Table 3.
Pivotal phase III trials of adjuvant treatments for pancreatic cancer
| Study | Regimens | No. of patients | Median disease-free survival (months) | p value | Median survival (months) | p value |
|---|---|---|---|---|---|---|
| ESPAC-1 2004 | Chemoradiotherapy | 73 | NR | NR | 13.9 |
p = 0.009* p = 0.05+ |
| 5-FU/folinic acid | 75 | NR | 21.6 | |||
| Chemoradiotherapy + 5-FU/folinic acid | 72 | NR | 19.9 | |||
| Observation | 69 | NR | 16.9 | |||
| CONKO-001 2007 | Gemcitabine | 179 | 13.4 | 0.001 | 22.1 | 0.06 |
| Observation | 175 | 6.9 | 20.2 | |||
| ESPAC-3 2010 | Gemcitabine | 537 | 14.3 | 0.53 | 23.6 | 0.39 |
| 5-FU/folinic acid | 551 | 14.1 | 23.0 | |||
| JASPAC-01 2016 | S-1 | 192 | 22.9 | 0.0001 | 46.5 | 0.0001 |
| Gemcitabine | 193 | 11.3 | 25.5 | |||
| ESPAC-4 2017 | Gemcitabine plus capecitabine | 364 | 13.9 | 0.082 | 28.0 | 0.032 |
| Gemcitabine | 366 | 13.1 | 25.5 | |||
| CONKO-005 2017 | Gemcitabine plus erlotinib | 219 | 11.4 | 0.26 | 24.5 | 0.61 |
| Gemcitabine | 215 | 11.4 | 26.5 | |||
| Unicancer GI PRODIGE 24/CCTG PA.6 2018 | Modified FOLFIRINOX | 247 | 21.6 | 0.001 | 54.4 | 0.003 |
| Gemcitabine | 246 | 12.8 | 35.0 | |||
| APACT 2019 | Gemcitabine plus nab-paclitaxel | 432 | 19.4 | 0.182 | 40.5 | 0.045 |
| Gemcitabine | 434 | 18.8 | 36.2 |
ESPAC European Study Group for Pancreatic Cancer 1, CONKO Charité Onkologie, JASPAC Japan Adjuvant Study Group of Pancreatic Cancer, GI gastrointestinal, PRODIGE partenariat de recherche en oncologie digestive, CTG PA Clinical Trials Group Pancreatic Adenocarcinoma, APACT adjuvant therapy for patients with resected pancreatic cancer
*Chemotherapy vs. no chemotherapy
+Chemoradiotherapy vs. no chemoradiotherapy