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Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study
DC Field | Value | Language |
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dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Li, Chung-Pin | - |
dc.contributor.author | Lee, Kyung-Hun | - |
dc.contributor.author | Chiu, Chang-Fang | - |
dc.contributor.author | Park, Joon Oh | - |
dc.contributor.author | Shan, Yan-Shen | - |
dc.contributor.author | Kim, Jun Suk | - |
dc.contributor.author | Chen, Jen-Shi | - |
dc.contributor.author | Shim, Hyun-Jeong | - |
dc.contributor.author | Rau, Kun-Ming | - |
dc.contributor.author | Choi, Hye Jin | - |
dc.contributor.author | Oh, Do-Youn | - |
dc.contributor.author | Belanger, Bruce | - |
dc.contributor.author | Chen, Li-Tzong | - |
dc.date.accessioned | 2021-01-31T11:06:57Z | - |
dc.date.available | 2021-01-31T11:06:57Z | - |
dc.date.created | 2020-06-01 | - |
dc.date.created | 2020-06-01 | - |
dc.date.issued | 2020-02 | - |
dc.identifier.citation | Cancer Science, Vol.111 No.2, pp.513-527 | - |
dc.identifier.issn | 1347-9032 | - |
dc.identifier.other | 101755 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173033 | - |
dc.description.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) | - |
dc.language | 영어 | - |
dc.publisher | Oxford University Press | - |
dc.title | Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI-1 study | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1111/cas.14264 | - |
dc.citation.journaltitle | Cancer Science | - |
dc.identifier.wosid | 000503545300001 | - |
dc.identifier.scopusid | 2-s2.0-85076774125 | - |
dc.citation.endpage | 527 | - |
dc.citation.number | 2 | - |
dc.citation.startpage | 513 | - |
dc.citation.volume | 111 | - |
dc.identifier.sci | 000533662400019 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.contributor.affiliatedAuthor | Oh, Do-Youn | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | RANDOMIZED PHASE-II | - |
dc.subject.keywordPlus | ADVANCED GASTRIC-CANCER | - |
dc.subject.keywordPlus | NANOLIPOSOMAL IRINOTECAN | - |
dc.subject.keywordPlus | 2ND-LINE THERAPY | - |
dc.subject.keywordPlus | PEP02 MM-398 | - |
dc.subject.keywordPlus | PLUS S-1 | - |
dc.subject.keywordPlus | GEMCITABINE | - |
dc.subject.keywordPlus | LEUCOVORIN | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordAuthor | Asian subgroup | - |
dc.subject.keywordAuthor | clinical trial | - |
dc.subject.keywordAuthor | phase 3 | - |
dc.subject.keywordAuthor | liposomal irinotecan | - |
dc.subject.keywordAuthor | metastatic pancreatic cancer | - |
dc.subject.keywordAuthor | NAPOLI-1 | - |
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