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

Cited 3 time in Web of Science Cited 4 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
Citation
Cancer Science, Vol.111 No.2, pp.513-527
Keywords
Asian subgroupclinical trialphase 3liposomal irinotecanmetastatic pancreatic cancerNAPOLI-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) 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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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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