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ASCO 2025 | EFS gains with PAXG regimen may redefine first-line therapy in stage I–III PDAC

Michele Reni, MD, IRCCS San Raffaele Scientific Institute, Milan, Italy, talks on the randomized Phase III trial (NCT04793932) comparing the modified FOLFIRINOX regimen with the PAXG regimen for stage I-III pancreatic ductal adenocarcinoma (PDAC), which showed that the PAXG regimen significantly prolongs event-free survival (EFS), with a EFS increase of almost six months and a three-year EFS rate more than doubling from 13% to 31%. He emphasizes the need to provide patients with answers sooner rather than waiting for mature overall survival (OS) data, suggesting that EFS data may be more indicative of treatment efficacy. Prof. Reni argues that the significant difference in outcomes between the two arms makes it unlikely that overall survival data will differ, and therefore, patients deserve faster results. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

I think that we should consider this as a new standard. Of course, one concern may be the overall survival data that are not yet mature, but I think we cannot wait for mature data because it will need again a couple of years to have mature data and actually we need to give something to our patients earlier. And I think that maybe it is unlikely that overall survival data will be different from event-free survival data because the internal consistency and the difference between the two arms is so large that it may be unlikely to have different results in terms of overall survival...

I think that we should consider this as a new standard. Of course, one concern may be the overall survival data that are not yet mature, but I think we cannot wait for mature data because it will need again a couple of years to have mature data and actually we need to give something to our patients earlier. And I think that maybe it is unlikely that overall survival data will be different from event-free survival data because the internal consistency and the difference between the two arms is so large that it may be unlikely to have different results in terms of overall survival. So I think that patients in this population need to have answers faster than overall survival data can provide. Furthermore, another reason to start with this new regimen tomorrow is that the toxicity profile was better and the quality of life was better as compared to modified FOLFIRI. So we have to abandon this regimen right now. Thank you.

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