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Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study

Authors
 Yung-Jue Bang  ;  Chung-Pin Li  ;  Kyung-Hun Lee  ;  Chang-Fang Chiu  ;  Joon Oh Park  ;  Yan-Shen Shan  ;  Jun Suk Kim  ;  Jen-Shi Chen  ;  Hyun-Jeong Shim  ;  Kun-Ming Rau  ;  Hye Jin Choi  ;  Do-Youn Oh  ;  Bruce Belanger  ;  Li-Tzong Chen 
Citation
 CANCER SCIENCE, Vol.111(2) : 513-527, 2020-02 
Journal Title
CANCER SCIENCE
ISSN
 1347-9032 
Issue Date
2020-02
MeSH
Adenocarcinoma / drug therapy* ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols / administration & dosage ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use ; Asians ; Endpoint Determination ; Female ; Fluorouracil / administration & dosage* ; Fluorouracil / therapeutic use ; Humans ; Irinotecan / administration & dosage* ; Irinotecan / therapeutic use ; Leucovorin / administration & dosage* ; Leucovorin / therapeutic use ; Liposomes ; Male ; Middle Aged ; Neoplasm Metastasis ; Pancreatic Neoplasms / drug therapy* ; Survival Analysis ; Treatment Outcome
Keywords
Asian subgroup ; clinical trial ; phase 3 ; liposomal irinotecan ; metastatic pancreatic cancer ; NAPOLI-1
Abstract
The global, randomized NAPOLI-1 phase 3 trial reported a survival benefit with liposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (nal-IRI+5-FU/LV) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) after previous gemcitabine-based therapy. Median overall survival (OS) with nal-IRI+5-FU/LV was 6.1 vs 4.2 months with 5-FU/LV alone (unstratified hazard ratio [HR] = 0.67, P = .012). Herein, we report efficacy and safety results from a post-hoc subgroup analysis of Asian patients treated at Asian centers. Primary study endpoint was OS; secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. Patients receiving nal-IRI+5-FU/LV (n = 34) had significantly longer median OS versus 5-FU/LV (n = 35) (8.9 vs 3.7 months; unstratified HR = 0.51, P = .025). Patients had significantly increased median PFS with nal-IRI+5-FU/LV versus 5-FU/LV (4.0 vs 1.4; unstratified HR = 0.48, P = .011), and increased ORR (8.8% vs 0; P = .114). nal-IRI monotherapy (n = 50) numerically improved efficacy endpoints versus 5-FU/LV (n = 48): median OS was 5.8 versus 4.3 months (HR = 0.83, P = .423) and median PFS was 2.8 versus 1.4 months (HR = 0.69, P = .155). Grade >= 3 neutropenia was reported more frequently with nal-IRI+5-FU/LV versus 5-FU/LV (54.5% vs 3.4%), and incidence of grade >= 3 diarrhea was comparable between the two arms (3.0% vs 6.9%). This subgroup analysis confirms nal-IRI+5-FU/LV as an efficacious treatment option that improves survival in Asian patients with mPDAC that progressed after gemcitabine-based therapy, with a safety profile agreeing with previous findings. The nal-IRI+5-FU/LV regimen should represent a new standard of care for these patients in Asia. (Clinicaltrials.gov: NCT01494506)
Files in This Item:
T9992020463.pdf Download
DOI
10.1111/cas.14264
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/22282913/190238
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