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Afatinib Not Recommended Post-CRT for Patients With Squamous Cell Carcinoma of the Head and Neck
Data shows that adding afatinib to standard chemoradiation therapy does not improve disease-free survival among patients with squamous cell carcinoma of the head and neck.
Researchers from the Yale Cancer Centre have presented the findings of a randomised, double-blind, placebo-controlled, phase three trial of afatinib as adjuvant therapy after chemoradiation in primary unresected, high- or intermediate-risk, squamous cell cancer of the head and neck patients.
The epidermal growth factor receptor is overexpressed in squamous cell carcinoma of the head and neck. Afatinib is an oral agent that inhibits this receptor.
In this phase three study, 617 patients with stage three or four squamous cell carcinoma of the head and neck were randomly assigned afatinib (411 patients) or placebo (206 patients). All patients had completed prior chemoradiation therapy with concurrent cisplatin or carboplatin. The primary endpoint was disease free survival.
Dose reduction of afatinib was required in 53 percent of patients, mostly due to diarrhoea or stomatitis. Treatment was discontinued entirely due to adverse effects in 15 percent of afatinib patients and four percent of placebo patients.
The study – the results of which were presented at the 2017 American Society of Clinical Oncology Annual Meeting in Chicago – found that squamous cell carcinoma recurrence rates were 23 percent in both groups.
Subgroup analyses did not provide guidance on benefits for any subgroup of patients. The researchers concluded that adding afatinib to standard chemoradiation therapy is not recommended for patients with primary unresected, high- or intermediate-risk squamous cell carcinoma of the head and neck.
Source: Cancer Therapy Advisor
Castellino, A. M. (June 14, 2017) Afatinib Not Recommended Post-CRT for Patients With Squamous Cell Carcinoma of the Head and Neck. Cancer Therapy Advisor. Article 668579.