trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment : The M77001 study group

Randomized phase ii trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment : The M77001 study group

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