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 |
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| Authors: | Dominique Trudel,David P. Labbé ,Monica Araya-Farias,Alain Doyen,Laurent Bazinet,Thierry Duchesne,Marie Plante,Jean Gré goire,Marie-Claude Renaud,Dimcho Bachvarov,Bernard Tê tu,Isabelle Bairati |
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| Affiliation: | 1. Laval University Cancer Research Center, Hôtel-Dieu-de-Québec, Centre Hospitalier Universitaire (CHU) de Québec, 11 Côte du Palais, Québec, Québec G1R 2J6, Canada;2. Department of Pathology/Applied Molecular Oncology, Toronto General Hospital, University Health Network, 200 Elizabeth Street, Toronto, Ontario M5G 2C4, Canada;3. Goodman Cancer Research Centre, McGill University, 1160 Pine Avenue West, Montréal, Québec H3A 1A3, Canada;4. Department of Medicine, Division of Experimental Medicine, McGill University, 1110 Pine Avenue West, Montréal, Québec H3A 1A3, Canada;5. Institute of Nutraceutical and Functional Food (INAF), Université Laval, Department of Food Science and Nutrition, Québec, Québec G1V 0A6, Canada;6. Mathematics and Statistics Department, Université Laval, Québec, Québec G1K 7P4, Canada;g Gyneco-Oncology Department, Hôtel-Dieu-de-Québec, Centre Hospitalier Universitaire (CHU) de Québec, 11 Côte du Palais, Québec, Québec G1R 2J6, Canada;h Anatomic Pathology and Cytology Department, Hôpital du St-Sacrement, Centre Hospitalier Universitaire (CHU) de Québec, 1050 Chemin Ste-Foy, Québec, Québec G1S 4L8, Canada |
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| Abstract: | ObjectivesA 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).MethodsEligible 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.ResultsDuring 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.ConclusionsDBGT supplementation does not appear to be a promising maintenance intervention in women with advanced stage ovarian cancer after standard treatment. |
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| Keywords: | Phase II study EGCG Green tea Maintenance therapy Advanced stage ovarian cancer |
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