Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial
Identifieur interne : 001558 ( Main/Exploration ); précédent : 001557; suivant : 001559Sequential or alternating administration of docetaxel (Taxotere®) combined with FEC in metastatic breast cancer: a randomised phase II trial
Auteurs : M. Spielmann [France] ; M. Tubiana-Hulin [France] ; M. Namer [France] ; H. Mansouri [France] ; P H Bougnoux [France] ; N. Tubiana-Mathieu [France] ; V. Lotz [France] ; J C Eymard [France]Source :
- British Journal of Cancer [ 0007-0920 ] ; 2002.
Abstract
The aim of this study, using a Fleming single-stage design, was to explore the efficacy and safety of Taxotere® 100 mg m−2 docetaxel and FEC 75 cyclophosphamide 500 mg m−2, fluorouracil 500 mg m−2 and epirubicin 75 mg m−2, in alternating and sequential schedules for the first-line treatment of metastatic breast cancer. One hundred and thirty-six women were randomly allocated, to one of three treatment regimens: DTX 100 plus FEC 75, alternated for eight courses (ALT); four courses of DTX 100 followed by four courses of FEC 75 (SEQ T); or four courses of FEC 75 followed by four courses of DTX 100 (SEQ F). One hundred and thirty-one women were evaluable for tumour response. Although the treatment outcome was equivalent in the two sequential arms and the alternating regimen (
© 2002
Url:
DOI: 10.1038/sj.bjc.6600165
PubMed: 11875727
PubMed Central: 2375306
Affiliations:
- France
- Centre-Val de Loire, Champagne-Ardenne, Grand Est, Limousin, Nouvelle-Aquitaine, Provence-Alpes-Côte d'Azur, Région Centre, Île-de-France
- Limoges, Nice, Paris, Reims, St Cloud, Tours, Villejuif
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Le document en format XML
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Spielmann</name><affiliation wicri:level="3"><nlm:aff id="aff1">Institut Gustave Roussy, 39-53 rue Camille Desmoulins, 94805 Villejuif, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut Gustave Roussy, 39-53 rue Camille Desmoulins, 94805 Villejuif</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region><settlement type="city">Villejuif</settlement></placeName></affiliation></author><author><name sortKey="Tubiana Hulin, M" sort="Tubiana Hulin, M" uniqKey="Tubiana Hulin M" first="M" last="Tubiana-Hulin">M. Tubiana-Hulin</name><affiliation wicri:level="3"><nlm:aff id="aff2">Centre René Huguenin, 35 rue Dailly, 92210 St Cloud, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre René Huguenin, 35 rue Dailly, 92210 St Cloud</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region><settlement type="city">St Cloud</settlement></placeName></affiliation></author><author><name sortKey="Namer, M" sort="Namer, M" uniqKey="Namer M" first="M" last="Namer">M. Namer</name><affiliation wicri:level="3"><nlm:aff id="aff3">Centre A Lacassagne, 33 avenue de Valombrose, 06189 Nice Cedex 02, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre A Lacassagne, 33 avenue de Valombrose, 06189 Nice Cedex 02</wicri:regionArea><placeName><region type="region" nuts="2">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation></author><author><name sortKey="Mansouri, H" sort="Mansouri, H" uniqKey="Mansouri H" first="H" last="Mansouri">H. Mansouri</name><affiliation wicri:level="3"><nlm:aff id="aff1">Institut Gustave Roussy, 39-53 rue Camille Desmoulins, 94805 Villejuif, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Institut Gustave Roussy, 39-53 rue Camille Desmoulins, 94805 Villejuif</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region><settlement type="city">Villejuif</settlement></placeName></affiliation></author><author><name sortKey="Bougnoux, P H" sort="Bougnoux, P H" uniqKey="Bougnoux P" first="P H" last="Bougnoux">P H Bougnoux</name><affiliation wicri:level="3"><nlm:aff id="aff4">Hôpital Bretonneau, 2 bld Tonnellé, 37044 Tours Cedex 1, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Hôpital Bretonneau, 2 bld Tonnellé, 37044 Tours Cedex 1</wicri:regionArea><placeName><region type="region" nuts="2">Centre-Val de Loire</region><region type="old region" nuts="2">Région Centre</region><settlement type="city">Tours</settlement></placeName></affiliation></author><author><name sortKey="Tubiana Mathieu, N" sort="Tubiana Mathieu, N" uniqKey="Tubiana Mathieu N" first="N" last="Tubiana-Mathieu">N. Tubiana-Mathieu</name><affiliation wicri:level="3"><nlm:aff id="aff5">CHU Dupuytren, 2 avenue Martin Luther King, 87042 Limoges, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>CHU Dupuytren, 2 avenue Martin Luther King, 87042 Limoges</wicri:regionArea><placeName><region type="region" nuts="2">Nouvelle-Aquitaine</region><region type="old region" nuts="2">Limousin</region><settlement type="city">Limoges</settlement></placeName></affiliation></author><author><name sortKey="Lotz, V" sort="Lotz, V" uniqKey="Lotz V" first="V" last="Lotz">V. Lotz</name><affiliation wicri:level="3"><nlm:aff id="aff6">Laboratoire Aventis, 46 Quai de la Rapée, 75601 Paris Cedex 12, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire Aventis, 46 Quai de la Rapée, 75601 Paris Cedex 12</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Eymard, J C" sort="Eymard, J C" uniqKey="Eymard J" first="J C" last="Eymard">J C Eymard</name><affiliation wicri:level="3"><nlm:aff id="aff7">Centre Jean Godinot, 1 avenue du Général Koenig BP 171, 51056 Reims Cedex, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Centre Jean Godinot, 1 avenue du Général Koenig BP 171, 51056 Reims Cedex</wicri:regionArea><placeName><region type="region" nuts="2">Grand Est</region><region type="old region" nuts="2">Champagne-Ardenne</region><settlement type="city">Reims</settlement></placeName></affiliation></author></analytic><series><title level="j">British Journal of Cancer</title><idno type="ISSN">0007-0920</idno><idno type="eISSN">1532-1827</idno><imprint><date when="2002">2002</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>The aim of this study, using a Fleming single-stage design, was to explore the efficacy and safety of Taxotere® 100 mg m<sup>−2</sup> docetaxel and FEC 75 cyclophosphamide 500 mg m<sup>−2</sup>, fluorouracil 500 mg m<sup>−2</sup> and epirubicin 75 mg m<sup>−2</sup>, in alternating and sequential schedules for the first-line treatment of metastatic breast cancer. One hundred and thirty-six women were randomly allocated, to one of three treatment regimens: DTX 100 plus FEC 75, alternated for eight courses (ALT); four courses of DTX 100 followed by four courses of FEC 75 (SEQ T); or four courses of FEC 75 followed by four courses of DTX 100 (SEQ F). One hundred and thirty-one women were evaluable for tumour response. Although the treatment outcome was equivalent in the two sequential arms and the alternating regimen (<italic>P</italic>=0.110, not significant), the response rate was less encouraging in the SEQ F arm (52.3%) than in the other two arms (71.1% for ALT and 70.5% for SEQ T), in which docetaxel was administered first. Time to progression was similar in the ALT, SEQ T and SEQ F arms (9.5, 9.3 and 10.4 months respectively). Grade 3–4 neutropenia was observed in nearly all patients; febrile neutropenia occurred in 9% (ALT), 16% (SEQ T) and 2% (SEQ F) of patients. Few patients (⩽9%) developed grade 3–4 non-haematological toxicities. Relative dose intensity was 97–99% for all regimens. All treatment regimens were active and well tolerated.</p><p><italic>British Journal of Cancer</italic> (2002) <bold>86</bold>, 692–697. DOI: <ext-link ext-link-type="doi" xlink:href="10.1038/sj/bjc/6600165">10.1038/sj/bjc/6600165</ext-link> <ext-link ext-link-type="uri" xlink:href="www.bjcancer.com">www.bjcancer.com</ext-link></p><p>© 2002 <ext-link ext-link-type="uri" xlink:href="http://www.crc.org.uk">Cancer Research UK</ext-link></p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>France</li></country><region><li>Centre-Val de Loire</li><li>Champagne-Ardenne</li><li>Grand Est</li><li>Limousin</li><li>Nouvelle-Aquitaine</li><li>Provence-Alpes-Côte d'Azur</li><li>Région Centre</li><li>Île-de-France</li></region><settlement><li>Limoges</li><li>Nice</li><li>Paris</li><li>Reims</li><li>St Cloud</li><li>Tours</li><li>Villejuif</li></settlement></list><tree><country name="France"><region name="Île-de-France"><name sortKey="Spielmann, M" sort="Spielmann, M" uniqKey="Spielmann M" first="M" last="Spielmann">M. Spielmann</name></region><name sortKey="Bougnoux, P H" sort="Bougnoux, P H" uniqKey="Bougnoux P" first="P H" last="Bougnoux">P H Bougnoux</name><name sortKey="Eymard, J C" sort="Eymard, J C" uniqKey="Eymard J" first="J C" last="Eymard">J C Eymard</name><name sortKey="Lotz, V" sort="Lotz, V" uniqKey="Lotz V" first="V" last="Lotz">V. Lotz</name><name sortKey="Mansouri, H" sort="Mansouri, H" uniqKey="Mansouri H" first="H" last="Mansouri">H. Mansouri</name><name sortKey="Namer, M" sort="Namer, M" uniqKey="Namer M" first="M" last="Namer">M. Namer</name><name sortKey="Tubiana Hulin, M" sort="Tubiana Hulin, M" uniqKey="Tubiana Hulin M" first="M" last="Tubiana-Hulin">M. Tubiana-Hulin</name><name sortKey="Tubiana Mathieu, N" sort="Tubiana Mathieu, N" uniqKey="Tubiana Mathieu N" first="N" last="Tubiana-Mathieu">N. Tubiana-Mathieu</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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