Table 2 Randomised adjuvant trials in resectable pancreatic cancer since publication of the ESPAC1 and ESPAC1-Plus studies.
From: New implications from long-term outcomes of perioperative therapy in resectable pancreatic cancer
Trial | Recruitment period | Treatment arms | Number of patients | Median overall survival (months) | 5-year overall survival (%) | Comments |
|---|---|---|---|---|---|---|
ESPAC1Plus [1] All patients and early follow-up of 2 × 2 factorial patients | 1994–2000 | No CRT | 178 | 16.1 | 19.5 | ECOG 0,1,2; R0/R1. Significant for chemotherapy overall but not in the 2 × 2 factorial. Not significant for CRT overall or in 2 × 2 factorial. |
CRT | 175 | 15.5 P = 0.24 | 10.3 | |||
No chemotherapy | 235 | 14.0 | 9.9 | |||
5FU/FA | 238 | 19.7 P = 0.0005 | 23.3 | |||
ESPAC1 [2] 2 × 2 factorial, final follow up | 1994–2000 | No CRT | 144 | 17.9 | 19.6 | ECOG 0,1,2. |
CRT | 145 | 15.9 P = 0.05 | 10.8 | R0/R1. | ||
No chemotherapy | 142 | 15.5 | 8.4 | |||
5FU/FA | 147 | 20.1 P = 0.009 | 21.1 | |||
Observation | 69 | 16.9 | 10.7 | |||
CRT | 73 | 13.9 | 7.3 | |||
5FU/FA | 75 | 21.6 | 29.0 | |||
CRT + 5FU/FA | 72 | 19.9 | 13.2 | |||
1998–2004 | GEM | 179 | 22.8 | 20.7 | Post-operative CA19-9 > 92.5 | |
Observation | 175 | 20.2 P = 0.01 | 10.4 | KU/L = 0.0%. | ||
EORTC 40891 [54] | 1987–1995 | CRT | 60 | 24.5 | 20 | T1-2, N0-1a, M0 pancreatic head cancer. |
Observation | 54 | 19 (P = 0.099) | 10 | |||
1998–2002 | 5FU/FA, 5FU + RT, 5FU/FA | 230 | – | – | Median survival only reported in 388 with pancreatic head tumours = 20.5 (GEM) vs. 16.9 (5FU) months, P = 0.09. | |
GEM, 5FU-RT, GEM | 221 | - P = 0.34 | – | |||
ESPAC-3 [7] | 2000–2007 | 5FU/FA | 551 | 23.0 | 15.9 | ECOG 0,1,2; R0/R1. |
GEM | 537 | 23.6 P = 0.39 | 17.5 | |||
JSAP-02 [57] | 2002–2005 | GEM + IORT in 27 | 58 | 22.3 | 23.9 | Karnofsky > 50. |
IORT in 47 then observation | 60 | 18.4 P = 0.19 | 10.6 | |||
CapRI [58] | 2004–2007 | 5FU, cisplatin, IFNα2b + RT, CI 5FU | 64 | 32.1 | 25 | ECOG 0,1,2; R0/R1. |
5FU/FA | 68 | 25.5 P = 0.49 | 25 | |||
JASPAC-01 [8] | 2007–2010 | GEM | 190 | 25.2 | 24.4 | ECOG 0 = 68.7%; post-op. CA19-9 > 37 KU/L = 21%; R1 pos. = 31%; LN pos. = 62.9%. |
S-1 | 187 | 46.5 P < 0.0001 | 44.1 | |||
CONKO-005 [59] | 2008–2013 | GEM | 217 | 26.2 | 20.0 | Karnofsky PS ≥ 60% |
GEM-erlotinib | 219 | 24.5 P = 0.061 | 25.0 | Only R0 resected patients. | ||
CONKO-006 [60] | 2008–2013 | GEM | 65 | 17.1 | – | Karnofsky PS ≥ 60%. |
GEM-sorafenib | 57 | 18.2 P = 0.94 | – | Only R1 patients. | ||
2008–2014 | GEM | 366 | 28.4 | 25.0 | R0 and R1 patients. | |
GEMCAP | 365 | 31.6 P = 0.031 | 32.0 | |||
NRG Oncology/RTOG 0848 [61, 62] 2-step trial | 2009–2014 | GEM | 163 | 29.9 | – | Post-op. CA 19-9 < 180 KU/L. |
GEM + erlotinib | 159 | 28.1 P = 0.62. | – | Step 1: 5 cycles GEM +/-erlotinib. Step 2: 6th cycle GEM+/-CRT. | ||
Chemotherapy | 174 | 31.0 | 23.0 | 1-sided test. | ||
Chemotherapy +CRT | 180 | 27.0 P = 0.38 | 28.0 | |||
2012–2016 | GEM | 246 | 35.5 | 31.4 | ECOG 0,1. Post-op CA 19-9 < 180 KU/L. <80 years. | |
mFOLFIRINOX | 247 | 53.5 P = 0.001 | 43.2 | |||
APACT [13] | 2014–2018 | GEM | 434 | 37.7 | 31.0 | ECOG 0,1; post-op CA 19-9 < 100 KU/L; primary endpoint DFS, not met. 18.0 (GEM) vs 19.4 (GEM + NabP) months, P = 0.1824. |
GEM-NabP | 432 | 41.8 P = 0.009, Not primary end point | 38.0 |
