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Real-world efficacy and safety of liposomal irinotecan plus fluorouracil/leucovorin in patients with metastatic pancreatic adenocarcinoma: a study by the Korean Cancer Study Group

Authors
 Changhoon Yoo  ;  Hyeon-Su Im  ;  Kyu-pyo Kim  ;  Do-Youn Oh  ;  Kyung-Hun Lee  ;  Hong Jae Chon  ;  Joo Hoon Kim  ;  Myoungjoo Kang  ;  Ilhwan Kim  ;  Guk Jin Lee  ;  Sung Yong Oh  ;  Younak Choi  ;  Hye Jin Choi  ;  Seung Tae Kim  ;  Joon Oh Park  ;  Baek-Yeol Ryoo 
Citation
 THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY, Vol.11 : 1758835919871126, 2019 
Journal Title
THERAPEUTIC ADVANCES IN MEDICAL ONCOLOGY
ISSN
 1758-8340 
Issue Date
2019
Keywords
chemotherapy ; liposomal irinotecan ; pancreatic adenocarcinoma ; real-world evidence
Abstract
Background: Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) was effective and well-tolerated in patients with metastatic pancreatic adenocarcinoma (mPAC) that progressed on gemcitabine-based therapy in the global NAPOLI-1 trial. Real-world data may further clarify the outcomes and safety profile of nal-IRI + 5-FU/LV in clinical practice. Methods: This retrospective analysis included patients with mPAC who received nal-IRI + 5-FU/LV following gemcitabine-based therapy under a Managed Access Program in Korea. Results: From January 2017 to April 2018, 86 patients across 10 institutions received nal-IRI + 5-FU/LV (median age, 61 years; 60% male; ECOG performance status, 0-1). A total of 35 (41%) and 51 (59%) patients had received less than two and two or more lines of chemotherapy before inclusion, respectively. At a median follow up of 6.4 months, median overall survival (OS) was 9.4 months (95% confidence interval [CI] 7.4-11.4) and median progression-free survival (PFS) was 3.5 months (95% CI 1.3-5.7). Six-month OS and PFS rates were 65.1% and 37.5%, respectively. Objective response and disease control rates were 10% and 55%, respectively. Most common grade 3-4 toxicities were neutropenia (37.2%), nausea (10.5%), vomiting (9.3%), anorexia (8.1%) and diarrhoea (4.7%). Conclusion: Real-life data for Korean patients indicate that, consistent with NAPOLI-1, nal-IRI + 5-FU/LV is effective and well-tolerated in patients with mPAC that progressed on gemcitabine-based therapy.
Files in This Item:
T201904455.pdf Download
DOI
10.1177/1758835919871126
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Choi, Hye Jin(최혜진) ORCID logo https://orcid.org/0000-0001-5917-1400
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/173304
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