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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 3.

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

Study characteristics Drug studied Comparison
drug		 Indication for treatment Primary outcome
CONKO-001 (Oettle et al. JAMA. 200731 & 2013.32) Gemcitabine Observation First-line adjuvant Disease-free survival, median – 13.4 months gemcitabine vs. 6.9 months observation (p <.001)
ESPAC-3 (Neoptolemos JP et al. JAMA. 2010.24) Gemcitabine Bolus 5-FU/Leucovorin (LV) First-line adjuvant Overall survival, median – 23 months 5-FU/LV vs. 23.6m for gemcitabine (p = 0.39)
JASPAC-01 (Uesaka et al. Lancet. 2016.25) Non-inferiority trial. S-1 Gemcitabine First-line adjuvant Overall survival, median – 46.1 months S-1 vs. 25.5 months gemcitabine. S-1 is non-inferior to gemcitabine (p< 0.0001), and p<0.0001 for superiority.
ESPAC-4 (Neoptolemos JP et al. Lancet. 2017.26) Gemcitabine/capecitabine (GemCap) Gemcitabine First-line adjuvant Overall survival, median – 28 months GemCap vs. 25.5 months gemcitabine (p = 0.032)