Phase I/II study of E7080 (lenvatinib), a multitargeted tyrosine kinase inhibitor, in patients (pts) with advanced hepatocellular carcinoma (HCC): Initial assessment of response rate.

伦瓦提尼 医学 索拉非尼 内科学 肝细胞癌 不利影响 胃肠病学 耐受性 酪氨酸激酶抑制剂 养生 实体瘤疗效评价标准 瑞戈非尼 肿瘤科 毒性 临床研究阶段 癌症 结直肠癌
作者
Kiwamu Okita,Hiromitsu Kumada,Kenji Ikeda,Masatoshi Kudo,Seiji Kawazoe,Yukio Osaki,Masafumi Ikeda,Toshiyuki Tamai,Takuya Suzuki
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
卷期号:30 (4_suppl): 320-320 被引量:16
标识
DOI:10.1200/jco.2012.30.4_suppl.320
摘要

320 Background: Lenvatinib is an oral tyrosine kinase inhibitor targeting VEGFR1-3, FGFR1-4, RET, KIT and PDGFRβ. Maximum tolerated dose (MTD) of lenvatinib for solid tumor pts was determined to be 25 mg once daily dosing (qd), and MTD for HCC pts with Child-Pugh A was determined to be 12 mg qd. A preliminary assessment of response rate is presented in this report. Methods: Between July 9, 2010 and June 22, 2011, 46 pts with advanced HCC with Child-Pugh A were enrolled in Japan (n=43) and Korea (n=3). Pts may have received up to one prior treatment regimen including sorafenib. Pts were treated with a starting dose of lenvatinib 12 mg once daily in 28 day cycles until disease progression or development of unmanageable toxicities. Response rate was assessed by RECIST 1.1 (modified to evaluate viable lesions). Results: The first 42 consecutively enrolled pts (med age: 67; M: 76%, F: 24%) were evaluable for response and form the basis of this report. 45% had extra hepatic spread, 24% received prior chemotherapy and 91% had prior locoregional therapy. 19% were withdrawn from therapy due to adverse event. The most common toxicities were hypertension 71% (Gr 3: 48%), anorexia 50% (Gr 3: 2.4%), proteinuria 45% (Gr 3: 14%), palmar-plantar erythrodysaesthesia syndrome 43% (Gr 3: 4.8%), fatigue 43% (Gr 3: 0%), and thrombocytopenia 33% (Gr 3: 19%). No pts experienced Gr 4 toxicity. Confirmed Partial Responses (PRs) were observed in 14 pts (RR: 33%, 95% CI: 20-50) based on investigator assessment. Updated efficacy including median Time to Progression and survival data will be reported. Conclusions: Lenvatinib 12 mg qd when administered to advanced HCC pts with Child-Pugh A is associated with manageable toxicity. The preliminary assessment of efficacy on the basis of overall response rate suggests that lenvatinib may represent a new potential therapeutic agent for advanced HCC pts. Further assessment of safety and efficacy is ongoing.

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
文艺的明杰完成签到 ,获得积分10
2秒前
2秒前
zd发布了新的文献求助10
2秒前
泡泡发布了新的文献求助10
3秒前
完美的幻悲完成签到 ,获得积分10
3秒前
栗子完成签到,获得积分10
3秒前
惊蛰发布了新的文献求助10
3秒前
昵称发布了新的文献求助10
4秒前
田様应助一米阳光采纳,获得10
4秒前
SYLH应助柏梦岚采纳,获得10
4秒前
研友_VZG7GZ应助柏梦岚采纳,获得10
4秒前
5秒前
修狗狗完成签到,获得积分10
5秒前
徐鑫完成签到,获得积分20
5秒前
大海很蓝完成签到 ,获得积分10
6秒前
6秒前
所所应助hxd采纳,获得10
6秒前
7秒前
越过山丘完成签到,获得积分10
7秒前
小杨发布了新的文献求助10
7秒前
脑洞疼应助缓慢夜阑采纳,获得10
8秒前
8秒前
隐形曼青应助材料生采纳,获得10
9秒前
岁岁安完成签到,获得积分10
9秒前
共享精神应助小张采纳,获得10
10秒前
笨笨鲜花完成签到,获得积分10
10秒前
小梁砖家发布了新的文献求助10
10秒前
Clearlove发布了新的文献求助10
10秒前
高兴凝安发布了新的文献求助20
11秒前
perfumei完成签到,获得积分10
11秒前
zd完成签到,获得积分10
11秒前
11秒前
12秒前
13秒前
13秒前
13秒前
Owen应助大黑采纳,获得10
14秒前
14秒前
15秒前
Alina1874发布了新的文献求助20
15秒前
高分求助中
Genetics: From Genes to Genomes 3000
Production Logging: Theoretical and Interpretive Elements 2500
Continuum thermodynamics and material modelling 2000
Healthcare Finance: Modern Financial Analysis for Accelerating Biomedical Innovation 2000
Applications of Emerging Nanomaterials and Nanotechnology 1111
Les Mantodea de Guyane Insecta, Polyneoptera 1000
Diabetes: miniguías Asklepios 800
热门求助领域 (近24小时)
化学 医学 材料科学 生物 工程类 有机化学 生物化学 纳米技术 内科学 物理 化学工程 计算机科学 复合材料 基因 遗传学 物理化学 催化作用 细胞生物学 免疫学 电极
热门帖子
关注 科研通微信公众号,转发送积分 3470747
求助须知:如何正确求助?哪些是违规求助? 3063674
关于积分的说明 9085172
捐赠科研通 2754236
什么是DOI,文献DOI怎么找? 1511336
邀请新用户注册赠送积分活动 698372
科研通“疑难数据库(出版商)”最低求助积分说明 698253