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A Phase I Study of Combination Chemotherapy with Gemcitabine and Oral S-1 for Advanced Pancreatic Cancer.
- Source :
- Oncology; 2005, Vol. 69 Issue 5, p421-427, 7p
- Publication Year :
- 2005
-
Abstract
- Objective: The aim of this study was to determine the maximum-tolerated dose and dose-limiting toxicity (DLT) of combination therapy with gemcitabine and S-1 in patients with advanced pancreatic cancer. Methods: Chemotherapy-naive patients with histologically or cytologically proven unresectable or metastatic pancreatic cancer were enrolled. The patients received gemcitabine intravenously over 30 min on days 1 and 8 and S-1 orally twice daily from days 1 to 14. Cycles were repeated every 21 days until disease progression. Patients were scheduled to receive gemcitabine (mg/m<superscript>2</superscript>/week) and S-1 (mg/m<superscript>2</superscript>/day) at four dose levels: 800/60 (level 1), 1,000/60 (level 2), 1,000/70 (level 3) and 1,000/80 (level 4). Results: Eighteen patients were enrolled in this study. The maximum-tolerated dose was not reached even at the highest dose level (level 4) because only 2 of the 6 patients at this level experienced DLT. The DLTs were neutropenia and rash. Six (33%) of the 18 patients achieved a partial response and median overall survival time was 7.6 months. Conclusions: Combination chemotherapy with gemcitabine and S-1 was well tolerated and showed good antitumor activity in the treatment of pancreatic cancer. We recommend a gemcitabine dose of 1,000 mg/m<superscript>2</superscript>/week and an S-1 dose of 80 mg/m<superscript>2</superscript>/day in further studies with this schedule. Copyright © 2005 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]
- Subjects :
- DRUG dosage
TOXICOLOGY
PANCREATIC cancer
DRUG therapy
METASTASIS
Subjects
Details
- Language :
- English
- ISSN :
- 00302414
- Volume :
- 69
- Issue :
- 5
- Database :
- Complementary Index
- Journal :
- Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 19103165
- Full Text :
- https://doi.org/10.1159/000089997