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Phase II Study of Bolus 5-Fluorouracil and Leucovorin Combined with Weekly Paclitaxel as First-Line Therapy for Advanced Gastric Cancer.
- Source :
- Oncology; Dec2011, Vol. 81 Issue 5/6, p291-297, 7p, 3 Charts, 1 Graph
- Publication Year :
- 2011
-
Abstract
- Objective: We evaluated the efficacy and safety of bolus 5-fluorouracil (5-FU) and leucovorin combined with weekly paclitaxel (FLTAX) in advanced gastric cancer (GC) patients. Methods: Patients with untreated stage IV GC received paclitaxel 80 mg/m<superscript>2</superscript> as a 1-hour infusion, followed by 5-FU 600 mg/m<superscript>2</superscript> as a bolus infusion and L-leucovorin 250 mg/m<superscript>2</superscript> as a 2-hour infusion on days 1, 8 and 15. Treatment cycles were repeated every 28 days. The primary endpoint was response rate. Results: Thirty-five patients were enrolled. The median age was 62 years (range 34-75). Twenty-one patients (60%) had diffuse-type cancer and 11 had peritoneal metastasis. The confirmed response rate was 43% (95% CI 26-61) with 15 partial responses. Stable disease was observed in 16 (46%) patients. Median progression-free survival and overall survival were 6.8 months (95% CI 5.8-7.4) and 16.2 months (95% CI 10.0-22.8), respectively. Grade 3-4 adverse events were: neutropenia (54%), febrile neutropenia (3%), diarrhea (6%) and sensory neuropathy (11%). Conclusion: FLTAX showed a desirable safety profile, and the efficacy against advanced GC was encouraging. FLTAX may be a good option for GC patients with deteriorated general condition, and a randomized clinical trial in such patients is currently underway. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00302414
- Volume :
- 81
- Issue :
- 5/6
- Database :
- Complementary Index
- Journal :
- Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 71819528
- Full Text :
- https://doi.org/10.1159/000334462