Review
Copyright ©2006 Baishideng Publishing Group Co.
World J Gastroenterol. Jul 28, 2006; 12(28): 4466-4472
Published online Jul 28, 2006. doi: 10.3748/wjg.v12.i28.4466
Table 3 Randomised controlled trials of adjuvant treatment for pancreatic ductal adenocarcima
TrialComparisonAdjuvant treatmentNumber of patientsConclusions
GITSG, 1985[58], 1987[59]CRT vs OBS2 × (20 Gy in 10 fractions + 500 mgm-2 5FU d 1-3) + weekly 5FU to recurrence49 pancreatic patients randomisedSignificant increase in median survival (20 vs 11 mo, P = 0.035) in 43 eligible patients
Norway, 1993[60]CT vs OBSAMF (40 mgm-2 doxorubicin, 6 mgm-2 mytomycin C, 500 mgm-2 5FU) once every 3 wk for six courses61 patients (47 pancreatic, 14 ampullary) randomised 46 additional nonrandomised patientsSignificant increase in median survival (23 vs 11 mo, P = 0.02) in 60 pancreatic and ampullary patients combined
EORTC, 1999[61]CRT vs OBS2 × (20 Gy in 10 fractions + 25 mgkg-1 5FU/FA d 1-5)218 patients (120 pancreatic, 93 ampullary) randomisedNS increase in median survival (25 vs 19 mo, P = 0.21) in 207 eligible patients NS increase in median survival in 114 eligible pancreatic patients (17 vs 13 mo, P = 0.099)
Japan, 2002[62]CT vs OBS6 mgm-2 mytomycin C d 1 + 310 mgm-2 5FU d 1-5 and d 15-20 followed by 100 mgm-2 oral 5FU daily until recurrence508 patients (173 pancreatic, 335 bile duct/gallbladder/ampullary) randomisedSignificant survival benefit in gallbladder No difference in 158 eligible pancreatic patients No difference in 48 eligible ampullary patients
ESPAC1, 2001[63], 2004[64]CRT vs no CRT CT vs no CT2 × (20 Gy in 10 fractions + 500 mgm-2 5FU/FA d 1-3)(20 mgm-2 FA + 425 mgm-2 5FU d 1-5) × six cycles289 pancreatic patients randomisedNS decrease in survival for CRT (P = 0.05) in 289 patients Significant increase in survival for CT (P = 0.009) in 289 eligible patients
CONKO-001, 2005[65]CT vs OBS1 gm-2 GEM, d 1, 8, 15, every 4 wk for 6 mo368 pancreatic patients randomisedSignificant increase in median DFS (14.2 vs 7.5 mo, P < 0.05) in 356 eligible patients