Esophageal cancer is the sixth most common cause of cancer deaths worldwide. Esophageal adenocarcinoma has become more common in Western countries. In many Asian countries, however, Esophageal Squamous Cell Carcinoma (ESCC) represents the most common esophageal cancer. In palliative chemotherapy for metastatic or recurrent ESCC, A combination of 5-fluorouracil and platinum was prescribed as a standard treatment for about 20 years. With this traditional regimen, the median progression free survival is approximately 7 months, and 1-year survival rate is reported to be 34%. Combinations of taxane and anthracycline are also considerable, but also shows the median survival less than one year. Though cytotoxic chemotherapy is current main treatment option, molecularly targeted agents are recently incorporated to improve survival in ESCC. There is a strong rationale for investigation of biologic agents targeting Epithelial Growth Factor Receptor (EGFR) family in ESCC. EGFR is frequently overexpressed in esophageal cancer and is known to be associated with poor prognosis. Several EGFR tyrosine kinase inhibitors (TKIs) have been studied in esophageal cancer subjects and have shown clinical effects. In a recent Phase II trial using dacomitinib, pan-human epidermal growth receptor TKI, Partial response was observed in 10 of the 49 esophageal cancer subjects, with a response rate of 20.8%. Based on notable rationale in exploring impact of EGFR inhibition, we suggest multicenter phase II study to determine antitumor activity and safety of a other potent pan-HER inhibitor, Poziotinib in Esophageal Squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Treatment with Poziotinib
Severance Hospital
Seoul, South Korea
Objective Response Rate
Objective Response Rate using RECIST 1.1
Time frame: every 8 weeks, assessed up to 100 weeks
Overall Survival
Time frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Progression Free Survival
Time frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Duration of Response
Time frame: From date of randomization until date of death from any cause, whichever came first, assessed up to 100 months
Safety assessed by incidence of treatment-emergent adverse events
To evaluate the safety of Poziotinib, pan HER inhibitor in recurrent/metastatic esophageal cancer
Time frame: up to 100 weeks
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