FOLFIRINOX: A new standard of care for advanced PDAC? At the 2010 American Society of Clinical Oncology Annual Meeting (ASCO), a French cooperative group presented results of a potentially practice-changing phase III clinical trial (PRODIGE 4/ACCORD 11).(18) In this study, 342 patients with previously untreated metastatic pancreatic cancer were randomized to receive either gemcitabine monotherapy or the combination of biweekly infusional 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) (ref). The investigators reported statistically significant improvements for the FOLFIRINOX arm in the primary endpoint, overall survival (median of 11.1 months vs 6.8 months, P < .0001); as well as 1-year survival rate (48.4% vs. 20.6%), median progression-free survival (6.4 vs. 3.3 months; P < .0001), and objective response rate (CR+PR, 31.6% vs. 9.4%; P = .0001)). Not surprisingly, the more complex FOLFIRINOX regimen was associated with higher rates of grade 3/4 toxicities, including neutropenia (45.7% vs 18.7%), febrile neutropenia (5.4% vs. 0.6%), fatigue (23.2% vs. 14.2%), and diarrhea (12.7% vs. 1.2%). Notably, while primary prophylaxis with growth factor support was not mandated in this trial, 42.5% of patients did ultimately receive such support. Moreover, most patients enrolled in this trial had non-pancreatic head tumors (approximately 64%) which is the opposite distribution of what one might expect in a representative pancreatic cancer population. Thus, it is conceivable that the FOLFIRINOX regimen, with its high rates of neutropenia, may lead to unacceptable rates of infectious complications (eg, ascending cholangitis and biliary sepsis), in patients with pancreatic head tumors with indwelling endobiliary stents.