A real-world analysis of nanoliposomal-irinotecan with 5-fluorouracil and folinic acid as third- or later-line therapy in patients with metastatic pancreatic adenocarcinoma

Jung Won Chun, Sang Myung Woo, Sang Hyub Lee, Jin Ho Choi, Namyoung Park, Joo Seong Kim, In Rae Cho, Woo Hyun Paik, Woo Jin Lee, Ji Kon Ryu, Yong-Tae Kim, Jung Won Chun, Sang Myung Woo, Sang Hyub Lee, Jin Ho Choi, Namyoung Park, Joo Seong Kim, In Rae Cho, Woo Hyun Paik, Woo Jin Lee, Ji Kon Ryu, Yong-Tae Kim

Abstract

Background: Nanoliposomal encapsulation of irinotecan (nal-IRI) with 5-fluorouracil and leucovorin (5-FU/LV) has shown a survival benefit for gemcitabine-pretreated patients with metastatic pancreatic adenocarcinoma (mPAC). The aim of this study was to evaluate the effectiveness and safety of nal-IRI with 5-FU/LV for use beyond second-line treatment after standard frontline therapy for mPAC.

Method: This multicenter, retrospective, non-comparative observational study included mPAC patients who received nal-IRI plus 5-FU/LV as third- or later-line therapy after disease progression on first-line FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel.

Results: In all, 128 patients who received nal-IRI plus 5-FU/LV beyond second-line treatment between October 2017 and July 2021 were analyzed. Most patients (82%) received nal-IRI plus 5-FU/LV as a third-line treatment. The median overall survival (OS) was 4.9 months and the median progression-free survival (PFS) was 2.4 months. Patients with better Eastern Cooperative Oncology Group (ECOG) performance status experienced significantly longer OS (ECOG 0, 8.7 months; ECOG 1, 4.8 months; ECOG 2, 2.9 months; p < 0.001) and PFS (3.9 months; 2.1 months; 1.5 months; p = 0.019). Patients who had not been previously treated with FFX or had a time to progression of 7 months or more on FFX experienced longer OS and PFS than those who did not (6.1 months and 5.6 versus 4.1 months, p = 0.053; 3.6 months and 2.4 versus 2.1 months, p = 0.002). The most common adverse events were neutropenia (56%) and anemia (51%).

Conclusion: Our real-world data indicated that nal-IRI plus 5-FU/LV can be effective not only as second-line therapy, but also as third-line or later-line treatment in selected patients. Nal-IRI plus 5-FU/LV may be particularly beneficial for the survival of patients that maintain good general condition or those with favorable prior experience to irinotecan.

Keywords: antineoplastic agents; carcinoma; irinotecan; liposomes; pancreatic ductal; survival.

Conflict of interest statement

Competing interests: The authors declare that there is no conflict of interest.

© The Author(s), 2022.

Figures

Figure 1.
Figure 1.
Flow chart of patients.
Figure 2.
Figure 2.
Kaplan–Meier survival analysis, patients who were treated with nal-IRI plus 5-FU/LV beyond second-line therapy: (a) from start of nal-IRI plus 5-FU/LV and (b) from start of first-line therapy. 5-FU/LV, 5-fluorouracil and leucovorin; naI-IRI, nanoliposomal encapsulation of irinotecan.
Figure 3.
Figure 3.
Kaplan–Meier survival analysis according to performance status: ECOG 0–2 (a, b), prior irinotecan exposure and response (c, d). ECOG, Eastern Cooperative Oncology Group.

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