Table 1. Summary on phase III clinical trials on patients with unresectable pancreatic cancer.
Authors and reference | Year of publication | Agent(s) | Arm | No. of patients | Percentage of patients (%) |
Response rate (%) | Median overall survival (months) | |
Locally advanced pancreatic cancer | Metastatic pancreatic cancer | |||||||
Berlin et al.[11] | 2002 | 5-FU | GEM + 5-FU | 160 | 10.6 | 89.4 | 6.9 | 6.7 |
GEM | 162 | 9.9 | 90.1 | 5.6 | 5.4 | |||
Herrmann et al.[12] | 2007 | Capecitabine | GEM + capecitabine | 160 | 20.0 | 80.0 | 10.0 | 8.4 |
GEM | 159 | 21.0 | 79.0 | 7.8 | 7.2 | |||
Cunningham et al.[13] | 2009 | Capecitabine | GEM + capecitabine | 267 | 30.0 | 70.0 | 19.1 | 6.2 |
GEM | 266 | 29.0 | 71.0 | 12.4 | 6.0 | |||
Colucci et al.[17] | 2010 | Cisplatin | GEM + cisplatin | 201 | 12.4 a | 84.6 | 12.9 | 7.2 |
GEM | 199 | 12.1 a | 82.9 | 10.1 | 8.3 | |||
Heinemann et al.[18] | 2006 | Cisplatin | GEM + cisplatin | 98 | 20.0 | 80.0 | 10.2 | 7.5 |
GEM | 97 | 21.1 | 78.9 | 8.2 | 6.0 | |||
Colucci et al.[19] | 2002 | Cisplatin | GEM + cisplatin | 54 | 19.0 a | 62.0 | 26.4 | 7.0 |
GEM | 53 | 26.0 a | 52.0 | 9.2 | 4.7 | |||
Wang et al.[20] | 2002 | Cisplatin | GEM + cisplatin | 22 | 18.0 a | 68.0 | 11.1 | 7.2 |
GEM | 20 | 20.0 a | 50.0 | 6.3 | 9.1 | |||
Louvet et al.[22] | 2005 | Oxaliplatin | GEM + oxaliplatin | 157 | 30.0 | 70.0 | 26.8 | 8.8 |
GEM | 156 | 32.0 | 68.0 | 17.3 | 6.9 | |||
Poplin et al.[10] | 2009 | Oxaliplatin | GEM + oxaliplatin | 272 | 10.7 | 89.3 | 9.0 | 5.7 |
GEM FDR | 277 | 10.2 | 88.8 | 10.0 | 6.2 | |||
GEM | 275 | 9.8 | 90.2 | 6.0 | 4.9 | |||
Stathopoulos et al.[26] | 2006 | Irinotecan | GEM + irinotecan | 60 | 22.0 | 78.0 | 15.0 | 6.4 |
GEM | 70 | 14.0 | 86.0 | 10 | 6.5 | |||
Rocha Lima et al.[52] | 2004 | Irinotecan | GEM + irinotecan | 180 | 15.0 b | 82.2 | 16.1 | 6.3 |
GEM | 180 | 13.3 b | 80.6 | 4.4 | 6.6 | |||
Abou-Alfa et al.[27] | 2006 | Exatecan | GEM + exatecan | 175 | 21.0 | 79.0 | 6.9 | 6.7 |
GEM | 174 | 22.0 | 78.0 | 5.2 | 6.2 | |||
Oettle et al.[28] | 2005 | Pemetrexed | GEM + pemetrexed | 283 | 9.9 c | 90.1 | 14.0 | 6.2 |
GEM | 282 | 8.9 c | 91.1 | 7.1 | 6.3 | |||
Dahan et al.[53] | 2010 | Leucovorin + 5-FU+cisplatin (LV5U2-CDDP) | LV5FU2-CDDP then GEM | 102 | 0 | 100 | 19.0 | 6.7 |
GEM then LV5FU2-CDDP | 100 | 0 | 100 | 22.0 | 8.0 | |||
Cantore et al.[54] | 2003 | 5-FU + leucovorin + epirubicin + carboplatin | 5-FU + leucovorin + epirubicin + carboplatin | 71 | 49.2 | 50.7 | 14.0 | 7.9 |
GEM | 67 | 47.4 | 52.2 | 5.9 | 5.9 | |||
Reni et al.[55] | 2005 | Cisplatin + epirubicin + 5-FU + GEM | Cisplatin + Epirubicin + 5-FU + GEM | 52 | 28.9 | 81.1 | 38.5 | 9 |
GEM | 47 | 29.8 | 70.2 | 8.5 | 9 | |||
Conroy et al.[30] | 2011 | FOLFIRINOX | FOLFIRINOX | 171 | 0 | 100 | 31.6 | 11.1 |
GEM | 171 | 0 | 100 | 9.4 | 6.8 | |||
Von Hoff et al.[25] | 2013 | Nab-paclitaxel | GEM + nab- paclitaxel | 431 | 0 | 100 | 23.0 | 8.5 |
GEM | 430 | 0 | 100 | 7.0 | 6.7 |
aRemaining belongs to stage II. bRemaining stage is unknown. cThe given value includes stage III and lower disease. 5-FU, fluorouracil; GEM, gemcitabine; FDR, fixed dose rate.