Table 1:

Select phase II and III trials of adjuvant or neoadjuvant treatment for resectable pancreatic ductal adenocarcinoma

Author group (trial title)Study typeTreatment armNo. of patientsSpecific inclusionPrimary outcomeDFSp valueOSp value
Conroy and colleagues25 (PRODIGE24-CCTG PA6)Phase IIIGemcitabine493ECOG 0–1; Age ≤ 76 yr; Baseline CA19.9 ≤ 180 U/mLDFS12.8< 0.001350.003
Tempero and colleagues27 (APACT)Phase IIIGemcitabine866ECOG 0–1; CA19.9 < 100 U/mLDFS by independent reviewer18.
Gemcitabine plus nab-paclitaxel19.440.5
Neoptomelos and colleagues28 (ESPAC-4)Phase IIIGemcitabine730WHO PS < 2OS13.10.0825.50.032
Gemcitabine plus capecitabine13.928.8
Oettle and colleagues29 (CONKO-001)Phase IIIObservation354Karnofsky PS ≥ 50%DFS6.7< 0.00120.20.01
Neoadjuvant trials
Motoi and colleagues30 (Prep-02/JSAP-05)Phase II/IIIGemcitabine/S1–surgery–S1364Resectable and BR; ECOG 0–1OSNR36.70.015
Versteijne and colleagues31 (PREOPANC)Phase IIIGemcitabine/radiation–surgery–gemcitabine246Resectable and BROS by intention to treat8.10.03160.096
Sohal and colleagues32 (SWOG 1505) (Abstract)Phase IIModified FOLFIRINOX–surgery–modified FOLFIRINOX102Resectable2-yr OS10.9*NR22.4NS
  • Note: BR = borderline resectable, CA19.9 = carbohydrate antigen 19.9, DFS = disease-free survival, ECOG = Eastern Cooperative Oncology Group, NR = not reported, NS = not significant, OS = overall survival, PS = Performance Status, S1 = type of chemotherapy, WHO = World Health Organization.

  • * DFS is from time of surgery.