Meet The Professors: Pancreatic Cancer Edition, 2016 - Video 8Phase III NAPOLI-1 trial of nal-IRI, with or without 5-fluorouracil and leucovorin, versus 5-fluorouracil and leucovorin in metastatic pancreatic cancer after previous gemcitabine-based therapy
1:50 minutes.
TRANSCRIPTION:
DR LOVE: Any thoughts about that Phase III NAPOLI trial — we’ll look at the data — in terms of the control arm, 5-FU/leucovorin? I know that’s kind of been debated. DR TEMPERO: A lot of us didn’t participate in that trial, because we were concerned that patients weren’t getting an adequate course of treatment with 5-FU and leucovorin, as that was the control arm. DR LOVE: And these people had just prior gemcitabine? That was the criteria to get in? DR TEMPERO: I believe they could have had — DR BEKAII-SAAB: You have to have failed. You had to have failed at any point, yeah. DR TEMPERO: But gemcitabine and nab paclitaxel, though? DR BEKAII-SAAB: No, just gemcitabine in this regimen. Yes, so any gemcitabine. DR TEMPERO: Any gemcitabine-based regimen. So at any rate, that was a concern of ours. So we really don’t know, for instance, how 5-FU/leucovorin and liposomal irinotecan would hold up against FOLFOX, for example. DR BEKAII-SAAB: So we participated in the trial. And there was a reason why the 5-FU regimen was chosen as the weekly regimen. It actually was to simulate the OFF, F-F regimen, so from the CONKO study that looked at OFF, so oxaliplatin/5-FU versus 5-FU. There’s really no data with the de Gramont regimen in pancreas cancer. And so the choice was to take an arm from a Phase III study as the comparator arm and use it here. It’s not the usual infusional 5-FU, the de Gramont infusional 5-FU, but it is a standard arm in the CONKO, at least in the CONKO list of studies. So I think it’s a reasonable arm, personally. It was a reasonable arm to compare to. |