Afatinib Not Recommended Post-CRT for Patients With Squamous Cell Carcinoma of the Head and Neck
Adding afatinib to standard CRT is not recommended for patients with primary unresected, high- or intermediate-risk HNSCC.
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Adding afatinib to standard chemoradiation (CRT) therapy does not improve disease-free survival (DFS) vs placebo among patients with squamous cell carcinoma of the head and neck (HNSCC), according to data presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1
Barbara Burtness, MD, of the Yale Cancer Center in New Haven, Connecticut, present data from the LUX-head and Neck 2 study (ClinicalTrials.gov Identifier: NCT01345669).
The epidermal growth factor receptor (EGFR) is overexpressed in SCCHN, making it a valid treatment target in this setting. Afatinib is an oral agent that inhibits EGFR.
For this phase 3 study, 617 patients with stage III/IVb HNSCC were randomly assigned 2:1 to afatinib (411 patients) or placebo (206 patients). All patients had completed prior CRT with concurrent cisplatin or carboplatin.
The primary endpoint was DFS. At a planned interim analysis, accrual was stopped for futility. DFS was 43.4 months for patients in the afatinib arm vs not reached for placebo.
Recurrence rates were 23% in both groups. The authors noted that “dose reduction of [afatinib] was required in 53% (mostly due to diarrhea, stomatitis). [Treatment] was discontinued due to [adverse events] in [afatinib] 15%, [placebo] 4%.”
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Subgroup analyses did not provide guidance on benefits for any subgroup of patients. The authors concluded that adding afatinib to standard CRT is not recommended for patients with primary unresected, high- or intermediate-risk HNSCC.
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- Burtness B, Haddad RI, Dinis J, et al. LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III tiral of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts). J Clin Oncol. 2017;35(suppl; abstr 6001).