Table 4. Randomised large-scale trials for adjuvant therapy of resected PDAC in the modern era.
Trial | Types of trial | N | Interventions | Primary endpoint | mDFS (months) | mOS (months) | Result |
---|---|---|---|---|---|---|---|
CONKO-001 [98] | Phase III | 368 | G. vs. Observation | DFS | 13.4 vs. 6.7 | 22.8 vs. 20.2 | Achieved primary endpoint |
RTOG 9704 [99] | RCT, Phase III | 451(Pancreatic-388) | 5-FU/Lv, → concurrent 5-FU-RT, --> 5-FU/Lv; vs. G.--> concurrent 5-FU-RT, followed by G. | OS | NR | 20.5 vs. 17.1 | Trend towards benefit with G, but statistically did not achieve endpoint |
ESPAC-3 [101] | RCT. Phase III | 1088 | G. vs. 5 -FU | OS | 14.3 vs. 14.1 | 23.6 vs. 23 | Did not achieve primary endpoint |
JASPAC-01 [100] | RCT, Phase III (Non inferiority) | 385 | G. vs. S1 | OS | 11.3 vs. 22.9 (RFS) | 25.5 vs. 46.5 | Achieved primary endpoint |
ESPAC-4 [103] | RCT, Phase III | 732 | G-C. vs. G | OS | 13.9 vs. 13.1 | 28 vs. 25.5 | Achieved primary endpoint |
Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group [102] | RCT, Phase III | 493 | mFOLFIRINOX vs. G. | DFS | 21.6 vs. 12.8 | 54.4 vs. 35 | Achieved primary endpoint |
APACT [104] | RCT, Phase III | 866 | nab-P/G vs. G. | DFS | 19.4 vs. 18.8 | 40.5 vs. 36. | Did not achieve primary endpoint |
N, Total number of patients; mDFS, Median Disease-free survival, mOS, Median Overall survival, JASPAC, Japan Adjuvant Study Group of Pancreatic Cancer; RTOG, Radiation Therapy Oncology Group, APACT, Adjuvant Therapy for Patients With Resected Pancreatic Cancer; G, Gemcitabine, 5-FU/LV - 5-fluorouracil/leucovorin, RT, Radiotherapy, RFS, Recurrence free survival, G-C, Gemcitabine-capecitabine, mFOLFIRINOX, Modified 5-fluorouracil-leucovorin-irinotecan-oxaliplatin, nab-P/G, Nab-Paclitaxel/gemcitabine, NR, Not reported.