Table 2.
Efficacy of liposomal irinotecan plus 5-fluorouracil and leucovorin in patients with metastatic pancreatic ductal adenocarcinoma after previous gemcitabine-based therapy: results from the NAPOLI-1 study
| Regimen [no. of pts] | Median OS | Median PFS | ORRa | |||
|---|---|---|---|---|---|---|
| mo (95% CI) | HR (95% CI) | mo (95% CI) | HR (95% CI) | % (95% CI) | RD (95% CI) | |
| Primary analysis (ITT population; after 313 OS events) [23] | ||||||
| nal-IRI + 5-FU/LVb,c [117] | 6.1 (4.8–8.9)d | 0.67 (0.49–0.92)* | 3.1 (2.7–4.2) | 0.56 (0.41–0.75)** | 16.2 (9.6–22.9)e | 15.4 (8.5–22.3)** |
| 5-FU/LVc,f [119] | 4.2 (3.3–5.3)d | – | 1.5 (1.4–1.8) | – | 0.8 (0–2.5)e | – |
| Pre-specified sensitivity analysis (PP population; after 313 OS events) [34] | ||||||
| nal-IRI + 5-FU/LVb,c [66] | 8.9 (6.4–10.5) | 0.57 (0.37–0.88)* | 4.3 (3.1–5.7) | 0.46 (NR)** | 22.7 (NR) | NR** |
| 5-FU/LVc,f [71] | 5.1 (4.0–7.2) | – | 1.6 (1.4–2.6) | – | 1.4 (NR) | – |
| Final analysis (ITT population; after 382 OS events) [33] | ||||||
| nal-IRI + 5-FU/LVb,c [117] | 6.2 (4.8–8.4) | 0.75 (0.57–0.99)* | 3.1 (2.7–4.2) | 0.57 (0.43–0.76)** | 17 (10–24) | 16.3 (9.2–23.3)** |
| 5-FU/LVc,f [119] | 4.2 (3.3–5.3) | – | 1.5 (1.4–1.8) | – | 1 (0–2) | – |
5-FU 5-fluorouracil, HR (unstratified) hazard ratio, inf. infusion, ITT intention-to-treat, LV leucovorin, mo months, nal-IRI liposomal irinotecan, NR not reported, ORR objective response rate, OS overall survival, PFS progression-free survival, PP per protocol, pts patients, RD rate difference
*p < 0.05, **p ≤ 0.0001 vs. 5-FU/LV
aAs per RECIST version1.1 criteria
b90-min inf. of nal-IRI 80 mg/m2 (salt base; equivalent to 70 mg/m2 free‐base) then a 30-min inf. of LV 400 mg/m2 and then a 46-h inf. of 5-FU 2400 mg/m2 for each 2-week cycle
cPts randomized under protocol 2 only
dPrimary efficacy endpoint
eResult reported in EU summary of product characteristics [17]
f30-min inf. of LV 200 mg/m2, then 24-h inf. of 5-FU 2000 mg/m2 for weeks 1–4 of each 6-week cycle