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Second-Line Combination Chemotherapy Under Study in Biliary Tract Cancer

By: Joshua D. Madera, MS
Posted: Monday, November 28, 2022

Combination treatment with fluorouracil (5-FU) and leucovorin (LV) may serve as a potential second-line therapeutic option for patients with biliary tract cancers, according to a poster presented at the European Society for Medical Oncology (ESMO) Congress 2022 (Abstract 53MO). The addition of pegylated liposomal irinotecan did not significantly improve overall or progression-free survival, suggesting the efficacy of fluorouracil and leucovorin alone, according to Arndt Vogel, MD, of the Hannover Medical School, Germany, and colleagues.

A total of 100 patients with histologically confirmed metastatic biliary tract cancer were recruited from 17 German centers for the NALIRICC phase II study. All patients were previously treated with gemcitabine-based therapy. Patients were divided into two treatment groups: biweekly treatment with 80 mg/m2 of pegylated liposomal irinotecan, 2,400 mg/m2 of 5-FU, and 400 mg/m2 of LV or 5-FU and LV. Patients were further stratified based on tumor type and assessed at 6-week increments.

The study findings revealed no significant differences in overall survival (6.9 months with pegylated liposomal irinotecan/5-FU/LV vs. 8.21 months with 5-FU/LV) or progression-free survival (2.76 months vs. 2.3 months, respectively) between treatment groups. Patients also had a similar quality of life, regardless of the combination treatment received. Moreover, patients treated with pegylated liposomal irinotecan/5-FU/LV combination therapy commonly experienced neutropenia (16.6%), diarrhea (14.6%), and nausea (8.3%), suggesting higher rates of toxicity. Furthermore, 27.5% of patients who initially received 5-FU/LV therapy required irinotecan-based therapies after disease progression.

Disclosure: For full disclosures of the study authors, visit

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