Table 1.
PRODIGE 4/ACCORD 11 and MPACT trials: indirect comparison of main results, demographics, and most common adverse reactions.
| Experimental arms |
Control arms |
|||
|---|---|---|---|---|
| FOLFIRINOX7 | nab-Paclitaxel + gemcitabine26 | Gemcitabine PRODIGE 4/ACCORD 117 |
Gemcitabine MPACT26 |
|
| Number of patients | 171 | 431 | 171 | 430 |
| PS | ECOG 0-1 | Karnofsky index ⩾ 70 |
ECOG 0-1 | Karnofsky index ⩾ 70 |
| Pancreatic head tumor location | 39.2% | 44% | 36.8% | 42% |
| Median age (range) | 61 (25–76) | 62 (27–86) | 61 (34–75) | 63 (27–86) |
| RR [investigator assessment] |
31.6% [95% CI: 24.7–39.1] | 29% [95% CI: 25–34] | 9.4% [95% CI: 5.4–14.7] |
8% [95% CI: 5–11] |
| Discontinuation of treatment for unacceptable toxicities | 3.8% | 20% | 10% | 7% |
| Progression-free survival | 6.4 months | 5.5 months | 3.3 months | 3.7 months |
| Median OS | 11.1 months | 8.5 months | 6.8 months | 6.7 months |
| Hazard ratio for death versus gemcitabine |
0.57 [95% CI: 0.45–0.73; p < 0.001] |
0.72 [95% CI: 0.58–0.82; p < 0.001] |
||
| Grade 3–4 toxicities | ||||
| Fatigue | 23.6% | 18% | 17.8% | 9% |
| Neutropenia | 45.7% | 38% | 21% | 27% |
| Febrile neutropenia | 5.4% | 3% | 1.2% | 1% |
| Diarrhea | 12.7% | 6% | 1.8% | 1% |
| Peripheral neuropathy | 9% | 17% | 0% | 1% |
| Vomiting | 23.6% | 6% | 8.3% | 4% |
| Growth factor use | 42.5% | 26% | 5.3% | 15% |
| Grade 2–3 alopecia | 11.4% | 50% | 1.2% | 5% |
| Second-line therapy | 56.7% | 38% | 60.3% | 42% |
PS, performance status; RR, response rate; OS, overall survival; CI, confidence interval.