A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection (KLTi) plus Gemcitabine versus Gemcitabine in Patients with Advanced Pancreatic Cancer.
A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection (KLTi) plus Gemcitabine versus Gemcitabine in Patients with Advanced Pancreatic Cancer.
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DOI：
10.7150/jca.15407
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发表时间：
2017
影响因子：
3.9
通讯作者：
Li D
中科院分区：
文献类型：
--
作者：
Schwartzberg LS;Arena FP;Bienvenu BJ;Kaplan EH;Camacho LH;Campos LT;Waymack JP;Tagliaferri MA;Chen MM;Li D
背景资料：本研究旨在评估KLTi联合吉西他滨治疗局部晚期或转移性胰腺癌患者的安全性和初步疗效。研究方法：在一项随机、开放标签研究中，局部晚期或转移性胰腺癌患者以2：1的比例随机接受KLTi+吉西他滨或吉西他滨单药治疗。在30 g/天、50 g/天和30 g/天水平下对三个连续队列进行了检测。吉西他滨在每个28天周期的第1、8和15天以1000 mg/m2给药。KLTi在每个28天周期的第1-5、8-12和1 - 5 -19天给药。患者接受研究治疗直至疾病进展。主要终点是ITT人群的无进展生存期。安全性评价基于接受任何研究治疗的患者。ClinicalTrials.gov标识符NCT 00733850。结果：85例患者接受随机化，包括队列1中的41例（28：13）、队列2中的18例（12：6）和队列3中的26例（17：9）。由于队列2和3中患者人群的剂量和/或变化不同，本手稿中列出了队列1单独给药和队列1+3联合给药的30 gm剂量的疗效数据。在ITT人群中，通过设盲独立放射学审查评估，30 gm KLTi +吉西他滨组的无进展生存期（PFS）有统计学显著性改善，中位PFS为112天，而吉西他滨组为58天（HR 0.50; 95% CI：0.27，0.92），p = 0.0240。两组间TEAE、CTCAE 3级或以上TEAE和SAE的发生率相似。无与KLTi +吉西他滨治疗相关的死亡。结论：康莱特注射液（30 g/天）联合吉西他滨标准方案显示了令人鼓舞的抗肿瘤活性临床证据和良好的耐受性安全性特征。
Background: This study was designed to assess the safety and preliminary efficacy of KLTi plus gemcitabine in patients with locally advanced or metastatic pancreatic cancer. Methods: In a randomized, open-label study, patients with locally advanced or metastatic pancreatic cancer were randomized 2:1 to receive KLTi plus gemcitabine or gemcitabine monotherapy. Three sequential cohorts were tested at 30 g/day, 50 g/day, and 30 g/day. Gemcitabine was administered at 1000 mg/m2 on days 1, 8 and 15 of each 28 day cycle. KLTi was administered on days 1-5, 8-12, and 15-19 of each 28 day cycle. Patients received study treatment until disease progression. The primary endpoint was progression-free survival in the ITT population. Safety evaluation was based on patients who received any study treatment. ClinicalTrials.gov identifier NCT00733850. Results: Eighty-five patients were randomized including 41 (28:13) in Cohort 1, 18 (12:6) in Cohort 2, and 26 (17:9) in Cohort 3. Due to a different dose and/or shift in patient populations in Cohort 2 and 3, efficacy data for the 30 gm dose are presented in this manuscript for Cohort 1 alone, and for the combination of Cohort 1+3. The 30 gm KLTi + gemcitabine group had a statistically significant improvement in progression-free survival (PFS) as assessed by blinded independent radiology review in the ITT population, with a median of 112 days, versus 58 days in the gemcitabine group (HR 0.50; 95% CI: 0.27, 0.92), p = 0.0240. The incidence rates of TEAEs, CTCAE Grade 3 or higher TEAEs, and SAEs were similar between the two arms. There were no deaths related to KLTi + gemcitabine treatment. Conclusion: Kanglaite Injection (30 g/day) plus a standard regimen of gemcitabine demonstrated encouraging clinical evidence of anti-neoplastic activity and a well-tolerated safety profile.
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影响因子：
--
作者：
Liu Y;Zhang W;Wang XJ;Liu S
通讯作者：
Liu S
胰腺癌患者的生存率提高了十年：SEER 数据库的时期分析，1981 年至 2010 年
影响因子：
4.6
作者：
Sun H;Ma H;Hong G;Sun H;Wang J
通讯作者：
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影响因子：
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作者：
Moore, Malcolm J.;Goldstein, David;Parulekar, Wendy
通讯作者：
Parulekar, Wendy
影响因子：
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作者：
Woo, Ju- Hyung;Li, Dapeng;Gabrielson, Edward
通讯作者：
Gabrielson, Edward
影响因子：
45.3
作者：
Burris, HA;Moore, MJ;VanHoff, DD
通讯作者：
VanHoff, DD