Efficacy and tolerability of the combination of Liposomal irinotecan and 5-fluorouracil/leucovorin in advanced pancreatic cancers: post-approval clinic experience

Liposomal Irinotecan: A Review in Metastatic Pancreatic Adenocarcinoma

“…Consistent with the results of pre-specified and/or post hoc analyses of NAPOLI-1 (Sect. 2.1 ), median OS was generally higher in patients who had not previously received conventional irinotecan compared with those who had previously received (and progressed on [ 25 , 27 ]) conventional irinotecan [ 25 , 27 , 28 , 31 ] (Table 3 ). Moreover, patients treated with nal-IRI + 5-FU/LV who had not progressed on prior conventional irinotecan showed improved survival outcomes compared with those who had progressed on prior conventional irinotecan [ 25 ] (Table 3 ).…”

“…2.1 ). More recently, the effectiveness of this combination has been evaluated in several retrospective, observational (real-world evidence) studies from one [ 24 – 26 ] or more [ 27 – 32 ] institutions in Austria [ 24 ], Italy [ 30 ], South Korea [ 27 ], Taiwan [ 26 ] or the USA [ 25 , 28 , 29 , 31 , 32 ] (Sect. 2.2 ).…”

“…Real-world studies investigating nal-IRI + 5-FU/LV have enrolled individuals ( n = 44–296) with advanced PDAC (i.e. unresectable, locally advanced or metastatic disease) that had progressed following gemcitabine-based chemotherapy in the neoadjuvant or adjuvant setting, or in a prior line of treatment for advanced disease [ 24 – 32 ] (some results only available as an abstract and/or poster [ 28 , 30 , 32 ]). The median age of study populations was 60–69 years, 38–61% were males and, where specified, 54–100% of evaluable patients had ECOG PS 0–1, and 61–83% of evaluable patients had elevated CA 19-9 levels [ 24 – 27 , 30 – 32 ].…”

“…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.)…”

“…These variations in baseline patient characteristics notwithstanding, median OS (from the time of nal-IRI + 5-FU/LV initiation) ranged from 4.2–9.4 months; median PFS ranged from 2.3–3.84 months (Table 3 ). The proportions of patients achieving an objective response (per RECIST v1.1 criteria) ranged from 5–19.2%; DCRs ranged from 40–54.7% [ 24 – 28 , 30 ].…”