Wang Tianxiao, Dong Jiahong, Zhang Yuewei, Ren Zhizhong, Liu Ying, Yang Xiaowei, Sun Dawei, Wang Yaqin
Department of Hepatobiliary Surgery, The Second Hospital, Shandong University Cheeloo College of Medicine, Jinan, China.
Hepatobiliary Pancreatic Center Department, Beijing Tsinghua Changgung Hospital Affiliated to Tsinghua University, Beijing, China.
Ann Transl Med. 2022 Apr;10(7):411. doi: 10.21037/atm-22-978.
Hyperbilirubinemia is a major barrier to anti-tumor treatment in patients with end-stage primary liver cancer. However, no research has demonstrated the efficacy and safety of hepatic artery infusion chemotherapy (HAIC) in primary liver cancer patients with hyperbilirubinemia. This study investigated HAIC with a modified oxaliplatin, fluorouracil, and leucovorin (mFOLFOX) regimen. The efficacy and safety of the treatment regimen was evaluated and the optimal conditions for further anti-tumor treatments were identified.
A total of 34 patients with hyperbilirubinemia (with an elevation of more than three times the upper limit of normal range in total bilirubin) who were not candidates for surgery, transplantation, tyrosine kinase inhibitor therapy, nor immune checkpoint inhibitor (ICI) therapy, and who received HAIC with the mFOLFOX regimen were enrolled in this study. The laboratory indexes (total bilirubin, tumor markers, and blood count), quality of life [World Health Organization Quality of Life (WHOQOL)-100 score], adverse reactions [Common Terminology Criteria for Adverse Events (CTCAE)-5.0], and overall survival were analyzed.
Between June 2017 and January 2021, 34 patients received a total of 81 cycles of HAIC after percutaneous transhepatic biliary drainage (PTBD). The total bilirubin (TBIL) decreased significantly at 1 month after the last cycle of HAIC (127.8 68.3 µmol/L; P<0.01). There was no significant decrease in platelet, white blood cell, nor red blood cell counts, suggesting that HAIC had limited toxicity on the hematopoietic system. The WHOQOL-100 score significantly increased at 3 months after HAIC (78.16 69.26; P<0.05). The median overall survival was 9.5 months (range, 2-24 months), the objective response rate was 14.7%, and the disease control rate was 61.8% in HAIC-treated patients. A total of 14 patients received targeted or immunological therapy after HAIC, and 2 of these patients achieved complete remission.
HAIC improved the liver function and the quality of life in patients with liver cancer and hyperbilirubinemia, which provided options for further anti-tumor treatments in such patients.
高胆红素血症是终末期原发性肝癌患者抗肿瘤治疗的主要障碍。然而，尚无研究证实肝动脉灌注化疗（HAIC）在高胆红素血症原发性肝癌患者中的疗效和安全性。本研究采用改良的奥沙利铂、氟尿嘧啶和亚叶酸钙（mFOLFOX）方案进行HAIC治疗。评估了该治疗方案的疗效和安全性，并确定了进一步抗肿瘤治疗的最佳条件。
本研究纳入了34例高胆红素血症患者（总胆红素升高超过正常范围上限的三倍），这些患者不适合手术、移植、酪氨酸激酶抑制剂治疗或免疫检查点抑制剂（ICI）治疗，并接受了mFOLFOX方案的HAIC治疗。分析了实验室指标（总胆红素、肿瘤标志物和血细胞计数）、生活质量[世界卫生组织生活质量（WHOQOL）-100评分]、不良反应[不良事件通用术语标准（CTCAE）-5.0]和总生存期。
2017年6月至2021年1月期间，34例患者在经皮经肝胆道引流（PTBD）后共接受了81个周期的HAIC治疗。在HAIC最后一个周期后1个月，总胆红素（TBIL）显著下降（127.8±68.3µmol/L；P<0.01）。血小板、白细胞和红细胞计数均无显著下降，表明HAIC对造血系统的毒性有限。HAIC治疗后3个月，WHOQOL-100评分显著升高（78.16±69.26；P<0.05）。接受HAIC治疗患者的中位总生存期为9.5个月（范围2-24个月），客观缓解率为14.7%，疾病控制率为61.8%。共有14例患者在HAIC治疗后接受了靶向或免疫治疗，其中2例患者实现了完全缓解。
HAIC改善了肝癌合并高胆红素血症患者的肝功能和生活质量，为这类患者进一步的抗肿瘤治疗提供了选择。
