奥沙利铂、氟尿嘧啶和亚叶酸钙肝动脉灌注与经动脉化疗栓塞治疗大肝细胞癌的随机III期试验
Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Transarterial Chemoembolization for Large Hepatocellular Carcinoma: A Randomized Phase III Trial.
作者信息
Li Qi-Jiong, He Min-Ke, Chen Huan-Wei, Fang Wan-Qiang, Zhou Yuan-Min, Xu Li, Wei Wei, Zhang Yao-Jun, Guo Ying, Guo Rong-Ping, Chen Min-Shan, Shi Ming
机构信息
Department of Hepatobiliary Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
First People's Hospital of Foshan, FoShan, China.
出版信息
J Clin Oncol. 2022 Jan 10;40(2):150-160. doi: 10.1200/JCO.21.00608. Epub 2021 Oct 14.
PURPOSE
In a previous phase II trial, hepatic arterial infusion chemotherapy (HAIC) with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) yielded higher treatment responses than transarterial chemoembolization (TACE) in large unresectable hepatocellular carcinoma. We aimed to compare the overall survival of patients treated with FOLFOX-HAIC versus TACE as first-line treatment in this population.
METHODS
In this randomized, multicenter, open-label trial, adults with unresectable hepatocellular carcinoma (largest diameter ≥ 7 cm) without macrovascular invasion or extrahepatic spread were randomly assigned 1:1 to FOLFOX-HAIC (oxaliplatin 130 mg/m, leucovorin 400 mg/m, fluorouracil bolus 400 mg/m on day 1, and fluorouracil infusion 2,400 mg/m for 24 hours, once every 3 weeks) or TACE (epirubicin 50 mg, lobaplatin 50 mg, and lipiodol and polyvinyl alcohol particles). The primary end point was overall survival by intention-to-treat analysis. Safety was assessed in patients who received ≥ 1 cycle of study treatment.
RESULTS
Between October 1, 2016, and November 23, 2018, 315 patients were randomly assigned to FOLFOX-HAIC (n = 159) or TACE (n = 156). The median overall survival in the FOLFOX-HAIC group was 23.1 months (95% CI, 18.5 to 27.7) versus 16.1 months (95% CI, 14.3 to 17.9) in the TACE group (hazard ratio, 0.58; 95% CI, 0.45 to 0.75; < .001). The FOLFOX-HAIC group showed a higher response rate than the TACE group (73 [46%] 28 [18%]; < .001) and a longer median progression-free survival (9.6 [95% CI, 7.4 to 11.9] 5.4 months [95% CI, 3.8 to 7.0], < .001). The incidence of serious adverse events was higher in the TACE group than in the FOLFOX-HAIC group (30% 19%, = .03). Two deaths in the FOLFOX-HAIC group and two in the TACE group were deemed to be treatment-related.
CONCLUSION
FOLFOX-HAIC significantly improved overall survival over TACE in patients with unresectable large hepatocellular carcinoma.
目的
在先前的一项II期试验中，对于不可切除的大型肝细胞癌，肝动脉灌注化疗（HAIC）联合氟尿嘧啶、亚叶酸钙和奥沙利铂（FOLFOX）的治疗反应率高于经动脉化疗栓塞术（TACE）。我们旨在比较在该人群中接受FOLFOX-HAIC与TACE作为一线治疗的患者的总生存期。
方法
在这项随机、多中心、开放标签试验中，将无大血管侵犯或肝外转移的不可切除肝细胞癌（最大直径≥7 cm）的成年人按1:1随机分配至FOLFOX-HAIC组（奥沙利铂130 mg/m²，亚叶酸钙400 mg/m²，第1天氟尿嘧啶推注400 mg/m²，氟尿嘧啶持续输注2400 mg/m²，每3周1次）或TACE组（表柔比星50 mg，洛铂50 mg，以及碘油和聚乙烯醇颗粒）。主要终点是意向性分析的总生存期。对接受≥1周期研究治疗的患者进行安全性评估。
结果
2016年10月1日至2018年11月23日期间，315例患者被随机分配至FOLFOX-HAIC组（n = 159）或TACE组（n = 156）。FOLFOX-HAIC组的中位总生存期为23.1个月（95%CI，18.5至27.7），而TACE组为16.1个月（95%CI，14.3至17.9）（风险比，0.58；95%CI，0.45至0.75；P <.001）。FOLFOX-HAIC组的缓解率高于TACE组（73例[46%]对28例[18%]；P <.001），中位无进展生存期更长（9.6个月[95%CI，7.4至11.9]对5.4个月[95%CI，3.8至7.0]，P <.001）。TACE组严重不良事件的发生率高于FOLFOX-HAIC组（30%对19%，P =.03）。FOLFOX-HAIC组有2例死亡，TACE组有2例死亡被认为与治疗相关。
结论
对于不可切除的大型肝细胞癌患者，FOLFOX-HAIC较TACE显著改善了总生存期。
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