Department of Liver Surgery and Transplantation, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China.
Front Immunol. 2022 Nov 25;13:1016736. doi: 10.3389/fimmu.2022.1016736. eCollection 2022.
Conversion therapy is feasible in patients with oncologically unresectable hepatocellular carcinoma (HCC). However, it is challenging to prospectively identify patients who are more likely to achieve successful conversion before initiating systemic therapy, either alone or combined with locoregional therapy.
Criteria for identifying potentially resectable patients with initially oncologically unresectable HCC before treatment with lenvatinib plus an anti-PD-1 antibody were proposed based on real-world evidence. Multivariate Firth logistic regression was used to validate the proposed criteria in a retrospective cohort of consecutive patients with advanced HCC, who received combination therapy with lenvatinib plus an anti-PD-1 antibody between September 2018 and September 2021.
The proposed criteria were as follows: (1) Eastern Cooperative Oncology Group performance status of 0 or 1; (2) Child-Pugh class A; (3) intrahepatic tumors confined to one lobe (left, right, or middle lobe), or present in one lobe alongside a single tumor with diameter ≤5 cm or up to three tumors each with diameter ≤3 cm in the remaining lobes, with R0 resection achievable by hemihepatectomy, alone or combined with locoregional therapy to the remaining lobes during surgery; and (4) no portal vein tumor thrombus involving the contralateral liver lobe or reaching the superior mesenteric vein, no hepatic vein tumor thrombus involving more than two major hepatic vein branches on the tumor side, and no tumor thrombus of the inferior vena cava reaching the atrium. Firth logistic regression confirmed the criteria were an independent predictor of surgery following conversion therapy with lenvatinib plus an anti-PD-1 antibody.
This study proposed and validated criteria for identifying patients with initially oncologically unresectable HCC who are potentially resectable when treated with combination therapy with lenvatinib plus an anti-PD-1 antibody. The proposed criteria could help standardize conversion therapy studies in advanced HCC.
对于肿瘤无法切除的肝细胞癌（HCC）患者，转化治疗是可行的。然而，在开始接受索拉非尼联合抗 PD-1 抗体系统治疗之前，无论是单独治疗还是联合局部区域治疗，预测哪些患者更有可能成功转化仍然具有挑战性。
根据真实世界证据，提出了在接受仑伐替尼联合抗 PD-1 抗体治疗前，识别初始肿瘤无法切除的 HCC 患者是否具有潜在可切除性的标准。采用多变量 Firth 逻辑回归方法，验证了 2018 年 9 月至 2021 年 9 月间连续接受仑伐替尼联合抗 PD-1 抗体联合治疗的晚期 HCC 患者回顾性队列中提出的标准。
提出的标准如下：（1）东部肿瘤协作组（ECOG）体能状态为 0 或 1；（2）Child-Pugh 分级为 A；（3）肿瘤局限于一叶（左叶、右叶或中叶），或一叶内存在单个肿瘤，直径≤5cm，或剩余叶内存在 3 个肿瘤，每个肿瘤直径均≤3cm，可通过半肝切除术实现 R0 切除，单独或联合局部区域治疗切除剩余叶肿瘤；（4）无门静脉肿瘤血栓累及对侧肝叶或侵犯肠系膜上静脉，无肝静脉肿瘤血栓侵犯肿瘤侧两支以上主要肝静脉分支，下腔静脉肿瘤血栓无侵犯心房。Firth 逻辑回归证实，这些标准是接受仑伐替尼联合抗 PD-1 抗体转化治疗后行手术的独立预测因素。
本研究提出并验证了一种标准，用于识别初始肿瘤无法切除的 HCC 患者，这些患者在接受仑伐替尼联合抗 PD-1 抗体联合治疗时具有潜在可切除性。这些标准有助于规范晚期 HCC 的转化治疗研究。
Zotero 插件