Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung: Final analysis of the randomised phase 3 LUX-Lung 8 trial

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dc.authoridardizzoni, andrea/0000-0003-2678-0714
dc.authorscopusid17734334700
dc.authorscopusid35400247700
dc.authorscopusid57212182378
dc.authorscopusid35465809000
dc.authorscopusid57196253114
dc.authorscopusid26662691100
dc.authorscopusid7102636370
dc.contributor.authorGoss, Glenwood D.
dc.contributor.authorCobo, Manuel
dc.contributor.authorLu, Shun
dc.contributor.authorSyrigos, Konstantinos
dc.contributor.authorLee, Ki Hyeong
dc.contributor.authorGoker, Erdem
dc.contributor.authorGeorgoulias, Vassilis
dc.date.accessioned2023-01-12T19:54:41Z
dc.date.available2023-01-12T19:54:41Z
dc.date.issued2021
dc.departmentN/A/Departmenten_US
dc.description.abstractBackground: LUX-Lung 8 was a randomised, controlled, phase 3 study comparing afatinib and erlotinib as sec-ond-line treatment of patients with advanced squamous cell carcinoma (SCC) of the lung. We report the final overall survival (OS) and safety analyses of LUX-Lung 8 and investigate the characteristics of patients who achieved long-term benefit (>12 months' treatment). Methods: LUX-Lung 8 (NCT01523587) enroled patients between March 2012 and January 2014 and this final analysis had a data cut-off of March 2018. Eligible patients had stage IIIB or IV lung SCC and had progressed after at least four cycles of platinum-based chemotherapy. Patients were randomly assigned (1:1) to receive afatinib (40 mg per day) or erlotinib (150 mg per day) until disease progression. Endpoints included OS and safety; a post-hoc analysis of patients with long-term benefit (>12 months on treatment) was also conducted. Findings: 795 eligible patients were randomly assigned (398 to afatinib, 397 to erlotinib). OS was significantly prolonged with afatinib compared with erlotinib (median 7.8 months vs 6.8 months; hazard ratio 0.84; 95% CI 0.73-0.97; p = 0.0193). These findings were consistent with those of the primary analysis and were consistent across subgroups. Adverse events (AEs) were manageable with dose interruption and reduction, with similar AEs being experienced between both groups. Twenty-one (5.3%) patients receiving afatinib and 13 (3.3%) patients receiving erlotinib achieved long-term benefit; median OS was 34.6 months and 20.1 months, respectively. Amongst 132 afatinib-treated patients who underwent tumour genetic analysis, ERBB family mutations were more common in patients with long-term benefit than in the overall population (50% vs 21%). Interpretation: Afatinib is a treatment option for patients with SCC of the lung progressing on chemotherapy who are ineligible for immunotherapy, particularly those with ERBB family genetic aberrations. Afatinib has a predictable and manageable tolerability profile, and long-term treatment may be well tolerated. Funding: Boehringer Ingelheim. (c) 2021 Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)en_US
dc.description.sponsorshipBoehringer Ingelheimen_US
dc.description.sponsorshipThis trial was funded by Boehringer Ingelheim. We thank the patients, their families, and all the investigators who participated in this study. Medical writing assistance was provided by Robert Harri-son, PhD of GeoMed, an Ashfield Company, and was supported finan-cially by Boehringer Ingelheim during the preparation of this report.en_US
dc.identifier.doi10.1016/j.eclinm.2021.100940
dc.identifier.issn2589-5370
dc.identifier.pmid34195574en_US
dc.identifier.scopus2-s2.0-85109135779en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://doi.org/10.1016/j.eclinm.2021.100940
dc.identifier.urihttps://hdl.handle.net/11454/76505
dc.identifier.volume37en_US
dc.identifier.wosWOS:000692793000011en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.relation.ispartofEclinicalmedicineen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectAfatiniben_US
dc.subjectERBBen_US
dc.subjectNon-small cell lung canceren_US
dc.subjectSecond-lineen_US
dc.subjectSquamous cell lung carcinomaen_US
dc.subjectOpen-Labelen_US
dc.subjectCanceren_US
dc.subjectAtezolizumaben_US
dc.subjectChemotherapyen_US
dc.subjectDocetaxelen_US
dc.subjectExpressionen_US
dc.subjectNivolumaben_US
dc.subjectHistologyen_US
dc.subjectReceptoren_US
dc.subjectNsclcen_US
dc.titleAfatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung: Final analysis of the randomised phase 3 LUX-Lung 8 trialen_US
dc.typeArticleen_US

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