erlotinib + Polyphenon E

The combination of erlotinib and Polyphenon E (PPE) is a drug therapy that has been studied in clinical trials, particularly for head and neck cancer premalignant lesions. Erlotinib is an EGFR tyrosine kinase inhibitor, while Polyphenon E is a green tea extract containing polyphenols that may have anti-cancer properties. A phase Ib study was conducted to evaluate this combination in patients with advanced premalignant lesions (APLs) of the oral cavity and larynx. The study used a fixed dose of PPE (200 mg three times a day) with dose escalation of erlotinib (50, 75, 100 mg daily) for 6 months. The treatment was well-tolerated, with skin rash being the main dose-limiting toxicity. The recommended doses for phase II studies were determined to be PPE 600 mg daily plus erlotinib 100 mg daily for 6 months. The combination showed promising results with a high rate of pathologic response - 47% pathologic complete response and 18% pathologic partial response among 17 evaluable patients. The 5-year cancer-free survival and overall survival rates were 66.3% and 93%, respectively. This combination therapy was developed based on preclinical studies showing synergistic effects between green tea polyphenon E and EGFR-tyrosine kinase inhibitors. The research was conducted as part of the NCI-funded Head and Neck Cancer SPORE (Specialized Program of Research Excellence) Program. The combination has been investigated for chemoprevention and/or prevention of second primary tumors in early-stage head and neck cancer. It has also been studied in advanced non-small cell lung cancer.

Brand names

Tarceva

Other names

erlotinib and green tea polyphenon EPPE + erlotinibPolyphenon E + erlotinib