Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, 676 North St. Clair Street, suite 850, Chicago, IL 60611, USA.
Invest New Drugs. 2010 Dec;28(6):854-8. doi: 10.1007/s10637-009-9297-6. Epub 2009 Aug 11.
Hepatobiliary cancers respond poorly to cytotoxic chemotherapy. We evaluated the activity and safety of ixabepilone, an epothilone B analogue which stabilizes microtubules, in a phase II trial in patients with advanced cancers of the gallbladder, bile duct, and liver.
Eligible patients had previously-untreated, histologically-proven unresectable hepatobiliary cancer. Ixabepilone, 40 mg/m(2), was administered intravenously over 3 h every 21 days.
Between January 2002 and April 2005, 54 patients (19 hepatocelluar carcinoma, 13 cholangiocarcinomas, 22 gallbladder carcinomas) were enrolled; 47 patients were evaluable for efficacy. The objective response rate was 8.5%; 51% had stable disease. Median overall survival was 7.0 months (95% CI, 5.0 to 10.8 months) and median progression-free survival was 2.6 months (95% CI, 1.4 to 4.1 months). Grade 3/4 toxicities included neutropenia (39%), fatigue (9%), allergic/hypersensitivity reaction (4%) and sensory neuropathy (4%).
Single agent ixabepilone has limited activity in advanced hepatobiliary cancers.
肝胆癌对细胞毒性化疗反应不佳。我们评估了 ixabepilone（一种稳定微管的表鬼臼毒素类似物）在晚期胆囊、胆管和肝癌患者的 II 期试验中的活性和安全性。
符合条件的患者为既往未经治疗、组织学证实无法切除的肝胆癌患者。Ixabepilone 剂量为 40mg/m²，静脉输注 3 小时，每 21 天一次。
2002 年 1 月至 2005 年 4 月期间，共纳入 54 例患者（19 例肝细胞癌、13 例胆管癌、22 例胆囊癌）；47 例患者可评估疗效。客观缓解率为 8.5%；51%的患者疾病稳定。总生存期的中位数为 7.0 个月（95%CI，5.0 至 10.8 个月），无进展生存期的中位数为 2.6 个月（95%CI，1.4 至 4.1 个月）。3/4 级毒性包括中性粒细胞减少症（39%）、疲劳（9%）、过敏/过敏反应（4%）和感觉神经病变（4%）。
单药 ixabepilone 在晚期肝胆癌中的活性有限。
