Phase II trial of nafamostat mesilate/gemcitabin/S-1 for unresectable pancreatic cancer.
Phase II trial of nafamostat mesilate/gemcitabin/S-1 for unresectable pancreatic cancer.
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DOI：
10.1371/journal.pone.0267623
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
Ikegami, Toru
中科院分区：
文献类型：
--
作者：
Uwagawa, Tadashi;Sakamoto, Taro;Gocho, Takeshi;Shiba, Hiroaki;Onda, Shinji;Yasuda, Jungo;Shirai, Yoshihiro;Hamura, Ryoga;Furukawa, Kenei;Yanaga, Katsuhiko;Ikegami, Toru
目的评价甲磺酸萘莫司他、吉西他滨和替吉奥联合化疗治疗不能手术切除的胰腺癌的疗效。本研究是一项单组、单中心、机构审查委员会批准的II期试验。患者接受甲磺酸萘法莫司他（4.8 mg/kg连续跨区域动脉输注）与吉西他滨（1000 mg/m2经静脉），第1天和第15天，口服S-1 [（80 mg/天（BSA <1.25 m2）、100 mg/天（1.25 ≤ BSA <1.5 m2）或120 mg/天（BSA ≥ 1.5 m2））。每隔28天重复该方案。47例可评价患者（男性/女性：31/16，年龄（中位数）：66（范围35 - 78）岁，III/IV期10/37。）是这项研究的候选人。2例III期患者（20%）可以接受转换手术。24例患者（51%）接受了后续治疗（一线/二线/四线，13/10/1，FOLFIRINOX：12，GEM/nab-PTX：18，TAS-118：3，S-1放化疗：2，GEM/厄洛替尼：1，nal-IRI：1，手术：2）。中位PFS和OS分别为9.7（95% CI，8.9 - 14.7个月）和14.2个月（99% CI，13.3 - 23.9个月）。IV期患者的中位PFS为9.2个月（95% CI，8.4 - 12.0个月）。未接受后续治疗的患者的中位OS为10.8个月（95% CI，9.1 - 13.8个月）。接受后续治疗患者的中位OS为19.3个月（95% CI，18.9 - 31.9个月）。7例患者发生了4级治疗相关血液学毒性。2例患者在6个周期或更晚后发生3级过敏反应。未观察到发热性中性粒细胞减少。NAM/GEM/S-1治疗是安全的，可能是不可切除的胰腺癌，特别是IV期癌症的有希望的选择。
To assess the efficacy of combination chemotherapy with nafamostat mesilate, gemcitabine and S-1 for unresectable pancreatic cancer patients. 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. 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. NAM/GEM/S-1 therapy is safe and could be promising option for unresectable pancreatic cancer, especially for stage IV cancer.
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影响因子：
50.5
作者：
Uwagawa, T.;Misawa, T.;Yanaga, K.
通讯作者：
Yanaga, K.
DOI：
10.1097/coc.0b013e31823a53b2
发表时间：
2013-02-01
影响因子：
2.6
作者：
Uwagawa, Tadashi;Misawa, Takeyuki;Yanaga, Katsuhiko
通讯作者：
Yanaga, Katsuhiko
DOI：
10.1385/ijgc:33:1:15
发表时间：
2003-01-01
期刊：
International journal of gastrointestinal cancer
影响因子：
--
作者：
Sclabas, Guido M;Fujioka, Shuichi;Chiao, Paul J
通讯作者：
Chiao, Paul J
影响因子：
2.9
作者：
Uwagawa, Tadashi;Sakamoto, Taro;Yanaga, Katsuhiko
通讯作者：
Yanaga, Katsuhiko
DOI：
10.1056/nejmoa1304369
发表时间：
2013-10-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Von Hoff DD;Ervin T;Arena FP;Chiorean EG;Infante J;Moore M;Seay T;Tjulandin SA;Ma WW;Saleh MN;Harris M;Reni M;Dowden S;Laheru D;Bahary N;Ramanathan RK;Tabernero J;Hidalgo M;Goldstein D;Van Cutsem E;Wei X;Iglesias J;Renschler MF
通讯作者：
Renschler MF