Phase II trial of sorafenib combined with concurrent transarterial chemoembolization with drug-eluting beads for hepatocellular carcinoma.
Phase II trial of sorafenib combined with concurrent transarterial chemoembolization with drug-eluting beads for hepatocellular carcinoma.
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DOI：
10.1200/jco.2011.37.1021
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发表时间：
2011-10-20
期刊：
影响因子：
--
通讯作者：
Geschwind JF
中科院分区：
文献类型：
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作者：
Pawlik TM;Reyes DK;Cosgrove D;Kamel IR;Bhagat N;Geschwind JF
评价阿霉素洗脱珠（DEB）联合索拉非尼经动脉化疗栓塞（TACE）治疗晚期肝细胞癌（HCC）的安全性和有效性。一项前瞻性单中心II期研究纳入了不可切除的HCC患者。该方案涉及索拉非尼400毫克，每天2次，联合DEB-TACE。评估了安全性和反应。DEB-TACE联合索拉非尼成功治疗了35例患者：平均年龄63岁；儿童A， 89%；巴塞罗那诊所肝癌C期，64%；东部肿瘤合作集团绩效状况分别为0、1、46%、54%；平均指数肿瘤大小为7.7 cm（标准差±4.2 cm）。患者接受了128个周期的治疗（索拉非尼加debtace， 60个周期；索拉非尼单独，68个周期）。每位患者的周期中位数为2个（范围为1至5个周期）；索拉非尼治疗的中位天数为71天（范围4至620天）。第一周期最常见的毒性是疲劳（94%）、厌食（67%）、肝酶改变（64%）和皮肤不良反应（48%）。虽然大多数患者至少经历一次3至4级毒性，但大多数毒性较轻（1至2,83% v 3至4,17%）。第二周期毒性降低。在整个研究过程中，有40次索拉非尼剂量中断和25次索拉非尼剂量减少。索拉非尼联合debtace的疾病控制率为95%（实体瘤组应答评价标准）/100%（欧洲肝脏研究协会[EASL]），客观应答率为58% （EASL）。索拉非尼联合DEB-TACE治疗不可切除的HCC患者耐受性良好且安全，大多数毒性与索拉非尼有关。通过调整索拉非尼的剂量，毒性是可控的。初步疗效数据令人鼓舞。
To evaluate safety and efficacy of combined transarterial chemoembolization (TACE) with doxorubicin-eluting beads (DEB) and sorafenib in patients with advanced hepatocellular carcinoma (HCC). A prospective single-center phase II study was undertaken involving patients with unresectable HCC. The protocol involved sorafenib 400 mg twice per day combined with DEB-TACE. Safety and response were assessed. DEB-TACE in combination with sorafenib was successfully administered in 35 patients: mean age, 63 years; Child’s A, 89%; Barcelona Clinic Liver Cancer stage C, 64%; Eastern Cooperative Oncology Group performance status of 0 and 1, 46% and 54%, respectively; and mean index tumor size, 7.7 cm (standard deviation, ± 4.2 cm). Patients underwent 128 cycles of therapy (sorafenib plus DEB-TACE, 60 cycles; sorafenib alone, 68 cycles). Median number of cycles per patient was two (range, one to five cycles); median number of days treated with sorafenib was 71 (range, 4 to 620 days). The most common toxicities during cycle one were fatigue (94%), anorexia (67%), alterations in liver enzymes (64%), and dermatologic adverse effects (48%). Although most patients experienced at least one grade 3 to 4 toxicity, most toxicities were minor (grade 1 to 2, 83% v grade 3 to 4, 17%). Toxicity during cycle two was decreased. Over the course of the study, there were 40 sorafenib dose interruptions and 25 sorafenib dose reductions. Sorafenib plus DEB-TACE was associated with a disease control rate of 95% (Response Evaluation Criteria in Solid Tumors Group)/100% (European Association for the Study of the Liver [EASL]), with an objective response of 58% (EASL). The combination of sorafenib and DEB-TACE in patients with unresectable HCC is well tolerated and safe, with most toxicities related to sorafenib. Toxicity is manageable with dose adjustment of sorafenib. Preliminary efficacy data are promising.