目的:评估吉西他滨和奥沙利铂(GEMOX)肝动脉灌注化疗(HAIC)联合全身吉西他滨化疗(GEM-SYS)联合来伐替尼和程序性细胞死亡蛋白-1(PD-1)抑制剂治疗大型不可切除肝内胆管癌(uICC)的疗效和安全性。
方法:从2019年11月至2022年12月,回顾性纳入21例接受GEMOX-HAIC(第1天)和GEM-SYS(第8天)(3w/周期)联合lenvatinib和PD-1抑制剂的大型uICC患者。局部肿瘤反应,无进展生存期(PFS),总生存期(OS),并对不良事件(AE)进行分析。通过实体瘤中的反应评价标准(RECIST)版本1.1评估肿瘤反应。通过不良事件通用术语标准(CTCAE)5.0版评估AE。
结果:中位随访时间为16.0个月(范围5-43.5个月)后,17名患者死亡。中位OS为19.5个月(范围9-43.5个月),中位PFS为6.0个月(范围2.5-38.5个月).1-,2-,3年OS率为71.4%,42.9%,和19.0%,分别。1-,2-,3年PFS率为33.3%,19.0%,和9.5%,分别。完整的响应,部分响应,疾病稳定,在0(0%)观察到进行性疾病,11(52.3%),5(23.8%),5名(23.8%)患者,分别。疾病控制率和客观有效率分别为76.1%和52.3%,分别。所有入选患者均未出现5级AE。
结论:GEMOX-HAIC加GEM-SYS联合lenvatinib和PD-1抑制剂对大型uICC患者有效且耐受性良好。
OBJECTIVE: To assess the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of gemcitabine and oxaliplatin (GEMOX) plus systemic gemcitabine chemotherapy (GEM-SYS) in combination with lenvatinib and programmed cell death protein-1 (PD-1) inhibitor for patients with large unresectable intrahepatic cholangiocarcinoma (uICC).
METHODS: From November 2019 to December 2022, 21 large uICC patients who underwent GEMOX-HAIC (Day 1) and GEM-SYS (Day 8) (3w/cycle) combined with lenvatinib and PD-1 inhibitor were retrospectively enrolled. Local tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were analyzed. Tumor response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. AEs were evaluated by the common terminology criteria for adverse events (CTCAE) version 5.0.
RESULTS: After a median follow-up duration of 16.0 months (range 5-43.5 months), 17 patients had died. The median OS was 19.5 months (range 9-43.5 months), and the median PFS was 6.0 months (range 2.5-38.5 months). The 1-, 2-, and 3-year OS rates were 71.4 %, 42.9 %, and 19.0 %, respectively. The 1-, 2-, and 3-year PFS rates were 33.3 %, 19.0 %, and 9.5 %, respectively. Complete response, partial response, stable disease, and progressive disease were observed in 0 (0 %), 11 (52.3 %), 5 (23.8 %), and 5 (23.8 %) patients, respectively. The disease control rate and objective response rate were 76.1 % and 52.3 %, respectively. None of the enrolled patients experienced grade 5 AEs.
CONCLUSIONS: GEMOX-HAIC plus GEM-SYS in combination with lenvatinib and PD-1 inhibitor was effective and well tolerated for patients with large uICC.