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
Notice bibliographique
Résumé
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.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,002 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».