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伊立替康肝动脉灌注化疗用于结直肠癌肝转移:一项I期临床研究的结果

Irinotecan hepatic arterial infusion chemotherapy for hepatic metastases from colorectal cancer: results of a phase I clinical study.

作者信息

Fiorentini G, Lucchi S R, Giovanis P, Cantore M, Guadagni S, Papiani G

机构信息

Department of Oncology and Hematology, City Hospital S Maria delle Croci, Ravenna, Italy.

出版信息

Tumori. 2001 Nov-Dec;87(6):388-90. doi: 10.1177/030089160108700606.

DOI:10.1177/030089160108700606
PMID:11989591
Abstract

BACKGROUND

Hepatic arterial infusion chemotherapy is a promising approach in liver metastases from colorectal cancer, but chemical hepatitis, biliary sclerosis, arterial thrombosis and right upper quadrant pain are limiting factors. Irinotecan (CPT-11) is an active drug in colorectal cancer. We planned a short hepatic arterial infusion of CPT-11 to describe the toxicity, to determine the dose-limiting toxicity, and to define the doses of CPT-11 to be recommended for phase II studies.

PATIENTS AND METHODS

Fourteen patients with a median liver substitution of 30% (10-60%) were enrolled. All patients received hepatic arterial infusion chemotherapy with CPT-11 on an outpatient basis every 3 weeks as a short, 30-min infusion.

RESULTS

At 240 mg/m2, 2 of 4 patients experienced grade 4 diarrhea and neutropenia, and 3 of them also reported grade 4 abdominal pain of the right upper quadrant. The maximum tolerated dose was reached at 240 mg/m2. The recommended doses of CPT-11 for phase II studies is 200 mg/m2, given every 3 weeks.

CONCLUSIONS

CPT-11 presents a low hepatic toxic profile and could be considered a new active drug, suitable for hepatic arterial infusion in liver metastases from colorectal cancer.

摘要

背景

肝动脉灌注化疗是治疗结直肠癌肝转移的一种有前景的方法,但化学性肝炎、胆汁性硬化、动脉血栓形成和右上腹疼痛是限制因素。伊立替康(CPT-11)是结直肠癌的一种活性药物。我们计划进行短疗程的CPT-11肝动脉灌注,以描述其毒性,确定剂量限制毒性,并确定推荐用于II期研究的CPT-11剂量。

患者和方法

纳入14例肝脏替代中位数为30%(10%-60%)的患者。所有患者每3周在门诊接受一次CPT-11肝动脉灌注化疗,为30分钟的短疗程灌注。

结果

在240mg/m²剂量时,4例患者中有2例出现4级腹泻和中性粒细胞减少,其中3例还报告有4级右上腹腹痛。最大耐受剂量为240mg/m²。推荐用于II期研究的CPT-11剂量为每3周200mg/m²。

结论

CPT-11具有较低的肝脏毒性,可被视为一种新的活性药物,适用于结直肠癌肝转移的肝动脉灌注。

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Irinotecan hepatic arterial infusion chemotherapy for hepatic metastases from colorectal cancer: results of a phase I clinical study.伊立替康肝动脉灌注化疗用于结直肠癌肝转移:一项I期临床研究的结果
Tumori. 2001 Nov-Dec;87(6):388-90. doi: 10.1177/030089160108700606.
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