Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial.

Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial.

Ann Oncol. 2016 Apr 15;

Authors: Clement PM, Gauler T, Machiels JH, Haddad RI, Fayette J, Licitra LF, Tahara M, Cohen EE, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Vermorken JB, LUX-H&N 1 investigators

Abstract
BACKGROUND: In the phase III LUX-Head & Neck 1 (LHN1) trial, afatinib significantly improved progression-free survival (PFS) versus methotrexate in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients progressing on/after platinum-based therapy. This report evaluates afatinib efficacy and safety in pre-specified subgroups of patients aged ≥65 and <65 years.
PATIENTS AND METHODS: Patients were randomized (2:1) to 40 mg/day oral afatinib or 40 mg/m(2)/week intravenous methotrexate. PFS was the primary endpoint; overall survival (OS) was the key secondary endpoint. Other endpoints: objective response rate (ORR), patient-reported outcomes, tumor shrinkage, and safety. Disease control rate (DCR) was also assessed.
RESULTS: Of 483 randomized patients, 27% (83 afatinib; 45 methotrexate) were aged ≥65 years (older) and 73% (239 afatinib; 116 methotrexate) <65 years (younger) at study entry. Similar PFS benefit with afatinib versus methotrexate was observed in older (median 2.8 versus 2.3 months, HR=0.68 [95% CI 0.45-1.03], P=0.061) and younger patients (2.6 versus 1.6 months, HR=0.79 [0.62-1.01], P=0.052). In older and younger patients, median OS with afatinib versus methotrexate was 7.3 versus 6.4 months (HR=0.84 [0.54-1.31]) and 6.7 versus 6.2 months (HR=0.98 [0.76-1.28]). ORRs with afatinib versus methotrexate were 10.8% versus 6.7% and 10.0% versus 5.2%; DCRs were 53.0% versus 37.8% and 47.7% versus 38.8% in older and younger patients, respectively. In both subgroups, the most frequent treatment-related adverse events were rash/acne (73%-77%) and diarrhea (70%-80%) with afatinib, and stomatitis (43%) and fatigue (31%-34%) with methotrexate. Fewer treatment-related discontinuations were observed with afatinib (each subgroup 7% versus 16%). A trend towards improved time to deterioration of global health status, pain and swallowing with afatinib was observed in both subgroups.
CONCLUSIONS: Advancing age (≥65 years) did not adversely affect clinical outcomes or safety with afatinib versus methotrexate in second-line R/M HNSCC patients.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT01345682.

PMID: 27084954 [PubMed - as supplied by publisher]

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