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Liposome Encapsulated Irinotecan Is Active in Cholangiocarcinoma
Standard first-line chemotherapy for advanced cholangiocarcinoma is gemcitabine and cisplatin. Recent data support the use of FOLFOX as a second-line regimen, but the benefits are marginal. Given the regulatory approval of specific molecular targeted agents in later-line therapy, genomic profiling of these cancers is now mandatory.
Investigators in South Korea report results of an industry-sponsored, open-label, randomized phase 2 trial comparing treatment with infusional 5-fluorouracil (5-FU) and leucovorin with or without the addition of liposome encapsulated irinotecan in patients with advanced biliary cancer that progressed on gemcitabine and cisplatin. Of 174 patients, half had progression after a median of less than 5.1 months of prior treatment; 43% had intrahepatic, 27% extrahepatic, and 30% gallbladder primaries; and 71% had hepatic metastases.
At a median follow-up of 11.8 months, progression-free survival by central review — the primary endpoint — was superior with liposome encapsulated irinotecan compared to without (median,7.1 vs. 1.4 months; hazard ratio, 0.56; P=0.0019). Overall survival was also superior with liposome encapsulated irinotecan (median, 8.65 vs. 5.5. months; P=0.035) and antitumor response by central review was higher (14.5% vs. 5.8%; P=0.068). Grade 3 or higher treatment-related adverse events were higher with liposome encapsulated irinotecan (7% vs. 1%).
Comment
Results from this phase 2 trial of liposome encapsulated irinotecan combined with 5-FU/leucovorin indicate significant second-line activity for this regimen in cholangiocarcinoma and appear more favorable than results with second line FOLFOX. This regimen will likely move forward as a second-line option in this disease, in particular in patients without a targeted therapy option after assessment with genomic profiling.
Citation(s)
Author:
Yoo C et al.
Title:
Liposomal irinotecan plus fluorouracil and leucovorin versus fluorouracil and leucovorin for metastatic biliary tract cancer after progression on gemcitabine plus cisplatin (NIFTY): A multicentre, open-label, randomised, phase 2b study.
Source:
Lancet Oncol
2021
Nov
; [e-pub].
(Abstract/FREE Full Text)
Empfohlen von
David H. Ilson, MD, PhD