RALOX方案 vs FOLFOX方案经肝动脉灌注化疗治疗中晚期肝细胞癌孰优孰劣？中国团队ASCO重磅发文

近年来，大量研究表明肝动脉灌注化疗（HAIC）能显著改善晚期肝细胞癌（HCC）患者生存。目前HAIC常用化疗方案为奥沙利铂联合氟尿嘧啶（FOLFOX），灌注时间46小时。雷替曲塞是喹唑啉叶酸盐类似物，作用机制与氟尿嘧啶类似，由于其半衰期更长，奥沙利铂联合雷替曲塞（RALOX）灌注化疗灌注时间可缩短至5小时。那么FOLFOX方案与RALOX方案灌注化疗治疗中晚期HCC的有效性及安全性孰优孰劣呢？

近期，南方医科大学南方医院陈锦章教授团队的一篇研究论文在线发表于美国临床肿瘤学会（ASCO），对RALOX和FOLFOX方案灌注化疗进行了比较，结果证明治疗中晚期HCC，RALOX和FOLFOX方案灌注化疗有效性及安全性无显著差异。以下对该内容进行简要介绍，供大家交流学习。

该研究一共纳入2019年3月至2020年11月收治于南方医科大学南方医院肝脏肿瘤中心的66例中晚期HCC患者。33 例患者接受FOLFOX方案灌注化疗（奥沙利铂 85 mg / m²，亚叶酸钙400mg / m²，5-氟尿嘧啶bolus 400mg / m²第 1 天， 5 -氟尿嘧啶输注 2400mg / m² 持续 46 小时，每 3 周一次）。另外 33 例患者接受了RALOX的方案灌注化疗（奥沙利铂100mg / m²，雷替曲塞3mg / m²，每 3 周 1 次）。分析比较两组客观缓解率（ORR），疾病控制率（DCR）、中位PFS(mPFS)及治疗相关不良反应（TRAE）。

根据RECIST1.1标准，FOLFOX组和RALOX组的ORR 均为33.3%（P= 1.00)。FOLFOX组和RALOX组DCR分别为90.9%和87.9%（P=1.00)。FOLFOX组中位PFS为10.7个月，RALOX组中位PFS则为7.9个月（P= 0.251)。两组3/4级治疗相关不良反应类似，主要包括转氨酶升高、白细胞及血小板减少、恶心呕吐等。

南方医科大学南方医院肝脏肿瘤中心陈锦章教授为本文通讯作者，南方医科大学南方医院肝脏肿瘤中心臧梦雅博士为本文第一作者。

参考文献：J Clin Oncol 40, 2022 (suppl 16; abstr e16166)

Hepatology Unit and Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China

Mengya Zang, Qi Li, Xiaoyun Hu, Guosheng Yuan, Rong Li, Yabing Guo, Jinzhang Chen

Hepatology Unit and Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China, Hepatology Unit and Department of Infectious Diseases, Nanfang Hospital Southern Medical University, Guangzhou, China

Abstract Disclosures

No funding received

Hepatic arterial infusion chemotherapy (HAIC) showed promising outcomes for advanced hepatocellular carcinoma (HCC) and was recommended in patients with advanced HCC in Asia. HAIC with oxaliplatin, 5-fluorouracil, and leucovorin (FOLFOX) was most commonly used in China. However, Continuous infusion (over 46 hours) with fluorouracil was inconvenient for arterial infusion. Raltitrexed, another antimetabolic drug with long plasma concentrations half-life, could be used in short infusions. HAIC with raltitrexed plus oxaliplatin (RALOX) was reported to be effective and safe in HCC. This study aimed to compare efficacy and safety of HAIC with raltitrexed plus oxaliplatin versus oxaliplatin plus fluorouracil in intermediate and advanced HCC.

Sixty-six patients with intermediated and advanced HCC were included in this retrospective study between March 2019 and November 2020. Thirty-three patients were treated with HAIC of FOLFOX (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracilbolus 400 mg/m2 on day 1, and 5-fluorouracil infusion 2400 mg/m2 for 46 h, every 3 weeks). Another thirty-three patients received HAIC of RALOX (oxaliplatin 100 mg/m2, raltitrexed3 mg/m2, every 3 weeks). Objective response rate (ORR), diseases control rate (DCR), progression-free survival (PFS) and treatment-related adverse events were analyzed.

The ORR was both 33.3% in the FOLFOX group and RALOX group per RECIST 1.1 criteria (P = 1.00). The DCR was 90.9% and 87.9% in the FOLFOX group and RALOX group, respectively (P = 1.00). The median PFS was 10.7 months in the FOLFOX group versus 7.9 months in the RALOX group (P= 0.251). Grade 3/4 treatment-related adverse events were comparable between the two groups, including neutropenia, thrombocytopenia, elevated aminotransferase level and nausea.

The efficacy and safety of HAIC with raltitrexed plus oxaliplatin was comparable to HAIC with oxaliplatin plus fluorouracil in intermediate and advanced HCC.

This material on this page is 2022 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact

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First Author：

Mengya Zang

Meeting：

2022 ASCO Annual Meeting

Session Type：

Publication Only

Session Title：

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track：

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track：

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Citation：

J Clin Oncol 40, 2022 (suppl 16; abstr e16166)

DOI：

10.1200/JCO.2022.40.16_suppl.e16166

Abstract #：

e16166