A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma.
A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma.
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DOI：
10.1007/s10147-017-1138-6
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发表时间：
2017-10
影响因子：
3.3
通讯作者：
Muto M
中科院分区：
文献类型：
--
作者：
Horimatsu T;Nakayama N;Moriwaki T;Hirashima Y;Fujita M;Asayama M;Moriyama I;Nakashima K;Baba E;Kitamura H;Tamura T;Hosokawa A;Yoshimura K;Muto M
多项研究表明，化疗可延长转移性或复发性小肠腺癌(SBA)患者的生存期；然而，目前仍没有标准的化疗方案。在这里，我们评估了5-氟尿嘧啶(5-FU)/L-亚叶酸钙(L-LV)/奥沙利铂(MFOLFOX6)方案作为治疗SBA患者的一线治疗方案的有效性和安全性。这是一项多中心、单臂、开放标签的II期研究。资格标准包括组织学确诊的腺癌，年龄20-80岁，东方合作肿瘤组表现状态(PS)0-2。主要终点是1年无进展生存(PFS)。次要终点包括总有效率(ORR)、总存活率(OS)、总PFS和安全性。2010年4月至2012年11月，来自12个机构的24名患者入选。中位年龄63岁(31~79岁)，男女之比为18/6，PS0/1者17/7，局部进展期/转移者2/22例。原发灶位于十二指肠14例(58%)，空肠10例(42%)。中位随访时间为14.7个月(3.7~40.3个月)。1年生存率为23.3%。ORR为9/20(45%)。中位PFS和OS时间分别为5.9个月(95%可信区间为3.0~10.2)和17.3个月(95%可信区间为11.7~19.0)。主要的3/4级毒性是中性粒细胞减少(38%)、贫血/周围神经病变(25%)和狭窄(17%)。没有与治疗相关的死亡。尽管没有达到主要终点，mFOLFOX6作为治疗SBA的一线药物显示出有效和良好的耐受性。
Several studies have suggested that chemotherapy prolonged survival in patients with metastatic or recurrent small bowel adenocarcinoma (SBA); however, there is still no standard chemotherapy regimen. Here, we evaluated the efficacy and safety of a 5-fluorouracil (5-FU)/L-leucovorin (l-LV)/oxaliplatin (mFOLFOX6) protocol as a first-line therapy for patients with SBA. This was a multicenter, single-arm, open-label phase II study. Eligibility criteria included histologically confirmed adenocarcinoma, age 20–80 years, and an Eastern Cooperative Oncology Group performance status (PS) of 0–2. The primary endpoint was 1-year progression-free survival (PFS). The secondary endpoints included overall response rate (ORR), overall survival (OS), overall PFS, and safety. Between April 2010 and November 2012, 24 patients were enrolled from 12 institutions. The median age of the patients was 63 years (range 31–79) and there was a male/female ratio of 18/6. The number of PS 0/1 patients was 17/7 and locally advanced/metastatic disease was seen in 2/22 patients, respectively. The primary tumor site was the duodenum in 14 patients (58%) and jejunum in 10 patients (42%). The median follow-up time was 14.7 months (3.7–40.3). The 1-year PFS was 23.3%. The ORR was 9/20 (45%). The median PFS and OS times were 5.9 months (95% confidence interval [CI] 3.0–10.2) and 17.3 months (95% CI 11.7–19.0), respectively. Major grade 3/4 toxicities were neutropenia (38%), anemia/peripheral neuropathy (25%), and stenosis (17%). There were no treatment-related deaths. Although the primary endpoint was not met, mFOLFOX6 showed effective and good tolerance as a first-line treatment for SBA.
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影响因子：
2.5
作者：
Suenaga, Mitsukuni;Mizunuma, Nobuyuki;Hatake, Kiyohiko
通讯作者：
Hatake, Kiyohiko
影响因子：
6.2
作者：
Dabaja, BS;Suki, D;Ajani, J
通讯作者：
Ajani, J
皇家马斯登（Royal Marsden）的小肠腺癌的经验，该腺癌用长期的静脉输液5-氟尿嘧啶治疗。
影响因子：
8.8
作者：
Crawley, C;Ross, P;Norman, A;Hill, A;Cunningham, D
通讯作者：
Cunningham, D
影响因子：
3
作者：
OURIEL, K;ADAMS, JT
通讯作者：
ADAMS, JT
影响因子：
6.2
作者：
Overman, Michael J.;Kopetz, Scoff;Wolff, Robert A.
通讯作者：
Wolff, Robert A.