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ESMO 2025 | Assessing chemotherapy regimens for pancreatic cancer in the FOOTPATH trial
Benedikt Westphalen, MD, Ludwig Maximilian University (LMU) Hospital Munich, Munich, Germany, discusses the final analysis of the Phase II FOOTPATH study (NCT03487016), a three-arm randomized clinical trial comparing the efficacy of different chemotherapy regimens in patients with pancreatic cancer. A split sequence of NALIRI and FOLFOX was superior in terms of progression-free survival and overall survival, with the added benefit of reduced toxicity by splitting a three-drug regimen into a two-drug alternating regimen. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
It’s a great honor to present FOOTPATH here, the final analysis of a three-arm randomized clinical trial. I hope the last trial that I have to run that is purely chemotherapy. So FOOTPATH was asking the question whether the then standard of care gemcitabine, nab-paclitaxel was superior or inferior compared to nanoliposomal irinotecan and 5FU, the NALIRI regimen, or a sequence of NALIRI alternating with modified FOLFOX 6, so a split FOLFIRINOX...
It’s a great honor to present FOOTPATH here, the final analysis of a three-arm randomized clinical trial. I hope the last trial that I have to run that is purely chemotherapy. So FOOTPATH was asking the question whether the then standard of care gemcitabine, nab-paclitaxel was superior or inferior compared to nanoliposomal irinotecan and 5FU, the NALIRI regimen, or a sequence of NALIRI alternating with modified FOLFOX 6, so a split FOLFIRINOX. And what we found is that the split sequence of NALIRI and FOLFOX was superior, both in terms of progression-free survival, which was the primary endpoint of the trial, and in the PERC protocol set, also superior in terms of overall survival, exactly matching what we had seen with classical FOLFIRINOX but also NALIRI ending up with an overall survival of 11.2 months. Why do we believe this trial is important? It shows you that you can safely and effectively split a three-drug regimen into a two-drug regimen, thereby lowering toxicity while retaining efficacy. So this is for the real world in situations where you believe it might be easier to go with a two-drug alternating regimen instead of putting three drugs in at the beginning.
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