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A phase I trial of gemcitabine, S-1 and LV combination (GSL) therapy in advanced pancreatic cancer.
- Source :
-
Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2014 Nov; Vol. 74 (5), pp. 911-5. Date of Electronic Publication: 2014 Aug 21. - Publication Year :
- 2014
-
Abstract
- Purpose: In our previous randomized controlled trial, the addition of S-1 to gemcitabine for advanced pancreatic cancer did not prolong overall survival (OS) significantly, despite its higher response rate and longer progression-free survival (PFS). Leucovorin is known to enhance efficacy of S-1, and we conducted this phase I trial of combination therapy of gemcitabine, S-1 and leucovorin (GSL).<br />Methods: Patients with advanced pancreatic cancer who had received no prior chemotherapy were eligible for this study. Gemcitabine was administered at an escalating dose of 600, 800 and 1,000 mg/m(2) over 30 min on day 1, and oral S-1 at a dose of 40 mg/m(2) twice daily and oral leucovorin at a dose of 25 mg twice daily on days 1-7, every 2 weeks. A standard "3 + 3" phase I dose escalation design was utilized.<br />Results: Fifteen patients were enrolled across three dose levels. Three patients developed DLTs: two patients in level 1 (grade 3 anorexia in 1 and grade 3 anorexia, stomatitis and diarrhea in 1) and one patient in level 2 (grade 3 deep vein thrombosis). No DLT was observed in level 3. Response rate and the disease control rate were 33 and 93 %, respectively. The median PFS and OS were 5.4 and 16.6 months. Ten of 12 patients (83 %) with elevated CA19-9 at baseline had a ≥ 50 % decline.<br />Conclusions: RD of gemcitabine in GSL was determined as 1,000 mg/m(2). GSL was well tolerable and showed promising results in advanced pancreatic cancer.
- Subjects :
- Aged
Anorexia chemically induced
Antineoplastic Combined Chemotherapy Protocols adverse effects
Deoxycytidine administration & dosage
Deoxycytidine adverse effects
Deoxycytidine analogs & derivatives
Diarrhea chemically induced
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Combinations
Female
Humans
Leucovorin administration & dosage
Leucovorin adverse effects
Male
Middle Aged
Oxonic Acid administration & dosage
Oxonic Acid adverse effects
Pancreatic Neoplasms pathology
Stomatitis chemically induced
Survival Analysis
Tegafur administration & dosage
Tegafur adverse effects
Treatment Outcome
Venous Thrombosis chemically induced
Gemcitabine
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Pancreatic Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1432-0843
- Volume :
- 74
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Cancer chemotherapy and pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 25143299
- Full Text :
- https://doi.org/10.1007/s00280-014-2563-0