CAJ | 학술논문

背景与目的:SHARP(sorafenib hcc assessment randomized protocol)和ORIENTAL(sorafenib in patients in asia-pacific region with hepatocellular carcinoma)两个Ⅲ期临床试验证实,多激酶抑制剂索拉非尼在一定程度上能延长晚期肝癌患者的总生存期(overall survival,OS),并显著改善无进展生存期(progress free survival,PFS)和延长疾病进展时间(time to progression,TTP),但治疗过程中出现的各种不良反应在一定程度上会影响其临床治疗.本研究使用索拉非尼治疗25例中晚期肝细胞癌患者,并对其不良反应情况及临床处理进行总结.方法:选取2008年1月-2009年10月期间符合原发性肝癌临床诊断标准的晚期肝癌患者25例,给予索拉非尼治疗所有患者均满足以下标准:(1)化疗栓塞术后病情进展;(2)广泛门脉癌栓无法栓塞;(3)肝门部、腹膜后淋巴结或肺、骨等多发转移者;(4)弥漫乏血供肿瘤;(5)签署知情同意书.在开始服用索拉非尼治疗后的前12周,观察患者不同级别不良反应发生情况,并给予相应临床处理.结果:共25例患者接受索拉非尼治疗,其中男性17例,女性8例,年龄范围30～72岁,平均51.44岁.期间9例患者死亡,其中3例在服药开始的12周内死亡.3例患者中断索拉非尼治疗,其中2例为治疗不满12周停药,1例为服药5个月后停药.共20例患者符合观察标准.不良反应发生情况如下:手足皮肤反应(hand-foot-skin reaction,HFSR)4例(4/20),腹泻4例(4/20),脱发5例(5/20),皮疹4例(4/20),乏力8例(8/20),白细胞和血小板减少4例(4/20),高血压1例(1/20),腹痛1例(1/20).这些不良反应经临床处理后,20例患者均能继续接受索拉非尼治疗.结论:索拉非尼治疗中晚期肝细胞癌具有良好的安全性和良好的耐受性.
배경여목적:SHARP(sorafenib hcc assessment randomized protocol)화ORIENTAL(sorafenib in patients in asia-pacific region with hepatocellular carcinoma)량개Ⅲ기림상시험증실,다격매억제제색랍비니재일정정도상능연장만기간암환자적총생존기(overall survival,OS),병현저개선무진전생존기(progress free survival,PFS)화연장질병진전시간(time to progression,TTP),단치료과정중출현적각충불량반응재일정정도상회영향기림상치료.본연구사용색랍비니치료25례중만기간세포암환자,병대기불량반응정황급림상처리진행총결.방법:선취2008년1월-2009년10월기간부합원발성간암림상진단표준적만기간암환자25례,급여색랍비니치료소유환자균만족이하표준:(1)화료전새술후병정진전;(2)엄범문맥암전무법전새;(3)간문부、복막후림파결혹폐、골등다발전이자;(4)미만핍혈공종류;(5)첨서지정동의서.재개시복용색랍비니치료후적전12주,관찰환자불동급별불량반응발생정황,병급여상응림상처리.결과:공25례환자접수색랍비니치료,기중남성17례,녀성8례,년령범위30～72세,평균51.44세.기간9례환자사망,기중3례재복약개시적12주내사망.3례환자중단색랍비니치료,기중2례위치료불만12주정약,1례위복약5개월후정약.공20례환자부합관찰표준.불량반응발생정황여하:수족피부반응(hand-foot-skin reaction,HFSR)4례(4/20),복사4례(4/20),탈발5례(5/20),피진4례(4/20),핍력8례(8/20),백세포화혈소판감소4례(4/20),고혈압1례(1/20),복통1례(1/20).저사불량반응경림상처리후,20례환자균능계속접수색랍비니치료.결론:색랍비니치료중만기간세포암구유량호적안전성화량호적내수성.
Background and purpose: Sorafenib hepatocellular carcinoma assessment randomized protocol (SHARP) and sorafenib in patients in Asia-Pacific region with hepatocellular carcinoma (ORIENTAL) had indicated that multi-kinase inhibitor sorafenib could prolong overall survival (OS) and time to progression (TTP) as well as improve progress free survival (PFS) in patients with advanced stage hepatocellular carcinoma. Drug-related adverse events in the course of treatment restricted its clinical application to a certain degree. This study was aimed to summerize the adverse events as well as the management of sorafenib in our clinic. Methods: Twenty-five cases clinically diagnosed as advanced hepatocellular carcinoma were enrolled from January 2008 to October 2009. All the patients who received sorafenib treatment met inclusion criteria as followed: (1) Progression of disease after trans-hepatic arterial chemoembolization therapy; (2) Extensive portal vein cancerous thrombus formation; (3) Portal zone or retroperitoneal lymph node metastasis or multiple remote metastasis, such as lung or bone; (4) Diffused poor blood supply to tumor; (5) Inform consent was obtained. All adverse events with different grade were observed during the beginning 12 weeks, and clinical treatment were carried out relatively. Results: Total of 25 cases were enrolled. Nine patients died of the disease, 3 of them died during the first 12 weeks, 3 patients abandoned sorafenib treatment, among them 2 died before the finish of 12 weeks treatment and 1 patient discontinued 5 months after the sorafenib treatment. Twenty cases finally assigned. Number of patients encountered drug-related adverse events were: HFSR (hand-foot-skin-reaction) 4(4/20), diarrhea 4(4/20), alopecia 5(5/20), rasb 4(4/20), fatigue 8(8/20), leukopenia and Thrombocytopenia 4(4/20), elevated blood pressure 1(1/20) and abdominal pain 1(1/20). After clinical management, 20 patients' sorafenib treatment were eventually not affected by adverse events. Conclusion: Sorafenib was well-tolerated and is a safe option of treatment for patients with advanced hepatocellular carcinoma.