Table 1.
Adjuvant chemotherapy
| Author/trial | Study period | No. of PDAC patients | Regimen | MST | Hazard ratio | p |
|---|---|---|---|---|---|---|
| Bakkevold | 1984–1987 | 47 | 5-FU + doxorubicin + mitomycin vs. no adjuvant treatment | OS: 23 vs. 11 M | – | 0.02 |
| Takada | 1986–1992 | 158 | 5-FU + mitomycin C vs. no adjuvant treatment |
5-year OS: 11.5 vs. 18.0% 5-year DFS: 8.6 vs. 7.8% |
– | NS |
| Kosuge/JSAP-01 | 1992–2000 | 89 | 5-FU + cisplatin vs. no adjuvant treatment |
OS: 12.5 vs. 15.8 M 5-year OS: 26.4 vs. 14.9% |
– | 0.94 |
| Neoptolemos/ESPAC-1 | 1994–2000 | 289 |
5-FU vs. no adjuvant chemotherapy 5-FU + radiation vs. no adjuvant CRT |
OS: 20.1 vs. 15.5 M OS: 15.9 vs. 17.9 M |
0.71 1.28 |
0.009 0.05 |
| Oettle/CONKO-001 | 1998–2004 | 354 | GEM (6 M) vs. no adjuvant treatment |
DFS: 13.4 vs. 6.7 M OS: 22.8 vs. 20.2 M |
0.55 0.76 |
< 0.001 0.01 |
| Ueno/JSAP-02 | 2002–2005 | 118 | GEM (3 M) vs. no adjuvant treatment |
DFS: 11.4 vs. 5 M OS: 22.3 vs. 18.4 M |
0.60 0.77 |
0.01 0.19 |
| Neoptolemos/ESPAC-3 | 2000–2008 | 434 | 5-FU vs. GEM | OS: 23.0 vs. 23.6 M | 0.94 | 0.39 |
| Uesaka/JASPAC 01 | 2007–2010 | 385 | S-1 vs. GEM |
OS: 46.5 vs. 25.5 M 5-year OS: 44.1 vs. 24.4% |
0.57 | < 0.0001 |
| Neoptolemos/ESPAC-4 | 2008–2014 | 730 | GEM + capecitabine vs. GEM |
DFS: 13.9 vs. 13.1 OS: 28.0 vs. 25.5 M |
0.82 |
0.082 0.032 |
| Conroy/PRODIGE 24/CCTG PA.6 | 2012–2016 | 493 | mFOLFIRINOX vs. GEM |
DFS: 21.6 vs. 12.8 M OS: 54.4 vs. 35.0 M |
0.58 0.64 |
< 0.0001 0.003 |
Phase III trials of adjuvant chemotherapy