First-line lenvatinib and sorafenib in RR-DTC from a shared real-life context.

IF 4.6
Vincenzo Marotta, Anna Tortora, Mariafelicia Valeriani, Alessia Caleo, Sara Gaeta, Teresa Infante, Francesco Stanzione, Luca Scafuri, Claudio Gambardella, Francesca Di Gennaro, Francesco Perri, Antongiulio Faggiano, Mario Vitale, Luciano Pezzullo
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Abstract

The kinase-inhibitors lenvatinib and sorafenib represent the first-line options for radioiodine-refractory differentiated thyroid cancer (RR-DTC). Comparative studies in the same study population or between similar cohorts are scarce. Our objective was to compare lenvatinib and sorafenib in naïve RR-DTC in a homogeneous real-life context. We performed a retrospective study involving two Institutions from the Italian region Campania. Primary endpoints were progression-free survival (PFS) and overall-survival (OS). Secondary endpoints were objective response rate (ORR), disease-control rate, adverse events graded ≥ 3, toxicity-related treatment withdrawal and dose reductions/interruptions. Forty-eight RR-DTC were included (median follow-up 45.5 months): 24 received lenvatinib from 2015 to 2021 and 24 sorafenib from 2012 to 2016. The sorafenib group showed higher disease-related symptoms rate (p=0.022), tumor burden (p=0.002) and cumulative radioiodine dose compared to lenvatinib. At univariate analysis, median PFS and OS were significantly longer for lenvatinib (30 and 53 months, respectively) compared to sorafenib (10 and 38 months, respectively) (p <0.001 and =0.037, respectively). At multivariate analysis, the significance was retained for PFS and lost for OS. ORR was higher for lenvatinib compared to sorafenib (p<0.001). Dose reductions and interruptions were more frequent for lenvatinib compared to sorafenib (p = 0.003 and 0.01, respectively). In our real-life context, RR-DTC treated with first-line sorafenib had more advanced disease compared to lenvatinib. Lenvatinib exerted stronger antitumor activity (improved PFS and ORR) compared to sorafenib, but did not improve OS. Sorafenib was more manageable.

一线lenvatinib和sorafenib治疗RR-DTC来自共同的现实生活背景。
激酶抑制剂lenvatinib和sorafenib是治疗放射性碘难治性分化型甲状腺癌(RR-DTC)的一线选择。在同一研究人群或相似队列之间的比较研究很少。我们的目的是比较lenvatinib和sorafenib在naïve RR-DTC的同质现实环境。我们进行了一项回顾性研究,涉及意大利坎帕尼亚地区的两个机构。主要终点为无进展生存期(PFS)和总生存期(OS)。次要终点为客观缓解率(ORR)、疾病控制率、≥3级不良事件、毒性相关的治疗停药和剂量减少/中断。纳入48例RR-DTC(中位随访45.5个月):2015年至2021年24例接受lenvatinib治疗,2012年至2016年24例接受索拉非尼治疗。索拉非尼组疾病相关症状发生率(p=0.022)、肿瘤负荷(p=0.002)和放射性碘累积剂量均高于lenvatinib组。在单因素分析中,lenvatinib的中位PFS和OS明显长于sorafenib(分别为10个月和38个月)
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