Department of Radiology, Oncology and Pathology, Policlinico Umberto I, Sapienza University of Rome, Rome, Italy;
Department of Medical Oncology, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy.
Anticancer Res. 2023 Feb;43(2):755-763. doi: 10.21873/anticanres.16215.
BACKGROUND/AIM: We conducted a retrospective analysis in our center (Umberto I Polyclinic) in collaboration with Campus Biomedico Polyclinic to assess the results of the REFLECT study, which was the first study that demonstrated the non-inferiority of Lenvatinib to Sorafenib.
We identified 21 patients affected by advanced hepatocellular carcinoma during the last 3 years who were treated in our centers. They were subdivided according to the treatment administered (Lenvatinib or Sorafenib). Progression-free survival (PFS) and overall survival (OS) were calculated, and subgroups were compared using the log-rank test. Specific predictive and prognostic factors were identified. The safety profile of the two drugs and the collateral effects were evaluated.
The OS in patients in the Lenvatinib arm was 19 (months and 12.5 months in the Sorafenib arm. PFS in patients in the Lenvatinib arm was 6 months and 2.5 months in the Sorafenib arm. OS and PFS in patients treated with Lenvatinib were higher in any subcategory analyzed whereas no positive predictors of response to Sorafenib were found. Based on data from literature, the albumin bilirubin index (ALBI) grade was found to be a key prognostic factor. Patients treated with Sorafenib had more adverse events than those treated with Lenvatinib (100% versus 81.8%, respectively). Patients treated with Sorafenib had more frequently hand-foot syndromes, diarrhea, and nausea whereas patients treated with Lenvatinib commonly had hypertension, proteinuria, and weight loss.
Lenvatinib was found to be better than Sorafenib in terms of both survival and toxicity, in advanced hepatic cell carcinoma patients.
背景/目的：我们与 Campus Biomedico 综合医院合作，对我们中心（Umberto I 综合医院）进行了回顾性分析，以评估 REFLECT 研究的结果，该研究首次证明仑伐替尼不劣于索拉非尼。
在过去的 3 年中，我们在我们的中心共确定了 21 名患有晚期肝细胞癌的患者。根据治疗方法（仑伐替尼或索拉非尼）对他们进行了细分。计算无进展生存期（PFS）和总生存期（OS），并使用对数秩检验比较亚组。确定了特定的预测和预后因素。评估了两种药物的安全性概况和副作用。
仑伐替尼组的 OS 为 19 个月（索拉非尼组为 12.5 个月）。仑伐替尼组的 PFS 为 6 个月（索拉非尼组为 2.5 个月）。在任何分析的亚组中，接受仑伐替尼治疗的患者的 OS 和 PFS 更高，而未发现索拉非尼反应的阳性预测因素。根据文献数据，白蛋白胆红素指数（ALBI）分级被认为是一个关键的预后因素。与接受仑伐替尼治疗的患者相比，接受索拉非尼治疗的患者发生更多不良事件（分别为 100%和 81.8%）。接受索拉非尼治疗的患者更常出现手足综合征、腹泻和恶心，而接受仑伐替尼治疗的患者则更常出现高血压、蛋白尿和体重减轻。
在晚期肝细胞癌患者中，仑伐替尼在生存和毒性方面均优于索拉非尼。
