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.
Afatinib as second-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck : subgroup analyses of treatment adherence, safety and mode of afatinib administration in the LUX-Head and Neck 1 trial / R. Haddad, J. Guigay, U. Keilholz, P.M. Clement, J. Fayette, L. de Souza Viana, F. Rolland, D. Cupissol, L. Geoffrois, G. Kornek, L. Licitra, B. Melichar, U. Ribaldo Nicolau, D. Rauch, S. Zanetta-Devauges, E.E.W. Cohen, J.P. Machiels, M. Tahara, J. Vermorken, Y. Geng, E. Zografos, T. Gauler. - In: ORAL ONCOLOGY. - ISSN 1368-8375. - 97(2019 Oct), pp. 82-91.
|Titolo:||Afatinib as second-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck : subgroup analyses of treatment adherence, safety and mode of afatinib administration in the LUX-Head and Neck 1 trial|
|Parole Chiave:||Adherence; Afatinib; Feeding tube; HNSCC; Methotrexate; Recurrent/metastatic; Safety|
|Settore Scientifico Disciplinare:||Settore MED/06 - Oncologia Medica|
|Data di pubblicazione:||ott-2019|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1016/j.oraloncology.2019.08.004|
|Appare nelle tipologie:||01 - Articolo su periodico|