CAJ | 학술논문

目的研究索拉非尼治疗不能手术的原发性肝细胞癌(HCC)的疗效以及预后影响因素.方法 2005年12月至2009年3月间,50例肝功能分级为Child-Pugh A级的不能手术的原发性HCC患者连续口服索拉非尼治疗,索拉非尼用法为400 mg/次,每日2次.每6～8周复查CT或MRI,根据实体瘤疗效评价标准(RECIST)进行疗效评价,根据美国国立癌症研究所常见毒性分级标准评价不良反应,观察患者的总生存时间(OS)和疾病进展时间(TTP).结果 50例患者均可评价疗效,其中疾病稳定(SD)28例,疾病稳定率为56.0%;疾病进展(PD)22例,占44.0%;无完全缓解(CR)和部分缓解(PR)患者.中位随访时间为15个月,随访期间共有17例患者死亡,全组患者的中位TTP为4个月,中位OS为14个月.索拉非尼治疗不能手术的原发性HCC患者的不良反应为皮肤损害、腹泻、高血压、脱发、骨髓抑制和肝功能损害等,大多为Ⅰ～Ⅱ级,经对症处理或调整用药剂量后多可恢复.单因素分析结果显示,有无远处转移是影响HCC患者TTP的主要因素.结论索拉非尼可有效治疗不能手术的原发性HCC,有无远处转移是影响HCC患者TTP的主要因素.
목적 연구색랍비니치료불능수술적원발성간세포암(HCC)적료효이급예후영향인소.방법 2005년12월지2009년3월간,50례간공능분급위Child-Pugh A급적불능수술적원발성HCC환자련속구복색랍비니치료,색랍비니용법위400 mg/차,매일2차.매6～8주복사CT혹MRI,근거실체류료효평개표준(RECIST)진행료효평개,근거미국국립암증연구소상견독성분급표준평개불량반응,관찰환자적총생존시간(OS)화질병진전시간(TTP).결과 50례환자균가평개료효,기중질병은정(SD)28례,질병은정솔위56.0%;질병진전(PD)22례,점44.0%;무완전완해(CR)화부분완해(PR)환자.중위수방시간위15개월,수방기간공유17례환자사망,전조환자적중위TTP위4개월,중위OS위14개월.색랍비니치료불능수술적원발성HCC환자적불량반응위피부손해、복사、고혈압、탈발、골수억제화간공능손해등,대다위Ⅰ～Ⅱ급,경대증처리혹조정용약제량후다가회복.단인소분석결과현시,유무원처전이시영향HCC환자TTP적주요인소.결론 색랍비니가유효치료불능수술적원발성HCC,유무원처전이시영향HCC환자TTP적주요인소.
Objective To evaluate the efficacy and analyze the prognostic factors of sorafenib treatment in patient with unresectable primary hepatocellular carcinoma ( HCC ). Methods During the period from December 2005 to March 2009, 50 patients with unresectable primary HCC of Child-Pugh status A were treated with sorafenib ( 400 mg, Bid). The tumor response was evaluated with CT or MRI imaging every 6-8 weeks according to the RECIST criteria. The overall survival (OS) and time to progression (TTP)were defined as the time from administration of sorafenib to the death or the last follow up and were evaluated by Kaplan-Meier method. Results There was no PR or CR, but 28 patients (56.0%) achieved stable disease. The median follow up time was 15 months with a median OS of 14 months and median TTP of 4 months. The common adverse events were dermal reaction (68.0%, 34/50), diarrhea (52.0%, 26/50),hypertension (4.0%, 2/50), hair loss ( 14.0%, 7/50), myelosuppression ( 16.0%, 8/50), and liver dysfunction (20.0%, 10/50). However, most of the drug-related adverse events were grade Ⅰ-Ⅱ and reversible. The patients with lower tumor burden and without distant metastasis had better prognosis.Conclusion Soafenib is effective for unresectable primary HCC with tolerable toxicity. Tumor stage is a predominant prognostic factor.