Clinical outcomes of patients with advanced hepatocellular carcinoma treated with sorafenib: a retrospective study of routine clinical practice in multi-institutions.
Clinical outcomes of patients with advanced hepatocellular carcinoma treated with sorafenib: a retrospective study of routine clinical practice in multi-institutions.
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DOI：
10.1186/s12885-015-1273-2
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发表时间：
2015-04-08
期刊：
影响因子：
3.8
通讯作者：
Lee HY
中科院分区：
文献类型：
--
作者：
Lee SH;Song IH;Noh R;Kang HY;Kim SB;Ko SY;Lee ES;Kim SH;Lee BS;Kim AN;Chae HB;Kim HS;Lee TH;Kang YW;Lee JD;Lee HY
索拉非尼是一种口服多激酶抑制剂，具有抗血管生成和抗增殖特性。大型临床试验的结果表明，索拉非尼延长了晚期肝细胞癌（HCC）患者的生存期和进展时间。本研究的目的是确定在韩国多个机构接受索拉非尼常规治疗的患者的结局，与正式的临床试验相比。2007年8月至2012年3月，在韩国大田-忠清省的7个转诊医疗中心回顾性招募了晚期HCC患者，以评估索拉非尼给药后的治疗反应、生存率和耐受性。根据实体瘤缓解评价标准1.1指南评估治疗缓解。在116例患者中，66例（57%）接受了HCC治疗，77例（66%）伴有Child-Pugh A级肝硬化。索拉非尼治疗的中位持续时间为67天（范围14 - 452天）。中位总生存期和中位进展时间分别为141天和90天。分别有0%、2%和29%的患者达到完全缓解、部分缓解和疾病稳定。与Child-Pugh A级肝硬化患者相比，Child-Pugh B级肝硬化患者的总体中位生存期（64天vs 168天，P = 0.004）显著更短，但中位进展时间并非如此。Child-Pugh B级肝硬化（P = 0.024）和高血清甲胎蛋白（P = 0.039）是总生存率低的独立危险因素。39例（3/4%）患者发生了3/4级不良事件，如手足皮肤反应和腹泻，需要调整剂量。索拉非尼治疗的晚期HCC患者的临床结局与在亚太地区进行的正式临床试验报告的结果相当。潜在的肝功能障碍是生存期缩短的最重要的危险因素。
Sorafenib is an orally administered multikinase inhibitor with antiangiogenic and antiproliferative properties. The results of large clinical trials demonstrate that sorafenib prolongs survival and the time to progression of patients with advanced hepatocellular carcinoma (HCC). The aim of the present study was to determine the outcomes of such patients who were routinely treated with sorafenib at multi-institutions in Korea, in contrast to formal clinical trials. Between August 2007 and March 2012, patients with advanced HCC in seven referral medical centers in Daejeon-Chungcheong Province of Korea were retrospectively enrolled to evaluate treatment response, survival, and tolerability following administration of sorafenib. The treatment response was assessed in accordance with the Response Evaluation Criteria in Solid Tumor 1.1 guidelines. Among 116 patients, 66 (57%) had undergone treatment for HCC, and 77 (66%) were accompanied with Child-Pugh A cirrhosis. The median duration of sorafenib treatment was 67 days (range 14–452 days). Median overall survival and median time to progression were 141 days and 90 days, respectively. Complete response, partial response, and stable disease were achieved for 0%, 2%, and 29% of patients, respectively. Overall median survival, but not the median time to progression, was significantly shorter for patients with Child-Pugh B cirrhosis compared with those with Child-Pugh A cirrhosis (64 days vs 168 days, P = 0.004). Child-Pugh B cirrhosis (P = 0.024) and a high level of serum alpha-fetoprotein (P = 0.039) were independent risk factors for poor overall survival. Thirty-nine (34%) patients experienced grade 3/4 adverse events such as hand-foot skin reactions and diarrhea that required dose adjustment. The clinical outcomes of sorafenib-treated patients with advanced HCC were comparable to those reported by formal clinical trial conducted in the Asia-Pacific region. Underlying hepatic dysfunction was the most important risk factor for shorter survival.
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影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
影响因子：
3
作者：
Kim, Jeong Eun;Ryoo, Baek-Yeol;Kang, Yoon-Koo
通讯作者：
Kang, Yoon-Koo
影响因子：
158.5
作者：
Llovet, Josep M.;Ricci, Sergio;Bruix, Jordi
通讯作者：
Bruix, Jordi
影响因子：
1.9
作者：
Woo, Hyun Young;Heo, Jeong;Cho, Mong
通讯作者：
Cho, Mong
索拉非尼对亚太地区晚期肝细胞癌患者的疗效和安全性：一项 III 期随机、双盲、安慰剂对照试验
影响因子：
51.1
作者：
Cheng, Ann-Lii;Kang, Yoon-Koo;Guan, Zhongzhen
通讯作者：
Guan, Zhongzhen