Department of Radiology, Medical School, National and Kapodistrian University of Athens, 19 Monis Kyccou, 15 669 Papagou, Athens, Greece.
Evgenidion and Attikon University Hospitals, Chaidari, Greece.
Cardiovasc Intervent Radiol. 2023 Jul;46(7):880-890. doi: 10.1007/s00270-023-03446-6. Epub 2023 Jun 19.
To describe safety and clinical outcomes among patients with metastatic colorectal cancer (mCRC) to the liver treated with transarterial chemoembolization with HepaSphere™ Microspheres 30-60 μm loaded with irinotecan (ΙRI-HEP-TACE).
In this prospective study (NCT04866290), 100 adults with confirmed mCRC to the liver who were ineligible for resection were enrolled and followed up to 24 months or death. Study outcomes among Salvage (patients not tolerating more cycles of chemotherapy) and Non-salvage patients included overall survival (OS), progression-free survival (PFS), objective response (OR), objective response rate (ORR), best tumor response (BTR), adverse events (AEs), and pharmacokinetics of irinotecan and its active metabolite, 7-ethyl-10-hydroxy-camptothecin (SN38).
The median age was 66 years (range: 31-89). Median OS was 15.08 months (95% confidence interval [CI]: 12.33-17.25). PFS was 8.52 months (95% CI: 6.0-9.0; p < 0.001). ORR was 42.2% (95% CI: 31.57-53.50) and 35.9% (95% CI: 25.57-47.62) based on modified RECIST (Response Evaluation Criteria in Solid Tumors) and RECIST 1.1 criteria. BTR was not significantly different between mRECIST and RECIST (p = 0.745). The Non-salvage group had a statistically significant difference in median OS relative to the Salvage group (15.3 vs. 3 months; p < 0.001). Pharmacokinetic analyses demonstrated no correlation of OS with plasma concentration of irinotecan and SN38 (all p > 0.05). Most AEs were Grade 2 (257/279), the most common AE was right upper abdominal pain (180/279). One major AE (tumor rupture) was reported.
IRI-HEP-TACE is an alternative treatment for patients with Non-salvage mCRC to the liver.
描述经动脉化疗栓塞术联合伊立替康载药微球（HepaSphere™ 微球 30-60μm）治疗转移性结直肠癌（mCRC）肝转移患者的安全性和临床结局。
本前瞻性研究（NCT04866290）纳入了 100 例无法接受手术切除的确诊 mCRC 肝转移的成年患者，随访时间为 24 个月或死亡。在 Salvage（不能耐受更多周期化疗的患者）和 Non-salvage 患者中，研究结局包括总生存期（OS）、无进展生存期（PFS）、客观缓解（OR）、客观缓解率（ORR）、最佳肿瘤缓解（BTR）、不良事件（AEs）以及伊立替康及其活性代谢物 7-乙基-10-羟基喜树碱（SN38）的药代动力学。
中位年龄为 66 岁（范围：31-89 岁）。中位 OS 为 15.08 个月（95%置信区间 [CI]：12.33-17.25）。PFS 为 8.52 个月（95% CI：6.0-9.0；p<0.001）。根据改良 RECIST（实体瘤反应评估标准）和 RECIST 1.1 标准，ORR 分别为 42.2%（95% CI：31.57-53.50）和 35.9%（95% CI：25.57-47.62）。mRECIST 和 RECIST 之间的 BTR 无显著差异（p=0.745）。与 Salvage 组相比，Non-salvage 组的中位 OS 存在统计学差异（15.3 个月 vs. 3 个月；p<0.001）。药代动力学分析显示，OS 与伊立替康和 SN38 的血浆浓度无相关性（均 p>0.05）。大多数 AE 为 2 级（279/279），最常见的 AE 是右上腹疼痛（180/279）。报告了 1 例主要 AE（肿瘤破裂）。
对于 Non-salvage mCRC 肝转移患者，IRI-HEP-TACE 是一种替代治疗方法。
