A pilot study of bendamustine in advanced bile duct cancer.
We performed a pilot study to evaluate the safety and tolerability of bendamustine in patients with advanced hilar bile duct cancer and impaired liver function. Six patients with histologically proven, unresectable adenocarcinoma of the hilar bile duct were treated with bendamustine 140 mg/m intravenously on day 1 of the first cycle and with bendamustine 100 mg/m on days 1 and 2 of the second to fourth cycle. Treatment cycles were repeated every 21 days. Primary endpoint was the safety and tolerability of the treatment; secondary endpoints were response rate, time to progression and overall survival. Transient lymphopenia grade 3 occurred in all six patients. No other grade 3 or 4 toxicities were present. The most common nonhematologic toxicity was mouth dryness grade 2 in six patients. Three patients had stable disease. No partial or complete responses were observed. Median time to progression was 3.3 months; median overall survival was 6 months. Our study demonstrates that bendamustine can be safely administered in patients with hilar bile duct cancer and impaired liver function. A potential role of bendamustine in combination therapies for bile duct cancer will be a subject of further trials.
Schoppmeyer
Konrad
K
Department of Medicine II, University of Leipzig, Germany. konrad.schoppmeyer@medizin.uni-leipzig.de
Kreth
Florian
F
Wiedmann
Marcus
M
Mössner
Joachim
J
Preiss
Rainer
R
Caca
Karel
K
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000652:urine; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use / Q000652:urine; D000069461:Bendamustine Hydrochloride; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000652:urine; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008111:Liver Function Tests; D008297:Male; D050217:Metabolic Detoxication, Phase II; D008875:Middle Aged; D009367:Neoplasm Staging; D009588:Nitrogen Mustard Compounds / Q000009:adverse effects / Q000627:therapeutic use / Q000652:urine; D010865:Pilot Projects
D000970:Antineoplastic Agents; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride