German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer.
Identifieur interne : 000410 ( PubMed/Corpus ); précédent : 000409; suivant : 000411German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer.
Auteurs : Gunter Von Minckwitz ; Volker Möbus ; Andreas Schneeweiss ; Jens Huober ; Christoph Thomssen ; Michael Untch ; Christian Jackisch ; Ingo J. Diel ; Dirk Elling ; Bettina Conrad ; Rolf Kreienberg ; Volkmar Müller ; Hans-Joachim Lück ; Ingo Bauerfeind ; Michael Clemens ; Marcus Schmidt ; Stefanie Noeding ; Helmut Forstbauer ; Jana Barinoff ; Antje Belau ; Valentina Nekljudova ; Nadia Harbeck ; Sibylle LoiblSource :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology [ 1527-7755 ] ; 2013.
English descriptors
- KwdEn :
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Breast Neoplasms (drug therapy), Breast Neoplasms (mortality), Breast Neoplasms (pathology), Capecitabine, Carcinoma, Ductal, Breast (drug therapy), Carcinoma, Ductal, Breast (mortality), Carcinoma, Ductal, Breast (pathology), Carcinoma, Lobular (drug therapy), Carcinoma, Lobular (mortality), Carcinoma, Lobular (pathology), Chemotherapy, Adjuvant, Cyclophosphamide (administration & dosage), Deoxycytidine (administration & dosage), Deoxycytidine (analogs & derivatives), Diphosphonates (administration & dosage), Epirubicin (administration & dosage), Female, Fluorouracil (administration & dosage), Fluorouracil (analogs & derivatives), Follow-Up Studies, Germany, Humans, Middle Aged, Neoplasm Grading, Neoplasm Staging, Paclitaxel (administration & dosage), Prognosis, Survival Rate, Young Adult.
- MESH :
- chemical , administration & dosage : Cyclophosphamide, Deoxycytidine, Diphosphonates, Epirubicin, Fluorouracil, Paclitaxel.
- chemical , analogs & derivatives : Deoxycytidine, Fluorouracil.
- chemical : Capecitabine.
- drug therapy : Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular.
- mortality : Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular.
- pathology : Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Chemotherapy, Adjuvant, Female, Follow-Up Studies, Germany, Humans, Middle Aged, Neoplasm Grading, Neoplasm Staging, Prognosis, Survival Rate, Young Adult.
Abstract
Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use.
DOI: 10.1200/JCO.2012.47.2167
PubMed: 23980081
Links to Exploration step
pubmed:23980081Le document en format XML
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Diel, Schwerpunktpraxis für gynäkologische Onkologie, Mannheim; Dirk Elling, Sana Klinikum Lichtenberg, Lichtenberg; Bettina Conrad, Frauenklinik, Kassel; Rolf Kreienberg, University Hospital Ulm, Ulm; Volkmar Müller, University Hospital Hamburg, Hamburg; Hans-Joachim Lück, Praxis Hannover; Stefanie Noeding, Nordstadt Krankenhaus, Hannover; Ingo Bauerfeind, Frauenklinik Landshut, Landshut; Michael Clemens, Klinikum Trier, Trier; Marcus Schmidt, University Hospital Mainz, Mainz; Helmut Forstbauer, Haematologic-Oncologic Praxis, Troisdorf; Jana Barinoff, Klinikum Mitte, Essen; Antje Belau, University Hospital, Greifswald; and Nadia Harbeck, Universität München, München, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Mobus, Volker" sort="Mobus, Volker" uniqKey="Mobus V" first="Volker" last="Möbus">Volker Möbus</name></author><author><name sortKey="Schneeweiss, Andreas" sort="Schneeweiss, Andreas" uniqKey="Schneeweiss A" first="Andreas" last="Schneeweiss">Andreas Schneeweiss</name></author><author><name sortKey="Huober, Jens" sort="Huober, Jens" uniqKey="Huober J" first="Jens" last="Huober">Jens Huober</name></author><author><name sortKey="Thomssen, Christoph" sort="Thomssen, Christoph" uniqKey="Thomssen C" first="Christoph" last="Thomssen">Christoph Thomssen</name></author><author><name sortKey="Untch, Michael" sort="Untch, Michael" uniqKey="Untch M" first="Michael" last="Untch">Michael Untch</name></author><author><name sortKey="Jackisch, Christian" sort="Jackisch, Christian" uniqKey="Jackisch C" first="Christian" last="Jackisch">Christian Jackisch</name></author><author><name sortKey="Diel, Ingo J" sort="Diel, Ingo J" uniqKey="Diel I" first="Ingo J" last="Diel">Ingo J. 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Diel, Schwerpunktpraxis für gynäkologische Onkologie, Mannheim; Dirk Elling, Sana Klinikum Lichtenberg, Lichtenberg; Bettina Conrad, Frauenklinik, Kassel; Rolf Kreienberg, University Hospital Ulm, Ulm; Volkmar Müller, University Hospital Hamburg, Hamburg; Hans-Joachim Lück, Praxis Hannover; Stefanie Noeding, Nordstadt Krankenhaus, Hannover; Ingo Bauerfeind, Frauenklinik Landshut, Landshut; Michael Clemens, Klinikum Trier, Trier; Marcus Schmidt, University Hospital Mainz, Mainz; Helmut Forstbauer, Haematologic-Oncologic Praxis, Troisdorf; Jana Barinoff, Klinikum Mitte, Essen; Antje Belau, University Hospital, Greifswald; and Nadia Harbeck, Universität München, München, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Mobus, Volker" sort="Mobus, Volker" uniqKey="Mobus V" first="Volker" last="Möbus">Volker Möbus</name></author><author><name sortKey="Schneeweiss, Andreas" sort="Schneeweiss, Andreas" uniqKey="Schneeweiss A" first="Andreas" last="Schneeweiss">Andreas Schneeweiss</name></author><author><name sortKey="Huober, Jens" sort="Huober, Jens" uniqKey="Huober J" first="Jens" last="Huober">Jens Huober</name></author><author><name sortKey="Thomssen, Christoph" sort="Thomssen, Christoph" uniqKey="Thomssen C" first="Christoph" last="Thomssen">Christoph Thomssen</name></author><author><name sortKey="Untch, Michael" sort="Untch, Michael" uniqKey="Untch M" first="Michael" last="Untch">Michael Untch</name></author><author><name sortKey="Jackisch, Christian" sort="Jackisch, Christian" uniqKey="Jackisch C" first="Christian" last="Jackisch">Christian Jackisch</name></author><author><name sortKey="Diel, Ingo J" sort="Diel, Ingo J" uniqKey="Diel I" first="Ingo J" last="Diel">Ingo J. Diel</name></author><author><name sortKey="Elling, Dirk" sort="Elling, Dirk" uniqKey="Elling D" first="Dirk" last="Elling">Dirk Elling</name></author><author><name sortKey="Conrad, Bettina" sort="Conrad, Bettina" uniqKey="Conrad B" first="Bettina" last="Conrad">Bettina Conrad</name></author><author><name sortKey="Kreienberg, Rolf" sort="Kreienberg, Rolf" uniqKey="Kreienberg R" first="Rolf" last="Kreienberg">Rolf Kreienberg</name></author><author><name sortKey="Muller, Volkmar" sort="Muller, Volkmar" uniqKey="Muller V" first="Volkmar" last="Müller">Volkmar Müller</name></author><author><name sortKey="Luck, Hans Joachim" sort="Luck, Hans Joachim" uniqKey="Luck H" first="Hans-Joachim" last="Lück">Hans-Joachim Lück</name></author><author><name sortKey="Bauerfeind, Ingo" sort="Bauerfeind, Ingo" uniqKey="Bauerfeind I" first="Ingo" last="Bauerfeind">Ingo Bauerfeind</name></author><author><name sortKey="Clemens, Michael" sort="Clemens, Michael" uniqKey="Clemens M" first="Michael" last="Clemens">Michael Clemens</name></author><author><name sortKey="Schmidt, Marcus" sort="Schmidt, Marcus" uniqKey="Schmidt M" first="Marcus" last="Schmidt">Marcus Schmidt</name></author><author><name sortKey="Noeding, Stefanie" sort="Noeding, Stefanie" uniqKey="Noeding S" first="Stefanie" last="Noeding">Stefanie Noeding</name></author><author><name sortKey="Forstbauer, Helmut" sort="Forstbauer, Helmut" uniqKey="Forstbauer H" first="Helmut" last="Forstbauer">Helmut Forstbauer</name></author><author><name sortKey="Barinoff, Jana" sort="Barinoff, Jana" uniqKey="Barinoff J" first="Jana" last="Barinoff">Jana Barinoff</name></author><author><name sortKey="Belau, Antje" sort="Belau, Antje" uniqKey="Belau A" first="Antje" last="Belau">Antje Belau</name></author><author><name sortKey="Nekljudova, Valentina" sort="Nekljudova, Valentina" uniqKey="Nekljudova V" first="Valentina" last="Nekljudova">Valentina Nekljudova</name></author><author><name sortKey="Harbeck, Nadia" sort="Harbeck, Nadia" uniqKey="Harbeck N" first="Nadia" last="Harbeck">Nadia Harbeck</name></author><author><name sortKey="Loibl, Sibylle" sort="Loibl, Sibylle" uniqKey="Loibl S" first="Sibylle" last="Loibl">Sibylle Loibl</name></author></analytic><series><title level="j">Journal of clinical oncology : official journal of the American Society of Clinical Oncology</title><idno type="eISSN">1527-7755</idno><imprint><date when="2013" type="published">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Breast Neoplasms (drug therapy)</term><term>Breast Neoplasms (mortality)</term><term>Breast Neoplasms (pathology)</term><term>Capecitabine</term><term>Carcinoma, Ductal, Breast (drug therapy)</term><term>Carcinoma, Ductal, Breast (mortality)</term><term>Carcinoma, Ductal, Breast (pathology)</term><term>Carcinoma, Lobular (drug therapy)</term><term>Carcinoma, Lobular (mortality)</term><term>Carcinoma, Lobular (pathology)</term><term>Chemotherapy, Adjuvant</term><term>Cyclophosphamide (administration & dosage)</term><term>Deoxycytidine (administration & dosage)</term><term>Deoxycytidine (analogs & derivatives)</term><term>Diphosphonates (administration & dosage)</term><term>Epirubicin (administration & dosage)</term><term>Female</term><term>Fluorouracil (administration & dosage)</term><term>Fluorouracil (analogs & derivatives)</term><term>Follow-Up Studies</term><term>Germany</term><term>Humans</term><term>Middle Aged</term><term>Neoplasm Grading</term><term>Neoplasm Staging</term><term>Paclitaxel (administration & dosage)</term><term>Prognosis</term><term>Survival Rate</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Cyclophosphamide</term><term>Deoxycytidine</term><term>Diphosphonates</term><term>Epirubicin</term><term>Fluorouracil</term><term>Paclitaxel</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Deoxycytidine</term><term>Fluorouracil</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Capecitabine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Breast Neoplasms</term><term>Carcinoma, Ductal, Breast</term><term>Carcinoma, Lobular</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Breast Neoplasms</term><term>Carcinoma, Ductal, Breast</term><term>Carcinoma, Lobular</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Breast Neoplasms</term><term>Carcinoma, Ductal, Breast</term><term>Carcinoma, Lobular</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Chemotherapy, Adjuvant</term><term>Female</term><term>Follow-Up Studies</term><term>Germany</term><term>Humans</term><term>Middle Aged</term><term>Neoplasm Grading</term><term>Neoplasm Staging</term><term>Prognosis</term><term>Survival Rate</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">23980081</PMID><DateCreated><Year>2013</Year><Month>09</Month><Day>30</Day></DateCreated><DateCompleted><Year>2013</Year><Month>11</Month><Day>26</Day></DateCompleted><DateRevised><Year>2016</Year><Month>11</Month><Day>25</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1527-7755</ISSN><JournalIssue CitedMedium="Internet"><Volume>31</Volume><Issue>28</Issue><PubDate><Year>2013</Year><Month>Oct</Month><Day>01</Day></PubDate></JournalIssue><Title>Journal of clinical oncology : official journal of the American Society of Clinical Oncology</Title><ISOAbbreviation>J. Clin. Oncol.</ISOAbbreviation></Journal><ArticleTitle>German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer.</ArticleTitle><Pagination><MedlinePgn>3531-9</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1200/JCO.2012.47.2167</ELocationID><Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use.</AbstractText><AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">The GAIN (German Adjuvant Intergroup Node-Positive) study was an open-label, randomized, controlled phase III trial with a 2 × 2 factorial design. Patients with node-positive early breast cancer were randomly assigned 1:1 to two different dose-dense chemotherapy regimens and 2:1 to ibandronate 50 mg per day orally for 2 years or observation. In all, 2,640 patients and 728 events were estimated to be required to demonstrate an increase in disease-free survival (DFS) by ibandronate from 75% to 79.5% by using a two-sided α = .05 and 1-β of 80%. We report here the efficacy analysis for ibandronate, which was released by the independent data monitoring committee because the futility boundary was not crossed after 50% of the required DFS events were observed.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Between June 2004 and August 2008, 2,015 patients were randomly assigned to ibandronate and 1,008 to observation. Patients randomly assigned to ibandronate showed no superior DFS or overall survival (OS) compared with patients randomly assigned to observation (DFS: hazard ratio, 0.945; 95% CI, 0.768 to 1.161; P = .589; OS: HR, 1.040; 95% CI, 0.763 to 1.419; P = .803). DFS was numerically longer if ibandronate was used in patients younger than 40 years or older than 60 years compared with patients age 40 to 59 years (test for interaction P = .093).</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>von Minckwitz</LastName><ForeName>Gunter</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Gunter von Minckwitz, Valentina Nekljudova, and Sibylle Loibl, German Breast Group, Neu-Isenburg; Volker Möbus, Klinikum Frankfurt-Hoechst, Frankfurt; Andreas Schneeweiss, National Center for Tumor Diseases Heidelberg, Heidelberg; Jens Huober, University Hospital Düsseldorf, Düsseldorf; Christoph Thomssen, University Hospital Halle an der Saale, Halle an der Saale; Michael Untch, Helios Klinikum Berlin Buch, Berlin; Christian Jackisch, Klinikum Offenbach, Offenbach; Ingo J. Diel, Schwerpunktpraxis für gynäkologische Onkologie, Mannheim; Dirk Elling, Sana Klinikum Lichtenberg, Lichtenberg; Bettina Conrad, Frauenklinik, Kassel; Rolf Kreienberg, University Hospital Ulm, Ulm; Volkmar Müller, University Hospital Hamburg, Hamburg; Hans-Joachim Lück, Praxis Hannover; Stefanie Noeding, Nordstadt Krankenhaus, Hannover; Ingo Bauerfeind, Frauenklinik Landshut, Landshut; Michael Clemens, Klinikum Trier, Trier; Marcus Schmidt, University Hospital Mainz, Mainz; Helmut Forstbauer, Haematologic-Oncologic Praxis, Troisdorf; Jana Barinoff, Klinikum Mitte, Essen; Antje Belau, University Hospital, Greifswald; and Nadia Harbeck, Universität München, München, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Möbus</LastName><ForeName>Volker</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Schneeweiss</LastName><ForeName>Andreas</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Huober</LastName><ForeName>Jens</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Thomssen</LastName><ForeName>Christoph</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Untch</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Jackisch</LastName><ForeName>Christian</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Diel</LastName><ForeName>Ingo J</ForeName><Initials>IJ</Initials></Author><Author ValidYN="Y"><LastName>Elling</LastName><ForeName>Dirk</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Conrad</LastName><ForeName>Bettina</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Kreienberg</LastName><ForeName>Rolf</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Müller</LastName><ForeName>Volkmar</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Lück</LastName><ForeName>Hans-Joachim</ForeName><Initials>HJ</Initials></Author><Author ValidYN="Y"><LastName>Bauerfeind</LastName><ForeName>Ingo</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Clemens</LastName><ForeName>Michael</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Schmidt</LastName><ForeName>Marcus</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Noeding</LastName><ForeName>Stefanie</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Forstbauer</LastName><ForeName>Helmut</ForeName><Initials>H</Initials></Author><Author ValidYN="Y"><LastName>Barinoff</LastName><ForeName>Jana</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Belau</LastName><ForeName>Antje</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Nekljudova</LastName><ForeName>Valentina</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Harbeck</LastName><ForeName>Nadia</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Loibl</LastName><ForeName>Sibylle</ForeName><Initials>S</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2013</Year><Month>08</Month><Day>26</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Clin 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