Common toxicities included fever, esophagitis, pneumonitis, anorexia, constipation, and gastroesophageal reflux. All patients developed transient and self-limiting lymphopenia, and there were no dose-limiting toxicities.
"Not only was our combinatorial therapy safe, but it induced the complete eradication of esophageal tumors in most patients," said Fujiwara. "These preliminary results indicate that there may be less invasive treatment options available for esophageal cancer patients who are unable to receive standard therapies for their disease."
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Histopathological examination of post-treatment biopsies taken from patients with PR revealed infiltration of CD8-positive T cells, suggesting that this combinatorial therapy may synergize with checkpoint inhibition, Fujiwara noted.
Limitations of this study include small sample size, which is consistent with a phase I dose-escalation trial.
This study was sponsored by the Ministry of Education, Science, and Culture in Japan and by the Japan Agency for Medical Research and Development. Fujiwara is a consultant for Oncolys BioPharma Inc.
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