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.
Adenocarcinoma
/ drug therapy
Adult
Aged
Aged, 80 and over
Anorexia
/ chemically induced
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Cisplatin
/ administration & dosage
Diarrhea
/ chemically induced
Docetaxel
/ administration & dosage
Drug Administration Schedule
Esophagogastric Junction
Fatigue
/ chemically induced
Febrile Neutropenia
/ epidemiology
Female
Fluorouracil
/ administration & dosage
Granulocyte Colony-Stimulating Factor
Humans
Male
Middle Aged
Neutropenia
/ chemically induced
Progression-Free Survival
Stomach Neoplasms
/ drug therapy
Vomiting
/ chemically induced
5-FU
cisplatin
docetaxel
fortnightly
gastric cancer
gastroesophageal cancer
hematological growth factors
weekly
Journal
Cancer medicine
ISSN: 2045-7634
Titre abrégé: Cancer Med
Pays: United States
ID NLM: 101595310
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
revised:
20
03
2021
received:
03
04
2020
accepted:
01
04
2021
pubmed:
1
6
2021
medline:
1
1
2022
entrez:
31
5
2021
Statut:
ppublish
Résumé
While docetaxel/cisplatin/5-fluorouracil (DCF) outperforms CF in first-line gastric adenocarcinoma, toxicity remains an issue. This multicenter phase II trial randomized chemonaïve metastatic gastric adenocarcinoma patients to fractionated weekly DCF (D 40 mg/m 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. 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.
Sections du résumé
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
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.
Identifiants
pubmed: 34057299
doi: 10.1002/cam4.3976
pmc: PMC8267119
doi:
Substances chimiques
Granulocyte Colony-Stimulating Factor
143011-72-7
Docetaxel
15H5577CQD
Cisplatin
Q20Q21Q62J
Fluorouracil
U3P01618RT
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
4366-4374Subventions
Organisme : Sanofi
Informations de copyright
© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
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