Table 4.
Pivotal phase III trials evaluating first-line treatment for advanced pancreatic cancer
| Study | Regimens | Eligibility | No. of patients | Response rate (%) | Median progression-free survival (months) | p value | Median survival (months) | Hazard ratio | p value |
|---|---|---|---|---|---|---|---|---|---|
| Gemcitabine vs. 5-FU 1997 | Gemcitabine | LA M | 63 | 5.4 | 9 weeks | 0.0002 | 5.65 | NR | 0.0025 |
| 5-FU | 63 | 0 | 4 weeks | 4.41 | |||||
| NCIC CTG PA.3 2007 | Gemcitabine plus erlotinib | LA M | 285 | 8.6 | 3.75 | 0.004 | 6.24 | 0.82 | 0.038 |
| Gemcitabine | 284 | 8.0 | 3.55 | 5.9 | |||||
| GEST 2013 | Gemcitabine plus S-1 | LA M | 275 | 29.3 | 5.7 | < 0.001* | 10.1 | 0.88 | 0.15* |
| S-1 | 280 | 21.0 | 3.8 | 0.02+ | 9.7 | 1.0 | 0.001+ | ||
| Gemcitabine | 277 | 13.3 | 4.1 | 8.8 | |||||
| PRODIGE 4/ ACCORD 11 2011 | FOLFIRINOX | M | 171 | 31.8 | 6.4 | < 0.001 | 11.1 | 0.57 | < 0.001 |
| Gemcitabine | 171 | 11.3 | 3.3 | 6.8 | |||||
| MPACT 2019 | Gemcitabine plus nab-paclitaxel | M | 431 | 23 | 5.5 | < 0.001 | 8.5 | 0.7 | < 0.001 |
| Gemcitabine | 430 | 7 | 3.7 | 6.7 |
L locally advanced, M metastatic, NCIC CTG PA National Cancer Institute of Canada—Clinical Trials Group Pancreatic Adenocarcinoma, GEST gemcitabine and TS-1 Trial, PRODIGE: partenariat de recherche en oncologie digestive, ACCORD actions concertées dans les cancers colorectaux et digestif, MPACT Metastatic Pancreatic Adenocarcinoma Clinical Trial
*Superiority to gemcitabine
+Non-inferiority to gemcitabine