Afatinib Delayed Progression of Recurrent Head and Neck Cancer

PET Scan of nasopharynx carcinoma; source: Sanko, Wikimedia Commons

The ErbB family blocker afatinib better delayed progression and deterioration of patient-reported outcomes in patients with recurrent or metastatic head and neck squamous cell carcinoma than did treatment with methotrexate, according to primary efficacy results of the Lux-Head & Neck 1 trial.

Specifically, patients treated with afatinib had a delayed worsening of symptoms, including pain and swallowing compared to patients treated with chemotherapy. Afatinib is the first tyrosine kinase inhibitor to demonstrate a significant benefit in patients with head and neck squamous cell carcinoma, according to Jean-Pascal Machiels, MD, a medical oncologist at Cliniques Universitaires St. Luc, in Brussels, Belgium, who presented the results of the Lux-Head & Neck 1 trial (Abstract 29LBA_PR), at the European Society for Medical Oncology (ESMO) 2014 Congress.

The phase III study randomly assigned patients with recurrent and/or metastatic head and neck squamous cell carcinoma to treatment with 40 mg per day afatinib (n = 322) or 40 mg/m² per week intravenous methotrexate (n = 161).

Patients assigned to afatinib had a significant improvement in progression-free survival compared with those assigned methotrexate (2.6 months vs 1.7 months; HR = 0.80; 95% CI, 0.65-0.98; P = .03). In addition, treatment with afatinib was associated with a higher rate of disease control compared with methotrexate (49.1% vs 38.5%; P = .04).

However, the researchers found no significant difference between the two treatments for overall survival (6.8 months vs 6.2 months) or overall response rate (10.2% vs 5.6%).

“Many potential reasons could explain why we were not able to demonstrate a survival benefit,” Machiels said in a prepared statement. “It could be simply because afatinib does not improve survival. However, 50% of the patients in both arms received subsequent therapies that could have influenced the survival benefit, for example a significant number of patients received subsequent anti-EGFR therapies in the methotrexate arm.”

The study was designed to look at differences in patient-reported outcomes. Data showed that treatment with afatinib delayed deterioration of global health status, pain, and swallowing compared with methotrexate (P < .03 for all). Afatinib was also associated with an improvement in reported pain (P = .03).

Rash/acne and diarrhea were the most commonly reported grade 3/4 drug-related adverse events reported in patients treated with afatinib. However, patients assigned afatinib had fewer treatment-related dose reductions, discontinuations, and fatal events.

Moving forward, Machiels hopes to focus research on identifying which patients will derive the most benefit from treatment with afatinib.