title: Phase I study of topical epigallocatechin-3-gallate (EGCG) in patients with breast cancer receiving adjuvant radiotherapy.
abstract: OBJECTIVE
  The purpose of this study was to investigate the safety, tolerability and preliminary effectiveness of topical epigallocatechin-3-gallate (EGCG) for radiation dermatitis in patients with breast cancer receiving adjuvant radiotherapy.
  
  
  METHODS
  Patients with breast cancer who received radiotherapy to the chest wall after mastectomy were enrolled. EGCG solution was sprayed to the radiation field from the initiation of Grade 1 radiation dermatitis until 2 weeks after completion of radiotherapy. EGCG concentration escalated from 40 to 660 μmol l(-1) in 7 levels with 3-6 patients in each level. EGCG toxicity was graded using the NCI (National Cancer Institute Common Terminology Criteria for Adverse Events) v. 3.0. Any adverse event >Grade 1 attributed to EGCG was considered dose-limiting toxicity. The maximum tolerated dose was defined as the dose level that induced dose-limiting toxicity in more than one-third of patients at a given cohort. Radiation dermatitis was recorded weekly by the Radiation Therapy Oncology Group scoring and patient-reported symptoms.
  
  
  RESULTS
  From March 2012 to August 2013, 24 patients were enrolled. Acute skin redness was observed in 1 patient and considered to be associated with the EGCG treatment at 140 μmol l(-1) level. Three more patients were enrolled at this level and did not experience toxicity to EGCG. The dose escalation stopped at 660 μmol l(-1). No other reported acute toxicity was associated with EGCG. Grade 2 radiation dermatitis was observed in eight patients during or after radiotherapy, but all decreased to Grade 1 after EGCG treatments. Patient-reported symptom scores were significantly decreased at 2 weeks after the end of radiotherapy in pain, burning, itching and tenderness, p < 0.05.
  
  
  CONCLUSIONS
  The topical administration of EGCG was well tolerated and the maximum tolerated dose was not found. EGCG may be effective in treating radiation dermatitis with preliminary investigation.
  
  
  CONCLUSIONS
  EGCG solution seemed to be feasible for treating radiation dermatitis in patients with breast cancer after mastectomy. It should be tested as a way to reduce radiation-induced normal tissue toxicity and complications in future years.
authors.affiliation: 1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
authors.forename: Hanxi
authors.initials: H
authors.lastname: Zhao
authors.affiliation: 1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
authors.forename: Wanqi
authors.initials: W
authors.lastname: Zhu
authors.affiliation: 2 Department of Radiation Oncology, Jinan Fourth People's Hospital, Jinan, Shandong.
authors.forename: Li
authors.initials: L
authors.lastname: Jia
authors.affiliation: 3 Department of Radiology, Shandong Cancer Hospital and Institute, Jinan, Shandong.|4 Shandong Key Laboratory of Radiation Oncology, Jinan, Shandong, China.
authors.forename: Xiaorong
authors.initials: X
authors.lastname: Sun
authors.affiliation: 4 Shandong Key Laboratory of Radiation Oncology, Jinan, Shandong, China.
authors.forename: Guanxuan
authors.initials: G
authors.lastname: Chen
authors.affiliation: 1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
authors.forename: Xianguang
authors.initials: X
authors.lastname: Zhao
authors.affiliation: 1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
authors.forename: Xiaolin
authors.initials: X
authors.lastname: Li
authors.affiliation: 1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
authors.forename: Xiangjiao
authors.initials: X
authors.lastname: Meng
authors.affiliation: 1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.
authors.forename: Lingling
authors.initials: L
authors.lastname: Kong
authors.affiliation: 1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.|4 Shandong Key Laboratory of Radiation Oncology, Jinan, Shandong, China.
authors.forename: Ligang
authors.initials: L
authors.lastname: Xing
authors.affiliation: 1 Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, Shandong.|4 Shandong Key Laboratory of Radiation Oncology, Jinan, Shandong, China.
authors.forename: Jinming
authors.initials: J
authors.lastname: Yu
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000975:Antioxidants / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000532:radiotherapy* / Q000601:surgery; D002392:Catechin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D011855:Radiodermatitis / Q000188:drug therapy*; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D000975:Antioxidants; D002392:Catechin; C045651:epigallocatechin gallate