Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer
Identifieur interne : 006D61 ( PascalFrancis/Curation ); précédent : 006D60; suivant : 006D62Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer
Auteurs : S. Chan [Royaume-Uni, États-Unis, Allemagne, Canada, Hongrie, Belgique, Afrique du Sud, Colombie, Espagne, Slovaquie, Italie, Australie, France, Irlande (pays)] ; K. Friedrichs ; D. Noel ; T. Pinter ; S. Van Belle ; D. Vorobiof ; R. Duarte ; M. G. Gil ; I. Bodrogi ; E. Murray ; L. Yelle ; G. Von Minckwitz ; S. Korec ; P. Simmonds ; F. Buzzi ; R. G. Mancha ; G. Richardson ; E. Walpole ; M. Ronzoni ; M. Murawsky ; M. Alakl ; A. Riva ; J. CrownSource :
- Journal of clinical oncology [ 0732-183X ] ; 1999.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Antibiotique, Homme.
English descriptors
- KwdEn :
Abstract
Purpose: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy. Patients and Methods: Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m2 or doxorubicin 75 mg/m2 every 3 weeks for a maximum of seven treatment cycles. Results: A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P = .008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel. Conclusion: The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer</title><author><name sortKey="Chan, S" sort="Chan, S" uniqKey="Chan S" first="S." last="Chan">S. Chan</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Clinical Oncology, City Hospital</s1><s2>Nottingham</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>CRC Wessex Medical Oncology Unit, Royal South Hants Hospital</s1><s2>Southampton</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Universitäts-Frauenklinik und Poliklinik, Universitäts-Krankenhaus Eppendorf</s1><s2>Hamburg</s2><s3>USA</s3></inist:fA14><country>États-Unis</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Klinik für Gynäkologie und Onkologie, Klinikum der Johann Wolfgang Goethe-Universität</s1><s2>Frankfurt</s2><s3>DEU</s3></inist:fA14><country>Allemagne</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Oncology Department, Hôpital du Sacré-Coeur de Montreal, and Oncology Department, Hôpital Notre-Dame</s1><s2>Montreal, Quebec</s2><s3>CAN</s3></inist:fA14><country>Canada</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Oncoradiology Department, Country Hospital</s1><s2>Gyor</s2><s3>HUN</s3></inist:fA14><country>Hongrie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>National Institute of Oncology</s1><s2>Budapest</s2><s3>HUN</s3></inist:fA14><country>Hongrie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Dienst Medische Oncologie, Universitair Ziekenhuis Gent</s1><s2>Gent</s2><s3>BEL</s3></inist:fA14><country>Belgique</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>The Sandton Oncology Centre</s1><s2>Johannesburg</s2><s3>ZAF</s3></inist:fA14><country>Afrique du Sud</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Radiation Oncology, Groote Schuur Hospital</s1><s2>Cape Town</s2><s3>ZAF</s3></inist:fA14><country>Afrique du Sud</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>National Institute of Cancerology</s1><s2>Bogota</s2><s3>COL</s3></inist:fA14><country>Colombie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Servicio Oncologia, Instituto Catalán de Oncología</s1><s2>Barcelona</s2><s3>ESP</s3></inist:fA14><country>Espagne</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Servicio Oncología, Hospital Provincial</s1><s2>Cordova</s2><s3>ESP</s3></inist:fA14><country>Espagne</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>National Cancer Institute</s1><s2>Bratislava</s2><s3>SVK</s3></inist:fA14><country>Slovaquie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Servizio Oncologico, Ospedale Civile S. 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Friedrichs</name></author><author><name sortKey="Noel, D" sort="Noel, D" uniqKey="Noel D" first="D." last="Noel">D. Noel</name></author><author><name sortKey="Pinter, T" sort="Pinter, T" uniqKey="Pinter T" first="T." last="Pinter">T. Pinter</name></author><author><name sortKey="Van Belle, S" sort="Van Belle, S" uniqKey="Van Belle S" first="S." last="Van Belle">S. Van Belle</name></author><author><name sortKey="Vorobiof, D" sort="Vorobiof, D" uniqKey="Vorobiof D" first="D." last="Vorobiof">D. Vorobiof</name></author><author><name sortKey="Duarte, R" sort="Duarte, R" uniqKey="Duarte R" first="R." last="Duarte">R. Duarte</name></author><author><name sortKey="Gil, M G" sort="Gil, M G" uniqKey="Gil M" first="M. G." last="Gil">M. G. Gil</name></author><author><name sortKey="Bodrogi, I" sort="Bodrogi, I" uniqKey="Bodrogi I" first="I." last="Bodrogi">I. Bodrogi</name></author><author><name sortKey="Murray, E" sort="Murray, E" uniqKey="Murray E" first="E." last="Murray">E. Murray</name></author><author><name sortKey="Yelle, L" sort="Yelle, L" uniqKey="Yelle L" first="L." last="Yelle">L. Yelle</name></author><author><name sortKey="Von Minckwitz, G" sort="Von Minckwitz, G" uniqKey="Von Minckwitz G" first="G." last="Von Minckwitz">G. Von Minckwitz</name></author><author><name sortKey="Korec, S" sort="Korec, S" uniqKey="Korec S" first="S." last="Korec">S. Korec</name></author><author><name sortKey="Simmonds, P" sort="Simmonds, P" uniqKey="Simmonds P" first="P." last="Simmonds">P. Simmonds</name></author><author><name sortKey="Buzzi, F" sort="Buzzi, F" uniqKey="Buzzi F" first="F." last="Buzzi">F. Buzzi</name></author><author><name sortKey="Mancha, R G" sort="Mancha, R G" uniqKey="Mancha R" first="R. G." last="Mancha">R. G. Mancha</name></author><author><name sortKey="Richardson, G" sort="Richardson, G" uniqKey="Richardson G" first="G." last="Richardson">G. Richardson</name></author><author><name sortKey="Walpole, E" sort="Walpole, E" uniqKey="Walpole E" first="E." last="Walpole">E. Walpole</name></author><author><name sortKey="Ronzoni, M" sort="Ronzoni, M" uniqKey="Ronzoni M" first="M." last="Ronzoni">M. Ronzoni</name></author><author><name sortKey="Murawsky, M" sort="Murawsky, M" uniqKey="Murawsky M" first="M." last="Murawsky">M. Murawsky</name></author><author><name sortKey="Alakl, M" sort="Alakl, M" uniqKey="Alakl M" first="M." last="Alakl">M. Alakl</name></author><author><name sortKey="Riva, A" sort="Riva, A" uniqKey="Riva A" first="A." last="Riva">A. Riva</name></author><author><name sortKey="Crown, J" sort="Crown, J" uniqKey="Crown J" first="J." last="Crown">J. Crown</name></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">99-0401102</idno><date when="1999">1999</date><idno type="stanalyst">PASCAL 99-0401102 INIST</idno><idno type="RBID">Pascal:99-0401102</idno><idno type="wicri:Area/PascalFrancis/Corpus">006293</idno><idno type="wicri:Area/PascalFrancis/Curation">006D61</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer</title><author><name sortKey="Chan, S" sort="Chan, S" uniqKey="Chan S" first="S." last="Chan">S. Chan</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Clinical Oncology, City Hospital</s1><s2>Nottingham</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>CRC Wessex Medical Oncology Unit, Royal South Hants Hospital</s1><s2>Southampton</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Universitäts-Frauenklinik und Poliklinik, Universitäts-Krankenhaus Eppendorf</s1><s2>Hamburg</s2><s3>USA</s3></inist:fA14><country>États-Unis</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Klinik für Gynäkologie und Onkologie, Klinikum der Johann Wolfgang Goethe-Universität</s1><s2>Frankfurt</s2><s3>DEU</s3></inist:fA14><country>Allemagne</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Oncology Department, Hôpital du Sacré-Coeur de Montreal, and Oncology Department, Hôpital Notre-Dame</s1><s2>Montreal, Quebec</s2><s3>CAN</s3></inist:fA14><country>Canada</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Oncoradiology Department, Country Hospital</s1><s2>Gyor</s2><s3>HUN</s3></inist:fA14><country>Hongrie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>National Institute of Oncology</s1><s2>Budapest</s2><s3>HUN</s3></inist:fA14><country>Hongrie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Dienst Medische Oncologie, Universitair Ziekenhuis Gent</s1><s2>Gent</s2><s3>BEL</s3></inist:fA14><country>Belgique</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>The Sandton Oncology Centre</s1><s2>Johannesburg</s2><s3>ZAF</s3></inist:fA14><country>Afrique du Sud</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Radiation Oncology, Groote Schuur Hospital</s1><s2>Cape Town</s2><s3>ZAF</s3></inist:fA14><country>Afrique du Sud</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>National Institute of Cancerology</s1><s2>Bogota</s2><s3>COL</s3></inist:fA14><country>Colombie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Servicio Oncologia, Instituto Catalán de Oncología</s1><s2>Barcelona</s2><s3>ESP</s3></inist:fA14><country>Espagne</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Servicio Oncología, Hospital Provincial</s1><s2>Cordova</s2><s3>ESP</s3></inist:fA14><country>Espagne</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>National Cancer Institute</s1><s2>Bratislava</s2><s3>SVK</s3></inist:fA14><country>Slovaquie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Servizio Oncologico, Ospedale Civile S. Maria</s1><s2>Terni</s2><s3>ITA</s3></inist:fA14><country>Italie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Unita di Radiochemioterapia, Ospedale San Raffaele</s1><s2>Milan</s2><s3>ITA</s3></inist:fA14><country>Italie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Department of Medical Oncology and Clinical Haematology, Monash Medical Centre</s1><s2>Clayton, Victoria</s2><s3>AUS</s3></inist:fA14><country>Australie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Department of Medical Oncology, Princess Alexandra Hospital</s1><s2>Woolloongabba, Queensland</s2><s3>AUS</s3></inist:fA14><country>Australie</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Rhône-Poulenc Rorer</s1><s2>Antony</s2><s3>FRA</s3></inist:fA14><country>France</country></affiliation><affiliation wicri:level="1"><inist:fA14 i1="20"><s1>St Vincent Hospital</s1><s2>Dublin</s2><s3>IRL</s3></inist:fA14><country>Irlande (pays)</country></affiliation></author><author><name sortKey="Friedrichs, K" sort="Friedrichs, K" uniqKey="Friedrichs K" first="K." last="Friedrichs">K. Friedrichs</name></author><author><name sortKey="Noel, D" sort="Noel, D" uniqKey="Noel D" first="D." last="Noel">D. Noel</name></author><author><name sortKey="Pinter, T" sort="Pinter, T" uniqKey="Pinter T" first="T." last="Pinter">T. Pinter</name></author><author><name sortKey="Van Belle, S" sort="Van Belle, S" uniqKey="Van Belle S" first="S." last="Van Belle">S. Van Belle</name></author><author><name sortKey="Vorobiof, D" sort="Vorobiof, D" uniqKey="Vorobiof D" first="D." last="Vorobiof">D. Vorobiof</name></author><author><name sortKey="Duarte, R" sort="Duarte, R" uniqKey="Duarte R" first="R." last="Duarte">R. Duarte</name></author><author><name sortKey="Gil, M G" sort="Gil, M G" uniqKey="Gil M" first="M. G." last="Gil">M. G. Gil</name></author><author><name sortKey="Bodrogi, I" sort="Bodrogi, I" uniqKey="Bodrogi I" first="I." last="Bodrogi">I. Bodrogi</name></author><author><name sortKey="Murray, E" sort="Murray, E" uniqKey="Murray E" first="E." last="Murray">E. Murray</name></author><author><name sortKey="Yelle, L" sort="Yelle, L" uniqKey="Yelle L" first="L." last="Yelle">L. Yelle</name></author><author><name sortKey="Von Minckwitz, G" sort="Von Minckwitz, G" uniqKey="Von Minckwitz G" first="G." last="Von Minckwitz">G. Von Minckwitz</name></author><author><name sortKey="Korec, S" sort="Korec, S" uniqKey="Korec S" first="S." last="Korec">S. Korec</name></author><author><name sortKey="Simmonds, P" sort="Simmonds, P" uniqKey="Simmonds P" first="P." last="Simmonds">P. Simmonds</name></author><author><name sortKey="Buzzi, F" sort="Buzzi, F" uniqKey="Buzzi F" first="F." last="Buzzi">F. Buzzi</name></author><author><name sortKey="Mancha, R G" sort="Mancha, R G" uniqKey="Mancha R" first="R. G." last="Mancha">R. G. Mancha</name></author><author><name sortKey="Richardson, G" sort="Richardson, G" uniqKey="Richardson G" first="G." last="Richardson">G. Richardson</name></author><author><name sortKey="Walpole, E" sort="Walpole, E" uniqKey="Walpole E" first="E." last="Walpole">E. Walpole</name></author><author><name sortKey="Ronzoni, M" sort="Ronzoni, M" uniqKey="Ronzoni M" first="M." last="Ronzoni">M. Ronzoni</name></author><author><name sortKey="Murawsky, M" sort="Murawsky, M" uniqKey="Murawsky M" first="M." last="Murawsky">M. Murawsky</name></author><author><name sortKey="Alakl, M" sort="Alakl, M" uniqKey="Alakl M" first="M." last="Alakl">M. Alakl</name></author><author><name sortKey="Riva, A" sort="Riva, A" uniqKey="Riva A" first="A." last="Riva">A. Riva</name></author><author><name sortKey="Crown, J" sort="Crown, J" uniqKey="Crown J" first="J." last="Crown">J. Crown</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="1999">1999</date></imprint></series></biblStruct></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>Anthracyclins</term><term>Antibiotic</term><term>Antimitotic</term><term>Antineoplastic agent</term><term>Chemotherapy</term><term>Comparative study</term><term>Docetaxel</term><term>Doxorubicin</term><term>Human</term><term>Malignant tumor</term><term>Mammary gland</term><term>Phase III trial</term><term>Prognosis</term><term>Randomization</term><term>Taxane derivatives</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Tumeur maligne</term><term>Glande mammaire</term><term>Stade avancé</term><term>Docétaxel</term><term>Antimitotique</term><term>Anticancéreux</term><term>Doxorubicine</term><term>Antibiotique</term><term>Chimiothérapie</term><term>Traitement</term><term>Randomisation</term><term>Essai clinique phase III</term><term>Etude comparative</term><term>Pronostic</term><term>Homme</term><term>Taxane dérivé</term><term>Anthracyclines</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Antibiotique</term><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy. Patients and Methods: Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m<sup>2</sup> or doxorubicin 75 mg/m<sup>2</sup> every 3 weeks for a maximum of seven treatment cycles. Results: A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P = .008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel. Conclusion: The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0732-183X</s0></fA01><fA03 i2="1"><s0>J. clin. oncol.</s0></fA03><fA05><s2>17</s2></fA05><fA06><s2>8</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer</s1></fA08><fA11 i1="01" i2="1"><s1>CHAN (S.)</s1></fA11><fA11 i1="02" i2="1"><s1>FRIEDRICHS (K.)</s1></fA11><fA11 i1="03" i2="1"><s1>NOEL (D.)</s1></fA11><fA11 i1="04" i2="1"><s1>PINTER (T.)</s1></fA11><fA11 i1="05" i2="1"><s1>VAN BELLE (S.)</s1></fA11><fA11 i1="06" i2="1"><s1>VOROBIOF (D.)</s1></fA11><fA11 i1="07" i2="1"><s1>DUARTE (R.)</s1></fA11><fA11 i1="08" i2="1"><s1>GIL (M. G.)</s1></fA11><fA11 i1="09" i2="1"><s1>BODROGI (I.)</s1></fA11><fA11 i1="10" i2="1"><s1>MURRAY (E.)</s1></fA11><fA11 i1="11" i2="1"><s1>YELLE (L.)</s1></fA11><fA11 i1="12" i2="1"><s1>VON MINCKWITZ (G.)</s1></fA11><fA11 i1="13" i2="1"><s1>KOREC (S.)</s1></fA11><fA11 i1="14" i2="1"><s1>SIMMONDS (P.)</s1></fA11><fA11 i1="15" i2="1"><s1>BUZZI (F.)</s1></fA11><fA11 i1="16" i2="1"><s1>MANCHA (R. G.)</s1></fA11><fA11 i1="17" i2="1"><s1>RICHARDSON (G.)</s1></fA11><fA11 i1="18" i2="1"><s1>WALPOLE (E.)</s1></fA11><fA11 i1="19" i2="1"><s1>RONZONI (M.)</s1></fA11><fA11 i1="20" i2="1"><s1>MURAWSKY (M.)</s1></fA11><fA11 i1="21" i2="1"><s1>ALAKL (M.)</s1></fA11><fA11 i1="22" i2="1"><s1>RIVA (A.)</s1></fA11><fA11 i1="23" i2="1"><s1>CROWN (J.)</s1></fA11><fA14 i1="01"><s1>Department of Clinical Oncology, City Hospital</s1><s2>Nottingham</s2><s3>GBR</s3></fA14><fA14 i1="02"><s1>CRC Wessex Medical Oncology Unit, Royal South Hants Hospital</s1><s2>Southampton</s2><s3>GBR</s3></fA14><fA14 i1="03"><s1>Universitäts-Frauenklinik und Poliklinik, Universitäts-Krankenhaus Eppendorf</s1><s2>Hamburg</s2><s3>USA</s3></fA14><fA14 i1="04"><s1>Klinik für Gynäkologie und Onkologie, Klinikum der Johann Wolfgang Goethe-Universität</s1><s2>Frankfurt</s2><s3>DEU</s3></fA14><fA14 i1="05"><s1>Oncology Department, Hôpital du Sacré-Coeur de Montreal, and Oncology Department, Hôpital Notre-Dame</s1><s2>Montreal, Quebec</s2><s3>CAN</s3></fA14><fA14 i1="06"><s1>Oncoradiology Department, Country Hospital</s1><s2>Gyor</s2><s3>HUN</s3></fA14><fA14 i1="07"><s1>National Institute of Oncology</s1><s2>Budapest</s2><s3>HUN</s3></fA14><fA14 i1="08"><s1>Dienst Medische Oncologie, Universitair Ziekenhuis Gent</s1><s2>Gent</s2><s3>BEL</s3></fA14><fA14 i1="09"><s1>The Sandton Oncology Centre</s1><s2>Johannesburg</s2><s3>ZAF</s3></fA14><fA14 i1="10"><s1>Department of Radiation Oncology, Groote Schuur Hospital</s1><s2>Cape Town</s2><s3>ZAF</s3></fA14><fA14 i1="11"><s1>National Institute of Cancerology</s1><s2>Bogota</s2><s3>COL</s3></fA14><fA14 i1="12"><s1>Servicio Oncologia, Instituto Catalán de Oncología</s1><s2>Barcelona</s2><s3>ESP</s3></fA14><fA14 i1="13"><s1>Servicio Oncología, Hospital Provincial</s1><s2>Cordova</s2><s3>ESP</s3></fA14><fA14 i1="14"><s1>National Cancer Institute</s1><s2>Bratislava</s2><s3>SVK</s3></fA14><fA14 i1="15"><s1>Servizio Oncologico, Ospedale Civile S. Maria</s1><s2>Terni</s2><s3>ITA</s3></fA14><fA14 i1="16"><s1>Unita di Radiochemioterapia, Ospedale San Raffaele</s1><s2>Milan</s2><s3>ITA</s3></fA14><fA14 i1="17"><s1>Department of Medical Oncology and Clinical Haematology, Monash Medical Centre</s1><s2>Clayton, Victoria</s2><s3>AUS</s3></fA14><fA14 i1="18"><s1>Department of Medical Oncology, Princess Alexandra Hospital</s1><s2>Woolloongabba, Queensland</s2><s3>AUS</s3></fA14><fA14 i1="19"><s1>Rhône-Poulenc Rorer</s1><s2>Antony</s2><s3>FRA</s3></fA14><fA14 i1="20"><s1>St Vincent Hospital</s1><s2>Dublin</s2><s3>IRL</s3></fA14><fA17 i1="01" i2="1"><s1>303 Study Group</s1><s3>INC</s3></fA17><fA20><s1>2341-2354</s1></fA20><fA21><s1>1999</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20094</s2><s5>354000086149360070</s5></fA43><fA44><s0>0000</s0><s1>© 1999 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>33 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>99-0401102</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Journal of clinical oncology</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>Purpose: This phase III study compared docetaxel and doxorubicin in patients with metastatic breast cancer who had received previous alkylating agent-containing chemotherapy. Patients and Methods: Patients were randomized to receive an intravenous infusion of docetaxel 100 mg/m<sup>2</sup> or doxorubicin 75 mg/m<sup>2</sup> every 3 weeks for a maximum of seven treatment cycles. Results: A total of 326 patients were randomized, 165 to receive doxorubicin and 161 to receive docetaxel. Overall, docetaxel produced a significantly higher rate of objective response than did doxorubicin (47.8% v 33.3%; P = .008). Docetaxel was also significantly more active than doxorubicin in patients with negative prognostic factors, such as visceral metastases (objective response, 46% v 29%) and resistance to prior chemotherapy (47% v 25%). Median time to progression was longer in the docetaxel group (26 weeks v 21 weeks; difference not significant). Median overall survival was similar in the two groups (docetaxel, 15 months; doxorubicin, 14 months). There was one death due to infection in each group, and an additional four deaths due to cardiotoxicity in the doxorubicin group. Although neutropenia was similar in both groups, febrile neutropenia and severe infection occurred more frequently in the doxorubicin group. For severe nonhematologic toxicity, the incidences of cardiac toxicity, nausea, vomiting, and stomatitis were higher among patients receiving doxorubicin, whereas diarrhea, neuropathy, fluid retention, and skin and nail changes were higher among patients receiving docetaxel. Conclusion: The observed differences in activity and toxicity profiles provide a basis for therapy choice and confirms the rationale for combination studies in early breast cancer.</s0></fC01><fC02 i1="01" i2="X"><s0>002B02R02</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Tumeur maligne</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Malignant tumor</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Tumor maligno</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Glande mammaire</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Mammary gland</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Glándula mamaria</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Stade avancé</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Advanced stage</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Estadio avanzado</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Docétaxel</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Docetaxel</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Docetaxel</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Antimitotique</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Antimitotic</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Antimitótico</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Anticancéreux</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Antineoplastic agent</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Anticanceroso</s0><s5>06</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Doxorubicine</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Doxorubicin</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Doxorubicina</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Antibiotique</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Antibiotic</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Antibiótico</s0><s5>08</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Chimiothérapie</s0><s5>09</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Chemotherapy</s0><s5>09</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Quimioterapia</s0><s5>09</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Traitement</s0><s5>10</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Treatment</s0><s5>10</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Tratamiento</s0><s5>10</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Randomisation</s0><s5>11</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Randomization</s0><s5>11</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Aleatorización</s0><s5>11</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Essai clinique phase III</s0><s5>12</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Phase III trial</s0><s5>12</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Ensayo clínico fase III</s0><s5>12</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Etude comparative</s0><s5>13</s5></fC03><fC03 i1="13" i2="X" l="ENG"><s0>Comparative study</s0><s5>13</s5></fC03><fC03 i1="13" i2="X" l="SPA"><s0>Estudio comparativo</s0><s5>13</s5></fC03><fC03 i1="14" i2="X" l="FRE"><s0>Pronostic</s0><s5>17</s5></fC03><fC03 i1="14" i2="X" l="ENG"><s0>Prognosis</s0><s5>17</s5></fC03><fC03 i1="14" i2="X" l="SPA"><s0>Pronóstico</s0><s5>17</s5></fC03><fC03 i1="15" i2="X" l="FRE"><s0>Homme</s0><s5>18</s5></fC03><fC03 i1="15" i2="X" l="ENG"><s0>Human</s0><s5>18</s5></fC03><fC03 i1="15" i2="X" l="SPA"><s0>Hombre</s0><s5>18</s5></fC03><fC03 i1="16" i2="X" l="FRE"><s0>Taxane dérivé</s0><s5>27</s5></fC03><fC03 i1="16" i2="X" l="ENG"><s0>Taxane derivatives</s0><s5>27</s5></fC03><fC03 i1="16" i2="X" l="SPA"><s0>Taxane derivado</s0><s5>27</s5></fC03><fC03 i1="17" i2="X" l="FRE"><s0>Anthracyclines</s0><s5>29</s5></fC03><fC03 i1="17" i2="X" l="ENG"><s0>Anthracyclins</s0><s5>29</s5></fC03><fC03 i1="17" i2="X" l="SPA"><s0>Antraciclinas</s0><s5>29</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Glande mammaire pathologie</s0><s2>NM</s2><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Mammary gland diseases</s0><s2>NM</s2><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Glándula mamaria patología</s0><s2>NM</s2><s5>37</s5></fC07><fN21><s1>256</s1></fN21></pA></standard></inist></record>Pour manipuler ce document sous Unix (Dilib)
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