Barcelona Clinic Liver Cancer Group, Servicio de Radiodiagnóstico, Hospital Clínic de Barcelona, Universitat de Barcelona, Barcelona, Spain.
Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Universitat de Barcelona, Barcelona, Spain.
Hepatology. 2018 Feb;67(2):612-622. doi: 10.1002/hep.29515. Epub 2018 Jan 2.
The clinical benefit of sorafenib in patients with hepatocellular carcinoma (HCC) has been undervalued due to the absence of complete responses, even though patients who develop early dermatologic reactions have shown to have a positive outcome. In addition, sorafenib is described as an antiangiogenic drug, but it also acts on immunological cells. Thus, the goal of this study was to assess the complete response rate in a retrospective cohort of HCC patients treated with sorafenib and to describe the profile of the patients who achieve complete response for identifying factors related to this event and their connection with the immunological profile of sorafenib. Ten Spanish centers submitted cases of complete response under sorafenib. The baseline characteristics, development of early dermatologic reactions, and cause of treatment discontinuation were annotated. Radiological images taken before starting sorafenib, at first control, after starting sorafenib, at the time of complete response, and at least 1 month after treatment were centrally reviewed. Of the 1119 patients studied, 20 had been classified as complete responders by the centers, but eight of these patients were excluded after central review. Ten patients had complete disappearance of all tumor sites, and two had just a small residual fibrotic scar. Thus, 12 patients were classified as complete responders (58% HCV, median age 59.7 years, 83.4% Child-Pugh class A, Eastern Cooperative Oncology Group performance status 0 91.7%, and Barcelona Clinic Liver Cancer stage C 83.3%). The median overall survival and treatment duration were 85.8 and 40.1 months, respectively. All but one patient developed early dermatologic reactions, and seven patients discontinued sorafenib after achieving complete response due to adverse events, patient decision, or liver decompensation. Conclusion: Complete response affects 1% of patients with HCC who are treated with sorafenib. The association of complete response with early dermatologic reactions supports the role of a specific immune/inflammatory patient profile in the improved response to sorafenib. (Hepatology 2018;67:612-622).
索拉非尼治疗肝细胞癌（HCC）的临床获益因缺乏完全缓解而被低估，尽管出现早期皮肤反应的患者已显示出良好的预后。此外，索拉非尼被描述为一种抗血管生成药物，但它也作用于免疫细胞。因此，本研究的目的是评估接受索拉非尼治疗的 HCC 患者的完全缓解率，并描述达到完全缓解的患者的特征，以确定与该事件相关的因素及其与索拉非尼免疫谱的关系。10 家西班牙中心提交了索拉非尼治疗下完全缓解的病例。注释了基线特征、早期皮肤反应的发生和治疗中断的原因。在开始索拉非尼前、首次控制时、开始索拉非尼后、完全缓解时以及治疗后至少 1 个月时进行了中心复查。在研究的 1119 例患者中，20 例被中心分类为完全缓解者，但其中 8 例在中心复查后被排除。10 例患者所有肿瘤部位完全消失，2 例仅残留小纤维疤痕。因此，12 例患者被分类为完全缓解者（58%HCV，中位年龄 59.7 岁，83.4%Child-Pugh 分级 A，东部肿瘤协作组表现状态 0 91.7%，巴塞罗那临床肝癌分期 C 83.3%）。中位总生存期和治疗持续时间分别为 85.8 和 40.1 个月。除 1 例患者外，所有患者均出现早期皮肤反应，7 例患者在达到完全缓解后因不良反应、患者决定或肝功能失代偿而停用索拉非尼。结论：索拉非尼治疗的 HCC 患者中，有 1%出现完全缓解。完全缓解与早期皮肤反应的关联支持特定的免疫/炎症患者特征与索拉非尼改善反应之间的关系。（《肝脏病学》2018；67：612-622）。
