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 : 000232 ( PascalFrancis/Curation ); précédent : 000231; suivant : 000233Is 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] ; 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. König [Allemagne] ; A. Scharl [Allemagne] ; K. Fehnle [Allemagne] ; M. Kaufmann [Allemagne]Source :
- Annals of oncology [ 0923-7534 ] ; 2002.
Descripteurs français
- Pascal (Inist)
- Mitoxantrone, Fluorouracil, Epirubicine, Cyclophosphamide, Tumeur maligne, Glande mammaire, Métastase, Stade avancé, Chimiothérapie, Traitement, Anticancéreux, Association médicamenteuse, Etude comparative, Homme, Qualité vie, Anthraquinone dérivé, Fluoropyrimidine dérivé, Pyrimidine dérivé, Anthracyclines, Moutarde à l'azote, Oxazaphosphinane dérivé, Femelle, Survie.
- 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, 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.
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<record><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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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></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><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0923-7534</s0></fA01><fA03 i2="1"><s0>Ann. oncol.</s0></fA03><fA05><s2>13</s2></fA05><fA06><s2>11</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>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</s1></fA08><fA11 i1="01" i2="1"><s1>HEIDEMANN (E.)</s1></fA11><fA11 i1="02" i2="1"><s1>STOEGER (H.)</s1></fA11><fA11 i1="03" i2="1"><s1>SOUCHON (R.)</s1></fA11><fA11 i1="04" i2="1"><s1>HIRSCHMANN (W.-D.)</s1></fA11><fA11 i1="05" i2="1"><s1>BODENSTEIN (H.)</s1></fA11><fA11 i1="06" i2="1"><s1>OBERHOFF (C.)</s1></fA11><fA11 i1="07" i2="1"><s1>FISCHER (J. T.)</s1></fA11><fA11 i1="08" i2="1"><s1>SCHULZE (M.)</s1></fA11><fA11 i1="09" i2="1"><s1>CLEMENS (M.)</s1></fA11><fA11 i1="10" i2="1"><s1>ANDREESEN (R.)</s1></fA11><fA11 i1="11" i2="1"><s1>MAHLKE (M.)</s1></fA11><fA11 i1="12" i2="1"><s1>KÖNIG (M.)</s1></fA11><fA11 i1="13" i2="1"><s1>SCHARL (A.)</s1></fA11><fA11 i1="14" i2="1"><s1>FEHNLE (K.)</s1></fA11><fA11 i1="15" i2="1"><s1>KAUFMANN (M.)</s1></fA11><fA14 i1="01"><s1>Department of Hematology and Medical Oncology, Deaconess Hospital, Oncological Center of Stuttgart</s1><s3>DEU</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Department of Medical Oncology, University of Graz</s1><s3>AUT</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Department of Radiation Oncology, General Hospital of Hagen</s1><s3>DEU</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Department of Medical Oncology, City Hospital of Kassel</s1><s3>DEU</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Department of Medical Oncology, City Hospital of Minden</s1><s3>DEU</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Gynecological Deportment, University of Essen</s1><s3>DEU</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Department of Medical Oncology, City Hospital of Karlsruhe</s1><s3>DEU</s3><sZ>7 aut.</sZ></fA14><fA14 i1="08"><s1>Department of Medical Oncology, City Hospital of Zittau</s1><s3>DEU</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>Department of Medical Oncology, Boromaeerinnen Hospital Trier</s1><s3>DEU</s3><sZ>9 aut.</sZ></fA14><fA14 i1="10"><s1>Department of Hematology and Medical Oncology, University of Regensburg</s1><s3>DEU</s3><sZ>10 aut.</sZ></fA14><fA14 i1="11"><s1>Gynecological Department, University of Mainz</s1><s3>DEU</s3><sZ>11 aut.</sZ></fA14><fA14 i1="12"><s1>Gynecological Department, University of Tuebingen</s1><s3>DEU</s3><sZ>12 aut.</sZ></fA14><fA14 i1="13"><s1>Gynecological Department, University of Cologne</s1><s3>DEU</s3><sZ>13 aut.</sZ></fA14><fA14 i1="14"><s1>Algora Munich</s1><s3>DEU</s3><sZ>14 aut.</sZ></fA14><fA14 i1="15"><s1>Gynecological Department, University of Frankfurt</s1><s3>DEU</s3><sZ>15 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>German Cancer Society. Interdisciplinary Breast Cancer Working Group</s1><s3>DEU</s3></fA17><fA20><s1>1717-1729</s1></fA20><fA21><s1>2002</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>22429</s2><s5>354000106878700040</s5></fA43><fA44><s0>0000</s0><s1>© 2003 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>39 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>03-0113411</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Annals of oncology</s0></fA64><fA66 i1="01"><s0>GBR</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B02R02</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Mitoxantrone</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Mitoxantrone</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Mitoxantrona</s0><s2>NK</s2><s2>FR</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Fluorouracil</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Fluorouracil</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Fluorouracilo</s0><s2>NK</s2><s2>FR</s2><s5>04</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Epirubicine</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Epirubicin</s0><s2>NK</s2><s2>FR</s2><s5>07</s5></fC03><fC03 i1="03" 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l="FRE"><s0>Stade avancé</s0><s5>16</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Advanced stage</s0><s5>16</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Estadio avanzado</s0><s5>16</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Chimiothérapie</s0><s5>17</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Chemotherapy</s0><s5>17</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Quimioterapia</s0><s5>17</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Traitement</s0><s5>18</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Treatment</s0><s5>18</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Tratamiento</s0><s5>18</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Anticancéreux</s0><s5>19</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Antineoplastic agent</s0><s5>19</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Anticanceroso</s0><s5>19</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Association médicamenteuse</s0><s5>20</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Drug combination</s0><s5>20</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Asociación medicamentosa</s0><s5>20</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Etude comparative</s0><s5>21</s5></fC03><fC03 i1="13" i2="X" l="ENG"><s0>Comparative study</s0><s5>21</s5></fC03><fC03 i1="13" i2="X" l="SPA"><s0>Estudio comparativo</s0><s5>21</s5></fC03><fC03 i1="14" i2="X" l="FRE"><s0>Homme</s0><s5>22</s5></fC03><fC03 i1="14" i2="X" l="ENG"><s0>Human</s0><s5>22</s5></fC03><fC03 i1="14" i2="X" l="SPA"><s0>Hombre</s0><s5>22</s5></fC03><fC03 i1="15" i2="X" l="FRE"><s0>Qualité vie</s0><s5>23</s5></fC03><fC03 i1="15" i2="X" l="ENG"><s0>Quality of life</s0><s5>23</s5></fC03><fC03 i1="15" i2="X" l="SPA"><s0>Calidad vida</s0><s5>23</s5></fC03><fC03 i1="16" i2="X" l="FRE"><s0>Anthraquinone dérivé</s0><s5>25</s5></fC03><fC03 i1="16" i2="X" l="ENG"><s0>Anthraquinone derivatives</s0><s5>25</s5></fC03><fC03 i1="16" i2="X" l="SPA"><s0>Antraquinona derivado</s0><s5>25</s5></fC03><fC03 i1="17" i2="X" l="FRE"><s0>Fluoropyrimidine dérivé</s0><s5>27</s5></fC03><fC03 i1="17" 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l="SPA"><s0>Oxazafosfinano derivado</s0><s5>32</s5></fC03><fC03 i1="22" i2="X" l="FRE"><s0>Femelle</s0><s5>78</s5></fC03><fC03 i1="22" i2="X" l="ENG"><s0>Female</s0><s5>78</s5></fC03><fC03 i1="22" i2="X" l="SPA"><s0>Hembra</s0><s5>78</s5></fC03><fC03 i1="23" i2="X" l="FRE"><s0>Survie</s0><s5>79</s5></fC03><fC03 i1="23" i2="X" l="ENG"><s0>Survival</s0><s5>79</s5></fC03><fC03 i1="23" i2="X" l="SPA"><s0>Sobrevivencia</s0><s5>79</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Glande mammaire pathologie</s0><s2>NM</s2><s5>69</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Mammary gland diseases</s0><s2>NM</s2><s5>69</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Glándula mamaria patología</s0><s2>NM</s2><s5>69</s5></fC07><fN21><s1>062</s1></fN21><fN82><s1>PSI</s1></fN82></pA></standard></inist></record>Pour manipuler ce document sous Unix (Dilib)
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|texte= 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
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