This transcript has been edited for clarity.
I'm David Kerr, professor of cancer medicine at University of Oxford. I've been interested in GI cancers, generally, for a long time now but I've become quite interested, recently — in biliary tract cancers. I've got a fantastic group of surgeons in Oxford that I work with. We're really starting to get our act together in terms of what we're doing with advanced metastatic biliary tract disease.
There's a really interesting article I just picked up in The Lancet from an excellent group of South Korean investigators, who published a randomized phase 2 trial in patients with advanced metastatic biliary tract cancer that's progressed despite initial treatment with gemcitabine plus cisplatin.
We know that the prognosis for these poor patients is appalling and absolutely dismal. They've done a second-line study in which they randomized around 180 patients to either infusional 5-FU plus leucovorin or infusional 5-FU plus leucovorin with the addition of liposomal irinotecan.
The primary endpoint was looking at centrally reviewed progression-free survival. There was a highly significant advantage in favor of the group who got liposomal irinotecan in addition to infusion of 5-FU plus leucovorin. Median progression-free survival was 7.1 months compared with 1.4 months for those who were treated only with 5-FU plus leucovorin.
Both drugs were relatively well tolerated. There was quite a bit more neutropenia in the group who received the liposomal-encapsulated irinotecan. This was a very nice positive study, leading the Korean investigators to suggest that this could be worthy of consideration as a new line of treatment for those patients who've progressed on frontline therapy.
This was a very nice study that was very well organized, and it just made me think a little about the cycle of time. When you've been a cancer doctor for a while, like me, things do come around again. Ecclesiastes spoke about how everything has a time, all things. I remember, as a young research fellow in Glasgow, working on liposomes, looking at the theories behind how they help distribute drugs more effectively towards the tumor, and the fascinating discussions about the physicochemical properties of liposomes, their size, their melt-ability, etc.
Here we are 30 years later with a very nice positive study showing that liposomal encapsulation looks as if it may help and make a difference. Have a look at the study. It's well conducted and from a great group, with genuine, interesting results.
The question is, where did the benefit come from? Was it the addition of irinotecan? Remember, the control was infusional 5-FU plus leucovorin. Or was it liposomal-encapsulated irinotecan?
You could argue, if you were being an academic purist, which I often am, that perhaps a better comparison would have been liposomal-encapsulated irinotecan and infusional 5-FU vs FOLFIRI — conventional intravenous irinotecan, infusional 5-FU, plus leucovorin. That's just me being me.
Have a look at this study, see what you think, and I'd be really interested in any comments that you might have. For the time being, Medscapers, over and out. Thanks for listening, as always.
David J. Kerr, CBE, MD, DSc, is a professor of cancer medicine at the University of Oxford. He is recognized internationally for his work in the research and treatment of colorectal cancer and has founded three university spin-out companies: COBRA Therapeutics, Celleron Therapeutics, and Oxford Cancer Biomarkers. In 2002, he was appointed Commander of the British Empire by Queen Elizabeth II.
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Cite this: David J. Kerr. Liposomal Irinotecan May Provide Benefit for Biliary Tract Cancer - Medscape - Dec 08, 2021.