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

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dc.contributor.author최혜진-
dc.date.accessioned2022-09-06T06:37:57Z-
dc.date.available2022-09-06T06:37:57Z-
dc.date.issued2020-02-
dc.identifier.issn1347-9032-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/190238-
dc.description.abstractThe 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)-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherWiley Publishing on behalf of the Japanese Cancer Association-
dc.relation.isPartOfCANCER SCIENCE-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdenocarcinoma / drug therapy*-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / administration & dosage-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / therapeutic use-
dc.subject.MESHAsians-
dc.subject.MESHEndpoint Determination-
dc.subject.MESHFemale-
dc.subject.MESHFluorouracil / administration & dosage*-
dc.subject.MESHFluorouracil / therapeutic use-
dc.subject.MESHHumans-
dc.subject.MESHIrinotecan / administration & dosage*-
dc.subject.MESHIrinotecan / therapeutic use-
dc.subject.MESHLeucovorin / administration & dosage*-
dc.subject.MESHLeucovorin / therapeutic use-
dc.subject.MESHLiposomes-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHNeoplasm Metastasis-
dc.subject.MESHPancreatic Neoplasms / drug therapy*-
dc.subject.MESHSurvival Analysis-
dc.subject.MESHTreatment Outcome-
dc.titleLiposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorYung-Jue Bang-
dc.contributor.googleauthorChung-Pin Li-
dc.contributor.googleauthorKyung-Hun Lee-
dc.contributor.googleauthorChang-Fang Chiu-
dc.contributor.googleauthorJoon Oh Park-
dc.contributor.googleauthorYan-Shen Shan-
dc.contributor.googleauthorJun Suk Kim-
dc.contributor.googleauthorJen-Shi Chen-
dc.contributor.googleauthorHyun-Jeong Shim-
dc.contributor.googleauthorKun-Ming Rau-
dc.contributor.googleauthorHye Jin Choi-
dc.contributor.googleauthorDo-Youn Oh-
dc.contributor.googleauthorBruce Belanger-
dc.contributor.googleauthorLi-Tzong Chen-
dc.identifier.doi10.1111/cas.14264-
dc.contributor.localIdA04219-
dc.relation.journalcodeJ00454-
dc.identifier.eissn1349-7006-
dc.identifier.pmid31789476-
dc.subject.keywordAsian subgroup-
dc.subject.keywordclinical trial-
dc.subject.keywordphase 3-
dc.subject.keywordliposomal irinotecan-
dc.subject.keywordmetastatic pancreatic cancer-
dc.subject.keywordNAPOLI-1-
dc.contributor.alternativeNameChoi, Hye Jin-
dc.contributor.affiliatedAuthor최혜진-
dc.citation.volume111-
dc.citation.number2-
dc.citation.startPage513-
dc.citation.endPage527-
dc.identifier.bibliographicCitationCANCER SCIENCE, Vol.111(2) : 513-527, 2020-02-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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