Efficacy and safety of lenvatinib monotreatment and lenvatinib-based combination therapy for patients with unresectable hepatocellular carcinoma: a retrospective, real-world study in China.
Efficacy and safety of lenvatinib monotreatment and lenvatinib-based combination therapy for patients with unresectable hepatocellular carcinoma: a retrospective, real-world study in China.
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乐伐替尼单药治疗和以乐伐替尼为基础的联合治疗对不可切除的肝细胞癌患者的疗效和安全性：一项在中国进行的回顾性真实世界研究。
DOI：
10.1186/s12935-021-02200-7
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发表时间：
2021-09-18
影响因子：
5.8
通讯作者：
Cheng Y
中科院分区：
文献类型：
--
作者：
Zhu Y;Sun P;Wang K;Xiao S;Cheng Y;Li X;Wang B;Li J;Yu W;Cheng Y
乐伐替尼和以乐伐替尼为基础的联合治疗在临床上广泛应用于不可切除的肝细胞癌（uHCC）患者，但其疗效和安全性还需要在真实的世界中进一步研究。这是一项回顾性研究，涉及2018年11月至2020年9月在南方医院接受乐伐替尼单药治疗和基于乐伐替尼的联合治疗的uHCC患者。通过客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、肿瘤进展时间（TTP）和总生存期（OS）评价疗效。记录治疗相关不良事件（TRAE）并进行分级。比较单药治疗和联合治疗的疗效和安全性。根据联合治疗的全身治疗线和药物方案进行分层分析。对于乐伐替尼单药治疗（n = 39），OS和PFS分别为80周和24.3周。对于联合治疗（n = 72），中位OS和PFS分别为99周和45.6周。联合治疗队列患者的OS、PFS和TTP显著长于单药治疗队列患者（OS：P = 0.04，PFS：P = 0.003; TTP，P = 0.005）。在单药治疗队列和联合治疗队列中，TRAE的发生率均得到控制。在单药治疗队列中，与一线治疗组相比，二线治疗组的OS和PFS显著降低，而在联合治疗队列中未观察到差异。三联疗法（乐伐替尼+PD-1抗体+TACE或HAIF）的疗效与乐伐替尼+PD-1抗体或乐伐替尼+TACE或HAIF相似。我们的真实世界研究表明，乐伐替尼单药治疗和基于乐伐替尼的联合治疗耐受性良好，在uHCC患者中具有令人鼓舞的疗效。与乐伐替尼单药治疗相比，以乐伐替尼为基础的联合治疗显示出更好的疗效。在一线TKI治疗失败的患者中，基于乐伐替尼的联合治疗可能是比乐伐替尼单药治疗更好的选择。基于乐伐替尼的三联疗法可能不优于双联疗法。在线版本包含补充材料，可通过10.1186/s12935-021-02200-7获得。
Lenvatinib and lenvatinib-based combination treatments are widely used in patients with unresectable hepatocellular carcinoma (uHCC) in clinical practice, but their curative effect and safety need further study in the real world. This was a retrospective study involving patients with uHCC receiving lenvatinib monotherapy and lenvatinib-based combination treatment between Nov, 2018 and Sep, 2020 in Nanfang Hospital. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of monotherapy and combination therapy were compared. Stratified analysis was performed according to systemic line of treatment and medication regimen for combination therapy. For lenvatinib monotherapy (n = 39), OS and PFS were 80 weeks and 24.3 weeks, respectively. For combination treatment (n = 72), median OS and PFS were 99 weeks and 45.6 weeks, respectively. OS, PFS, and TTP for patients in the combination treatment cohort were significantly longer compared to those of patients in the monotreatment cohort (OS: P = 0.04, PFS: P = 0.003; TTP, P = 0.005). The incidence of TRAEs could be controlled both in the monotherapy cohort and the combination treatment cohort. In the monotherapy cohort, OS and PFS were significantly decreased in the second-line treatment group compared with the first-line treatment group, while no differences were observed in the combination cohort. The efficacy of triple therapy (lenvatinib plus PD-1 antibody plus TACE or HAIF) was similar to lenvatinib plus PD-1 antibody or lenvatinib plus TACE or HAIF. Our real-world study showed that lenvatinib monotherapy and lenvatinib-based combination therapy were well tolerated, with encouraging efficacies in patients with uHCC. Lenvatinib-based combination therapy showed a better curative effect compared with lenvatinib single-agent therapy. In patients who have failed first-line TKI treatment, lenvatinib-based combination therapy may be a better choice than lenvatinib single-agent therapy. Lenvatinib-based triple therapy may not have an advantage over dual therapy. The online version contains supplementary material available at 10.1186/s12935-021-02200-7.
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影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
与PD-1/PD-L1阻滞有关的毒性。
DOI：
10.1097/ppo.0000000000000296
发表时间：
2018
期刊：
Cancer journal (Sudbury, Mass.)
影响因子：
--
作者：
Wang DY;Johnson DB;Davis EJ
通讯作者：
Davis EJ
影响因子：
158.5
作者：
Llovet, Josep M.;Ricci, Sergio;Bruix, Jordi
通讯作者：
Bruix, Jordi
影响因子：
45.3
作者：
Finn, Richard S.;Ikeda, Masafumi;Llovet, Josep M.
通讯作者：
Llovet, Josep M.
影响因子：
2.3
作者：
Hiraoka, Atsushi;Kumada, Takashi;Michitaka, Kojiro
通讯作者：
Michitaka, Kojiro