Irinotecan With 5-FU/FA in Advanced Biliary Tract Adenocarcinomas
| Autor: | Joachim Mössner, Karel Caca, K. Schoppmeyer, Jürgen Feisthammel, Manfred Schulze, Marcus Wiedmann |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty medicine.medical_treatment Phases of clinical research Antineoplastic Agents Adenocarcinoma Irinotecan Gastroenterology Bile duct cancer Folinic acid Folic Acid Internal medicine medicine Humans Gallbladder cancer Aged Chemotherapy business.industry Middle Aged medicine.disease Survival Analysis Regimen Biliary Tract Neoplasms Oncology Tolerability Vitamin B Complex Camptothecin Female Fluorouracil business medicine.drug |
| Zdroj: | American Journal of Clinical Oncology. 30:319-324 |
| ISSN: | 0277-3732 |
| DOI: | 10.1097/01.coc.0000258124.72884.7a |
| Popis: | Objectives: Biliary cancer has a poor prognosis and lacks a standard palliative chemotherapy. The purpose of this prospective single-arm phase II study was to determine the activity and tolerability of irinotecan, 5-fluorouracil, and folinic acid in advanced biliary cancer. Patients and Methods: Patients with inoperable intrahepatic cholangiocarcinoma (ICC) or gallbladder cancer (GBC) and no prior chemotherapy were eligible. Irinotecan 80 mg/m2, followed by folinic acid 500 mg/m2 and 5-FU 2000 mg/m2 infused over 24 hours (Fufiri) were administered weekly 6 times, every 8 weeks. The primary endpoint was response rate, and secondary endpoints were overall survival (OS), progression-free survival (PFS), and toxicity. Results: Seventeen patients with ICC and 13 patients with GBC were enrolled. All patients were evaluable for safety. WHO grade 3/4 drug-related adverse events occurred in 8 patients (27%), consisting of diarrhea and leukopenia in 5 and 3 patients, respectively. One patient with diarrhea grade 4 finally succumbed to sepsis. Objective response rate was 10% (95% confidence interval, 2.1%–26.5%), with an additional 10% of patients showing stable disease. Median overall survival was 166 days and 273 days, and median progression-free survival was 84 days and 159 days for ICC and GBC, respectively. Conclusions: Fufiri is a well-tolerated regimen in patients with ICC and GBC but has only modest activity in advanced biliary tract cancer. |
| Databáze: | OpenAIRE |
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