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

Cited 35 time in Web of Science Cited 40 time in Scopus
Authors

Bang, Yung-Jue; Li, Chung-Pin; Lee, Kyung-Hun; Chiu, Chang-Fang; Park, Joon Oh; Shan, Yan-Shen; Kim, Jun Suk; Chen, Jen-Shi; Shim, Hyun-Jeong; Rau, Kun-Ming; Choi, Hye Jin; Oh, Do-Youn; Belanger, Bruce; Chen, Li-Tzong

Issue Date
2020-02
Publisher
Oxford University Press
Citation
Cancer Science, Vol.111 No.2, pp.513-527
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) a nd m edian 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)
ISSN
1347-9032
URI
https://hdl.handle.net/10371/173033
DOI
https://doi.org/10.1111/cas.14264
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  • Department of Medicine
Research Area DNA 손상 반응 타겟 물질의 면역조절 효과, Effect of DNA damage response target substances on immunomodulatory action, Efficacy and biomarker validation studies of targeted therapeutics, Resistance mechanisms according to targeted therapeutics, 표적 항암제 내성 기전 연구, 표적 항암제의 효과 검증 및 바이오마커 규명

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