TY - JOUR
T1 - The epothilone B analogue ixabepilone in patients with advanced hepatobiliary cancers
T2 - A trial of the University of Chicago phase II consortium
AU - Nimeiri, Halla S.
AU - Singh, Deepti A.
AU - Kasza, Kristen
AU - Taber, David A.
AU - Ansari, Rafat H.
AU - Vokes, Everett E.
AU - Kindler, Hedy L.
N1 - Funding Information:
Supported by NCI grant N01-CM-17102
PY - 2010/12
Y1 - 2010/12
N2 - Purpose 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. Methods Eligible patients had previously-untreated, histologically-proven unresectable hepatobiliary cancer. Ixabepilone, 40 mg/m2, was administered intravenously over 3 h every 21 days. Results 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%). Conclusion Single agent ixabepilone has limited activity in advanced hepatobiliary cancers.
AB - Purpose 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. Methods Eligible patients had previously-untreated, histologically-proven unresectable hepatobiliary cancer. Ixabepilone, 40 mg/m2, was administered intravenously over 3 h every 21 days. Results 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%). Conclusion Single agent ixabepilone has limited activity in advanced hepatobiliary cancers.
KW - Epothilone
KW - Hepatobiliary cancers
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U2 - 10.1007/s10637-009-9297-6
DO - 10.1007/s10637-009-9297-6
M3 - Article
C2 - 19669700
AN - SCOPUS:78549295200
VL - 28
SP - 854
EP - 858
JO - Investigational New Drugs
JF - Investigational New Drugs
SN - 0167-6997
IS - 6
ER -
