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Adjustments to the FOLFIRINOX Combination for Improved Tolerability in Pancreatic Cancer

Since the May 12, 2011 New England Journal of Medicine article that reported the possible superiority of the 5-FU based four-drug FOLFIRINOX regimen over gemcitabine in the treatment of metastatic pancreatic cancer (ductal adenocarcinoma of the pancreas), researchers have been at work trying to discover the best use of this information – and ways to perhaps improve on it. A case in point is the blog entry just prior to this one (FOLFIRINOX for neoadjuvant therapy in pancreatic cancer).

Also, we have reported on research of chemotherapy combinations that contain similar but fewer drug agents, such as the ones termed OFF and SOX.  These are essentially modified FOLFIRINOX regimens. But there has arisen the term “Modified FOLFIRINOX Regimen” by which researchers appear to mean that tiny (to date) body of research on smaller tweaks to the standard FOLFIRINOX combination:  oxaliplatin – 85 mg per M2 (body-surface area); irinotecan – 180 mg/ M2; leucovorin, 400 mg/M2; and fluorouracil (5-FU) – 400 mg/M2 given as a bolus followed by 2400 mg/M2 given as a 46-hour continuous infusion.

El-Rayes and colleagues at Emory University have published a study involving such a modified FOLFIRINOX regimen in the November 2013 issue of the journal Pancreas. They postulated that eliminating the bolus portion of the 5-FU and adding hematopoietic growth factor to FOLFIRINOX might continue to provide the efficacy of the drug-combination while improving the safety profile of the side-effects.  They looked at 60 patients with pancreatic cancer in various stages of disease who were treated using this modified combination.

The authors found that the median overall survival duration for these patients with metastatic pancreatic cancer treated with this modified FOLFIRINOX regimen was 9.0 months.  Also, importantly, the safety profile DID appear to be improved.  The researchers suggest that this regimen can be given more safely than standard FOLFIRINOX, and without losing efficacy.

This is an interesting finding demanding further research.

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Dale O’Brien, MD