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. Author manuscript; available in PMC: 2018 Nov 1.
Published in final edited form as: Clin Ther. 2017 Sep 19;39(11):2125–2134. doi: 10.1016/j.clinthera.2017.08.015

Table 2.

Selected randomized phase III clinical trials investigating systemic treatment for progressive advanced pancreatic cancer

Study characteristics Drug studied Comparison
drug		 Indication for treatment Primary outcome
CONKO-003 (Pelzer U et al. Eur J Cancer. 2011.20 & Oettle H et al. JCO.2014.30) Oxaliplatin/5-FU/ Leucovorin (OFF) 5-FU/Leucovorin (LV) Second-line for advanced stage after progression while receiving first-line gemcitabine Overall survival, median – 5.9 months OFF vs. 3.3 months 5-FU/LV (p = 0.01)
PANCREOX (Gill et al. JCO. 2016.21) mFOLFOX6 (infusional Fluorouracil, LV, Oxaliplatin) Infusional 5-FU/LV Second-line for progressive advanced stage, must have had gemcitabine as first-line therapy Progression-free survival, median – 3.1 months mFOLFOX6 vs. 2.9 months 5-FU/LV pP = 0.989)
NAPOLI-1 (Wang-Gillam A et al. Lancet. 2016.22 5-FU/LV Nanoliposomal Irinotecan (NPiri) monotherapy or NPiri/ 5-FU/LV Subsequent-line treatment for metastatic disease, must have had prior gemcitabine Overall survival, median – 6.1 months NPiri/5-FU/LV vs. 4.2 months 5-FU/LV (p = 0.012) – 4.9 months NPiri vs. 4.2 months 5-FU/LV (p = 0.94)