Efficacy and Tolerability of Topical Polyphenon E in Multiple “Seborrheic Keratosis-Like” Lesions of the Groin in an Immunocompetent 26-Year-Old Man

Polyphenon E 10%, a green tea extract containing epigallocatechin gallate (EGCG) as the main active compound, is a topical formulation indicated for the treatment of genital warts. Polyphenon E has also shown to be very effective in the treatment of periungual and plane warts. Here, we report a dramatic clinical effect of topical treatment with polyphenon E in a subject with multiple “seborrheic keratosis-like” lesions of the genital area. An immunocompetent 26-year-old Caucasian man came to our attention in October 2018. The subject, a regular blood donor, presented several (more than 100) light brown dome-shaped papular lesions in the groin area and in the penile shaft. A clinical diagnosis of Bowenoid papulosis-like multiple condylomata of the groin was made. A 2-month imiquimod treatment did not induce any relevant improvement in terms of volume and number of lesions. A treatment with Polyphenon E, a topical green tea extract with 10% of EGCG (Veregen®), was therefore started. After 2 months of Polyphenon E treatment, a dramatic reduction of the majority of the lesions was observed. After 3 months of treatment, all the lesions disappeared with only hyperchromic residues. Histological and immunohistological findings supported seborrheic keratosis as the conclusive diagnosis. This case report suggests that topical green tea extract could be very effective in the treatment of “seborrheic keratosis-like” lesions of the inguinal area.

Phase 1b study of chemoprevention with green tea polyphenon E (PPE) and epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (Erlotinib) in patients (pts) with advanced premalignant (AP) lesions of the head and neck.

6049 Background: Based on the strong synergistic effects between green tea polyphenon E (PPE) and EGFR-TKI in our preclinical studies (Int J Cancer, 2008; Cancer Prev Res, 2009; JCO, 2009), we conducted a phase 1b study with PPE and erlotinib combination for APL (mild-, moderate-, severe-dysplasia or carcinoma in situ [CIS]) of the oral cavity and larynx from 2/2011 to 11/2017 at Emory Winship Cancer Institute. Methods: All pts were enrolled after signing the IRB approved Informed Consent Form. Tissue biopsy before and at 6-months (6-M) treatment was mandatory, and cytobrushed samples of the APL and normal buccal mucosa at 3-, 6-, and 12-M were obtained for biomarker studies. Treatment included fixed dose of PPE (200 mg, P.O.,TID) and dose escalation of erlotinib P.O., (50mg [level 1], 75mg [level 2] and 100mg [level 3]) for 6-M. The primary endpoint was safety and toxicity, and secondary endpoints were evaluation of pathologic responses, cancer free survival (CFS) and biomarker modulation. Results: Out of 27 enrolled pts, 6 control subjects for biomarker studies, 2 ineligible, and 19 were treated with PPE and erlotinib for 6-M. Clinical characteristics of treated patients included median age, 63 yrs. (range,33-78); 9 M/10 F; 10 former or current smokers/9 never smokers; 15 severe dysplasia or CIS, 2 moderate dysplasia, 2 mild dysplasia; 13 had surgical resection; 17 oral cavity primary; and 2 at larynx. 3 pts were treated at dose level 1, 4 at level 2, and 12 at level 3. Toxicity (G0 or G1 excluded) were: skin rash (1 G3, 1 G2), pruritus/dry skin (1 G2), fatigue (1 G2), diarrhea (1 G2), epistaxis (1 G2), and hypertension (2 G3, 1 G2). Skin rash (associated with erlotinib) may be DLT and MTD has not been reached. The recommend doses for phase 2 or 3 studies will be PPE 200mg TID plus erlotinib 100mg QD. 17 pts were assessed for pathologic responses at 6-M: pCR 7/17 (41%), pPR 2/17 (12%), pSD 5/17 (29%) and pPD (3/17 (18%). The median follow up was 32 months. Median CFS has not been reached. 16 pts are alive at the time of data analyses and 1 pt died (by noncancerous reason). Biomarker studies are ongoing for tissues and/or cytobrushed samples. Conclusions: The treatment of the combination of green tea PPE plus erlotinib for 6-M was well tolerated in pts with APL of the head and neck, and showed significant pathologic response rates (pCR and pPR, 53%). This combination therefore deserves further investigation for efficacy testing. Clinical trial information: NCT01116336.

Efficacy and Tolerability of Topical Green Tea Extract (Polyphenon E) Application in a “Therapy-Resistant” Plantar Wart

Plantar warts account for 30% of all cutaneous warts. These lesions could be very painful, especially if the lesion is located over pressure sites such as the metatarsal head. Plantar wart treatment remains a challenging therapeutic problem. A 67-year-old immunocompetent nonsmoking man presented with a large mosaic plantar wart on his right foot. The lesion had been present for 5 years. Several cryotherapy sessions (a total of 6 procedures) had been performed with no success. The lesion was therefore treated with a 5-fluorouracil (5-FU) regimen and then with a topical combination of 5-FU and salicylic acid, but also these approaches failed. At the initial visit, a large (16 cm2) mosaic wart lesion was present. Treatment with topical Polyphenon E, 10%, twice daily was prescribed and started. After 3 months of treatment, the lesion completely disappeared. Interestingly, no curettage or mechanical pickling of the hyperkeratotic parts of the lesion were performed before the start of the treatment. Local tolerability was evaluated as very good by the patient.