meRfi®-GM
NCT01345682 - LUX-Head & Neck 1 - >/= 2L - Afatinib vs Methotrexate & Head & Neck squamous cell carcinoma (HNSCC)
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Contents
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Parallel Assignment
Masking : None (Open Label)
Primary outcome measures:
Progression-free Survival (PFS)
Subgroups of HNSCC patients who may achieve increased benefit from afatinib were identified based on prespecified tumor biomarkers (p16-negative, EGFR-amplified, HER3-low, PTEN-high). Future studies are warranted to validate these findings
The authors' conclusion was that Increasing age ( ≥ 65 years) did not adversely affect clinical outcomes or safety with afatinib versus methotrexate in second-line R/M Head & Neck squamous cell carcinoma (HNSCC)…
References (Sources)
- Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 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
- Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer