Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial
Identifieur interne : 001C29 ( Istex/Corpus ); précédent : 001C28; suivant : 001C30Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial
Auteurs : E. Heidemann ; H. Stoeger ; R. Souchon ; W.-D. Hirschmann ; H. Bodenstein ; C. Oberhoff ; J. T. Fischer ; M. Schulze ; M. Clemens ; R. Andreesen ; M. Mahlke ; M. Ko Nig ; A. Scharl ; K. Fehnle ; M. KaufmannSource :
- Annals of Oncology [ 0923-7534 ] ; 2002-11.
English descriptors
Abstract
Background: To determine whether patients with high-risk metastatic breast cancer draw benefit from combination chemotherapy as first-line treatment. Patients and methods: A total of 260 women with measurable metastatic breast cancer fulfilling high-risk criteria, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either mitoxantrone 12 mg/m2 or the combination of fluorouracil 500 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (FEC) every 3 weeks. Treatment was continued until complete remission plus two cycles, or until disease progression. In the case of partial remission or stable disease, treatment was stopped after 12 cycles. Second-line treatment was vindesine, mitomycin and prednisolone. Gain from treatment was estimated using a modified Brunner’s score composed of time to progression, patients’ rating of the treatment benefit, alopecia, vomiting and performance status. Results: After recruitment from 1992 to 1997 and observation from 1997 to 1999, the final evaluation showed that single-agent treatment with mitoxantrone does not differ significantly from combination treatment with FEC in terms of response, objective remission rate, remission duration, time to response, time to best response, time to progression or overall survival. There was, however, a significant difference in gain from treatment using a modified Brunner’s score favoring the single-agent treatment arm. There was no evidence that any subgroup would fare better with combination treatment. Conclusions: No significant difference was detected between the treatment with mitoxantrone as a single agent and the combination of low-dose FEC in terms of response or survival; therefore, the imperative of the necessity of first-line combination chemotherapy for patients with high-risk metastatic breast cancer may be questioned. Since toxicity and quality of life score favored the single-agent mitoxantrone treatment arm, this treatment may be offered to patients preferring quality of life to a potential small prolongation of survival.
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DOI: 10.1093/annonc/mdf306
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial</title><author><name sortKey="Heidemann, E" sort="Heidemann, E" uniqKey="Heidemann E" first="E." last="Heidemann">E. Heidemann</name><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Stoeger, H" sort="Stoeger, H" uniqKey="Stoeger H" first="H." last="Stoeger">H. Stoeger</name><affiliation><mods:affiliation>Department of Medical Oncology, University of Graz, Austria;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Souchon, R" sort="Souchon, R" uniqKey="Souchon R" first="R." last="Souchon">R. Souchon</name><affiliation><mods:affiliation>Department of Radiation Oncology, General Hospital of Hagen;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Hirschmann, W D" sort="Hirschmann, W D" uniqKey="Hirschmann W" first="W.-D." last="Hirschmann">W.-D. Hirschmann</name><affiliation><mods:affiliation>Department of Medical Oncology, City Hospital of Kassel;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Bodenstein, H" sort="Bodenstein, H" uniqKey="Bodenstein H" first="H." last="Bodenstein">H. Bodenstein</name><affiliation><mods:affiliation>Department of Medical Oncology, City Hospital of Minden;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Oberhoff, C" sort="Oberhoff, C" uniqKey="Oberhoff C" first="C." last="Oberhoff">C. Oberhoff</name><affiliation><mods:affiliation>Gynecological Department, University of Essen;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Fischer, J T" sort="Fischer, J T" uniqKey="Fischer J" first="J. T." last="Fischer">J. T. Fischer</name><affiliation><mods:affiliation>Department of Medical Oncology, City Hospital of Karlsruhe;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Schulze, M" sort="Schulze, M" uniqKey="Schulze M" first="M." last="Schulze">M. Schulze</name><affiliation><mods:affiliation>Department of Medical Oncology, City Hospital of Zittau;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Clemens, M" sort="Clemens, M" uniqKey="Clemens M" first="M." last="Clemens">M. Clemens</name><affiliation><mods:affiliation>Department of Medical Oncology, Boromaeerinnen Hospital Trier;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Andreesen, R" sort="Andreesen, R" uniqKey="Andreesen R" first="R." last="Andreesen">R. Andreesen</name><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, University of Regensburg;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Mahlke, M" sort="Mahlke, M" uniqKey="Mahlke M" first="M." last="Mahlke">M. Mahlke</name><affiliation><mods:affiliation>Gynecological Department, University of Mainz;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Ko Nig, M" sort="Ko Nig, M" uniqKey="Ko Nig M" first="M." last="Ko Nig">M. Ko Nig</name><affiliation><mods:affiliation>Gynecological Department, University of Tuebingen;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Scharl, A" sort="Scharl, A" uniqKey="Scharl A" first="A." last="Scharl">A. Scharl</name><affiliation><mods:affiliation>Gynecological Department, University of Cologne;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Fehnle, K" sort="Fehnle, K" uniqKey="Fehnle K" first="K." last="Fehnle">K. Fehnle</name><affiliation><mods:affiliation>Algora Munich;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Kaufmann, M" sort="Kaufmann, M" uniqKey="Kaufmann M" first="M." last="Kaufmann">M. Kaufmann</name><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:56FE3D851265994664E8C24E2F5037BEB39CAD54</idno><date when="2002" year="2002">2002</date><idno type="doi">10.1093/annonc/mdf306</idno><idno type="url">https://api.istex.fr/document/56FE3D851265994664E8C24E2F5037BEB39CAD54/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001C29</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001C29</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial</title><author><name sortKey="Heidemann, E" sort="Heidemann, E" uniqKey="Heidemann E" first="E." last="Heidemann">E. Heidemann</name><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Stoeger, H" sort="Stoeger, H" uniqKey="Stoeger H" first="H." last="Stoeger">H. Stoeger</name><affiliation><mods:affiliation>Department of Medical Oncology, University of Graz, Austria;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Souchon, R" sort="Souchon, R" uniqKey="Souchon R" first="R." last="Souchon">R. Souchon</name><affiliation><mods:affiliation>Department of Radiation Oncology, General Hospital of Hagen;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Hirschmann, W D" sort="Hirschmann, W D" uniqKey="Hirschmann W" first="W.-D." last="Hirschmann">W.-D. Hirschmann</name><affiliation><mods:affiliation>Department of Medical Oncology, City Hospital of Kassel;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Bodenstein, H" sort="Bodenstein, H" uniqKey="Bodenstein H" first="H." last="Bodenstein">H. Bodenstein</name><affiliation><mods:affiliation>Department of Medical Oncology, City Hospital of Minden;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Oberhoff, C" sort="Oberhoff, C" uniqKey="Oberhoff C" first="C." last="Oberhoff">C. Oberhoff</name><affiliation><mods:affiliation>Gynecological Department, University of Essen;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Fischer, J T" sort="Fischer, J T" uniqKey="Fischer J" first="J. T." last="Fischer">J. T. Fischer</name><affiliation><mods:affiliation>Department of Medical Oncology, City Hospital of Karlsruhe;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Schulze, M" sort="Schulze, M" uniqKey="Schulze M" first="M." last="Schulze">M. Schulze</name><affiliation><mods:affiliation>Department of Medical Oncology, City Hospital of Zittau;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Clemens, M" sort="Clemens, M" uniqKey="Clemens M" first="M." last="Clemens">M. Clemens</name><affiliation><mods:affiliation>Department of Medical Oncology, Boromaeerinnen Hospital Trier;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Andreesen, R" sort="Andreesen, R" uniqKey="Andreesen R" first="R." last="Andreesen">R. Andreesen</name><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, University of Regensburg;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Mahlke, M" sort="Mahlke, M" uniqKey="Mahlke M" first="M." last="Mahlke">M. Mahlke</name><affiliation><mods:affiliation>Gynecological Department, University of Mainz;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Ko Nig, M" sort="Ko Nig, M" uniqKey="Ko Nig M" first="M." last="Ko Nig">M. Ko Nig</name><affiliation><mods:affiliation>Gynecological Department, University of Tuebingen;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Scharl, A" sort="Scharl, A" uniqKey="Scharl A" first="A." last="Scharl">A. Scharl</name><affiliation><mods:affiliation>Gynecological Department, University of Cologne;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Fehnle, K" sort="Fehnle, K" uniqKey="Fehnle K" first="K." last="Fehnle">K. Fehnle</name><affiliation><mods:affiliation>Algora Munich;</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author><author><name sortKey="Kaufmann, M" sort="Kaufmann, M" uniqKey="Kaufmann M" first="M." last="Kaufmann">M. Kaufmann</name><affiliation><mods:affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><title level="j" type="abbrev">Ann Oncol</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2002-11">2002-11</date><biblScope unit="volume">13</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1717">1717</biblScope><biblScope unit="page" to="1729">1729</biblScope></imprint><idno type="ISSN">0923-7534</idno></series><idno type="istex">56FE3D851265994664E8C24E2F5037BEB39CAD54</idno><idno type="DOI">10.1093/annonc/mdf306</idno><idno type="local">mdf306</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Key words: metastatic breast cancer, quality of life, single-agent treatment, survival, time to progression</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Background: To determine whether patients with high-risk metastatic breast cancer draw benefit from combination chemotherapy as first-line treatment. Patients and methods: A total of 260 women with measurable metastatic breast cancer fulfilling high-risk criteria, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either mitoxantrone 12 mg/m2 or the combination of fluorouracil 500 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (FEC) every 3 weeks. Treatment was continued until complete remission plus two cycles, or until disease progression. In the case of partial remission or stable disease, treatment was stopped after 12 cycles. Second-line treatment was vindesine, mitomycin and prednisolone. Gain from treatment was estimated using a modified Brunner’s score composed of time to progression, patients’ rating of the treatment benefit, alopecia, vomiting and performance status. Results: After recruitment from 1992 to 1997 and observation from 1997 to 1999, the final evaluation showed that single-agent treatment with mitoxantrone does not differ significantly from combination treatment with FEC in terms of response, objective remission rate, remission duration, time to response, time to best response, time to progression or overall survival. There was, however, a significant difference in gain from treatment using a modified Brunner’s score favoring the single-agent treatment arm. There was no evidence that any subgroup would fare better with combination treatment. Conclusions: No significant difference was detected between the treatment with mitoxantrone as a single agent and the combination of low-dose FEC in terms of response or survival; therefore, the imperative of the necessity of first-line combination chemotherapy for patients with high-risk metastatic breast cancer may be questioned. Since toxicity and quality of life score favored the single-agent mitoxantrone treatment arm, this treatment may be offered to patients preferring quality of life to a potential small prolongation of survival.</div></front></TEI><istex><corpusName>oup</corpusName><author><json:item><name>E. Heidemann</name><affiliations><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>H. Stoeger</name><affiliations><json:string>Department of Medical Oncology, University of Graz, Austria;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>R. Souchon</name><affiliations><json:string>Department of Radiation Oncology, General Hospital of Hagen;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>W.-D. Hirschmann</name><affiliations><json:string>Department of Medical Oncology, City Hospital of Kassel;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>H. Bodenstein</name><affiliations><json:string>Department of Medical Oncology, City Hospital of Minden;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>C. Oberhoff</name><affiliations><json:string>Gynecological Department, University of Essen;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>J. T. Fischer</name><affiliations><json:string>Department of Medical Oncology, City Hospital of Karlsruhe;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>M. Schulze</name><affiliations><json:string>Department of Medical Oncology, City Hospital of Zittau;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>M. Clemens</name><affiliations><json:string>Department of Medical Oncology, Boromaeerinnen Hospital Trier;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>R. Andreesen</name><affiliations><json:string>Department of Hematology and Medical Oncology, University of Regensburg;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>M. Mahlke</name><affiliations><json:string>Gynecological Department, University of Mainz;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>M. König</name><affiliations><json:string>Gynecological Department, University of Tuebingen;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>A. Scharl</name><affiliations><json:string>Gynecological Department, University of Cologne;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>K. Fehnle</name><affiliations><json:string>Algora Munich;</json:string><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item><json:item><name>M. Kaufmann</name><affiliations><json:string>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Key words: metastatic breast cancer, quality of life, single-agent treatment, survival, time to progression</value></json:item></subject><language><json:string>eng</json:string></language><originalGenre><json:string>other</json:string></originalGenre><abstract>Background: To determine whether patients with high-risk metastatic breast cancer draw benefit from combination chemotherapy as first-line treatment. Patients and methods: A total of 260 women with measurable metastatic breast cancer fulfilling high-risk criteria, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either mitoxantrone 12 mg/m2 or the combination of fluorouracil 500 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (FEC) every 3 weeks. Treatment was continued until complete remission plus two cycles, or until disease progression. In the case of partial remission or stable disease, treatment was stopped after 12 cycles. Second-line treatment was vindesine, mitomycin and prednisolone. Gain from treatment was estimated using a modified Brunner’s score composed of time to progression, patients’ rating of the treatment benefit, alopecia, vomiting and performance status. Results: After recruitment from 1992 to 1997 and observation from 1997 to 1999, the final evaluation showed that single-agent treatment with mitoxantrone does not differ significantly from combination treatment with FEC in terms of response, objective remission rate, remission duration, time to response, time to best response, time to progression or overall survival. There was, however, a significant difference in gain from treatment using a modified Brunner’s score favoring the single-agent treatment arm. There was no evidence that any subgroup would fare better with combination treatment. Conclusions: No significant difference was detected between the treatment with mitoxantrone as a single agent and the combination of low-dose FEC in terms of response or survival; therefore, the imperative of the necessity of first-line combination chemotherapy for patients with high-risk metastatic breast cancer may be questioned. Since toxicity and quality of life score favored the single-agent mitoxantrone treatment arm, this treatment may be offered to patients preferring quality of life to a potential small prolongation of survival.</abstract><qualityIndicators><score>10</score><pdfVersion>1.2</pdfVersion><pdfPageSize>612 x 792 pts (letter)</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>1</keywordCount><abstractCharCount>2087</abstractCharCount><pdfWordCount>6815</pdfWordCount><pdfCharCount>44577</pdfCharCount><pdfPageCount>13</pdfPageCount><abstractWordCount>293</abstractWordCount></qualityIndicators><title>Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial</title><refBibs><json:item><author></author><host><author></author><title>Mannheim), M. Graubner (Schotten), W. Kaboth (Muenchen-Schwabing), E. 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uri="https://api.istex.fr/document/56FE3D851265994664E8C24E2F5037BEB39CAD54/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial</title><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Oxford University Press</publisher><availability><p>OUP</p></availability><date>2002</date></publicationStmt><notesStmt><note>Received 14 January 2002; revised 13 May 2002; accepted 5 June 2002</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial</title><author xml:id="author-1"><persName><forename type="first">E.</forename><surname>Heidemann</surname></persName><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-2"><persName><forename type="first">H.</forename><surname>Stoeger</surname></persName><affiliation>Department of Medical Oncology, University of Graz, Austria;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-3"><persName><forename type="first">R.</forename><surname>Souchon</surname></persName><affiliation>Department of Radiation Oncology, General Hospital of Hagen;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-4"><persName><forename type="first">W.-D.</forename><surname>Hirschmann</surname></persName><affiliation>Department of Medical Oncology, City Hospital of Kassel;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-5"><persName><forename type="first">H.</forename><surname>Bodenstein</surname></persName><affiliation>Department of Medical Oncology, City Hospital of Minden;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-6"><persName><forename type="first">C.</forename><surname>Oberhoff</surname></persName><affiliation>Gynecological Department, University of Essen;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-7"><persName><forename type="first">J. T.</forename><surname>Fischer</surname></persName><affiliation>Department of Medical Oncology, City Hospital of Karlsruhe;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-8"><persName><forename type="first">M.</forename><surname>Schulze</surname></persName><affiliation>Department of Medical Oncology, City Hospital of Zittau;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-9"><persName><forename type="first">M.</forename><surname>Clemens</surname></persName><affiliation>Department of Medical Oncology, Boromaeerinnen Hospital Trier;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-10"><persName><forename type="first">R.</forename><surname>Andreesen</surname></persName><affiliation>Department of Hematology and Medical Oncology, University of Regensburg;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-11"><persName><forename type="first">M.</forename><surname>Mahlke</surname></persName><affiliation>Gynecological Department, University of Mainz;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-12"><persName><forename type="first">M.</forename><surname>König</surname></persName><affiliation>Gynecological Department, University of Tuebingen;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-13"><persName><forename type="first">A.</forename><surname>Scharl</surname></persName><affiliation>Gynecological Department, University of Cologne;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-14"><persName><forename type="first">K.</forename><surname>Fehnle</surname></persName><affiliation>Algora Munich;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author><author xml:id="author-15"><persName><forename type="first">M.</forename><surname>Kaufmann</surname></persName><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation></author></analytic><monogr><title level="j">Annals of Oncology</title><title level="j" type="abbrev">Ann Oncol</title><idno type="pISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2002-11"></date><biblScope unit="volume">13</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1717">1717</biblScope><biblScope unit="page" to="1729">1729</biblScope></imprint></monogr><idno type="istex">56FE3D851265994664E8C24E2F5037BEB39CAD54</idno><idno type="DOI">10.1093/annonc/mdf306</idno><idno type="local">mdf306</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2002</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Background: To determine whether patients with high-risk metastatic breast cancer draw benefit from combination chemotherapy as first-line treatment. Patients and methods: A total of 260 women with measurable metastatic breast cancer fulfilling high-risk criteria, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either mitoxantrone 12 mg/m2 or the combination of fluorouracil 500 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (FEC) every 3 weeks. Treatment was continued until complete remission plus two cycles, or until disease progression. In the case of partial remission or stable disease, treatment was stopped after 12 cycles. Second-line treatment was vindesine, mitomycin and prednisolone. Gain from treatment was estimated using a modified Brunner’s score composed of time to progression, patients’ rating of the treatment benefit, alopecia, vomiting and performance status. Results: After recruitment from 1992 to 1997 and observation from 1997 to 1999, the final evaluation showed that single-agent treatment with mitoxantrone does not differ significantly from combination treatment with FEC in terms of response, objective remission rate, remission duration, time to response, time to best response, time to progression or overall survival. There was, however, a significant difference in gain from treatment using a modified Brunner’s score favoring the single-agent treatment arm. There was no evidence that any subgroup would fare better with combination treatment. Conclusions: No significant difference was detected between the treatment with mitoxantrone as a single agent and the combination of low-dose FEC in terms of response or survival; therefore, the imperative of the necessity of first-line combination chemotherapy for patients with high-risk metastatic breast cancer may be questioned. Since toxicity and quality of life score favored the single-agent mitoxantrone treatment arm, this treatment may be offered to patients preferring quality of life to a potential small prolongation of survival.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>KWD</head><item><term>Key words: metastatic breast cancer, quality of life, single-agent treatment, survival, time to progression</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2002-11">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2016-12-22">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/56FE3D851265994664E8C24E2F5037BEB39CAD54/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus oup" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="US-ASCII"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Publishing DTD v2.3 20070202//EN" URI="journalpublishing.dtd" name="istex:docType"></istex:docType><istex:document><article xml:lang="en" article-type="other"><front><journal-meta><journal-id journal-id-type="hwp">annonc</journal-id><journal-id journal-id-type="nlm-ta">Ann Oncol</journal-id><journal-id journal-id-type="publisher-id">annonc</journal-id><journal-title>Annals of Oncology</journal-title><abbrev-journal-title abbrev-type="publisher">Ann Oncol</abbrev-journal-title><issn pub-type="ppub">0923-7534</issn><issn pub-type="epub">1569-8041</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="other">mdf306</article-id><article-id pub-id-type="doi">10.1093/annonc/mdf306</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original article</subject><subj-group><subject>Breast cancer</subject></subj-group></subj-group></article-categories><title-group><article-title>Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Heidemann</surname><given-names>E.</given-names></name><xref rid="CHDECHHC">1</xref><xref rid="FN1">+</xref></contrib><contrib contrib-type="author"><name><surname>Stoeger</surname><given-names>H.</given-names></name><xref rid="CHDJFCDF">2</xref></contrib><contrib contrib-type="author"><name><surname>Souchon</surname><given-names>R.</given-names></name><xref rid="CHDBAGGG">3</xref></contrib><contrib contrib-type="author"><name><surname>Hirschmann</surname><given-names>W.-D.</given-names></name><xref rid="CHDCEAJA">4</xref></contrib><contrib contrib-type="author"><name><surname>Bodenstein</surname><given-names>H.</given-names></name><xref rid="CHDIBCDD">5</xref></contrib><contrib contrib-type="author"><name><surname>Oberhoff</surname><given-names>C.</given-names></name><xref rid="CHDIDJDD">6</xref></contrib><contrib contrib-type="author"><name><surname>Fischer</surname><given-names>J. T.</given-names></name><xref rid="CHDEDJAD">7</xref></contrib><contrib contrib-type="author"><name><surname>Schulze</surname><given-names>M.</given-names></name><xref rid="CHDJBEBG">8</xref></contrib><contrib contrib-type="author"><name><surname>Clemens</surname><given-names>M.</given-names></name><xref rid="CHDIBBJC">9</xref></contrib><contrib contrib-type="author"><name><surname>Andreesen</surname><given-names>R.</given-names></name><xref rid="CHDBFDIG">10</xref></contrib><contrib contrib-type="author"><name><surname>Mahlke</surname><given-names>M.</given-names></name><xref rid="CHDGHAEH">11</xref></contrib><contrib contrib-type="author"><name><surname>König</surname><given-names>M.</given-names></name><xref rid="CHDBDEEE">12</xref></contrib><contrib contrib-type="author"><name><surname>Scharl</surname><given-names>A.</given-names></name><xref rid="CHDIDJAE">13</xref></contrib><contrib contrib-type="author"><name><surname>Fehnle</surname><given-names>K.</given-names></name><xref rid="CHDDJHCA">14</xref></contrib><contrib contrib-type="author"><name><surname>Kaufmann</surname><given-names>M.</given-names></name></contrib><contrib contrib-type="group-author"><on-behalf-of> On behalf of the Interdisciplinary Breast Cancer Working Group of the German Cancer Society</on-behalf-of><xref rid="CHDDGIGD">15</xref></contrib><aff><target target-type="aff" id="CHDECHHC"></target><label>1</label>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany; <target target-type="aff" id="CHDJFCDF"></target><label>2</label>Department of Medical Oncology, University of Graz, Austria; <target target-type="aff" id="CHDBAGGG"></target><label>3</label>Department of Radiation Oncology, General Hospital of Hagen; <target target-type="aff" id="CHDCEAJA"></target><label>4</label>Department of Medical Oncology, City Hospital of Kassel; <target target-type="aff" id="CHDIBCDD"></target><label>5</label>Department of Medical Oncology, City Hospital of Minden; <target target-type="aff" id="CHDIDJDD"></target><label>6</label>Gynecological Department, University of Essen; <target target-type="aff" id="CHDEDJAD"></target><label>7</label>Department of Medical Oncology, City Hospital of Karlsruhe; <target target-type="aff" id="CHDJBEBG"></target><label>8</label>Department of Medical Oncology, City Hospital of Zittau; <target target-type="aff" id="CHDIBBJC"></target><label>9</label>Department of Medical Oncology, Boromaeerinnen Hospital Trier; <target target-type="aff" id="CHDBFDIG"></target><label>10</label>Department of Hematology and Medical Oncology, University of Regensburg; <target target-type="aff" id="CHDGHAEH"></target><label>11</label>Gynecological Department, University of Mainz; <target target-type="aff" id="CHDBDEEE"></target><label>12</label>Gynecological Department, University of Tuebingen; <target target-type="aff" id="CHDIDJAE"></target><label>13</label>Gynecological Department, University of Cologne; <target target-type="aff" id="CHDDJHCA"></target><label>14</label>Algora Munich; <target target-type="aff" id="CHDDGIGD"></target><label>15</label>Gynecological Department, University of Frankfurt, Germany</aff></contrib-group><pub-date pub-type="ppub"><month>11</month><year>2002</year></pub-date><volume>13</volume><issue>11</issue><fpage>1717</fpage><lpage>1729</lpage><permissions><copyright-year>2002</copyright-year></permissions><abstract xml:lang="en"><p><bold>Background:</bold></p><p>To determine whether patients with high-risk metastatic breast cancer draw benefit from combination chemotherapy as first-line treatment.</p><p><bold>Patients and methods:</bold></p><p>A total of 260 women with measurable metastatic breast cancer fulfilling high-risk criteria, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either mitoxantrone 12 mg/m<sup>2</sup> or the combination of fluorouracil 500 mg/m<sup>2</sup>, epirubicin 50 mg/m<sup>2</sup> and cyclophosphamide 500 mg/m<sup>2</sup> (FEC) every 3 weeks. Treatment was continued until complete remission plus two cycles, or until disease progression. In the case of partial remission or stable disease, treatment was stopped after 12 cycles. Second-line treatment was vindesine, mitomycin and prednisolone. Gain from treatment was estimated using a modified Brunner’s score composed of time to progression, patients’ rating of the treatment benefit, alopecia, vomiting and performance status.</p><p><bold>Results:</bold></p><p>After recruitment from 1992 to 1997 and observation from 1997 to 1999, the final evaluation showed that single-agent treatment with mitoxantrone does not differ significantly from combination treatment with FEC in terms of response, objective remission rate, remission duration, time to response, time to best response, time to progression or overall survival. There was, however, a significant difference in gain from treatment using a modified Brunner’s score favoring the single-agent treatment arm. There was no evidence that any subgroup would fare better with combination treatment.</p><p><bold>Conclusions:</bold></p><p>No significant difference was detected between the treatment with mitoxantrone as a single agent and the combination of low-dose FEC in terms of response or survival; therefore, the imperative of the necessity of first-line combination chemotherapy for patients with high-risk metastatic breast cancer may be questioned. Since toxicity and quality of life score favored the single-agent mitoxantrone treatment arm, this treatment may be offered to patients preferring quality of life to a potential small prolongation of survival.</p></abstract><kwd-group kwd-group-type="KWD" xml:lang="en"><kwd><bold>Key words:</bold> metastatic breast cancer, quality of life, single-agent treatment, survival, time to progression</kwd></kwd-group><custom-meta-wrap><custom-meta><meta-name>hwp-legacy-fpage</meta-name><meta-value>1717</meta-value></custom-meta><custom-meta><meta-name>hwp-legacy-dochead</meta-name><meta-value>Original Paper</meta-value></custom-meta></custom-meta-wrap></article-meta><notes><p content-type="arthw-misc">Received 14 January 2002; revised 13 May 2002; accepted 5 June 2002</p></notes></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial</title></titleInfo><titleInfo type="alternative" lang="en" contentType="CDATA"><title>Is first-line single-agent mitoxantrone in the treatment of high-risk metastatic breast cancer patients as effective as combination chemotherapy? No difference in survival but higher quality of life were found in a multicenter randomized trial</title></titleInfo><name type="personal"><namePart type="given">E.</namePart><namePart type="family">Heidemann</namePart><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Stoeger</namePart><affiliation>Department of Medical Oncology, University of Graz, Austria;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Souchon</namePart><affiliation>Department of Radiation Oncology, General Hospital of Hagen;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.-D.</namePart><namePart type="family">Hirschmann</namePart><affiliation>Department of Medical Oncology, City Hospital of Kassel;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Bodenstein</namePart><affiliation>Department of Medical Oncology, City Hospital of Minden;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Oberhoff</namePart><affiliation>Gynecological Department, University of Essen;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. T.</namePart><namePart type="family">Fischer</namePart><affiliation>Department of Medical Oncology, City Hospital of Karlsruhe;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Schulze</namePart><affiliation>Department of Medical Oncology, City Hospital of Zittau;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Clemens</namePart><affiliation>Department of Medical Oncology, Boromaeerinnen Hospital Trier;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Andreesen</namePart><affiliation>Department of Hematology and Medical Oncology, University of Regensburg;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Mahlke</namePart><affiliation>Gynecological Department, University of Mainz;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">König</namePart><affiliation>Gynecological Department, University of Tuebingen;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">A.</namePart><namePart type="family">Scharl</namePart><affiliation>Gynecological Department, University of Cologne;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.</namePart><namePart type="family">Fehnle</namePart><affiliation>Algora Munich;</affiliation><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Kaufmann</namePart><affiliation>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart, Germany;</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="other" displayLabel="other"></genre><originInfo><publisher>Oxford University Press</publisher><dateIssued encoding="w3cdtf">2002-11</dateIssued><copyrightDate encoding="w3cdtf">2002</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">Background: To determine whether patients with high-risk metastatic breast cancer draw benefit from combination chemotherapy as first-line treatment. Patients and methods: A total of 260 women with measurable metastatic breast cancer fulfilling high-risk criteria, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either mitoxantrone 12 mg/m2 or the combination of fluorouracil 500 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (FEC) every 3 weeks. Treatment was continued until complete remission plus two cycles, or until disease progression. In the case of partial remission or stable disease, treatment was stopped after 12 cycles. Second-line treatment was vindesine, mitomycin and prednisolone. Gain from treatment was estimated using a modified Brunner’s score composed of time to progression, patients’ rating of the treatment benefit, alopecia, vomiting and performance status. Results: After recruitment from 1992 to 1997 and observation from 1997 to 1999, the final evaluation showed that single-agent treatment with mitoxantrone does not differ significantly from combination treatment with FEC in terms of response, objective remission rate, remission duration, time to response, time to best response, time to progression or overall survival. There was, however, a significant difference in gain from treatment using a modified Brunner’s score favoring the single-agent treatment arm. There was no evidence that any subgroup would fare better with combination treatment. Conclusions: No significant difference was detected between the treatment with mitoxantrone as a single agent and the combination of low-dose FEC in terms of response or survival; therefore, the imperative of the necessity of first-line combination chemotherapy for patients with high-risk metastatic breast cancer may be questioned. Since toxicity and quality of life score favored the single-agent mitoxantrone treatment arm, this treatment may be offered to patients preferring quality of life to a potential small prolongation of survival.</abstract><note>Received 14 January 2002; revised 13 May 2002; accepted 5 June 2002</note><subject lang="en"><genre>KWD</genre><topic>Key words: metastatic breast cancer, quality of life, single-agent treatment, survival, time to progression</topic></subject><relatedItem type="host"><titleInfo><title>Annals of Oncology</title></titleInfo><titleInfo type="abbreviated"><title>Ann Oncol</title></titleInfo><genre type="journal">journal</genre><identifier type="ISSN">0923-7534</identifier><identifier type="eISSN">1569-8041</identifier><identifier type="PublisherID">annonc</identifier><identifier type="PublisherID-hwp">annonc</identifier><identifier type="PublisherID-nlm-ta">Ann Oncol</identifier><part><date>2002</date><detail type="volume"><caption>vol.</caption><number>13</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>1717</start><end>1729</end></extent></part></relatedItem><identifier type="istex">56FE3D851265994664E8C24E2F5037BEB39CAD54</identifier><identifier type="DOI">10.1093/annonc/mdf306</identifier><identifier type="local">mdf306</identifier><recordInfo><recordContentSource>OUP</recordContentSource></recordInfo></mods></metadata><annexes><json:item><extension>jpeg</extension><original>true</original><mimetype>image/jpeg</mimetype><uri>https://api.istex.fr/document/56FE3D851265994664E8C24E2F5037BEB39CAD54/annexes/jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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