Sorafenib in Combination With Capecitabine: An Oral Regimen for Patients With HER2-Negative Locally Advanced or Metastatic Breast Cancer

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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorBASELGA, Jose
dc.contributor.authorSEGALLA, Jose Getulio Martins
dc.contributor.authorROCHE, Henri
dc.contributor.authorGIGLIO, Auro del
dc.contributor.authorPINCZOWSKI, Helio
dc.contributor.authorCIRUELOS, Eva M.
dc.contributor.authorCABRAL FILHO, Sebastiao
dc.contributor.authorGOMEZ, Patricia
dc.contributor.authorEYLL, Brigitte Van
dc.contributor.authorBERMEJO, Begona
dc.contributor.authorLLOMBART, Antonio
dc.contributor.authorGARICOCHEA, Bernardo
dc.contributor.authorDURAN, Miguel Angel Climent
dc.contributor.authorHOFF, Paulo Marcelo Gehm
dc.contributor.authorESPIE, Marc
dc.contributor.authorMORAES, Andre Augusto Junior Gemeinder de
dc.contributor.authorRIBEIRO, Ronaldo Albuquerque
dc.contributor.authorMATHIAS, Clarissa
dc.contributor.authorGIL, Miguel Gil
dc.contributor.authorOJEDA, Belen
dc.contributor.authorMORALES, Josefa
dc.contributor.authorRO, Sunhee Kwon
dc.contributor.authorLI, Shell
dc.contributor.authorCOSTA, Frederico
dc.date.accessioned2013-07-30T17:51:48Z
dc.date.available2013-07-30T17:51:48Z
dc.date.issued2012
dc.description.abstractPurpose Sorafenib is a multikinase inhibitor with antiangiogenic/antiproliferative activity. A randomized, double-blind, placebo-controlled phase IIB trial assessed sorafenib with capecitabine for locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) -negative breast cancer. Patients and Methods Patients were randomly assigned to first-or second-line capecitabine 1,000 mg/m(2) orally twice a day for days 1 to 14 of every 21-day cycle with sorafenib 400 mg orally twice a day or placebo. The primary end point was progression-free survival (PFS). Results In total, 229 patients were enrolled. The addition of sorafenib to capecitabine resulted in a significant improvement in PFS versus placebo (median, 6.4 v 4.1 months; hazard ratio [HR], 0.58; 95% CI, 0.41 to 0.81; P = .001) with sorafenib favored across subgroups, including first-line (HR, 0.50; 95% CI, 0.30 to 0.82) and second-line (HR, 0.65; 95% CI, 0.41 to 1.04) treatment. There was no significant improvement for overall survival (median, 22.2 v 20.9 months; HR, 0.86; 95% CI, 0.61 to 1.23; P = .42) and overall response (38% v 31%; P = .25). Toxicities (sorafenib v placebo) of any grade included rash (22% v 8%), diarrhea (58% v 30%), mucosal inflammation (33% v 21%), neutropenia (13% v 4%), hypertension (18% v 12%), and hand-foot skin reaction/hand-foot syndrome (HFSR/HFS; 90% v 66%); grade 3 to 4 toxicities were comparable between treatment arms except HFSR/HFS (44% v 14%). Reasons for discontinuation in the sorafenib and placebo arms included disease progression (63% v 82%, respectively), adverse events (20% v 9%, respectively), and death (0% v 1%, respectively). Conclusion Addition of sorafenib to capecitabine improved PFS in patients with HER2-negative advanced breast cancer. The dose of sorafenib used in this trial resulted in unacceptable toxicity for many patients. A phase III confirmatory trial has been initiated with a reduced sorafenib dose.
dc.description.indexMEDLINE
dc.description.sponsorshipRoche
dc.description.sponsorshipSOLTI Group
dc.description.sponsorshipOnyx Pharmaceuticals
dc.description.sponsorshipBayer HealthCare Pharmaceuticals
dc.identifier.citationJOURNAL OF CLINICAL ONCOLOGY, v.30, n.13, p.1484-1491, 2012
dc.identifier.doi10.1200/JCO.2011.36.7771
dc.identifier.issn0732-183X
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/1421
dc.language.isoeng
dc.publisherAMER SOC CLINICAL ONCOLOGY
dc.relation.ispartofJournal of Clinical Oncology
dc.rightsrestrictedAccess
dc.rights.holderCopyright AMER SOC CLINICAL ONCOLOGY
dc.subject.otherphase-iii trial
dc.subject.othertumor angiogenesis
dc.subject.othersolid tumors
dc.subject.othermultikinase inhibitor
dc.subject.othertherapy
dc.subject.otherbevacizumab
dc.subject.othergrowth
dc.subject.othercarcinoma
dc.subject.otherantibody
dc.subject.otherprogression
dc.subject.wosOncology
dc.titleSorafenib in Combination With Capecitabine: An Oral Regimen for Patients With HER2-Negative Locally Advanced or Metastatic Breast Cancer
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryFrança
hcfmusp.affiliation.countryEspanha
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisofr
hcfmusp.affiliation.countryisoes
hcfmusp.author.externalBASELGA, Jose:Massachusetts Gen Hosp, Ctr Canc, Div Hematol Oncol, Boston, MA 02114 USA
hcfmusp.author.externalSEGALLA, Jose Getulio Martins:Fundacao Dr Amaral Carvalho, Jau, Brazil
hcfmusp.author.externalROCHE, Henri:Inst Claudius Regaud, Toulouse, France
hcfmusp.author.externalGIGLIO, Auro del:Ctr Estudos & Pesquisas Hematol & Oncol, Fac Med ABC, Santo Andre, Brazil
hcfmusp.author.externalPINCZOWSKI, Helio:Ctr Estudos & Pesquisas Hematol & Oncol, Fac Med ABC, Santo Andre, Brazil
hcfmusp.author.externalCIRUELOS, Eva M.:Hosp Univ 12 Octubre, Madrid, Spain
hcfmusp.author.externalCABRAL FILHO, Sebastiao:Clin Santa Casa Belo Horizonte, Belo Horizonte, MG, Brazil
hcfmusp.author.externalGOMEZ, Patricia:Vall dHebron Univ Hosp, Vall dHebron Inst Oncol, Barcelona, Spain
hcfmusp.author.externalBERMEJO, Begona:Univ Valencia, Hosp Clin, Valencia, Spain
hcfmusp.author.externalLLOMBART, Antonio:Hosp Univ Arnau de Vilanova Lleida, Lleida, Spain
hcfmusp.author.externalGARICOCHEA, Bernardo:Pontificia Univ Rio Grande Sul, Hosp Sao Lucas, Porto Alegre, RS, Brazil
hcfmusp.author.externalDURAN, Miguel Angel Climent:Inst Valenciano Oncol, Valencia, Spain
hcfmusp.author.externalESPIE, Marc:Hop St Louis, Assistance Publ Hop Paris, Ctr Malad Sein, Paris, France
hcfmusp.author.externalMORAES, Andre Augusto Junior Gemeinder de:Ctr Canc Santa Casa Piracicaba Sao Paulo, Sao Paulo, Brazil
hcfmusp.author.externalRIBEIRO, Ronaldo Albuquerque:Hosp Canc Ceara, Inst Canc Ceara, Fortaleza, Ceara, Brazil
hcfmusp.author.externalMATHIAS, Clarissa:Hosp Portugues Bahia, Salvador, BA, Brazil
hcfmusp.author.externalGIL, Miguel Gil:Inst Invest Biomed Bellvitge, Inst Catalan Oncol, Barcelona, Spain
hcfmusp.author.externalOJEDA, Belen:Hosp Santa Creu & Sant Pau, Barcelona, Spain
hcfmusp.author.externalMORALES, Josefa:Spanish Breast Canc Res Grp, Grp Espanol Estudio Tratamiento & Otras Estrategi, Sabadell, Spain
hcfmusp.author.externalRO, Sunhee Kwon:Onyx Pharmaceut, San Francisco, CA USA
hcfmusp.author.externalLI, Shell:Onyx Pharmaceut, San Francisco, CA USA
hcfmusp.author.externalCOSTA, Frederico:Inst Brasileiro Pesquisaem Canc, Sao Paulo, Brazil
hcfmusp.citation.scopus157
hcfmusp.contributor.author-fmusphcPAULO MARCELO GEHM HOFF
hcfmusp.description.beginpage1484
hcfmusp.description.endpage1491
hcfmusp.description.issue13
hcfmusp.description.volume30
hcfmusp.origemWOS
hcfmusp.origem.pubmed22412143
hcfmusp.origem.scopus2-s2.0-84862988257
hcfmusp.origem.wosWOS:000303859400018
hcfmusp.publisher.cityALEXANDRIA
hcfmusp.publisher.countryUSA
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hcfmusp.remissive.sponsorshipBayer
hcfmusp.remissive.sponsorshipRoche
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