ESMO 2014: Afatinib Improves Progression-Free Survival in Advanced Head and Neck Cancer
The tyrosine kinase inhibitor afatinib (Gilotrif) was significantly superior to methotrexate as second-line therapy in patients with advanced squamous cell carcinoma of the head and neck who progressed after platinum-based chemotherapy, according to results of the LUX-Head & Neck 1 trial. The group treated with afatinib had a 20% reduction in risk of progression or death compared with methotrexate, and importantly, experienced improvements in the debilitating symptoms associated with this cancer. The findings were presented at the ESMO 2014 Congress in Madrid, Spain (Abstract LBA29_PR).
“Afatinib is the first oral tyrosine kinase inhibitor to demonstrate efficacy and improved patient-reported outcomes in a phase III trial in this setting. Afatinib treatment decreased pain, significantly delayed worsening of symptoms including pain and swallowing, and improved global health status compared with methotrexate,” said Jean-Pascal Machiels, MD, of Institut Roi Albert II, Cliniques Universitaires St. Luc in Brussels, Belgium.
“Squamous cell carcinoma of the head and neck is typically a disease of misery that occurs mostly in males and does not get much attention from the scientific community,” he continued. “About 50% of patients treated with radiation or surgery will relapse, and at relapse they can get chemotherapy. After that there are not many options,” he told listeners. Median survival is typically from 3 to 6 months after progression on platinum-based chemotherapy.
Study Details
This phase III trial included 474 patients with incurable squamous cell carcinoma of the head and neck that had progressed on prior platinum-based treatment. Patients were randomly assigned 2:1 to oral afatinib at 40 mg/d or intravenous methotrexate at 40 mg/m2/wk.
The primary endpoint, progression-free survival, was significantly better for those treated with afatinib: 42.8% vs 30.5% for the methotrexate group (P = .030). Median progression-free survival was 2.6 months vs 1.7 months, respectively.
Tumor shrinkage was greater, response rate was higher, and disease control rate was significantly higher in the afatinib arm vs methotrexate.
Overall survival was not significantly different between the two arms, however.
Toxicity was as expected with both afatinib and methotrexate. Fewer treatment-related dose reductions and discontinuations, as well as fewer fatal events were reported with afatinib compared with methotrexate.
For full disclosures of the study authors, view the study abstract at www.esmo.org.
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