Patients age 65 years or older with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) did not have worse clinical outcomes or safety with second-line afatinib vs methotrexate compared with younger patients, a study published in the journal Annals of Oncology has shown.1

The phase 3 LUX-Head & Neck 1 trial demonstrated that afatinib significantly improved progression-free survival vs methotrexate in patients with recurrent and/or metastatic HNSCC who progressed on or after platinum-based therapy. For this subgroup analysis, researchers compared afatinib efficacy and safety with that of methotrexate in patients 65 years and older and those younger than 65 years.

Of the 483 patients randomly assigned to receive either methotrexate or afatinib, 27% were 65 years or older and 73% were younger than 65 years. Results showed that progression-free survival was 2.8 months with afatinib and 2.3 months with methotrexate among older patients (HR, 0.68; 95% CI, 0.45-1.03; P = .061).

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Among younger patients, median progression-free survival was 2.6 months and 1.6 months with afatinib and methotrexate, respectively (HR, 0.79; 95% CI, 0.62-1.01; P = .052).

Median overall survival and objective response rate were also similar between subgroups. Median overall survival with afatinib vs methotrexate was 7.3 months vs 6.4 months (HR, 0.84; 95% CI, 0.54-1.31) among older patients and 6.7 months vs 6.2 months (HR, 0.98; 95% CI, 0.76-1.28) among younger patients.

Objective response rates with afatinib vs methotrexate were 10.8% vs 6.7% for older patients and 10.0% vs 5.2% for younger patients.

In terms of safety, the most frequently reported treatment-related adverse events were rash/acne and diarrhea with afatinib, and stomatitis and fatigue with methotrexate, in both age subgroups. Further, a similar proportion of younger and older patients discontinued treatment, which occurred less with afatinib.


1. Clement PM, Gauler T, Machiels JH, et al. 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 [published online ahead of print April 15, 2016]. Ann Oncol. doi:10.1093/annonc/mdw151.