A phase I study for adjuvant chemotherapy of gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1202)
A phase I study for adjuvant chemotherapy of gemcitabine plus S-1 in patients with biliary tract cancer undergoing curative resection without major hepatectomy (KHBO1202)
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吉西他滨联合 S-1 辅助化疗用于接受根治性切除但未进行肝大部切除的胆道癌患者的 I 期研究 (KHBO1202)
DOI：
10.1007/s00280-017-3513-4
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发表时间：
2018
影响因子：
3
通讯作者：
Ioka Tatsuya
中科院分区：
文献类型：
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作者：
Yanagimoto Hiroaki;Toyokawa Hideyoshi;Sakai Daisuke;Wada Hiroshi;Satoi Sohei;Yamamoto Tomohisa;Nagano Hiroaki;Toyoda Masanori;Ajiki Tetsuo;Satake Hironaga;Tsuji Akihito;Miyamoto Atsushi;Tsujie Masanori;Takemura Shigekazu;Yanagihara Kazuhiro;Ioka Tatsuya
目的探讨吉西他滨（GEM）联合替吉奥（S-1，GS）治疗胆道癌（BTC）的推荐剂量（RD）。（第1天和第8天静脉给药）和S-1（第1-14天口服给药，每日两次，停药1周，每3周一次，持续24周），剂量为1000/80（水平2），1000/65（水平1），800/65（水平-1）和800/50（水平-2）。结果31例患者（17例男性和14例女性;中位年龄，70岁）入组。选择水平1作为起始剂量。7例患者中有3例在水平1时出现剂量限制性毒性，剂量降至水平-1。12例患者中有5例发生了4级中性粒细胞减少（水平-1），剂量降至水平-2。1例患者发生4级中性粒细胞减少症（水平-2）。另1例患者因3级中性粒细胞减少（水平-2）而无法接受第8天给药。确认水平-1为该方案的最大耐受剂量，水平-2为RD。1年和2年无复发生存率分别为77.0%和54.0%。GS完成组患者的无复发生存率显著高于GS中止组。结论水平-2被确认为RD（GEM 800 mg/m2和S-1 50 mg/m2），用于治愈性切除的BTC患者的GS辅助化疗，无需进行大部分肝切除术。
PurposeTo determine the recommended dose (RD) of gemcitabine (GEM) plus S-1 (GS) in curatively resected biliary tract cancer (BTC) patients without major hepatectomy.MethodsA standard 3 + 3 dose-escalation design was used with planned dose levels (mg/m2) of GEM (administered intravenously on days 1 and 8) and S-1 (administered orally twice daily on days 1–14, with a 1-week rest, every 3 weeks for up to 24 weeks) of 1000/80 (Level 2), 1000/65 (Level 1), 800/65 (Level − 1), and 800/50 (Level − 2).ResultsThirty-one patients (17 men and 14 women; median age, 70 years) were enrolled. Level 1 was chosen as the starting dose. Three of seven patients developed dose-limiting toxicities at Level 1 and the dose was de-escalated to Level − 1. Five of 12 patients developed Grade 4 neutropenia at Level − 1 and the dose was de-escalated to Level − 2. One patient developed Grade 4 neutropenia at Level − 2. Another patient was unable to receive the day 8 dose due to Grade 3 neutropenia at Level − 2. Level − 1 was confirmed as the maximum tolerated dose and Level − 2 the RD for this regimen. The 1- and 2-year recurrence-free survival rates were 77.0 and 54.0%, respectively. The recurrence-free survival rate of patients in the GS completion group was significantly higher than that of the GS discontinuation group.ConclusionsLevel − 2 was confirmed as the RD (GEM 800 mg/m2and S-1 50 mg/m2) for GS adjuvant chemotherapy in curatively resected BTC patients without major hepatectomy.
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影响因子：
3
作者：
Kanai, Masashi;Yoshimura, Kenichi;Hatano, Etsuro
通讯作者：
Hatano, Etsuro
影响因子：
3.5
作者：
Park, Inkeun;Lee, Jae-Lyun;Lee, Jungshin
通讯作者：
Lee, Jungshin
DOI：
10.1007/s00534-008-0015-0
发表时间：
2009-01-01
期刊：
JOURNAL OF HEPATO-BILIARY-PANCREATIC SURGERY
影响因子：
--
作者：
Miyakawa, Shuichi;Ishihara, Shin;Nagakawa, Takukazu
通讯作者：
Nagakawa, Takukazu
影响因子：
3
作者：
Kobayashi, Shogo;Nagano, Hiroaki;Ioka, Tatsuya
通讯作者：
Ioka, Tatsuya
影响因子：
5.7
作者：
Morizane, Chigusa;Okusaka, Takuji;Furuse, Junji
通讯作者：
Furuse, Junji