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Based on preclinical studies of the synergies between green tea polyphenol E (PPE) and EGFR-tyrosine kinase inhibitors, Shin et al. conducted a Phase IB trial to study the safety of PPE combined elotinib (EGFR inhibitors) for advanced precancerogative lesions (APL) in the mouth and throat.
a fixed dose of PPE (200 mg/time, 3 times/day) and an incremental dose of erotinie (50, 75 or 100 mg/day).
and performed an tissue biopsy at baseline and 6 months of treatment.
end points are safety and toxicity, and secondary endpoints are pathological response, cancer-free survival (CFS), overall survival (OS), and biomarkers.
recruited 21 patients, 19 of whom received research treatment and 17 completed six months of PPA-erotinie treatment.
the main characteristics of patients treated: 15 cases of severe heterogenous or in-place cancer and 17 cases of oral cancer.
only rashes are associated with dose-limiting toxicity and MTD.
recommended phase II study dose is PPE 600 mg/day plus elotinie 100 mg/day for 6 months.
17 patients were assessed for pathological response: pathological complete remission (47%) and pathological partial response (18%).
five years, CFS and OS were 66.3% and 93%, respectively.
among the biomarkers tested, only erK phosphate was associated with a therapeutic response.
above, in APL patients with head and neck, the use of PPA and erlotinib combined therapy was well-to-do and showed high pathological remission rates and high CFS.
this option deserves further study for the prevention and/or prevention of secondary primary tumors for early head and neck cancer.
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