Skip to main content
. 2013 Dec 17;45(2):190–201. doi: 10.1007/s12029-013-9561-z

Table 1.

Summary of positive clinical trials that lead to practice changes in metastatic PDA

Intervention Study description No. of patients Comparison Median OS Median DFS or TTP ORR 1-year survival References
Gemcitabine
Phase 3 Randomized, multicenter international 160 Gemcitabine vs. 5-Flourouracil 5.65 vs. 4.41 months 9 vs. 4 weeks 5.4 % vs. 0 % 18 % vs. 2 % Burris H, et al. [1]
FOLFIRINOX
Phase 2 Single arm; multicenter 47 None 10.2 (8.1–14.4 months) 8.2 (5.3–11.6 months) 26 % (13–39 %) 43 % Conroy et al. [5]
Phase 3 Phases 2–3, randomized, placebo-controlled, multicenter, international. 342 FOLFIRINOX vs. Gemcitabine 11.1 vs. 6.8 months 6.4 vs. 3.3 months 31.6 % vs. 9.4 % 48 % vs. 20 % Conroy et al. [3]
Nab-Paclitaxel
Phase 2 Single arm, open-label, multicenter, phase I/II 67 None 12.2 (8.9–18 months) 7.9 (5.8–11 months) 46 % (N/A) 48 % Von Hoff et al. [21]
Phase 3 Randomized phase III, multicenter 861 Gemcitabine ± Nab-Paclitaxel or Placebo 8.5 vs. 6.7 months 5.5 vs. 3.7 months 23 % vs. 7 % 35 % vs. 22 % Von Hoff et al. [22]
Erlotinib
Phase 3 Randomized, double-blinded, placebo-controlled, international 569 Gemcitabine ± erlotinib or Placebo 6.24 vs. 5.91 months 3.75 vs. 3.55 months 8.6 % vs. 8.0 % 23 % vs. 17 % Moore M, et al. [25]