HNSCC Clinical Trial
Head and neck cancer is the sixth most common cancer and more than 650,000 new cases are
diagnosed each year worldwide. About 60% of the HNSCC patients present with unresectable
locally advanced disease at diagnosis and treated with multimodality approach. Despite such
approach, majority (70%) of patients develop local or/and regional recurrences. Additional
10% of patients present with distant metastasis at diagnosis. Most patients with recurrent or
metastatic disease are treated with single agent chemotherapy, combination chemotherapy or
targeted therapies.
Despite its public health magnitude, HNSCC in Asian countries has received a limited
attention for the drug development and cancer-related research. In fact, HNSCC ranked 7th
among men and 10th among women by incidence in China, the largest producer and consumer of
tobacco and alcohol. Recently, Chen et al. documented a 1:1:2 subset distribution for cancers
of oral cavity, pharynx, and larynx in China, similar to the distribution reported in Korea
but quite different from the general distribution of 5:2:3 in whites. Ethnic disparities in
HNSCC also include its prognosis and this is partly explained by HPV-active disease ratio and
genetic factors. Therefore, there is a strong need for an additional research in patients
with HNSCC in Asia.
Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to
poor prognosis in patients with HNSCC. The association between EGFR-activated signaling
pathways and tumor cell survival are well documented in many studies. EGFR targeting
strategies showed clinical anti-tumor efficacy in patients with HNSCC, especially with
monoclonal antibody, cetuximab. In the Extreme study, it was shown that the addition of
cetuximab to platinum-5-FU significantly prolonged the median overall survival from 7.4
months to 10.1 months compared to platinum-5FU alone in the first-line setting.
HM781-36B is a irreversible pan-HER inhibitor. In preclinical studies, HM781-36B has much
lower IC50 values than gefitinib in cell lines engineered to express EGFRvIII mutations and
produces tumor growth inhibition in gefitinib-resistant xenografts. A phase I trial of
HM781-36B in patients with advanced solid tumors showed clinically significant anti-tumor
activity and a phase II trials of HM781-36B in patients with non-small cell lung cancer and
advanced gastric cancer are currently ongoing.
We suggest a phase II trial of HM781-36B in patients with recurrent or metastatic HNSCC who
are resistant or ineligible/intolerant to platinum-based chemotherapy. The aim of current
trial is to evaluate the antitumor efficacy and safety profile of HM781-36B and to identify
biomarker to predict the tumor response to HM781-36B.
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