The role of nanoliposomal irinotecan plus fluorouracil/leucovorin in the continuum of care of patients with metastatic pancreatic ductal adenocarcinoma

Procaccio, Letizia; Merz, Valeria; Fasano, Morena; Vaccaro, Vanja; Giommoni, Elisa; Pretta, Andrea; Noventa, Silvia; Satolli, Maria Antonietta; Giordano, Guido; Zichi, Clizia; Pinto, Carmine; Zecchetto, Camilla; Barsotti, Giulia; Vita, Ferdinando De; Milella, Michèle; Antonuzzo, Lorenzo; Scartozzi, Mario; Zaniboni, Alberto; Spadi, Rosella; Casalino, Simona; Bergamo, Francesca; Toni, Chiara De; Melisi, Davide

doi:10.1002/cam4.6111

Cited by 8 publications

(4 citation statements)

References 30 publications

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“…The proportions of patients with prior 5-FU and platinum were also lower, but there was no signi cant difference when compared with other clinical trials [13]. In addition, there was no signi cant difference in patient backgrounds compared to other real-world clinical observational studies [19][20][21][22][23][24][25][26][27][28][29][30]. Therefore, our study cohort is reasonable and similar with those in previous reports.…”

Section: Discussionsupporting

confidence: 82%

“…The safety pro le of NFF in the current study appears acceptable in comparison with that in previous reports [19][20][21][22][23][24][25][26][27][28][29][30]. The incidence rates of grade 3 or 4 AEs were < 30%.…”

Section: Discussionsupporting

confidence: 47%

“…The mOS was 8.1 months, longer than that of the NAPOLI-1 study (median, 6.1 months) and of many retrospective and prospective studies [19][20][21][22][23][24][25][26][27][28][29][30]. This can be attributed to several reasons.…”

Section: Discussionmentioning

confidence: 94%

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Nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable or recurrent pancreatic cancer: A multicenter retorospective ovservational study (NAPOLEON-2)

Kodama,

Imajima,

Shimokawa

et al. 2024

Preprint

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Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard regimen after gemcitabine-based therapy for patients with unresectable or recurrent pancreatic cancer. However, there are limited clinical data on its efficacy and safety in the real-world. We therefore initiated a retrospective and prospective observational study (NAPOLEON-2). The results of the retrospective part were reported herein. In this retrospective study, we evaluated 161 consecutive patients who received NFF as second-or-later-line regimen. The main endpoint was overall survival (OS), and the other endpoints were response rate, disease control rate, progression-free survival (PFS), dose intensity, and adverse events (AEs). The median age was 67 years (range, 38–85 years). The median OS and PFS were 8.1 and 3.4 months, respectively. The objective response and disease control rates were 5% and 52%, respectively. The median relative dose intensity was 81.6% for nanoliposomal irinotecan and 82.9% for fluorouracil. Grade 3 or 4 hematological and nonhematological AEs occurred in 47 and 42 patients, respectively. Common grade 3 or 4 AEs included neutropenia (24%), anorexia (12%), and leukocytopenia (12%). Subanalysis of patients treated with second-line and third-or-later-line demonstrated no statistical significant difference in OS (7.6 months vs. 9.1 months, respectively; hazard ratio, 0.92; 95% confidence interval, 0.64–1.35; p = 0.68). In conclusion, NFF has acceptable efficacy and safety profile even in real-world clinical settings. The prospective study is in progress to validate these findings.

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Section: Discussionsupporting

confidence: 82%

Section: Discussionsupporting

confidence: 47%

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Nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable or recurrent pancreatic cancer: A multicenter retorospective ovservational study (NAPOLEON-2)

Kodama,

Imajima,

Shimokawa

et al. 2024

Preprint

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“…Pancreatic adenocarcinoma (PC) is one of the most lethal tumors accounting for more than 400,000 deaths worldwide annually; given the poor prognosis, incidence and mortality still have similar rates (1)(2)(3). Five-year overall survival (OS) is less than 10%.…”

Section: Introductionmentioning

confidence: 99%

KRAS-related miR-143 expression is associated with lymph node involvement and correlates with outcome in pancreatic adenocarcinoma patients

Lavacchi,

Polvani,

Taddei

et al. 2023

Front. Oncol.

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IntroductionPancreatic adenocarcinoma (PC) is one of the most lethal malignancies; even after resection the patients’ 5-year disease-free survival (DFS) is lower than 26%. The genetic mutational landscape of PC is dominated by activating KRAS mutations, that have been reported in approximately 90% of cases; however, beyond KRAS - direct mutations, several KRAS-targeting miRNAs appear to be downregulated, strengthening the already activated RAS signaling. In addition, the interplay between miRNAs and RAS includes poorly investigated downstream miRNAs. The aim of this study was to determine the prognostic value of some of these candidate KRAS-related miRNAs.Patients and methodsBetween 2015 and 2022, 44 patients with pathologically confirmed PC, who received surgery and were enrolled by the Clinical Oncology Unit, Careggi University Hospital, Florence (Italy). PC Total RNA was extracted from FFPE sections, retro-transcribed and the resulting cDNA was then used for qPCR analysis. A panel of KRAS-related miRNA (miR-155, miR-206 and miR-143) was analyzed.ResultsIn this observational study patients sex distribution was unequal with 34.1% being male and 65.9% female. The most frequent tumor localization was the head of the pancreas (65.9%) and the pathological stages were pT1-2 (45.5%), pT3 (54.5%), pN0 (22.7%), pN+ (77.3%). Adjuvant therapy was administered to 63.6% of patients; disease recurrence was observed in 69% of cases. Twenty-three patients, whose RNA was of adequate quality, were used in the mRNAs expression studies. When comparing the miRNA expression between PC and a pool of healthy tissues, miR-155 was overexpressed and miR-206 downregulated in PC, while miR-143 expression was unchanged. However, when categorized in low- and high- miR-143 expressing PC (according to the median value), high miR-143 was associated with nodal involvement (pN+) (p=0.029), who in turn was linked with shorter DFS (p=0.009) and overall survival (OS) (p=0.021) compared to pN0. A trend toward inferior DFS was observed for higher expression of miR-206 (p=0.095) and miR-143 (p=0.092). Finally, responders to a first-line treatment for advanced disease had miR-155 overexpressed (p=0.048).ConclusionsmiRNAs are involved in PC tumorigenesis and metastatic spread. In light of miR-143 association with lymphatic spread and poor prognosis, a comprehensive analysis of miRNA interplay with KRAS deserves further investigation.

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