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 : 001C45 ( Main/Curation ); précédent : 001C44; suivant : 001C46Is 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 [Allemagne] ; H. Stoeger [Autriche, Allemagne] ; R. Souchon [Allemagne] ; W.-D. Hirschmann [Allemagne] ; H. Bodenstein [Allemagne] ; C. Oberhoff [Allemagne] ; J. T. Fischer [Allemagne] ; M. Schulze [Allemagne] ; M. Clemens [Allemagne] ; R. Andreesen [Allemagne] ; M. Mahlke [Allemagne] ; M. Ko Nig [Allemagne] ; A. Scharl [Allemagne] ; K. Fehnle [Allemagne] ; M. Kaufmann [Allemagne]Source :
- Annals of Oncology [ 0923-7534 ] ; 2002-11.
Descripteurs français
- Pascal (Inist)
- Anthracyclines, Anthraquinone dérivé, Anticancéreux, Association médicamenteuse, Chimiothérapie, Cyclophosphamide, Epirubicine, Etude comparative, Femelle, Fluoropyrimidine dérivé, Fluorouracil, Glande mammaire, Homme, Mitoxantrone, Moutarde à l'azote, Métastase, Oxazaphosphinane dérivé, Pyrimidine dérivé, Qualité vie, Stade avancé, Survie, Traitement, Tumeur maligne.
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Advanced stage, Anthracyclins, Anthraquinone derivatives, Antineoplastic agent, Chemotherapy, Comparative study, Cyclophosphamide, Drug combination, Epirubicin, Female, Fluoropyrimidine derivatives, Fluorouracil, Human, Key words: metastatic breast cancer, quality of life, single-agent treatment, survival, time to progression, Malignant tumor, Mammary gland, Metastasis, Mitoxantrone, Nitrogen mustard, Oxazaphosphinane derivatives, Pyrimidine derivatives, Quality of life, Survival, Treatment.
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.
Url:
DOI: 10.1093/annonc/mdf306
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Heidemann</name><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Stoeger, H" sort="Stoeger, H" uniqKey="Stoeger H" first="H." last="Stoeger">H. 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Hirschmann</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Bodenstein, H" sort="Bodenstein, H" uniqKey="Bodenstein H" first="H." last="Bodenstein">H. Bodenstein</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Oberhoff, C" sort="Oberhoff, C" uniqKey="Oberhoff C" first="C." last="Oberhoff">C. 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Fischer</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Schulze, M" sort="Schulze, M" uniqKey="Schulze M" first="M." last="Schulze">M. Schulze</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Clemens, M" sort="Clemens, M" uniqKey="Clemens M" first="M." last="Clemens">M. Clemens</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Andreesen, R" sort="Andreesen, R" uniqKey="Andreesen R" first="R." last="Andreesen">R. Andreesen</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Mahlke, M" sort="Mahlke, M" uniqKey="Mahlke M" first="M." last="Mahlke">M. Mahlke</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></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></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Scharl, A" sort="Scharl, A" uniqKey="Scharl A" first="A." last="Scharl">A. Scharl</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Fehnle, K" sort="Fehnle, K" uniqKey="Fehnle K" first="K." last="Fehnle">K. Fehnle</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Kaufmann, M" sort="Kaufmann, M" uniqKey="Kaufmann M" first="M." last="Kaufmann">M. Kaufmann</name><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></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>Advanced stage</term><term>Anthracyclins</term><term>Anthraquinone derivatives</term><term>Antineoplastic agent</term><term>Chemotherapy</term><term>Comparative study</term><term>Cyclophosphamide</term><term>Drug combination</term><term>Epirubicin</term><term>Female</term><term>Fluoropyrimidine derivatives</term><term>Fluorouracil</term><term>Human</term><term>Key words: metastatic breast cancer, quality of life, single-agent treatment, survival, time to progression</term><term>Malignant tumor</term><term>Mammary gland</term><term>Metastasis</term><term>Mitoxantrone</term><term>Nitrogen mustard</term><term>Oxazaphosphinane derivatives</term><term>Pyrimidine derivatives</term><term>Quality of life</term><term>Survival</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Anthracyclines</term><term>Anthraquinone dérivé</term><term>Anticancéreux</term><term>Association médicamenteuse</term><term>Chimiothérapie</term><term>Cyclophosphamide</term><term>Epirubicine</term><term>Etude comparative</term><term>Femelle</term><term>Fluoropyrimidine dérivé</term><term>Fluorouracil</term><term>Glande mammaire</term><term>Homme</term><term>Mitoxantrone</term><term>Moutarde à l'azote</term><term>Métastase</term><term>Oxazaphosphinane dérivé</term><term>Pyrimidine dérivé</term><term>Qualité vie</term><term>Stade avancé</term><term>Survie</term><term>Traitement</term><term>Tumeur maligne</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</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><double idat="0923-7534:2002:Heidemann E:is:first:line"><INIST><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">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 wicri:level="1"><inist:fA14 i1="01"><s1>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</s1><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Stoeger, H" sort="Stoeger, H" uniqKey="Stoeger H" first="H." last="Stoeger">H. Stoeger</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Medical Oncology, University of Graz</s1><s3>AUT</s3><sZ>2 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Department of Medical Oncology, University of Graz</wicri:noRegion></affiliation></author><author><name sortKey="Souchon, R" sort="Souchon, R" uniqKey="Souchon R" first="R." last="Souchon">R. Souchon</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Radiation Oncology, General Hospital of Hagen</s1><s3>DEU</s3><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>General Hospital of Hagen</wicri:noRegion><wicri:noRegion>Department of Radiation Oncology, General Hospital of Hagen</wicri:noRegion></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 wicri:level="1"><inist:fA14 i1="04"><s1>Department of Medical Oncology, City Hospital of Kassel</s1><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>City Hospital of Kassel</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, City Hospital of Kassel</wicri:noRegion></affiliation></author><author><name sortKey="Bodenstein, H" sort="Bodenstein, H" uniqKey="Bodenstein H" first="H." last="Bodenstein">H. Bodenstein</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Medical Oncology, City Hospital of Minden</s1><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>City Hospital of Minden</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, City Hospital of Minden</wicri:noRegion></affiliation></author><author><name sortKey="Oberhoff, C" sort="Oberhoff, C" uniqKey="Oberhoff C" first="C." last="Oberhoff">C. Oberhoff</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Gynecological Deportment, University of Essen</s1><s3>DEU</s3><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Essen</wicri:noRegion><wicri:noRegion>Gynecological Deportment, University of Essen</wicri:noRegion></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 wicri:level="1"><inist:fA14 i1="07"><s1>Department of Medical Oncology, City Hospital of Karlsruhe</s1><s3>DEU</s3><sZ>7 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>City Hospital of Karlsruhe</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, City Hospital of Karlsruhe</wicri:noRegion></affiliation></author><author><name sortKey="Schulze, M" sort="Schulze, M" uniqKey="Schulze M" first="M." last="Schulze">M. Schulze</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Department of Medical Oncology, City Hospital of Zittau</s1><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>City Hospital of Zittau</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, City Hospital of Zittau</wicri:noRegion></affiliation></author><author><name sortKey="Clemens, M" sort="Clemens, M" uniqKey="Clemens M" first="M." last="Clemens">M. Clemens</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Medical Oncology, Boromaeerinnen Hospital Trier</s1><s3>DEU</s3><sZ>9 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Boromaeerinnen Hospital Trier</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, Boromaeerinnen Hospital Trier</wicri:noRegion></affiliation></author><author><name sortKey="Andreesen, R" sort="Andreesen, R" uniqKey="Andreesen R" first="R." last="Andreesen">R. Andreesen</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Hematology and Medical Oncology, University of Regensburg</s1><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Regensburg</wicri:noRegion><wicri:noRegion>Department of Hematology and Medical Oncology, University of Regensburg</wicri:noRegion></affiliation></author><author><name sortKey="Mahlke, M" sort="Mahlke, M" uniqKey="Mahlke M" first="M." last="Mahlke">M. Mahlke</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Gynecological Department, University of Mainz</s1><s3>DEU</s3><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Mainz</wicri:noRegion><wicri:noRegion>Gynecological Department, University of Mainz</wicri:noRegion></affiliation></author><author><name sortKey="Konig, M" sort="Konig, M" uniqKey="Konig M" first="M." last="König">M. König</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Gynecological Department, University of Tuebingen</s1><s3>DEU</s3><sZ>12 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Tuebingen</wicri:noRegion><wicri:noRegion>Gynecological Department, University of Tuebingen</wicri:noRegion></affiliation></author><author><name sortKey="Scharl, A" sort="Scharl, A" uniqKey="Scharl A" first="A." last="Scharl">A. Scharl</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Gynecological Department, University of Cologne</s1><s3>DEU</s3><sZ>13 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Cologne</wicri:noRegion><wicri:noRegion>Gynecological Department, University of Cologne</wicri:noRegion></affiliation></author><author><name sortKey="Fehnle, K" sort="Fehnle, K" uniqKey="Fehnle K" first="K." last="Fehnle">K. Fehnle</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Algora Munich</s1><s3>DEU</s3><sZ>14 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Algora Munich</wicri:noRegion><wicri:noRegion>Algora Munich</wicri:noRegion></affiliation></author><author><name sortKey="Kaufmann, M" sort="Kaufmann, M" uniqKey="Kaufmann M" first="M." last="Kaufmann">M. Kaufmann</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Gynecological Department, University of Frankfurt</s1><s3>DEU</s3><sZ>15 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Frankfurt</wicri:noRegion><wicri:noRegion>Gynecological Department, University of Frankfurt</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">03-0113411</idno><date when="2002">2002</date><idno type="stanalyst">PASCAL 03-0113411 INIST</idno><idno type="RBID">Pascal:03-0113411</idno><idno type="wicri:Area/PascalFrancis/Corpus">000C83</idno><idno type="wicri:Area/PascalFrancis/Curation">000232</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000A96</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000A96</idno><idno type="wicri:doubleKey">0923-7534:2002:Heidemann E:is:first:line</idno><idno type="wicri:Area/Main/Merge">001F61</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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 wicri:level="1"><inist:fA14 i1="01"><s1>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</s1><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Stoeger, H" sort="Stoeger, H" uniqKey="Stoeger H" first="H." last="Stoeger">H. Stoeger</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Medical Oncology, University of Graz</s1><s3>AUT</s3><sZ>2 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Department of Medical Oncology, University of Graz</wicri:noRegion></affiliation></author><author><name sortKey="Souchon, R" sort="Souchon, R" uniqKey="Souchon R" first="R." last="Souchon">R. Souchon</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Radiation Oncology, General Hospital of Hagen</s1><s3>DEU</s3><sZ>3 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>General Hospital of Hagen</wicri:noRegion><wicri:noRegion>Department of Radiation Oncology, General Hospital of Hagen</wicri:noRegion></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 wicri:level="1"><inist:fA14 i1="04"><s1>Department of Medical Oncology, City Hospital of Kassel</s1><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>City Hospital of Kassel</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, City Hospital of Kassel</wicri:noRegion></affiliation></author><author><name sortKey="Bodenstein, H" sort="Bodenstein, H" uniqKey="Bodenstein H" first="H." last="Bodenstein">H. Bodenstein</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Medical Oncology, City Hospital of Minden</s1><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>City Hospital of Minden</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, City Hospital of Minden</wicri:noRegion></affiliation></author><author><name sortKey="Oberhoff, C" sort="Oberhoff, C" uniqKey="Oberhoff C" first="C." last="Oberhoff">C. Oberhoff</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Gynecological Deportment, University of Essen</s1><s3>DEU</s3><sZ>6 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Essen</wicri:noRegion><wicri:noRegion>Gynecological Deportment, University of Essen</wicri:noRegion></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 wicri:level="1"><inist:fA14 i1="07"><s1>Department of Medical Oncology, City Hospital of Karlsruhe</s1><s3>DEU</s3><sZ>7 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>City Hospital of Karlsruhe</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, City Hospital of Karlsruhe</wicri:noRegion></affiliation></author><author><name sortKey="Schulze, M" sort="Schulze, M" uniqKey="Schulze M" first="M." last="Schulze">M. Schulze</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Department of Medical Oncology, City Hospital of Zittau</s1><s3>DEU</s3><sZ>8 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>City Hospital of Zittau</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, City Hospital of Zittau</wicri:noRegion></affiliation></author><author><name sortKey="Clemens, M" sort="Clemens, M" uniqKey="Clemens M" first="M." last="Clemens">M. Clemens</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Department of Medical Oncology, Boromaeerinnen Hospital Trier</s1><s3>DEU</s3><sZ>9 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Boromaeerinnen Hospital Trier</wicri:noRegion><wicri:noRegion>Department of Medical Oncology, Boromaeerinnen Hospital Trier</wicri:noRegion></affiliation></author><author><name sortKey="Andreesen, R" sort="Andreesen, R" uniqKey="Andreesen R" first="R." last="Andreesen">R. Andreesen</name><affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Department of Hematology and Medical Oncology, University of Regensburg</s1><s3>DEU</s3><sZ>10 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Regensburg</wicri:noRegion><wicri:noRegion>Department of Hematology and Medical Oncology, University of Regensburg</wicri:noRegion></affiliation></author><author><name sortKey="Mahlke, M" sort="Mahlke, M" uniqKey="Mahlke M" first="M." last="Mahlke">M. Mahlke</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Gynecological Department, University of Mainz</s1><s3>DEU</s3><sZ>11 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Mainz</wicri:noRegion><wicri:noRegion>Gynecological Department, University of Mainz</wicri:noRegion></affiliation></author><author><name sortKey="Konig, M" sort="Konig, M" uniqKey="Konig M" first="M." last="König">M. König</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Gynecological Department, University of Tuebingen</s1><s3>DEU</s3><sZ>12 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Tuebingen</wicri:noRegion><wicri:noRegion>Gynecological Department, University of Tuebingen</wicri:noRegion></affiliation></author><author><name sortKey="Scharl, A" sort="Scharl, A" uniqKey="Scharl A" first="A." last="Scharl">A. Scharl</name><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Gynecological Department, University of Cologne</s1><s3>DEU</s3><sZ>13 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Cologne</wicri:noRegion><wicri:noRegion>Gynecological Department, University of Cologne</wicri:noRegion></affiliation></author><author><name sortKey="Fehnle, K" sort="Fehnle, K" uniqKey="Fehnle K" first="K." last="Fehnle">K. Fehnle</name><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Algora Munich</s1><s3>DEU</s3><sZ>14 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>Algora Munich</wicri:noRegion><wicri:noRegion>Algora Munich</wicri:noRegion></affiliation></author><author><name sortKey="Kaufmann, M" sort="Kaufmann, M" uniqKey="Kaufmann M" first="M." last="Kaufmann">M. Kaufmann</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Gynecological Department, University of Frankfurt</s1><s3>DEU</s3><sZ>15 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>University of Frankfurt</wicri:noRegion><wicri:noRegion>Gynecological Department, University of Frankfurt</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno><imprint><date when="2002">2002</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Anthracyclins</term><term>Anthraquinone derivatives</term><term>Antineoplastic agent</term><term>Chemotherapy</term><term>Comparative study</term><term>Cyclophosphamide</term><term>Drug combination</term><term>Epirubicin</term><term>Female</term><term>Fluoropyrimidine derivatives</term><term>Fluorouracil</term><term>Human</term><term>Malignant tumor</term><term>Mammary gland</term><term>Metastasis</term><term>Mitoxantrone</term><term>Nitrogen mustard</term><term>Oxazaphosphinane derivatives</term><term>Pyrimidine derivatives</term><term>Quality of life</term><term>Survival</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Mitoxantrone</term><term>Fluorouracil</term><term>Epirubicine</term><term>Cyclophosphamide</term><term>Tumeur maligne</term><term>Glande mammaire</term><term>Métastase</term><term>Stade avancé</term><term>Chimiothérapie</term><term>Traitement</term><term>Anticancéreux</term><term>Association médicamenteuse</term><term>Etude comparative</term><term>Homme</term><term>Qualité vie</term><term>Anthraquinone dérivé</term><term>Fluoropyrimidine dérivé</term><term>Pyrimidine dérivé</term><term>Anthracyclines</term><term>Moutarde à l'azote</term><term>Oxazaphosphinane dérivé</term><term>Femelle</term><term>Survie</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></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/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. 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></INIST><ISTEX><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></author><author><name sortKey="Stoeger, H" sort="Stoeger, H" uniqKey="Stoeger H" first="H." last="Stoeger">H. Stoeger</name></author><author><name sortKey="Souchon, R" sort="Souchon, R" uniqKey="Souchon R" first="R." last="Souchon">R. Souchon</name></author><author><name sortKey="Hirschmann, W D" sort="Hirschmann, W D" uniqKey="Hirschmann W" first="W.-D." last="Hirschmann">W.-D. Hirschmann</name></author><author><name sortKey="Bodenstein, H" sort="Bodenstein, H" uniqKey="Bodenstein H" first="H." last="Bodenstein">H. Bodenstein</name></author><author><name sortKey="Oberhoff, C" sort="Oberhoff, C" uniqKey="Oberhoff C" first="C." last="Oberhoff">C. Oberhoff</name></author><author><name sortKey="Fischer, J T" sort="Fischer, J T" uniqKey="Fischer J" first="J. T." last="Fischer">J. T. Fischer</name></author><author><name sortKey="Schulze, M" sort="Schulze, M" uniqKey="Schulze M" first="M." last="Schulze">M. Schulze</name></author><author><name sortKey="Clemens, M" sort="Clemens, M" uniqKey="Clemens M" first="M." last="Clemens">M. Clemens</name></author><author><name sortKey="Andreesen, R" sort="Andreesen, R" uniqKey="Andreesen R" first="R." last="Andreesen">R. Andreesen</name></author><author><name sortKey="Mahlke, M" sort="Mahlke, M" uniqKey="Mahlke M" first="M." last="Mahlke">M. Mahlke</name></author><author><name sortKey="Ko Nig, M" sort="Ko Nig, M" uniqKey="Ko Nig M" first="M." last="Ko Nig">M. Ko Nig</name></author><author><name sortKey="Scharl, A" sort="Scharl, A" uniqKey="Scharl A" first="A." last="Scharl">A. Scharl</name></author><author><name sortKey="Fehnle, K" sort="Fehnle, K" uniqKey="Fehnle K" first="K." last="Fehnle">K. Fehnle</name></author><author><name sortKey="Kaufmann, M" sort="Kaufmann, M" uniqKey="Kaufmann M" first="M." last="Kaufmann">M. Kaufmann</name></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><idno type="wicri:Area/Istex/Curation">001B12</idno><idno type="wicri:Area/Istex/Checkpoint">000B54</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Checkpoint">000B54</idno><idno type="wicri:doubleKey">0923-7534:2002:Heidemann E:is:first:line</idno><idno type="wicri:Area/Main/Merge">001E94</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 wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Stoeger, H" sort="Stoeger, H" uniqKey="Stoeger H" first="H." last="Stoeger">H. Stoeger</name><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Autriche</country><wicri:regionArea>Department of Medical Oncology, University of Graz</wicri:regionArea><wicri:noRegion>University of Graz</wicri:noRegion></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Souchon, R" sort="Souchon, R" uniqKey="Souchon R" first="R." last="Souchon">R. Souchon</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></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></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Bodenstein, H" sort="Bodenstein, H" uniqKey="Bodenstein H" first="H." last="Bodenstein">H. Bodenstein</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Oberhoff, C" sort="Oberhoff, C" uniqKey="Oberhoff C" first="C." last="Oberhoff">C. Oberhoff</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></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></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Schulze, M" sort="Schulze, M" uniqKey="Schulze M" first="M." last="Schulze">M. Schulze</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Clemens, M" sort="Clemens, M" uniqKey="Clemens M" first="M." last="Clemens">M. Clemens</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Andreesen, R" sort="Andreesen, R" uniqKey="Andreesen R" first="R." last="Andreesen">R. Andreesen</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Mahlke, M" sort="Mahlke, M" uniqKey="Mahlke M" first="M." last="Mahlke">M. Mahlke</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></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></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Scharl, A" sort="Scharl, A" uniqKey="Scharl A" first="A." last="Scharl">A. Scharl</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Fehnle, K" sort="Fehnle, K" uniqKey="Fehnle K" first="K." last="Fehnle">K. Fehnle</name><affiliation></affiliation><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></affiliation></author><author><name sortKey="Kaufmann, M" sort="Kaufmann, M" uniqKey="Kaufmann M" first="M." last="Kaufmann">M. Kaufmann</name><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">Allemagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</wicri:regionArea><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion><wicri:noRegion>Oncological Center of Stuttgart</wicri:noRegion></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></double></record>Pour manipuler ce document sous Unix (Dilib)
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