Annals of Oncology 12:501-504, 2001
© 2001 European Society for Medical Oncology
research-article |
A phase II trial of irinotecan (CPT-11) for unresectable biliary tree carcinoma
1Division of Hematology/Oncology, Boston Center for Liver Cancer, Beth Israel Deaconess Medical Center, Harvard Medical School Boston, Massachusetts
2Department of medicine, Division of Gastrointestinal Oncology, Memorial Sloan Kettering Cancer Center New York, USA
Correspondence to: E Stuart, MD, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA, E-mail kstuart{at}caregroup.harvard.edu
BackgroundUnresectable adenocarcinomas of the biliary tree have a very poor prognosis No good chemotherapeutic regimen is available Irinotecan has not yet been fully tested in this disease. We evaluated its activity in unresectable bile duct cancers
Patients and methods Twenty-five consecutive eligible patients at our two institutions were treated with irinotecan at a starting dose of 125 mg/m2 A cycle consisted of once-a-week treatments for four consecutive weeks, followed by two weeks of rest. All patients were required to have histologically confirmed diagnosis, clinically documented metastatic or unresectable carcinoma and measurable disease Patients were evaluated for response, toxicity, and survival
Results A total of 83 cycles of therapy were delivered Two patients had a partial response (8%, 95% confidence interval (CI) 0%–18%) and ten additional patients had stable disease for at least two months (40%, 95% CI 20.8%–59 2%) The therapy was well tolerated, with moderate myelosuppression and diarrhea as the main toxicities The overall median survival was 10 months
Conclusions Irinotecan has minimal activity in biliary tree carcinomas, but is well tolerated with appropriate supportive care, and produces occasional objective responses.
biliary tree carcinoma, cholangiocarcinoma, gallbladder carcinoma, irinotecan, phase II trial