11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial

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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.authorCAMERON, David
dc.contributor.authorPICCART-GEBHART, Martine J.
dc.contributor.authorGELBER, Richard D.
dc.contributor.authorPROCTER, Marion
dc.contributor.authorGOLDHIRSCH, Aron
dc.contributor.authorAZAMBUJA, Evandro de
dc.contributor.authorCASTRO JR., Gilberto
dc.contributor.authorUNTCH, Michael
dc.contributor.authorSMITH, Ian
dc.contributor.authorGIANNI, Luca
dc.contributor.authorBASELGA, Jose
dc.contributor.authorAL-SAKAFF, Nedal
dc.contributor.authorLAUER, Sabine
dc.contributor.authorMCFADDEN, Eleanor
dc.contributor.authorLEYLAND-JONES, Brian
dc.contributor.authorBELL, Richard
dc.contributor.authorDOWSETT, Mitch
dc.contributor.authorJACKISCH, Christian
dc.contributor.groupauthorHerceptin Adjuvant HERA Trial
dc.date.accessioned2017-06-09T15:38:30Z
dc.date.available2017-06-09T15:38:30Z
dc.date.issued2017
dc.description.abstractBackground Clinical trials have shown that trastuzumab, a recombinant monoclonal antibody against HER2 receptor, significantly improves overall survival and disease-free survival in women with HER2-positive early breast cancer, but long-term follow-up data are needed. We report the results of comparing observation with two durations of trastuzumab treatment at a median follow-up of 11 years, for patients enrolled in the HERA (HERceptin Adjuvant) trial. Methods HERA (BIG 1-01) is an international, multicentre, open-label, phase 3 randomised trial of 5102 women with HER2-positive early breast cancer, who were enrolled from hospitals in 39 countries between Dec 7, 2001, and June 20, 2005. After completion of all primary therapy (including, surgery, chemotherapy, and radiotherapy as indicated), patients were randomly assigned (1: 1: 1) to receive trastuzumab for 1 year (once at 8 mg/kg of bodyweight intravenously, then 6 mg/kg once every 3 weeks) or for 2 years (with the same dose schedule), or to the observation group. Primary endpoint is disease-free survival, and analyses are in the intention-to-treat population. Hazard ratios (HRs) were estimated from Cox models, and survival curves were estimated by the Kaplan-Meier method. Comparison of 2 years versus 1 year of trastuzumab is based on 366-day landmark analyses. This study is registered with ClinicalTrials.gov (NCT00045032). Findings Of the 5102 women randomly assigned in the HERA trial, three patients had no evidence of having provided written informed consent to participate. We followed up the intention-to-treat population of 5099 patients (1697 in observation, 1702 in 1-year trastuzumab, and 1700 in 2-years trastuzumab groups). After a median follow-up of 11 years (IQR 10.09-11.53), random assignment to 1 year of trastuzumab significantly reduced the risk of a disease-free survival event (HR 0.76, 95% CI 0.68-0.86) and death (0.74, 0.64-0.86) compared with observation. 2 years of adjuvant trastuzumab did not improve disease free-survival outcomes compared with 1 year of this drug (HR 1.02, 95% CI 0.89-1.17). Estimates of 10-year disease-free survival were 63% for observation, 69% for 1 year of trastuzumab, and 69% for 2 years of trastuzumab. 884 (52%) patients assigned to the observation group selectively crossed over to receive trastuzumab. Cardiac toxicity remained low in all groups and occurred mostly during the treatment phase. The incidence of secondary cardiac endpoints was 122 (7.3%) in the 2-years trastuzumab group, 74 (4.4%) in the 1-year trastuzumab group, and 15 (0.9%) in the observation group. Interpretation 1 year of adjuvant trastuzumab after chemotherapy for patients with HER2-positive early breast cancer significantly improves long-term disease-free survival, compared with observation. 2 years of trastuzumab had no additional benefit.
dc.description.indexMEDLINE
dc.description.sponsorshipF Hoffmann-La Roche (Roche)
dc.identifier.citationLANCET, v.389, n.10075, p.1195-1205, 2017
dc.identifier.doi10.1016/S0140-6736(16)32616-2
dc.identifier.eissn1474-547X
dc.identifier.issn0140-6736
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/20214
dc.language.isoeng
dc.publisherELSEVIER SCIENCE INC
dc.relation.ispartofLancet
dc.rightsrestrictedAccess
dc.rights.holderCopyright ELSEVIER SCIENCE INC
dc.subject.otherrandomized controlled-trial
dc.subject.otheropen-label
dc.subject.otherphase-3 trial
dc.subject.othermulticenter
dc.subject.otherpertuzumab
dc.subject.othersystem
dc.subject.wosMedicine, General & Internal
dc.title11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryInglaterra
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryEscócia
hcfmusp.affiliation.countryBélgica
hcfmusp.affiliation.countryAustrália
hcfmusp.affiliation.countrySuíça
hcfmusp.affiliation.countryItália
hcfmusp.affiliation.countryisogb
hcfmusp.affiliation.countryisobe
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisoit
hcfmusp.affiliation.countryisoch
hcfmusp.affiliation.countryisoau
hcfmusp.author.externalCAMERON, David:Univ Edinburgh, Canc Res Ctr, Western Gen Hosp, Edinburgh EH4 2XU, Midlothian, Scotland
hcfmusp.author.externalPICCART-GEBHART, Martine J.:Univ Libre Bruxelles, Dept Med, Brussels, Belgium
hcfmusp.author.externalGELBER, Richard D.:Univ Libre Bruxelles, BrEAST Data Ctr, Inst Jules Bordet, Brussels, Belgium; Harvard TH Chan Sch Publ Hlth, Dept Biostat & Computat Biol, Dana Farber Canc Inst, Harvard Med Sch, Boston, MA USA
hcfmusp.author.externalPROCTER, Marion:Frontier Sci & Technol Res Fdn Inc, Boston, MA USA
hcfmusp.author.externalGOLDHIRSCH, Aron:Frontier Sci Scotland Ltd, Kincraig, Kingussie, Scotland
hcfmusp.author.externalAZAMBUJA, Evandro de:Univ Libre Bruxelles, Med Oncol Clin, Brussels, Belgium
hcfmusp.author.externalUNTCH, Michael:Univ Sao Paulo, Clin Oncol, Inst Canc Estado Sao Paulo, Fac Med, Sao Paulo, Brazil
hcfmusp.author.externalSMITH, Ian:Helios Klinikum Berlin Buch, Multidisciplinary Breast Canc Ctr, Berlin, Germany; Royal Marsden Hosp, Breast Unit, London, England
hcfmusp.author.externalGIANNI, Luca:Inst Canc Res, London, England
hcfmusp.author.externalBASELGA, Jose:Hosp San Raffaele, Dept Med Oncol, Inst Sci, Milan, Italy
hcfmusp.author.externalAL-SAKAFF, Nedal:Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
hcfmusp.author.externalLAUER, Sabine:Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
hcfmusp.author.externalMCFADDEN, Eleanor:F Hoffmann La Roche, Basel, Switzerland
hcfmusp.author.externalLEYLAND-JONES, Brian:Frontier Sci Scotland Ltd, Kincraig, Kingussie, Scotland
hcfmusp.author.externalBELL, Richard:Avera Canc Inst, Ctr Precis Oncol, Sioux Falls, SD USA
hcfmusp.author.externalDOWSETT, Mitch:Helios Klinikum Berlin Buch, Multidisciplinary Breast Canc Ctr, Berlin, Germany; Royal Marsden Hosp, Breast Unit, London, England
hcfmusp.author.externalJACKISCH, Christian:Deakin Univ, Waurn Ponds, Vic, Australia
hcfmusp.citation.scopus734
hcfmusp.contributor.author-fmusphcGILBERTO DE CASTRO JUNIOR
hcfmusp.description.beginpage1195
hcfmusp.description.endpage1205
hcfmusp.description.issue10075
hcfmusp.description.volume389
hcfmusp.origemWOS
hcfmusp.origem.pubmed28215665
hcfmusp.origem.scopus2-s2.0-85013031141
hcfmusp.origem.wosWOS:000397143700032
hcfmusp.publisher.cityNEW YORK
hcfmusp.publisher.countryUSA
hcfmusp.relation.referenceBianchini G, 2014, LANCET ONCOL, V15, pE58, DOI 10.1016/S1470-2045(13)70477-7
hcfmusp.relation.referenceChan A, 2016, LANCET ONCOL, V17, P367, DOI 10.1016/S1470-2045(15)00551-3
hcfmusp.relation.referenceCOX DR, 1972, J R STAT SOC B, V34, P187
hcfmusp.relation.referencede Azambuja E, 2014, LANCET ONCOL, V15, P1137, DOI 10.1016/S1470-2045(14)70320-1
hcfmusp.relation.referencede Azambuja E, 2014, J CLIN ONCOL, V32, P2159, DOI 10.1200/JCO.2013.53.9288
hcfmusp.relation.referenceGianni L, 2016, LANCET ONCOL, V17, P791, DOI 10.1016/S1470-2045(16)00163-7
hcfmusp.relation.referenceGianni L, 2011, LANCET ONCOL, V12, P236, DOI 10.1016/S1470-2045(11)70033-X
hcfmusp.relation.referenceGoldhirsch A, 2013, LANCET, V382, P1021, DOI 10.1016/S0140-6736(13)61094-6
hcfmusp.relation.referenceHudis CA, 2007, J CLIN ONCOL, V25, P2127, DOI 10.1200/JCO.2006.10.3523
hcfmusp.relation.referenceKalbfleisch JD, 2002, STAT ANAL FAILURE TI, p[193, 247]
hcfmusp.relation.referenceKAPLAN EL, 1958, J AM STAT ASSOC, V53, P457, DOI 10.2307/2281868
hcfmusp.relation.referencePerez EA, 2011, J CLIN ONCOL, V29, P3366, DOI 10.1200/JCO.2011.35.0868
hcfmusp.relation.referencePiccart-Gebhart M, 2016, J CLIN ONCOL, V34, P1034, DOI 10.1200/JCO.2015.62.1797
hcfmusp.relation.referencePiccart-Gebhart MJ, 2005, NEW ENGL J MED, V353, P1659, DOI 10.1056/NEJMoa052306
hcfmusp.relation.referenceRomond EH, 2005, NEW ENGL J MED, V353, P1673, DOI 10.1056/NEJMoa052122
hcfmusp.relation.referenceSlamon D, 2011, NEW ENGL J MED, V365, P1273, DOI 10.1056/NEJMoa0910383
hcfmusp.relation.referenceSmith I, 2007, LANCET, V369, P29, DOI 10.1016/S0140-6736(07)60028-2
hcfmusp.relation.referenceSwain SM, 2015, NEW ENGL J MED, V372, P724, DOI 10.1056/NEJMoa1413513
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