Branco Fernanda, Alencar Regiane S M, Volt Fernanda, Sartori Giovana, Dode Andressa, Kikuchi Luciana, Tani Claudia M, Chagas Aline L, Pfiffer Tulio, Hoff Paulo, Carrilho Flair J, Mattos Angelo A
Irmandade Santa Casa de Misericórdia de Porto Alegre Hospital, Department of Hepatology, Federal University of Health Sciences of Porto Alegre, Brazil.
São Paulo Clínicas Liver Cancer Group, São Paulo, Cancer Institute of São Paulo and Clínicas Hospital School of Medicine University of São Paulo, Brazil.
Ann Hepatol. 2017 March-April;16(2):263-268. doi: 10.5604/16652681.1231585.
The presence of dermatologic reaction as an adverse event to sorafenib treatment in patients with unresectable hepatocellular carcinoma has been indicated as a prognostic factor for survival in a recent prospective analysis. To date, this is the only clinical predictor of treatment response, which can be evaluated earlier in the treatment and, therefore, contribute to a better and more individualized patient management.
This retrospective study included 127 patients treated with sorafenib under real-life practice conditions in two hepatology reference centers in Brazil. Demographic data, disease/medical history and time of sorafenib administration as well as adverse events related to the medication were recorded in a database.
Cirrhosis was present in 94% of patients, 85.6% were Child-Pugh A, 80.3%BCLC-C, 81% had vascular invasion and/or extrahepatic spread and 95% had a performance status 0 to 1.The median duration of treatment was 10.1 months (range: 0.1-47 months).The most common adverse event within the first 60 days of treatment were diarrhea (62.2%) and dermatological reaction (42%).The median overall survival for the cohort was 20 months, and it was higher for patients who developed dermatological reactions within the first 60 days compared to those who did not present this adverse event.
This retrospective analysis showed the use of sorafenib in patients selected according to BCLC staging, and it is the first external validation of early dermatologic adverse events as a predictor of overall survival in patients with advanced hepatocellular carcinoma.
在一项近期的前瞻性分析中，皮肤反应作为不可切除肝细胞癌患者索拉非尼治疗的不良事件，已被指出是生存的一个预后因素。迄今为止，这是治疗反应的唯一临床预测指标，其可在治疗早期进行评估，因此有助于更好且更个体化地管理患者。
这项回顾性研究纳入了在巴西两个肝病参考中心按照实际临床情况接受索拉非尼治疗的127例患者。人口统计学数据、疾病/病史、索拉非尼给药时间以及与该药物相关的不良事件均记录在一个数据库中。
94%的患者存在肝硬化，85.6%为Child-Pugh A级，80.3%为BCLC-C期，81%有血管侵犯和/或肝外转移，95%的患者体能状态为0至1级。治疗的中位持续时间为10.1个月（范围：0.1 - 47个月）。治疗前60天内最常见的不良事件是腹泻（62.2%）和皮肤反应（42%）。该队列的中位总生存期为20个月，与未出现此不良事件的患者相比，在治疗前60天内出现皮肤反应的患者总生存期更长。
这项回顾性分析显示了根据BCLC分期选择患者使用索拉非尼的情况，并且这是早期皮肤不良事件作为晚期肝细胞癌患者总生存期预测指标的首次外部验证。
