Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial

Machiels, Jean-Pascal H; Haddad, Robert I; Fayette, Jérôme; Licitra, Lisa F; Tahara, Makoto; Vermorken, Jan B; Clement, Paul; Gauler, Thomas; Cupissol, Didier; Grau, Juan José; Guigay, Joël; Caponigro, Francesco; de Castro, Gilberto; de Souza Viana, Luciano; Keilholz, Ulrich; Del Campo, Joseph M; Cong, Xiuyu Julie; Ehrnrooth, Eva; Cohen, Ezra EW

doi:10.1016/S1470-2045(15)70124-5

Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial

Author:

Machiels, Jean-Pascal H

Haddad, Robert I ; Fayette, Jérôme ; Licitra, Lisa F ; Tahara, Makoto ; Vermorken, Jan B ; Clement, Paul ; Gauler, Thomas ; Cupissol, Didier ; Grau, Juan José ; Guigay, Joël ; Caponigro, Francesco ; de Castro, Gilberto ; de Souza Viana, Luciano ; Keilholz, Ulrich ; Del Campo, Joseph M ; Cong, Xiuyu Julie ; Ehrnrooth, Eva ; Cohen, Ezra EW

Keywords:

Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Carcinoma, Squamous Cell, Disease-Free Survival, Female, Head and Neck Neoplasms, Humans, Male, Methotrexate, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Platinum, Quinazolines, Treatment Outcome, Science & Technology, Life Sciences & Biomedicine, Oncology, CHEMOTHERAPY PLUS CETUXIMAB, HUMAN-PAPILLOMAVIRUS, RETROSPECTIVE ANALYSIS, SOLID TUMORS, EFFICACY, P16(INK4A), BIOMARKER, Afatinib, Squamous Cell Carcinoma of Head and Neck, LUX-H&N 1 investigators, 1112 Oncology and Carcinogenesis, Oncology & Carcinogenesis, 3211 Oncology and carcinogenesis

Abstract:

Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC) progressing after first-line platinum regimens have a poor prognosis and few treatment options. Afatinib, an irreversible ERBB family blocker, has shown efficacy in a phase 2 study in this setting. We aimed to assess the efficacy and safety of afatinib compared with methotrexate as second-line treatment in patients with recurrent or metastatic HNSCC progressing on or after platinum-based therapy.