1. Fortnightly or fractionated weekly docetaxel-cisplatin-5-FU as first-line treatment in advanced gastric and gastroesophageal junction adenocarcinoma: The randomized phase II DoGE study.
- Author
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Deleporte A, Van den Eynde M, Forget F, Holbrechts S, Delaunoit T, Houbiers G, Kalantari HR, Laurent S, Vanderstraeten E, De Man M, Vergauwe P, Clausse M, Van Der Auwera J, D'Hondt L, Pierre P, Ghillemijn B, Covas A, Paesmans M, Ameye L, Awada A, Sclafani F, and Hendlisz A
- Subjects
- Adenocarcinoma mortality, Adenocarcinoma pathology, Adult, Aged, Aged, 80 and over, Anorexia chemically induced, Anorexia epidemiology, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Cisplatin administration & dosage, Cisplatin adverse effects, Diarrhea chemically induced, Diarrhea epidemiology, Docetaxel administration & dosage, Docetaxel adverse effects, Drug Administration Schedule, Fatigue chemically induced, Fatigue epidemiology, Febrile Neutropenia epidemiology, Female, Fluorouracil administration & dosage, Fluorouracil adverse effects, Granulocyte Colony-Stimulating Factor, Humans, Male, Middle Aged, Neutropenia chemically induced, Neutropenia epidemiology, Progression-Free Survival, Stomach Neoplasms mortality, Stomach Neoplasms pathology, Vomiting chemically induced, Vomiting epidemiology, Adenocarcinoma drug therapy, Antineoplastic Combined Chemotherapy Protocols adverse effects, Esophagogastric Junction, Stomach Neoplasms drug therapy
- Abstract
Background: While docetaxel/cisplatin/5-fluorouracil (DCF) outperforms CF in first-line gastric adenocarcinoma, toxicity remains an issue., Methods: This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m
2 , C 35 mg/m², F 1800 mg/m² over 24 h, on days 1 and 8 every 3 weeks, arm (1) or fortnightly DCF (D 50 mg/m2 , C 50 mg/m², F 2000 mg/m² over 48 h every 2 weeks, arm (2). Prophylactic granulocyte colony-stimulating factor (G-CSF) was not allowed. The primary endpoint was the rate of febrile neutropenia within the first six treatment weeks (early FN)., Results: A total of 106 eligible patients were recruited. The early and overall FN rates were 9.5% and 17% in arm 1, respectively, and 5.9% and 8% in arm 2, respectively. Grade ≥3 toxicities occurred in 81% of patients in arm 1 and 90% of patients in arm 2, the most common being neutropenia (33% vs. 61%), fatigue (27% vs. 25%), vomiting (21% vs. 12%), anorexia (19% vs. 18%), and diarrhea (17% vs. 10%). Median progression-free survival and overall survival were 5.1 (95% CI, 3.2-6.5) and 8.2 months (95% CI, 6.0-14.5), respectively, in arm 1 and 5.2 (95% CI, 3.0-6.9) and 11.9 months (95% CI, 7.4-15.9), respectively, in arm 2., Conclusions: Fractionated weekly and fortnightly DCF regimens are associated with a low risk of early FN, and a better hematological toxicity profile as compared to historical DCF without compromising efficacy. Both regimens offer greater convenience removing the need for systematic use of prophylactic G-CSF., (© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)- Published
- 2021
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