Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 510120, China; Department of Interventional Radiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 510120, China; Department of Interventional Radiology, Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University, Shanwei, 516600, China.
Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 510120, China; Department of Interventional Radiology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 510120, China; Department of Interventional Radiology, Shenshan Medical Center, Memorial Hospital of Sun Yat-sen University, Shanwei, 516600, China.
Int Immunopharmacol. 2024 Oct 25;140:112872. doi: 10.1016/j.intimp.2024.112872. Epub 2024 Aug 8.
PURPOSE: 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.
目的：评估吉西他滨和奥沙利铂肝动脉灌注化疗（GEMOX）联合全身吉西他滨化疗（GEM-SYS）联合仑伐替尼和程序性死亡蛋白-1（PD-1）抑制剂治疗不可切除的大型肝内胆管癌（uICC）患者的疗效和安全性。
方法：回顾性纳入 2019 年 11 月至 2022 年 12 月期间接受 GEMOX-HAIC（第 1 天）和 GEM-SYS（第 8 天）（3w/cycle）联合仑伐替尼和 PD-1 抑制剂治疗的 21 例大型 uICC 患者。分析局部肿瘤反应、无进展生存期（PFS）、总生存期（OS）和不良事件（AEs）。采用实体瘤反应评价标准（RECIST）1.1 版评价肿瘤反应。采用不良事件通用术语标准（CTCAE）5.0 版评价 AE。
结果：中位随访时间为 16.0 个月（范围 5-43.5 个月），17 例患者死亡。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 率分别为 71.4%、42.9%和 19.0%。1、2、3 年 PFS 率分别为 33.3%、19.0%和 9.5%。完全缓解、部分缓解、疾病稳定和疾病进展分别见于 0（0%）、11（52.3%）、5（23.8%）和 5（23.8%）例患者。疾病控制率和客观缓解率分别为 76.1%和 52.3%。无 5 级 AE。
结论：GEMOX-HAIC 联合 GEM-SYS 联合仑伐替尼和 PD-1 抑制剂治疗不可切除的大型 uICC 患者有效且耐受良好。
Int Immunopharmacol. 2024-3-10
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