Review
Copyright ©The Author(s) 2016.
World J Gastrointest Oncol. Mar 15, 2016; 8(3): 248-257
Published online Mar 15, 2016. doi: 10.4251/wjgo.v8.i3.248
Table 1 Standard adjuvant therapy
Gemcitabine 1000 mg/m2i.v. 30 mind1, 8, 15, q29
6 cycles
5-flourouracil 425 mg/m2i.v. Bolusd1-5, q29
Folinic acid 20 mg/m2i.v. Bolus6 cycles
Table 2 Completed adjuvant phase III trials
Ref.Treatment groupMedian OS (mo)3-yr-survival5-yr-survival
CONKO-001[38,39]Gem22.837%21%
Observation20.220%9%
ESPAC-3[40]Gem23.6
5-FU/folinsäure23.0
JASPAC-01[43]S12 yr 70%
Gem2 yr 53%
RTOG 97-04RCT + Gem20.531%24%
(pancreatic head)[57]RCT + 5-FU/FS16.922%11%
CONKO-005[45]Gem + Erlotinib24.636%28%
Gem26.533%19%
Table 3 Ongoing adjuvant trials
TrialRegistration No.Treatment groupsPatients planned
ESPAC-4ISRCTN96397434Gem + capecitabine732
Gem
APACTNCT01964430Gem + nab-paclitaxel800
Gem
ACCORD24NCT01526135FOLFIRINOX490
Gem
RTOG-0848NCT01013649Gem + RCT (capecitabine or 5-FU)950
Gem
Algenpantucel ImmunotherapyNCT01072981Gem ± RCT + Algenpantucel-I vaccine722
Gem ± RCT
Table 4 Ongoing neoadjuvant/borderline resectable trials
TrialRegistration No.Treatment groupsPrimary endpointPatients planned
NEONAXNCT020475132 cycles Gem + nab-paclitaxel neoadjuvantDFS166
4 cycles Gem + nab-paclitaxel adjuvant
6 cycles Gem + nab-paclitaxel adjuvant
Perioperative mFOLFIRINOXNCT020474743 cycles FOLFORINOXDFS46
Neoadjuvant + adjuvant
NEOLAPNCT021251362 cycles Gem + nab-paclitaxelConversion rate168
+ 2 × FOLFIRINOX(including locally advanced PDAC)
+ adjuvant 3 × Gem + nab-paclitaxel
4 cycles Gem + nab-paclitaxel
+ adjuvant 3 × Gem + nab-paclitaxel