. 2020 Jul 6;80(10):1007–1018. doi: 10.1007/s40265-020-01336-6

Table 3.

Efficacy of liposomal irinotecan plus 5-fluorouracil and leucovorin in patients with advanced pancreatic ductal adenocarcinoma after previous gemcitabine-based therapy: results from retrospective observational real-world studies

Study [country]	No. of pts [med. age; years]	No. of prior lines of advanced disease ther. (% of pts)	Median survival outcomes [months] (pt subgroup)
Barzi et al. [31] [USA]	242 [67 (range 41–85)]	0–1: 57 ≥ 2: 43	OS 4.9^a 5.5 (nal-IRI + 5-FU/LV as ≤ 2^nd line ther.)^b 4.1 (nal-IRI + 5-FU/LV as ≥ 3^rd line ther.) 5.7 (no prior IRI)^c 4.0 (prior IRI)
Cockrum et al. [32] [USA]	257^d [68 (range 61–73)]	0–1: 64 ≥ 2: 36	OS 4.2^a
Glassman et al. [25] [USA]	56 [68 (range 42–88)]	0–1: 43 2: 38 ≥ 3: 20	OS 5.3^a 9.0 (nal-IRI + 5-FU/LV as 2nd line ther.)^e 4.1 (nal-IRI + 5-FU/LV as ≥ 3rd line ther.) 7.7 (no prior IRI)^f 9.0 (did not progress on prior IRI)^g 3.9 (progressed on prior IRI) PFS 2.9^a 4.8 (nal-IRI + 5-FU/LV as 2nd line ther.)^e 2.2 (nal-IRI + 5-FU/LV as ≥ 3rd line ther.) 4.8 (no prior IRI)^f 5.7 (did not progress on prior IRI)^g 2.2 (progressed on prior IRI)
Kieler et al. [24] [Austria]	52 [65 (range 59–73)]	0–1: 60 2: 27 ≥ 3: 13	OS 6.79^a 7.41 (nal-IRI + 5-FU/LV as ≤ 2nd line ther.)^h PFS 3.84^a 4.49 (nal-IRI + 5-FU/LV as ≤ 2nd line ther.)^h,i 3.0 (nal-IRI + 5-FU/LV as ≥ 3rd line ther.)
Paluri et al. [28] [USA]	51 [NR]	NR	OS 5.1^a 11 (nal-IRI + 5-FU/LV as 2nd line ther)^j 4.7 (no prior IRI) 3.9 (prior IRI) PFS 2.3^a 9 (nal-IRI + 5-FU/LV as 2nd line ther.)^j 3.2 (no prior IRI) 2.2 (prior IRI)
Pellino et al. [30] [Italy]	296 [69 (range 30–82)]	1: 72 ≥ 2: 25	OS 7.1^a PFS 3.3^a
Su et al. [26] [Taiwan]	44 [60 (range 26–80)]	1: 73 ≥ 2: 27	OS 6.6^a PFS 2.5^a
Yoo et al. [27] [South Korea]	86 [61 (range 37–79)]	0–1: 40.7 2: 41.9 ≥ 3: 17.5	OS 9.4^a Not reached (< 2 prior lines of ther.) 7.9 (≥ 2 prior lines of ther.) 10.2 (no prior IRI)^f 4.4 (progressed on prior IRI) PFS 3.5^a 6.0 (< 2 prior lines of ther.) 3.0 (≥ 2 prior lines of ther.) 4.4 (no prior IRI)^f 1.7 (progressed on prior IRI)

Study [country]

No. of pts [med. age; years]

No. of prior lines of advanced disease ther. (% of pts)

Median survival outcomes [months] (pt subgroup)

Barzi et al. [31]

[USA]

242

[67 (range 41–85)]

0–1: 57

≥ 2: 43

OS 4.9^a

5.5 (nal-IRI + 5-FU/LV as ≤ 2^nd line ther.)^b

4.1 (nal-IRI + 5-FU/LV as ≥ 3^rd line ther.)

5.7 (no prior IRI)^c

4.0 (prior IRI)

Cockrum et al. [32]

[USA]

257^d

[68 (range 61–73)]

0–1: 64

≥ 2: 36

OS 4.2^a

Glassman et al. [25]

[USA]

[68 (range 42–88)]

0–1: 43

2: 38

≥ 3: 20

OS 5.3^a

9.0 (nal-IRI + 5-FU/LV as 2nd line ther.)^e

4.1 (nal-IRI + 5-FU/LV as ≥ 3rd line ther.)

7.7 (no prior IRI)^f

9.0 (did not progress on prior IRI)^g

3.9 (progressed on prior IRI)

PFS 2.9^a

4.8 (nal-IRI + 5-FU/LV as 2nd line ther.)^e

2.2 (nal-IRI + 5-FU/LV as ≥ 3rd line ther.)

4.8 (no prior IRI)^f

5.7 (did not progress on prior IRI)^g

2.2 (progressed on prior IRI)

Kieler et al. [24]

[Austria]

[65 (range 59–73)]

0–1: 60

2: 27

≥ 3: 13

OS 6.79^a

7.41 (nal-IRI + 5-FU/LV as ≤ 2nd line ther.)^h

PFS 3.84^a

4.49 (nal-IRI + 5-FU/LV as ≤ 2nd line ther.)^h,i

3.0 (nal-IRI + 5-FU/LV as ≥ 3rd line ther.)

Paluri et al. [28]

[USA]

[NR]

OS 5.1^a

11 (nal-IRI + 5-FU/LV as 2nd line ther)^j

4.7 (no prior IRI)

3.9 (prior IRI)

PFS 2.3^a

9 (nal-IRI + 5-FU/LV as 2nd line ther.)^j

3.2 (no prior IRI)

2.2 (prior IRI)

Pellino et al. [30]

[Italy]

296

[69 (range 30–82)]

1: 72

≥ 2: 25

OS 7.1^a

PFS 3.3^a

Su et al. [26]

[Taiwan]

[60 (range 26–80)]

1: 73

≥ 2: 27

OS 6.6^a

PFS 2.5^a

Yoo et al. [27]

[South Korea]

[61 (range 37–79)]

0–1: 40.7

2: 41.9

≥ 3: 17.5

OS 9.4^a

Not reached (< 2 prior lines of ther.)

7.9 (≥ 2 prior lines of ther.)

10.2 (no prior IRI)^f

4.4 (progressed on prior IRI)

PFS 3.5^a

6.0 (< 2 prior lines of ther.)

3.0 (≥ 2 prior lines of ther.)

4.4 (no prior IRI)^f

1.7 (progressed on prior IRI)

5-FU 5-fluorouracil, GEM gemcitabine, IRI conventional (non-liposomal) irinotecan LV leucovorin, nab-P nanoparticle albumin-bound paclitaxel, NR not reported, nal-IRI liposomal irinotecan, OS overall survival, PFS progression-free survival, pt(s) patient(s), ther therapy

^aResult for whole study population

^bn = 130; p = 0.0033 versus nal-IRI + 5-FU/LV as ≥ 3^rd line ther. subgroup (n = 112)

^cn = 146; p = 0.0019 versus prior IRI subgroup (n = 96)

^d17 pts had not received prior GEM

^en = 25 (all received GEM alone or nab-P + GEM as 1st line ther.). p < 0.01 versus nal-IRI + 5-FU/LV as ≥ 3rd line ther. subgroup (n = 26)

^fn = 23 [25] and 68 [27]; p < 0.05 versus progressed on prior IRI subgroup (n = 27 [25] and 18 [27])

^gn = 6; p < 0.05 versus progressed on prior IRI subgroup (n = 27)

^hn = 30 (25 received nab-P + GEM in the 1^st line)

ⁱHazard ratio 0.53 (95% CI 0.28–1.01) vs. nal-IRI + 5-FU/LV as ≥ 3rd line ther. subgroup (n = 21)

^jFollowing or nab-P + GEM as 1st line therapy; n = 15