The LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levels

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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.authorWERUTSKY, Gustavo
dc.contributor.authorMALUF, Fernando Cotait
dc.contributor.authorCRONEMBERGER, Eduardo Henrique
dc.contributor.authorSOUZA, Vinicius Carrera
dc.contributor.authorMARTINS, Suelen Patricia dos Santos
dc.contributor.authorPEIXOTO, Fabio
dc.contributor.authorSMALETZ, Oren
dc.contributor.authorSCHUTZ, Fabio
dc.contributor.authorHERCHENHORN, Daniel
dc.contributor.authorSANTOS, Telma
dc.contributor.authorCARCANO, Flavio Mavignier
dc.contributor.authorMUNIZ, David Queiroz
dc.contributor.authorNUNES FILHO, Paulo R. S.
dc.contributor.authorZAFFARONI, Facundo
dc.contributor.authorBARRIOS, Carlos
dc.contributor.authorFAY, Andre
dc.date.accessioned2019-06-26T17:34:07Z
dc.date.available2019-06-26T17:34:07Z
dc.date.issued2019
dc.description.abstractBackgroundTestosterone suppression is the standard treatment for advanced prostate cancer, and it is associated with side-effects that impair patients' quality of life, like sexual dysfunction, osteoporosis, weight gain, and increased cardiovascular risk. We hypothesized that abiraterone acetate with prednisone (AAP) and apalutamide, alone or in combination, can be an effective hormonal therapy also possibly decreasing castration-associated side effects.MethodsPhase II, open-label, randomized, efficacy trial of abiraterone acetate plus prednisone (AAP) and Androgen Deprivation Therapy (ADT) versus apalutamide versus the combination of AAP (without ADT) and apalutamide. Key eligibility criteria are confirmed prostate adenocarcinoma; biochemical relapse after definitive treatment (PSA4ng/ml and doubling time less than 10months, or PSA20ng/ml); newly diagnosed locally advanced or metastatic prostate cancer; asymptomatic to moderately symptomatic regarding bone symptoms. Patients with other histology besides adenocarcinoma or previous use of hormonal therapy or chemotherapy were excluded.DiscussionThere is an urgent need to study and validate regimens such as new hormonal agents that may add benefit to castration with an acceptable safety profile. We aim to evaluate if apalutamide in monotherapy or in combination with AAP is an effective and safety hormonal treatment that can spare patients of androgen deprivation therapy.Trial registrationThis trial was registered in ClinicalTrials.gov on October 16, 2017, under Identifier: NCT02867020.eng
dc.description.indexMEDLINEeng
dc.description.sponsorshipJanssen-Cilag Farmaceutica Ltda
dc.description.sponsorshipLatin American Cooperative Oncology Group (LACOG)
dc.identifier.citationBMC CANCER, v.19, article ID 487, 8p, 2019
dc.identifier.doi10.1186/s12885-019-5709-y
dc.identifier.issn1471-2407
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/32557
dc.language.isoeng
dc.publisherBMCeng
dc.relation.ispartofBMC Cancer
dc.rightsrestrictedAccesseng
dc.rights.holderCopyright BMCeng
dc.subjectCastration-sensitive prostate cancereng
dc.subjectHormonal therapyeng
dc.subjectAndrogen deprivation therapyeng
dc.subjectAbirateroneeng
dc.subjectApalutamideeng
dc.subjectGoserelineng
dc.subject.otherandrogen deprivationeng
dc.subject.otherfunctional assessmenteng
dc.subject.othersurvivaleng
dc.subject.othertherapyeng
dc.subject.othermeneng
dc.subject.wosOncologyeng
dc.titleThe LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levelseng
dc.typearticleeng
dc.type.categoryoriginal articleeng
dc.type.versionpublishedVersioneng
dspace.entity.typePublication
hcfmusp.author.externalWERUTSKY, Gustavo:Latin Amer Cooperat Oncol Grp, Ipiranga Ave 6681,99A Room, BR-806 Porto Alegre, RS, Brazil
hcfmusp.author.externalMALUF, Fernando Cotait:Hosp Sao Jose, Sao Paulo, Brazil
hcfmusp.author.externalCRONEMBERGER, Eduardo Henrique:Ctr Reg Integrado Oncol, Fortaleza, Ceara, Brazil
hcfmusp.author.externalSOUZA, Vinicius Carrera:Clin Assistencia Multidisciplinar Oncol, Salvador, BA, Brazil
hcfmusp.author.externalMARTINS, Suelen Patricia dos Santos:Ctr Estudos & Pesquisa Hematol & Oncol, Santo Andre, Brazil
hcfmusp.author.externalPEIXOTO, Fabio:Amer Ctr Oncol Integrado, Rio De Janeiro, Brazil
hcfmusp.author.externalSMALETZ, Oren:Hosp Israelita Albert Einstein, Sao Paulo, Brazil
hcfmusp.author.externalSCHUTZ, Fabio:Beneficiencia Portuguesa Sao Paulo, Sao Paulo, Brazil
hcfmusp.author.externalHERCHENHORN, Daniel:ONcol Dor, Rio De Janeiro, Brazil
hcfmusp.author.externalSANTOS, Telma:Janssen Cilag Pharmaceut, Sao Paulo, Brazil
hcfmusp.author.externalCARCANO, Flavio Mavignier:Hosp Canc Barretos, Barretos, Brazil
hcfmusp.author.externalNUNES FILHO, Paulo R. S.:Latin Amer Cooperat Oncol Grp, Ipiranga Ave 6681,99A Room, BR-806 Porto Alegre, RS, Brazil
hcfmusp.author.externalZAFFARONI, Facundo:Latin Amer Cooperat Oncol Grp, Ipiranga Ave 6681,99A Room, BR-806 Porto Alegre, RS, Brazil
hcfmusp.author.externalBARRIOS, Carlos:Latin Amer Cooperat Oncol Grp, Ipiranga Ave 6681,99A Room, BR-806 Porto Alegre, RS, Brazil
hcfmusp.author.externalFAY, Andre:PUCRS Sch Med, Porto Alegre, RS, Brazil
hcfmusp.citation.scopus11
hcfmusp.contributor.author-fmusphcDAVID QUEIROZ BORGES MUNIZ
hcfmusp.description.articlenumber487
hcfmusp.description.volume19
hcfmusp.origemWOS
hcfmusp.origem.pubmed31122212
hcfmusp.origem.scopus2-s2.0-85066402119
hcfmusp.origem.wosWOS:000468884500005
hcfmusp.publisher.cityLONDONeng
hcfmusp.publisher.countryENGLANDeng
hcfmusp.relation.referenceBARRIE SE, 1994, J STEROID BIOCHEM, V50, P267, DOI 10.1016/0960-0760(94)90131-7eng
hcfmusp.relation.referenceCella D, 2009, VALUE HEALTH, V12, P124, DOI 10.1111/j.1524-4733.2008.00409.xeng
hcfmusp.relation.referenceChang D, 2014, J MED IMAG RADIAT ON, V58, P223, DOI 10.1111/1754-9485.12124eng
hcfmusp.relation.referenceChi KN, 2009, EUR UROL, V56, P594, DOI 10.1016/j.eururo.2009.06.027eng
hcfmusp.relation.referenceCrawford ED, 2015, J UROLOGY, V194, P1537, DOI 10.1016/j.juro.2015.06.106eng
hcfmusp.relation.referenceDe Bono JS, 2011, NEW ENGL J MED, V364, P1995, DOI 10.1056/NEJMoa1014618eng
hcfmusp.relation.referenceEfstathiou E, 2014, J CLIN ONCOL, V32, DOI 10.1200/jco.2014.32.15_suppl.5000eng
hcfmusp.relation.referenceEsper P, 1997, UROLOGY, V50, P920, DOI 10.1016/S0090-4295(97)00459-7eng
hcfmusp.relation.referenceFizazi K, 2017, NEW ENGL J MED, V377, P352, DOI 10.1056/NEJMoa1704174eng
hcfmusp.relation.referenceFizazi K, 2012, LANCET ONCOL, V13, P983, DOI 10.1016/S1470-2045(12)70379-0eng
hcfmusp.relation.referenceGartrell BA, 2015, EUR UROL, V68, P850, DOI 10.1016/j.eururo.2015.06.039eng
hcfmusp.relation.referenceHershman DL, 2016, JAMA ONCOL, V2, P453, DOI 10.1001/jamaoncol.2015.4655eng
hcfmusp.relation.referenceHussain M, 2006, J CLIN ONCOL, V24, P3984, DOI 10.1200/JCO.2006.06.4246eng
hcfmusp.relation.referenceJames ND, 2017, NEW ENGL J MED, V377, P338, DOI 10.1056/NEJMoa1702900eng
hcfmusp.relation.referenceJames ND, 2016, LANCET, V387, P1163, DOI 10.1016/S0140-6736(15)01037-5eng
hcfmusp.relation.referencePosadas EM, 2017, J CLIN ONCOL, V35, DOI 10.1200/JCO.2017.35.6_suppl.173eng
hcfmusp.relation.referenceRathkopf DE, 2017, ANN ONCOL, V28, P2264, DOI 10.1093/annonc/mdx283eng
hcfmusp.relation.referenceRathkopf DE, 2013, J CLIN ONCOL, V31, P3525, DOI 10.1200/JCO.2013.50.1684eng
hcfmusp.relation.referenceRathkopf DE, 2013, ASCO M S, V31, P48eng
hcfmusp.relation.referenceRozet F, 2016, WORLD J UROL, V34, P1505, DOI 10.1007/s00345-016-1803-9eng
hcfmusp.relation.referenceRyan CJ, 2013, NEW ENGL J MED, V368, P138, DOI 10.1056/NEJMoa1209096eng
hcfmusp.relation.referenceSmith MR, 2018, NEW ENGL J MED, V378, P1408, DOI 10.1056/NEJMoa1715546eng
hcfmusp.relation.referenceSmith MR, 2016, EUR UROL, V70, P963, DOI 10.1016/j.eururo.2016.04.023eng
hcfmusp.relation.referenceSweeney CJ, 2015, NEW ENGL J MED, V373, P737, DOI 10.1056/NEJMoa1503747eng
hcfmusp.relation.referenceTombal B, 2014, LANCET ONCOL, V15, P592, DOI 10.1016/S1470-2045(14)70129-9eng
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