Phase II trial of nafamostat mesilate/gemcitabin/S-1 for unresectable pancreatic cancer

Author:

Uwagawa TadashiORCID,Sakamoto Taro,Gocho Takeshi,Shiba Hiroaki,Onda Shinji,Yasuda Jungo,Shirai Yoshihiro,Hamura Ryoga,Furukawa Kenei,Yanaga KatsuhikoORCID,Ikegami Toru

Abstract

Purpose To assess the efficacy of combination chemotherapy with nafamostat mesilate, gemcitabine and S-1 for unresectable pancreatic cancer patients. 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 NAM/GEM/S-1 therapy is safe and could be promising option for unresectable pancreatic cancer, especially for stage IV cancer.

Funder

Japan Society for the Promotion of Science

Publisher

Public Library of Science (PLoS)

Subject

Multidisciplinary

Reference20 articles.

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