Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial(aEuro)

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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.authorCLEMENT, P. M.
dc.contributor.authorGAULER, T.
dc.contributor.authorMACHIELS, J. P.
dc.contributor.authorHADDAD, R. I.
dc.contributor.authorFAYETTE, J.
dc.contributor.authorLICITRA, L. F.
dc.contributor.authorTAHARA, M.
dc.contributor.authorCOHEN, E. E. W.
dc.contributor.authorCUPISSOL, D.
dc.contributor.authorGRAU, J. J.
dc.contributor.authorGUIGAY, J.
dc.contributor.authorCAPONIGRO, F.
dc.contributor.authorCASTRO JR., G. de
dc.contributor.authorVIANA, L. de Souza
dc.contributor.authorKEILHOLZ, U.
dc.contributor.authorCAMPO, J. M. del
dc.contributor.authorCONG, X. J.
dc.contributor.authorEHRNROOTH, E.
dc.contributor.authorVERMORKEN, J. B.
dc.contributor.groupauthorLUX-H&N 1 Investigators
dc.date.accessioned2016-12-20T16:43:22Z
dc.date.available2016-12-20T16:43:22Z
dc.date.issued2016
dc.description.abstractIn the LUX-Head & Neck 1 study, older age (a parts per thousand yen65 years) did not adversely affect the benefit in patient-reported outcomes and antitumor activity observed with afatinib over methotrexate, which was consistent with findings from the overall population. Safety in older patients was also consistent with the overall population, favoring afatinib in terms of fewer dose reductions and discontinuations.In the phase III LUX-Head & Neck 1 (LHN1) trial, afatinib significantly improved progression-free survival (PFS) versus methotrexate in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients progressing on/after platinum-based therapy. This report evaluates afatinib efficacy and safety in prespecified subgroups of patients aged a parts per thousand yen65 and < 65 years. Patients were randomized (2:1) to 40 mg/day oral afatinib or 40 mg/m(2)/week intravenous methotrexate. PFS was the primary end point; overall survival (OS) was the key secondary end point. Other end points included: objective response rate (ORR), patient-reported outcomes, tumor shrinkage, and safety. Disease control rate (DCR) was also assessed. Of 483 randomized patients, 27% (83 afatinib; 45 methotrexate) were aged a parts per thousand yen65 years (older) and 73% (239 afatinib; 116 methotrexate) < 65 years (younger) at study entry. Similar PFS benefit with afatinib versus methotrexate was observed in older {median 2.8 versus 2.3 months, hazard ratio (HR) = 0.68 [95% confidence interval (CI) 0.45-1.03], P = 0.061} and younger patients [2.6 versus 1.6 months, HR = 0.79 (0.62-1.01), P = 0.052]. In older and younger patients, the median OS with afatinib versus methotrexate was 7.3 versus 6.4 months [HR = 0.84 (0.54-1.31)] and 6.7 versus 6.2 months [HR = 0.98 (0.76-1.28)]. ORRs with afatinib versus methotrexate were 10.8% versus 6.7% and 10.0% versus 5.2%; DCRs were 53.0% versus 37.8% and 47.7% versus 38.8% in older and younger patients, respectively. In both subgroups, the most frequent treatment-related adverse events were rash/acne (73%-77%) and diarrhea (70%-80%) with afatinib, and stomatitis (43%) and fatigue (31%-34%) with methotrexate. Fewer treatment-related discontinuations were observed with afatinib (each subgroup 7% versus 16%). A trend toward improved time to deterioration of global health status, pain, and swallowing with afatinib was observed in both subgroups. Advancing age (a parts per thousand yen65 years) did not adversely affect clinical outcomes or safety with afatinib versus methotrexate in second-line R/M HNSCC patients. NCT01345682 (ClinicalTrials.gov).
dc.description.indexMEDLINE
dc.description.sponsorshipBoehringer Ingelheim
dc.identifier.citationANNALS OF ONCOLOGY, v.27, n.8, p.1585-1593, 2016
dc.identifier.doi10.1093/annonc/mdw151
dc.identifier.eissn1569-8041
dc.identifier.issn0923-7534
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/17215
dc.language.isoeng
dc.publisherOXFORD UNIV PRESS
dc.relation.ispartofAnnals of Oncology
dc.rightsrestrictedAccess
dc.rights.holderCopyright OXFORD UNIV PRESS
dc.subjectafatinib
dc.subjectmethotrexate
dc.subjectHNSCC
dc.subjectsecond-line
dc.subjectphase III
dc.subjectolder
dc.subject.otherchemotherapy plus cetuximab
dc.subject.otherplatinum-based therapy
dc.subject.otheropen-label
dc.subject.othercancer
dc.subject.wosOncology
dc.titleAfatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial(aEuro)
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryDinamarca
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryBélgica
hcfmusp.affiliation.countryAlemanha
hcfmusp.affiliation.countryFrança
hcfmusp.affiliation.countryItália
hcfmusp.affiliation.countryJapão
hcfmusp.affiliation.countryEspanha
hcfmusp.affiliation.countryisobe
hcfmusp.affiliation.countryisode
hcfmusp.affiliation.countryisous
hcfmusp.affiliation.countryisofr
hcfmusp.affiliation.countryisoit
hcfmusp.affiliation.countryisojp
hcfmusp.affiliation.countryisoes
hcfmusp.affiliation.countryisodk
hcfmusp.author.externalCLEMENT, P. M.:Katholieke Univ Leuven, Dept Oncol, Herestr 49, B-3000 Leuven, Belgium; UZ Leuven, Dept Gen Med Oncol, Leuven, Belgium
hcfmusp.author.externalGAULER, T.:Univ Hosp Essen, West German Canc Ctr, Dept Med Canc Res, Essen, Germany
hcfmusp.author.externalMACHIELS, J. P.:Catholic Univ Louvain, Clin Univ St Luc, Med Oncol Serv, Inst Roi Albert 2, Brussels, Belgium; Catholic Univ Louvain, Inst Rech Clin & Expt Pole MIRO, Brussels, Belgium
hcfmusp.author.externalHADDAD, R. I.:Harvard Med Sch, Dana Farber Canc Inst, Dept Med Oncol, Boston, MA USA
hcfmusp.author.externalFAYETTE, J.:Univ Lyon, Ctr Leon Berard, Dept Med Oncol, Lyon, France
hcfmusp.author.externalLICITRA, L. F.:Fdn IRCCS Ist Nazl Tumori, Dept Med Oncol, Milan, Italy
hcfmusp.author.externalTAHARA, M.:Natl Canc Ctr Hosp East, Head & Neck Med Oncol, Kashiwa, Chiba, Japan
hcfmusp.author.externalCOHEN, E. E. W.:Univ Calif San Diego, Dept Med, Moores Canc Ctr, La Jolla, CA 92093 USA
hcfmusp.author.externalCUPISSOL, D.:Inst Canc Montpellier Val dAurelle, Med Oncol Serv, Montpellier, France
hcfmusp.author.externalGRAU, J. J.:Hosp Clin Barcelona, Dept Med Oncol, Barcelona, Spain; Univ Barcelona, Barcelona, Spain
hcfmusp.author.externalGUIGAY, J.:Gustave Roussy, Dept Med Oncol, Villejuif, France; Ctr Antoine Lacassagne, Nice, France
hcfmusp.author.externalCAPONIGRO, F.:Natl Tumor Inst Naples, Head & Neck Med Oncol, Head & Neck, Dept Melanoma,Soft Tissues,Muscolo Scheletal, Naples, Italy
hcfmusp.author.externalVIANA, L. de Souza:Hosp Canc Barretos, Dept Med Oncol, Sao Paulo, Brazil
hcfmusp.author.externalKEILHOLZ, U.:Charite Comprehens Canc Ctr, Berlin, Germany
hcfmusp.author.externalCAMPO, J. M. del:Hosp Univ Vall DHebron, Dept Med Oncol, Barcelona, Spain
hcfmusp.author.externalCONG, X. J.:Boehringer Ingelheim Pharmaceut Inc, Biometr & Data Management, Ridgefield, CT USA
hcfmusp.author.externalEHRNROOTH, E.:Boehringer Ingelheim Danmark AS, Div Oncol, Copenhagen, Denmark
hcfmusp.author.externalVERMORKEN, J. B.:Univ Antwerp Hosp, Dept Med Oncol, Edegem, Belgium
hcfmusp.citation.scopus32
hcfmusp.contributor.author-fmusphcGILBERTO DE CASTRO JUNIOR
hcfmusp.description.beginpage1585
hcfmusp.description.endpage1593
hcfmusp.description.issue8
hcfmusp.description.volume27
hcfmusp.origemWOS
hcfmusp.origem.pubmed27084954
hcfmusp.origem.scopus2-s2.0-84985021943
hcfmusp.origem.wosWOS:000383182800029
hcfmusp.publisher.cityOXFORD
hcfmusp.publisher.countryENGLAND
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