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Obstetrical & Gynecological Survey:
doi: 10.1097/01.ogx.0000446909.04052.1e
Gynecology: Gynecologic Oncology

A 2-Stage, Single-Arm, Phase 2 Study of Epigallocatechin Gallate–Enriched Green Tea Drink as a Maintenance Therapy in Women With Advanced-Stage Ovarian Cancer

Trudel, Dominique; Labbé, David P.; Araya-Farias, Monica; Doyen, Alain; Bazinet, Laurent; Duchesne, Thierry; Plante, Marie; Grégoire, Jean; Renaud, Marie-Claude; Bachvarov, Dimcho; Têtu, Bernard; Bairati, Isabelle

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Abstract

ABSTRACT: First-line treatment of epithelial ovarian cancer includes debulking surgery and platinum/taxane combination chemotherapy. The initial rate of response is high, but most patients eventually die of a recurring disease. It has been suggested that green tea may be useful to maintain response to first-line therapy after primary treatment. The anticancer actions of green tea for ovarian cancer and other types of cancer have been attributed to the catechins, epigallocatechin gallate (EGCG) and epicatechin gallate. Double-brewed green tea (DBGT) is an EGCG-enriched tea that has significant antitumor activity.

This trial was a 2-stage, single-arm, phase 2 study that assessed the efficacy and safety of DBGT as a maintenance treatment in women with advanced-stage ovarian cancer who were in complete clinical remission after cytoreductive surgery and first-line chemotherapy. The trial was conducted at a single center, the Centre Hospitalier Universitaire de Québec. All patients received 500 mL of DBGT to drink daily until recurrence or during a follow-up of 18 months. The primary study endpoint was the absence of recurrence at 18 months. The study used an intention-to-treat design.

From 2007 to 2011, a total of 306 women were identified with International Federation of Gynecology and Obstetrics stage III to IV serous or endometrioid ovarian cancer who had undergone complete response after debulking surgery followed by 6 to 8 cycles of platinum/taxane chemotherapy. Of these women, 257 were not eligible and 23 were not evaluated for eligibility. Among the remaining 26 eligible women, 10 declined to participate and 16 enrolled in the first stage. According to the treatment plan, if 7 or fewer women were free of recurrence at 18 months of follow-up, the trial was stopped. Otherwise, enrollment would continue to a total of 46 patients.

The trial was terminated after the first stage at 18 months of follow-up because only 5 of the 16 women were free of recurrence. The median adherence of the women to DBGT was 98.1% (interquartile range, 89.7%–100%). However, 6 women (37.5%) discontinued participation before the end of the follow-up. There was no severe toxicity. All adverse events were of grade 1.

These data suggest that DBGT supplementation is not a promising maintenance therapy for women with advanced-stage ovarian cancer after first-line treatment.

© 2014 by Lippincott Williams & Wilkins.

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