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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 1.

Selected randomized phase III clinical trials investigating first-line systemic treatment for advanced pancreatic cancer

Study
characteristics		 Drug studied Comparison
drug		 Indication for treatment Primary outcome
Burris et al. JCO. 1997.5 Gemcitabine Bolus 5-FU First line for advanced stage (locally advanced or metastatic) Clinical benefit response (Pain, KPS, weight) – 23.8% gemcitabine vs. 4.8% 5-FU (p = 0.0022)
Cunningham D et al. JCO. 2009.27 Gemcitabine/Capecitabine (GemCap) Gemcitabine First line for advanced stage (locally advanced or metastatic) Overall survival, median – 7.1 months GemCap vs. 6.2 months gemcitabine (p = 0.008)
NCIC CTG PA.3 (Moore et al. JCO. 2007.16) Gemcitabine/Erlotinib Gemcitabine/Placebo First line for advanced stage (locally advanced or metastatic) Overall survival, median – 6.24 months gemcitabine/erlotinib vs. 5.91 months gemcitabine (p = 0.038)
AIO group (Boeck et al. Anticancer Drugs. 2010.26 & Heinemann V et al. Gut. 2013.17) Capecitabine/Erlotinib followed by Capecitabine Gemcitabine/Erlotirib followed by Gemcitabine Treatment-naïve advanced stage (trial to investigate sequencing of drugs upon failure with first-line) Time to treatment failure of second-line therapy – 4.2 months for both arms
PRODIGE (Conroy T et al. NEJM. 2011.6) FOLFIRINOX Gemcitabine First-line for metastatic Overall survival, median – 11.1 months FOLFIRINOX vs. 6.8 months gemcitabine (p < 0.001)
MPACT (von Hoff D et al. NEJM. 2013.7) Gemcitabine/Nab-paclitaxel Gemcitabine First line for metastatic Overall survival, median – 8.5 months gemcitabine/ nab-paclitaxel vs. 6.7 months gemcitabine (p < 0.001)
GEST (Ueno H et al. JCO. 2013.29) Non-inferiority trial. S-1 monotherapy or Gemcitabine/S-1 Gemcitabine First line for advanced stage (locally advanced or metastatic) Overall survival, median – 8.8 months for gemcitabine, 9.7 months for S-1, 10.1 months for gemcitabine/S-1. S-1 non-inferior to gemcitabine (p < 0.001).