Abstract | PURPOSE: MATERIALS AND METHODS: The study was conducted as a single-arm, single center, institutional review board-approved phase II trial. Patients received nafamosntat mesilate (4.8 mg/kg continuous transregional arterial infusion) with gemcitabine (1000 mg/m2 transvenous) on days 1 and15, and with oral S-1 [(80 mg/day (BSA<1.25 m2), 100 mg/day (1.25 ≤ BSA<1.5 m2), or 120 mg/day (BSA ≥1.5 m2)] on days 1-14 or, days 1-7 and 15-21. This regimen was repeated at 28-day intervals. RESULTS: Forty-seven evaluable patients (Male/Female: 31/16, Age (median): 66 (range 35-78) yrs, Stage III/IV 10/37.) were candidates in this study. Two patients in stage III (20%) could undergo conversion surgery. Twenty-four patients (51%) underwent subsequent treatment (1st line/ 2nd line / 4th line, 13/ 10/ 1, FOLFIRINOX: 12, GEM/nab-PTX: 18, TAS-118: 3, chemoradiation with S-1: 2, GEM/ Erlotinib: 1, nal-IRI: 1, surgery: 2). Median PFS and OS were 9.7 (95% CI, 8.9-14.7 mo) and 14.2 months (99% CI, 13.3-23.9 mo), respectively. Median PFS in stage IV patients was 9.2 months (95% CI, 8.4-12.0 mo). Median OS in patients without subsequent treatment was 10.8 months (95% CI, 9.1-13.8 mo). Median OS in patients with subsequent treatment was 19.3 months (95% CI, 18.9-31.9 mo). Grade 4 treatment-related hematological toxicities were encountered in 7 patients. Two patients developed grade 3 allergic reaction after 6 cycles or later. No febrile neutropenia has been observed. CONCLUSION:
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Authors | Tadashi Uwagawa, Taro Sakamoto, Takeshi Gocho, Hiroaki Shiba, Shinji Onda, Jungo Yasuda, Yoshihiro Shirai, Ryoga Hamura, Kenei Furukawa, Katsuhiko Yanaga, Toru Ikegami |
Journal | PloS one
(PLoS One)
Vol. 17
Issue 5
Pg. e0267623
( 2022)
ISSN: 1932-6203 [Electronic] United States |
PMID | 35544539
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzamidines
- Guanidines
- Deoxycytidine
- nafamostat
- Gemcitabine
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Topics |
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Benzamidines
- Deoxycytidine
(analogs & derivatives)
- Female
- Guanidines
- Humans
- Male
- Pancreatic Neoplasms
(surgery)
- Treatment Outcome
- Gemcitabine
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