CAJ | 학술논문

目的：探讨索拉非尼治疗中晚期肝细胞癌（ HCC ）的疗效，并考察应用索拉菲尼后血清甲胎蛋白（ AFP）水平变化以及AFP应答对于HCC患者预后影响，为索拉非尼治疗HCC效果评价提供临床依据。方法经病理证实或临床确诊的中晚期HCC患者61例，连续口服索拉非尼，根据实体肿瘤的疗效评价标准（ RECIST ）进行疗效评价，并在第6周检测患者血清AFP水平，并进行影像学检查，应用Cox比例风险模型检测HCC患者风险比。结果61例患者中位无进展生存期（PFS）为7个月（95％CI 2祆．1～14．3个月），中位总生存时间（OS）为11个月（95％CI 7．2～23．6个月）。 RECIST 评定，CR 2例（3．3％），PR 6例（9．8％），SD 37例（60．7％），PD 16例（26．2％），疾病控制率为73．8％。 AFP应答组与非应答组PFS与OS差异有统计学意义（ P ＜0．05）；而影像学肿瘤控制组与影像学肿瘤进展组PFS与OS差异均无统计学意义（ P ＞0．05）。 AFP应答组PFS与OS的风险比分别为0．58（95％CI 0．26～0．97）和0．68（95％CI 0．31～0．89），而影像学肿瘤控制组PFS与OS的风险比分别为0．96（95％CI 0．35～1．57）和0．98（95％CI 0．71～2．46）。在多因素Cox回归分析中，CLIP评分和AFP应答这两个因素均具有显著性。服用索拉非尼主要不良反应为手足皮肤反应和白细胞、血小板减少，经对症处理或减小剂量后均可明显缓解。结论索拉非尼治疗中晚期肝细胞癌疗效显著， AFP应答可以作为监测索拉非尼治疗中晚期肝细胞癌疗效的检测标志物。
목적：탐토색랍비니치료중만기간세포암（ HCC ）적료효，병고찰응용색랍비니후혈청갑태단백（ AFP）수평변화이급AFP응답대우HCC환자예후영향，위색랍비니치료HCC효과평개제공림상의거。방법경병리증실혹림상학진적중만기HCC환자61례，련속구복색랍비니，근거실체종류적료효평개표준（ RECIST ）진행료효평개，병재제6주검측환자혈청AFP수평，병진행영상학검사，응용Cox비례풍험모형검측HCC환자풍험비。결과61례환자중위무진전생존기（PFS）위7개월（95％CI 2천．1～14．3개월），중위총생존시간（OS）위11개월（95％CI 7．2～23．6개월）。 RECIST 평정，CR 2례（3．3％），PR 6례（9．8％），SD 37례（60．7％），PD 16례（26．2％），질병공제솔위73．8％。 AFP응답조여비응답조PFS여OS차이유통계학의의（ P ＜0．05）；이영상학종류공제조여영상학종류진전조PFS여OS차이균무통계학의의（ P ＞0．05）。 AFP응답조PFS여OS적풍험비분별위0．58（95％CI 0．26～0．97）화0．68（95％CI 0．31～0．89），이영상학종류공제조PFS여OS적풍험비분별위0．96（95％CI 0．35～1．57）화0．98（95％CI 0．71～2．46）。재다인소Cox회귀분석중，CLIP평분화AFP응답저량개인소균구유현저성。복용색랍비니주요불량반응위수족피부반응화백세포、혈소판감소，경대증처리혹감소제량후균가명현완해。결론색랍비니치료중만기간세포암료효현저， AFP응답가이작위감측색랍비니치료중만기간세포암료효적검측표지물。
Objective To investigate therapeutic effect of sorafenib for advanced hepatocelluar carcinoma ( HCC ) , including progression free survival (PFS), overall survival (OS) and alpha fetoprotein(AFP) variation to identify the prog-nostic usefulness of AFP response in clinic application .Methods Pathologically confirmed or clinically diagnosed patients with advanced HCC in 61 cases, continuous oral sorafenib efficacy evaluation based on Response Evaluation Criteria in Solid Tumors (RECIST), and in the first six weeks, detected serum AFP level and did imaging examination , using the Cox propor-tional hazards model to detect patients with HCC risk ratio .Results 61 patients with median PFS was 7 months (95% CI 2.1-14.3 months), and median OS was 11 months (95% CI 7.2-23.6 months).RECIST assessment, CR in 2 cases (3.3%), PR in 6 cases (9.8%), SD in 37 cases (60.7%), PD in 16 cases (26.2%);disease control rate was 73.8%. AFP responders and non-responders PFS with OS difference was statistically significant ( P <0.05);while the control group and radiographic imaging of tumor progression and OS ,PFS group differences were not statistically significant ( P >0.05) AFP response group risk ratio of PFS and OS was 0.58 (95%CI 0.26-0.97) and 0.68 (95%CI 0.31-0.89), while the risk of radiological controls PFS with OS ratios were 0.96 (95%CI 0.35-1.57) and 0.98 (95%CI 0.71-2.46).In mul-tivariate Cox regression analysis , CLIP score and AFP responses of these two factors was significant .Taking sorafenib main ad-verse reactions were hand-foot skin reaction and white blood cells , thrombocytopenia , after symptomatic treatment or reduce the dose can be significantly alleviated .Conclusion The sorafenib was efficient in the treatment of advanced HCC .AFP re-sponse may be considered as a novel method to capture sorafenib activity in advanced HCC .