Introduction
Definition of R/BR and diagnostic modalities
Past
Past 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 |
Past adjuvant CRT
Author/trial | Study period | No. of PDAC patients | Regimen | MST | Hazard ratio | p |
---|---|---|---|---|---|---|
Kalser/GITSG | 1974–1982 | 43 | 5-FU + RT vs. no adjuvant treatment | OS: 20.0 vs. 11.0 M | – | 0.035 |
Klinkenbijl/EORTC 40891 | 1987–1995 | 114 | 5-FU + RT vs. no adjuvant treatment | OS: 17.1 vs. 12.6 M | – | 0.099 |
Neoptolemos/ESPAC-1 | 1994–2000 | 289 | 5-FU + RT vs. no adjuvant treatment | OS: 15.9 vs. 17.9 M | 1.28 | 0.053 |
Regine/RTOG9704 | 1998–2002 | 451 | 5-FU + RT + GEM vs. 5-FU + RT | OS: 18.8 vs. 16.7 M | 0.79 | 0.047 |
Past intraoperative radiotherapy (IORT)
Present
Present adjuvant chemotherapy
Present adjuvant CRT and IORT
Present neoadjuvant therapy
Future
Future adjuvant/neoadjuvant therapy
Trial | Patients’ resectability | Phase | Regimen | Primary outcomes | Targeted population |
---|---|---|---|---|---|
JSAP-04 | R0/R1 | III | Adjuvant GEM + S1 vs. GEM | RFS | 300 |
NEOPAC | R-PDAC | III | Neoadjuvant GEM + oxaliplatin vs. upfront surgery | PFS | 310 |
NEOPA | R-PDAC | III | Neoadjuvant CRT with GEM vs. upfront surgery | 3-year OS | 410 |
JASPAC04 | R-PDAC | II | Neoadjuvant CRT with S1 vs. neoadjuvant GEM + S1 | 2-year RFS | 100 |
GABARNANCE | BR-PDAC | II/III | Neoadjuvant GEM + nab-paclitaxel vs. neoadjuvant CRT with S1 | R0 ratio/OS | 110 |
JASPAC05 | BR-PDAC | II | Neoadjuvant CRT with S1 | R0 ratio | 50 |
Prep-03, NS014-1 | BR-PDAC | I/II | Neoadjuvant CRT with GEM + S1 | MTD, RD/R0 ratio | 12–24 |