Nanoliposomal irinotecan in combination with leucovorin and 5‑fluorouracil in advanced biliary tract cancers

Abstract

Biliary tract cancers (BTC) are rare but aggressive. Due to limited anti-tumor effects of current second- and later-line treatment regimens, novel treatment options are required. Nanoliposomal irinotecan in combination with leucovorin and 5-fluorouracil (FOLFnal-IRI) achieved promising results as a second-line treatment in patients with pancreatic cancer, warranting further investigation in BTC. In the present study, a retrospective analysis of patients receiving FOLFnal-IRI after initial platinum-based chemotherapy for advanced BTC between January 2016 and August 2020 at the University Hospital Cologne (Cologne, Germany) was performed. A total of 11 patients were identified who met the inclusion criteria. A total of 4 patients (36.4%) were female and the median age was 54 years. The proportion of patients suffering from gallbladder carcinoma, intrahepatic and extrahepatic cholangiocarcinoma was 18.2, 63.6 and 9.1%, respectively. Furthermore, 7 patients (63.6%) received FOLFnal-IRI as their second-, 3 (27.3%) as third- and one (9.1%) as their fourth-line therapy. The disease control rate was 54.5% and 3 grade III toxicities were recorded. Progression-free survival and overall survival (OS) after initiation of FOLFnal-IRI was 5.1 and 12.4 months, respectively. OS after initial diagnosis was 24.7 months. FOLFnal-IRI demonstrated promising antitumor potential with an acceptable safety profile as a subsequent therapy regimen in advanced biliary tract malignancies. Further randomized controlled trials of its value as a treatment option for BTC appear justified.

Effect of FGFR2 Alterations on Overall and Progression-Free Survival in Patients Receiving Systemic Therapy for Intrahepatic Cholangiocarcinoma

“…Among 174 patients analyzed for efficacy, the median PFS in the liposomal irinotecan plus fluorouracil and leucovorin cohort was observed to be significantly longer than in the fluorouracil and leucovorin alone cohort (7.1 vs 1.4 months; p = 0.0019) [ 35 ]. Support for these findings was provided by a small retrospective study of 14 patients receiving nanoliposomal irinotecan in combination with leucovorin plus fluorouracil for advanced biliary tract cancer, who had initially received platinum-based chemotherapy [ 36 ]. Among 11 patients analyzed, the results demonstrated median PFS and OS on second-line chemotherapy of 6.1 months and 12.1 months, respectively [ 36 ].…”

“…Support for these findings was provided by a small retrospective study of 14 patients receiving nanoliposomal irinotecan in combination with leucovorin plus fluorouracil for advanced biliary tract cancer, who had initially received platinum-based chemotherapy [ 36 ]. Among 11 patients analyzed, the results demonstrated median PFS and OS on second-line chemotherapy of 6.1 months and 12.1 months, respectively [ 36 ].…”