Abstract | PURPOSE: MATERIALS AND METHODS: A single-arm, single center, institutional review board-approved phase II trial was conducted. Thirty-five of 38 consecutive patients were included in the study. Patients received nafamostat mesilate (4.8 mg/kg continuous regional arterial infusion) with gemcitabine (1000 mg/m intravenously) on days 1, 8, and 15. This treatment was repeated at 28-day intervals. The primary endpoints were to evaluate overall survival and 1-year survival rate. The secondary endpoints were to assess therapeutic response and clinical benefit response. Overall survival times were estimated by the Kaplan-Meier survival analysis. RESULTS: The median survival time was 10.0 months, and the 1-year survival rate was 40.0%. The response rate and disease control rate were 17.1% and 88.6%, respectively. A fraction of 25% of the patients who required opioids for cancer-related pain could reduce their opioid intake, and 37.1% of the patients showed healthy weight gain. Among the patients with metastatic pancreatic cancer, the median survival time was 9.0 months, and the 1-year survival rate was 32.0%. The proposed regimen offers an economic advantage compared with recent therapy regimens that have shown significant improvements in median survival over standard chemotherapy with gemcitabine. CONCLUSIONS: An alternative regimen for unresectable pancreatic cancer, especially for metastatic pancreatic cancer, is proposed based on acceptable survival time, clinical benefit, and cost advantage.
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Authors | Tadashi Uwagawa, Takeyuki Misawa, Nobuhiro Tsutsui, Ryusuke Ito, Takeshi Gocho, Shoichi Hirohara, Shunichi Sadaoka, Katsuhiko Yanaga |
Journal | American journal of clinical oncology
(Am J Clin Oncol)
Vol. 36
Issue 1
Pg. 44-8
(Feb 2013)
ISSN: 1537-453X [Electronic] United States |
PMID | 22157216
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Chemical References |
- Benzamidines
- Guanidines
- Deoxycytidine
- nafamostat
- Gemcitabine
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage)
- Benzamidines
- Deoxycytidine
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Female
- Guanidines
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Infusions, Intra-Arterial
- Kaplan-Meier Estimate
- Male
- Middle Aged
- Pancreatic Neoplasms
(drug therapy, mortality, pathology)
- Treatment Outcome
- Gemcitabine
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