Aziz Zaanan1, Emmanuelle Samalin2, Thomas Aparicio3, Olivier Bouche4, Pierre Laurent-Puig5, Sylvain Manfredi6, Pierre Michel7, Carole Monterymard8, Marie Moreau8, Philippe Rougier9, David Tougeron10, Julien Taieb11, Christophe Louvet12. 1. Department of Gastroenterology and Digestive Oncology, European Georges Pompidou Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France; Paris Descartes University, Sorbonne Paris Cité, France; INSERM UMR-S1147, Centre Universitaire des Saints-Pères, Paris, France. Electronic address: aziz.zaanan@aphp.fr. 2. Digestive Oncology Department, Institut du Cancer de Montpellier, Montpellier, France. 3. Departement of Gastroenterology and Digestive Oncology, Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France. 4. Department of Gastroenterology and Digestive Oncology, Reims University Hospital, Reims, France. 5. INSERM UMR-S1147, Centre Universitaire des Saints-Pères, Paris, France; Department of Biology, European Georges Pompidou Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France. 6. Department of Gastroenterology and Digestive Oncology, University of Bourgogne Franche-Comté, Dijon, France. 7. Department of Digestive Oncology, Rouen University Hospital, Rouen, France. 8. Fédération Francophone de Cancérologie Digestive (FFCD), Dijon, France. 9. Department of Hepato-Gastroenterology and Digestive Oncology, University Hospital Hotel Dieu, Nantes, France. 10. Department of Gastroenterology, Poitiers University Hospital, Poitiers, France. 11. Department of Gastroenterology and Digestive Oncology, European Georges Pompidou Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France; Paris Descartes University, Sorbonne Paris Cité, France. 12. Department of Medical Oncology, Mutualiste Montsouris Institute, Paris, France.
Abstract
INTRODUCTION: In advanced gastric cancer, doublet regimen including platinum salts and fluoropyrimidine is considered as a standard first-line treatment. The addition of docetaxel (75 mg/m2 q3w) to cisplatin (75 mg/m2 q3w) and 5-fluorouracil has been shown to improve efficacy. However, this regimen (DCF) was associated with frequent severe toxicities (including more complicated neutropenia), limiting its use in clinical practice. Interesting alternative docetaxel-based regimens have been developed that need to be validated. AIM: GASTFOX study is a randomized phase III trial comparing FOLFOX alone or with docetaxel at 50 mg/m2 (TFOX regimen) in first-line treatment for advanced gastric cancer. In both arms, cycle is repeated every 2 weeks until disease progression or unacceptable toxicity. MATERIALS AND METHODS:Main eligibility criteria: histologically proven locally advanced or metastatic gastric or esogastric junction adenocarcinoma, HER negative status, measurable disease, ECOG performance status 0 or 1, and adequate renal, hepatic and bone marrow functions. RESULTS: The primary endpoint is radiological/clinical progression-free survival (PFS). A difference of 2 months for the median PFS in favor of TFOX is expected (HR = 0.73) Based on a two-sided α risk of 5% and a power of 90%, 454 events are required to show this difference. Secondary endpoints included overall survival, overall response rate, safety, quality of life and the therapeutic index. CONCLUSION: This study is planned to include 506 patients to demonstrate the superiority of TFOX over FOLFOX in first-line advanced gastric cancer treatment (NCT03006432).
RCT Entities:
INTRODUCTION: In advanced gastric cancer, doublet regimen including platinum salts and fluoropyrimidine is considered as a standard first-line treatment. The addition of docetaxel (75 mg/m2 q3w) to cisplatin (75 mg/m2 q3w) and 5-fluorouracil has been shown to improve efficacy. However, this regimen (DCF) was associated with frequent severe toxicities (including more complicated neutropenia), limiting its use in clinical practice. Interesting alternative docetaxel-based regimens have been developed that need to be validated. AIM: GASTFOX study is a randomized phase III trial comparing FOLFOX alone or with docetaxel at 50 mg/m2 (TFOX regimen) in first-line treatment for advanced gastric cancer. In both arms, cycle is repeated every 2 weeks until disease progression or unacceptable toxicity. MATERIALS AND METHODS: Main eligibility criteria: histologically proven locally advanced or metastatic gastric or esogastric junction adenocarcinoma, HER negative status, measurable disease, ECOG performance status 0 or 1, and adequate renal, hepatic and bone marrow functions. RESULTS: The primary endpoint is radiological/clinical progression-free survival (PFS). A difference of 2 months for the median PFS in favor of TFOX is expected (HR = 0.73) Based on a two-sided α risk of 5% and a power of 90%, 454 events are required to show this difference. Secondary endpoints included overall survival, overall response rate, safety, quality of life and the therapeutic index. CONCLUSION: This study is planned to include 506 patients to demonstrate the superiority of TFOX over FOLFOX in first-line advanced gastric cancer treatment (NCT03006432).
Authors: Camille Evrard; Thomas Aparicio; Emilie Soularue; Karine Le Malicot; Jérôme Desramé; Damien Botsen; Farid El Hajbi; Daniel Gonzalez; Come Lepage; Olivier Bouché; David Tougeron Journal: Biomedicines Date: 2022-05-23
Authors: Daniel Walden; Mohamad Bassam Sonbol; Skye Buckner Petty; Harry H Yoon; Mitesh Borad; Tanios S Bekaii-Saab; Daniel H Ahn Journal: Front Oncol Date: 2021-09-10 Impact factor: 6.244