He M R, Zheng Z K, Wu T Q, Chen M S, Zhou Z G
Department of Liver Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China,Guangdong Provincial Clinical Research Center for Cancer, Guangzhou 510060, China.
Zhonghua Wai Ke Za Zhi. 2024 Apr 1;62(4):309-315. doi: 10.3760/cma.j.cn112139-20231214-00271.
To explore the efficacy and safety of hepatic arterial infusion chemotherapy(HAIC) for unresectable hepatitis B-related intrahepatic cholangiocarcinoma(ICC). This is a retrospective controlled study. Data from 140 unresectable ICC patients who received HAIC treatment at Sun Yat-sen University Cancer Center from March 2015 to June 2023 were retrospectively collected, including 72 patients in the hepatitis B surface antigen(HBsAg)negative group (43 males and 29 females, aged (59.6±9.5)years(range: 34 to 81 years)), 68 cases in the HBsAg-positive group (48 males, 20 females, aged (53.4±11.4)years(range: 29 to 82 years)). HAIC treatment used the FOLFOX regimen combined with oxaliplatin, leucovorin,and fluorouracil. The differences in effects, prognosis,and adverse reactions between the two groups of patients after HAIC treatment were analyzed. All variables were expressed as categorical data. The test or Fisher's exact probability method was used to compare between groups. The Kaplan-Meier method was used to draw survival curves. The difference of survival curve between groups were compared through the Log-rank test. According to the Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1,the objective response rate(ORR) of the HBsAg-negative group was 23.2%(16/69),and the ORR of the HBsAg-positive group was 40.3%(25/62). The difference in ORR between the two groups was statistically significant(=4.459,=0.035). According to the modified RECIST(mRECIST) criteria,the ORR of the HBsAg-negative group was 27.5%(19/69), and the ORR of the HBsAg-positive group was 45.2%(28/62). The difference in ORR between the two groups was statistically significant(=4.410,=0.036). The median progression-free survival(PFS) of the HBsAg-negative group and the positive group were 7.1 months(95%: 5.8 to 13.2 months) and 7.3 months (95%: 5.7 to 10.3 months), respectively, and the median overall survival(OS) were 16.3 months (95%: 12.5 to 33.9 months) and 15.9 months (95%: 9.2 to 20.7 months) respectively. There were no statistically significant differences in PFS and OS between the two groups (both >0.05). The main serious adverse reactions of the two groups of patients included increased AST, increased ALT, thrombocytopenia,and neutropenia. There were no statistically significant differences in various adverse reactions between the two groups after HAIC treatment (all >0.05). Patients with HBsAg-positive unresectable ICC are more likely to benefit from HAIC treatment.
探讨肝动脉灌注化疗(HAIC)治疗不可切除的乙型肝炎相关肝内胆管癌(ICC)的疗效和安全性。这是一项回顾性对照研究。回顾性收集了2015年3月至2023年6月在中山大学肿瘤防治中心接受HAIC治疗的140例不可切除ICC患者的数据,其中乙型肝炎表面抗原(HBsAg)阴性组72例(男43例,女29例,年龄(59.6±9.5)岁(范围:34至81岁)),HBsAg阳性组68例(男48例,女20例,年龄(53.4±11.4)岁(范围:29至82岁))。HAIC治疗采用FOLFOX方案联合奥沙利铂、亚叶酸钙和氟尿嘧啶。分析两组患者HAIC治疗后的疗效、预后及不良反应差异。所有变量均以分类数据表示。采用检验或Fisher精确概率法进行组间比较。采用Kaplan-Meier法绘制生存曲线。通过对数秩检验比较组间生存曲线差异。根据实体瘤疗效评价标准(RECIST)1.1版,HBsAg阴性组的客观缓解率(ORR)为23.2%(16/69),HBsAg阳性组的ORR为40.3%(25/62)。两组ORR差异有统计学意义(=4.459,=0.035)。根据改良RECIST(mRECIST)标准,HBsAg阴性组的ORR为27.5%(19/69),HBsAg阳性组的ORR为45.2%(28/62)。两组ORR差异有统计学意义(=4.410,=0.036)。HBsAg阴性组和阳性组的中位无进展生存期(PFS)分别为7.1个月(95%:5.8至13.2个月)和7.3个月(95%:5.7至10.3个月),中位总生存期(OS)分别为16.3个月(95%:12.5至33.9个月)和15.9个月(95%:9.2至20.7个月)。两组PFS和OS差异均无统计学意义(均>0.05)。两组患者主要的严重不良反应包括谷草转氨酶升高、谷丙转氨酶升高、血小板减少和中性粒细胞减少。HAIC治疗后两组各项不良反应差异均无统计学意义(均>0.05)。HBsAg阳性的不可切除ICC患者更可能从HAIC治疗中获益。