Afatinib was associated with significant improvements in progression-free survival and had a manageable safety profile compared with methotrexate for the second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy, a new study published in the journalThe Lancet Oncology has shown.
For the open-label, controlled, phase III, researchers enrolled 483 patients with histologically or cytologically confimred head and neck squamous cell carcinoma that was recurrent, metastatic, or both who had progressed on or following first-line platinum-based therapy. Patients were only included if they were not eligible to undergo salvage surgery or receive radiotherapy.
Patients were randomly assigned 2:1 to receive afatinib 40mg/day orally or methotrexate 40mg/m2 per week intravenously.
Results showed that after a median follow-up of 6.7 months, median progression-free survival was 2.6 months (95% CI: 2.0-2.7) in the afatinib group compared with 1.7 months (95% CI: 1.5-2.4) in the methotrexate group (HR = 0.80; 95% CI: 0.65-0.98; P = 0.030).
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In regard to safety, the most common grade 3 or 4 afatinib-associated adverse events were rash or acne, diarrhea, stomatitis, fatigue, and neutropenia.
Serious adverse events occurred more frequently in afatinib-treated patients versus those who received methotrexate (14% vs 11%).
The authors conclude that their findings warrant further investigation into the use of ErbB EGFR tyrosine kinase inhibitors in patients with head and neck squamous cell carcinoma.
- Machiels J-P, Haddad RI, Fayette J, et al. 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. Lancet Oncol. 2015. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)70124-5.