Table 3. Five-Year Outcomes From Randomized Clinical Trials of Adjuvant Chemotherapy in Patients With Resected PDAC.
| Source | Patients, No. | Adjuvant therapy | Median follow-up, mo (IQR) | DFS | OS | ||
|---|---|---|---|---|---|---|---|
| Median, mo (95% CI) | 5-y, % | Median, mo (95% CI) | 5-y, % | ||||
| ESPAC-19 | 147 | FU + leucovorin | 47.0 (33-62) | 15.3 (10.5-19.2) | NA | 20.1 (16.5-22.7) | 21.1a |
| 142 | Observation | 47.0 (33-62) | 9.4 (8.4-15.2) | NA | 15.5 (13.0-17.7) | 8.0a | |
| CONKO-00110 | 179 | Gemcitabine | 136 (104-144) | 13.4 (11.6-15.3) | 16.6 | 22.8 (NA) | 20.7 |
| 175 | Observation | 136 (104-144) | 6.7 (6.0-7.5) | 7.0 | 20.2 (NA) | 10.4 | |
| JSAP-0213 | 58 | Gemcitabine | 60.4 (40.6-77.1) | 11.4 (8.0-14.5) | NA | 22.3 (16.1-30.7) | 23.9 |
| 60 | Observation | 60.4 (40.6-77.1) | 5.0 (3.7-8.9) | NA | 18.4 (15.1-25.3) | 10.6 | |
| ESPAC-312 | 537 | Gemcitabine | 34.2 (27.1-43.4) | 14.3 (13.5-15.6)b | NA | 23.6 (21.4-26.4) | 17.5a |
| 551 | FU + leucovorin | 34.2 (27.1-43.4) | 14.1 (12.5-15.3)b | NA | 23.0 (21.1-25.0) | 15.9a | |
| JASPAC-0120 | 187 | S-1 | 79.3 (72.0-89.0) | 22.9 (NA)c | 33.3 | 46.5 (37.8-63.7) | 44.1a |
| 190 | Gemcitabine | 83.2 (71.8-88.5) | 11.3 (9.7-13.6)c | 16.8 | 25.5 (22.5-29.6) | 24.4a | |
| ESPAC-411 | 364 | Gemcitabine + capecitabine | 43.2 (39.7-45.5) | 13.9 (12.1-16.6) | 18.6 | 28.0 (23.5-31.5) | 28.8a |
| 366 | Gemcitabine | 43.2 (39.7-45.5) | 13.1 (11.6-15.3)c | 11.9 | 25.5 (22.7-27.9) | 16.3a | |
| APACT21 | 432 | Gemcitabine + nab-paclitaxel | 63.2 (NA)c | 16.6 (NA) | NA | 41.8 (NA)d | 38d |
| 434 | Gemcitabine | 63.2 (NA)c | 13.7 (NA) | NA | 37.7 (NA)d | 31d | |
| PRODIGE 24 | 247 | mFOLFIRINOX | 69.7 (59.4-84.1) | 21.4 (17.5-26.7) | 26.1 | 53.5 (22.4-NE) | 43.2 |
| 246 | Gemcitabine | 69.7 (59.4-84.1) | 12.8 (11.6-15.2) | 19.0 | 35.5 (20.3-80.8) | 31.4 | |
Abbreviations: DFS, disease-free survival; FU, fluorouracil; mFOLFIRINOX, modified fluorouracil, leucovorin, irinotecan, and oxaliplatin; NA, not available; NE, nonestimable; OS, overall survival; PDAC, pancreatic ductal adenocarcinoma.
a
Estimated 5-year survival.
b
Progression-free survival.
c
Recurrence-free survival.
d
Post hoc analysis; data cutoff date of April 9, 2021 (88% mature).