A phase II trial of gemcitabine, S-1 and LV combination (GSL) therapy in patients with advanced pancreatic cancer.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Deoxycytidine
/ administration & dosage
Drug Combinations
Female
Follow-Up Studies
Humans
Leucovorin
/ administration & dosage
Liver Neoplasms
/ drug therapy
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Oxonic Acid
/ administration & dosage
Pancreatic Neoplasms
/ drug therapy
Peritoneal Neoplasms
/ drug therapy
Prognosis
Survival Rate
Tegafur
/ administration & dosage
Gemcitabine
Chemotherapy
Gemcitabine
Leucovorin
Pancreatic cancer
S-1
Journal
Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330
Informations de publication
Date de publication:
04 2019
04 2019
Historique:
received:
05
10
2018
accepted:
25
10
2018
pubmed:
10
11
2018
medline:
6
2
2020
entrez:
10
11
2018
Statut:
ppublish
Résumé
Purpose Our previous phase I trial suggested feasibility of addition of leucovorin (LV) to S-1 and gemcitabine therapy in advanced pancreatic cancer. The aim of this phase II trial was to assess the efficacy and toxicity of gemcitabine, S-1 and LV (GSL) combination therapy for advanced pancreatic cancer. Methods Chemotherapy-naïve patients with histologically or cytologically proven advanced pancreatic cancer were enrolled. Gemcitabine was administered at a dose of 1000 mg/m2 by 30 min infusion on days 1, S-1 40 mg/m2 orally twice daily and LV 25 mg orally twice daily on days 1 to 7 every 2 weeks. Primary end point was progression free survival (PFS). Results A total of 49 patients with advanced pancreatic cancer (19 locally advanced and 30 metastatic) were enrolled. Overall response rate and disease control rate were 32.7% and 87.8%. The median PFS and overall survival (OS) were 10.8 (95% confidence interval [CI], 7.4-13.5) and 20.7 (95% CI 13.0-NA) months with 1-year survival rate of 73.4%. Major Grade 3-4 toxicities were neutropenia (22.4%) and stomatitis (14.3%). No toxicity related death was observed. Conclusions In this single center, phase II trial, gemcitabine, S-1 and LV combination therapy was tolerable and can potentially be a treatment option for advanced pancreatic cancer.
Identifiants
pubmed: 30411217
doi: 10.1007/s10637-018-0691-9
pii: 10.1007/s10637-018-0691-9
doi:
Substances chimiques
Drug Combinations
0
Deoxycytidine
0W860991D6
S 1 (combination)
150863-82-4
Tegafur
1548R74NSZ
Oxonic Acid
5VT6420TIG
Leucovorin
Q573I9DVLP
Gemcitabine
0
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
338-344Références
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