Journal
GYNECOLOGIC ONCOLOGY
Volume 131, Issue 2, Pages 357-361Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.ygyno.2013.08.019
Keywords
Phase II study; EGCG; Green tea; Maintenance therapy; Advanced stage ovarian cancer
Categories
Funding
- Cancer Research Society
- Fonds de la Recherche en Sante du Quebec (FRSQ)
- Terry Fox Foundation Strategic Health Research Training Program in Cancer Research at Canadian Institute of Health Research (CIHR)
- Ontario Institute of Cancer Research (OICR)
- CIHR
- CIHR/FRSQ of the McGill Integrated Cancer Research Training Program [FRN53888]
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Objectives. 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 Quebec. 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. (C) 2013 Elsevier Inc. All rights reserved.
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