TY - JOUR
T1 - Afatinib as second-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck
T2 - Subgroup analyses of treatment adherence, safety and mode of afatinib administration in the LUX-Head and Neck 1 trial
AU - Haddad, Robert
AU - Guigay, Joel
AU - Keilholz, Ulrich
AU - Clement, Paul M.
AU - Fayette, Jérôme
AU - de Souza Viana, Luciano
AU - Rolland, Frédéric
AU - Cupissol, Didier
AU - Geoffrois, Lionnel
AU - Kornek, Gabriela
AU - Licitra, Lisa
AU - Melichar, Bohuslav
AU - Ribaldo Nicolau, Ulisses
AU - Rauch, Daniel
AU - Zanetta-Devauges, Sylvie
AU - Cohen, Ezra E.W.
AU - Machiels, Jean Pascal
AU - Tahara, Makoto
AU - Vermorken, Jan
AU - Geng, Yuan
AU - Zografos, Eleftherios
AU - Gauler, Thomas
PY - 2019/10
Y1 - 2019/10
N2 - 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.
AB - 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.
KW - Adherence
KW - Afatinib
KW - Feeding tube
KW - HNSCC
KW - Methotrexate
KW - Recurrent/metastatic
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85070953500&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85070953500&partnerID=8YFLogxK
U2 - 10.1016/j.oraloncology.2019.08.004
DO - 10.1016/j.oraloncology.2019.08.004
M3 - Article
C2 - 31450171
AN - SCOPUS:85070953500
VL - 97
SP - 82
EP - 91
JO - Oral Oncology
JF - Oral Oncology
SN - 1368-8375
ER -