OBJECTIVES: Patients with head and neck squamous cell carcinoma (HNSCC) can experience severe symptom burden and/or difficulty swallowing, leading to problems with treatment adherence/administration. In LUX-Head and Neck 1 (LH&N1; NCT01345682), second-line afatinib improved progression-free survival (PFS) versus methotrexate in patients with recurrent/metastatic HNSCC. We report adherence and safety across pre-specified and additional subgroups potentially linked to afatinib PFS benefit in LH&N1 (p16 status, smoking history), and afatinib adherence, safety and efficacy by administration (oral versus feeding tube; post-hoc analysis). METHODS: Patients were randomized (2:1) to afatinib (40 mg/day) or intravenous methotrexate (40 mg/m2/week). RESULTS: Among 320 afatinib-treated and 160 methotrexate-treated patients, 83-92% and 76-92% (of patients with data available) across all subgroups took ≥80% of treatment. Across p16 status and smoking history subgroups, the most common treatment-related adverse events (AEs) were diarrhea (70-91%), rash/acne (72-84%), stomatitis (34-73%) with afatinib; and included stomatitis (39-100%), fatigue (22-50%), nausea (19-36%) with methotrexate. Dose reduction decreased AE incidence/severity. Baseline characteristics were generally similar between oral/feeding tube (n = 276/n = 46) groups. 89%/89% (of patients with data available) took ≥80% of assigned afatinib. Median PFS was 2.6 versus 2.7 months (hazard ratio: 0.997; 95% confidence interval: 0.72-1.38). The most common afatinib-related AEs were: rash/acne (74% versus 74%), diarrhea (73% versus 65%), stomatitis (40% versus 30%). CONCLUSION: Subgroup analyses of LH&N1 demonstrate that afatinib has predictable and manageable safety across patient subgroups, with high treatment adherence, and is effective via oral and feeding tube administration.

Boehringer Ingelheim Investment Co Ltd Shanghai China

Boehringer Ingelheim Ltd Berkshire UK

Centre Antoine Lacassagne FHU OncoAge Université Côte d'Azur Nice France

Department of Head and Neck Medical Oncology Fondazione IRCCS Istituto Nazionale Tumori and University of Milan Milan Italy

Department of Head and Neck Medical Oncology National Cancer Center Hospital East Kashiwa Japan

Department of Medical Oncology Antwerp University Hospital Edegem Belgium

Department of Medical Oncology Dana Farber Cancer Institute Harvard Medical School and Department of Medicine Brigham and Women's Hospital Boston MA USA

Department of Medical Oncology Hospital de Câncer de Barretos Barretos São Paulo Brazil

Department of Medical Oncology Institut de Cancérologie de l'Ouest Nantes France

Department of Medical Oncology Institut de Cancérologie de Lorraine Vandœuvre lès Nancy France

Department of Medicine West German Cancer Center University Hospital Essen of the University Duisburg Essen Essen Germany

Department of Oncology AC Camargo Cancer Center São Paulo SP Brazil

Department of Oncology KU Leuven Leuven Cancer Institute Leuven Belgium

Department of Oncology Palacky University Medical School Olomouc Czech Republic

Institut du Cancer de Montpellier Val d'Aurelle Montpellier France

Institut Roi Albert 2 Service d'Oncologie Médicale Cliniques Universitaires Saint Luc and Institut de Recherche Clinique et Expérimentale Université Catholique de Louvain Brussels Belgium

Klinische Abteilung für Onkologie Universitätsklinik für Innere Medizin Vienna Austria

Medical Department Charité Comprehensive Cancer Center Berlin Germany

Medical Oncology Centre Léon Bérard Lyon France

Moores Cancer Center University of California San Diego La Jolla CA USA

Service d'Oncologie Médicale Centre Georges François Leclerc Dijon Cedex France

Swiss Group for Clinical Cancer Research Bern Switzerland

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