title: A two-stage, single-arm, phase II study of EGCG-enriched green tea drink as a maintenance therapy in women with advanced stage ovarian cancer.
abstract: OBJECTIVE
  A two-stage, single-arm, phase II study was conducted to assess the effectiveness and safety of an epigallocatechin gallate (EGCG)-enriched tea drink, the double-brewed green tea (DBGT), as a maintenance treatment in women with advanced stage serous or endometrioid ovarian cancer (clinicaltrials.gov, NCT00721890).
  
  
  METHODS
  Eligible women had FIGO stage III-IV serous or endometrioid ovarian cancer. They had to undergo complete response after debulking surgery followed by 6 to 8 cycles of platinum/taxane chemotherapy at the Centre Hospitalier Universitaire de Québec. They all had to drink the DBGT, 500 mL daily until recurrence or during a follow-up of 18 months. The primary endpoint was the absence of recurrence at 18 months. Statistical analyses were done according to the principle of intention to treat. Using a two-stage design, the first stage consisted of 16 enrolled patients. At the end of the follow-up, if 7 or fewer patients were free of recurrence, the trial stopped. Otherwise, accrual would continue to a total of 46 patients.
  
  
  RESULTS
  During the first stage of the study, only 5 of the 16 women remained free of recurrence 18 months after complete response. Accordingly, the clinical trial was terminated. Women's adherence to DBGT was high (median daily intake during intervention, 98.1%, interquartile range: 89.7-100%), but 6 women discontinued the intervention before the end of their follow-up. No severe toxicity was reported.
  
  
  CONCLUSIONS
  DBGT supplementation does not appear to be a promising maintenance intervention in women with advanced stage ovarian cancer after standard treatment.
authors.affiliation: Laval University Cancer Research Center, Hôtel-Dieu-de-Québec, Centre Hospitalier Universitaire (CHU) de Québec, 11 Côte du Palais, Québec, Québec G1R 2J6, Canada; Department of Pathology/Applied Molecular Oncology, Toronto General Hospital, University Health Network, 200 Elizabeth Street, Toronto, Ontario M5G 2C4, Canada.
authors.forename: Dominique
authors.initials: D
authors.lastname: Trudel
authors.forename: David P
authors.initials: DP
authors.lastname: Labbé
authors.forename: Monica
authors.initials: M
authors.lastname: Araya-Farias
authors.forename: Alain
authors.initials: A
authors.lastname: Doyen
authors.forename: Laurent
authors.initials: L
authors.lastname: Bazinet
authors.forename: Thierry
authors.initials: T
authors.lastname: Duchesne
authors.forename: Marie
authors.initials: M
authors.lastname: Plante
authors.forename: Jean
authors.initials: J
authors.lastname: Grégoire
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Renaud
authors.forename: Dimcho
authors.initials: D
authors.lastname: Bachvarov
authors.forename: Bernard
authors.initials: B
authors.lastname: Têtu
authors.forename: Isabelle
authors.initials: I
authors.lastname: Bairati
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D018269:Carcinoma, Endometrioid / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D002392:Catechin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003131:Combined Modality Therapy; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D043823:Taxoids / Q000008:administration & dosage; D013662:Tea
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D013662:Tea; D002392:Catechin; C045651:epigallocatechin gallate
keywords: Advanced stage ovarian cancer; EGCG; Green tea; Maintenance therapy; Phase II study