{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T19:19:21Z","timestamp":1784575161871,"version":"3.55.0"},"reference-count":32,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,12,20]],"date-time":"2019-12-20T00:00:00Z","timestamp":1576800000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The global, randomized NAPOLI\u20101 phase 3 trial reported a survival benefit with liposomal irinotecan (nal\u2010IRI) plus 5\u2010fluorouracil\/leucovorin (nal\u2010IRI+5\u2010FU\/LV) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) after previous gemcitabine\u2010based therapy. Median overall survival (OS) with nal\u2010IRI+5\u2010FU\/LV was 6.1 vs 4.2\u00a0months with 5\u2010FU\/LV alone (unstratified hazard ratio [HR]\u00a0=\u00a00.67, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.012). Herein, we report efficacy and safety results from a post\u2010hoc subgroup analysis of Asian patients treated at Asian centers. Primary study endpoint was OS; secondary endpoints included progression\u2010free survival (PFS), objective response rate (ORR), and safety. Patients receiving nal\u2010IRI+5\u2010FU\/LV (n\u00a0=\u00a034) had significantly longer median OS versus 5\u2010FU\/LV (n\u00a0=\u00a035) (8.9 vs 3.7\u00a0months; unstratified HR\u00a0=\u00a00.51, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.025). Patients had significantly increased median PFS with nal\u2010IRI+5\u2010FU\/LV versus 5\u2010FU\/LV (4.0 vs 1.4; unstratified HR\u00a0=\u00a00.48, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.011), and increased ORR (8.8% vs 0; <jats:italic>P<\/jats:italic>\u00a0=\u00a0.114). nal\u2010IRI monotherapy (n\u00a0=\u00a050) numerically improved efficacy endpoints versus 5\u2010FU\/LV (n\u00a0=\u00a048): median OS was 5.8 versus 4.3\u00a0months (HR\u00a0=\u00a00.83, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.423) and median PFS was 2.8 versus 1.4\u00a0months (HR\u00a0=\u00a00.69, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.155). Grade \u22653 neutropenia was reported more frequently with nal\u2010IRI+5\u2010FU\/LV versus 5\u2010FU\/LV (54.5% vs 3.4%), and incidence of grade \u22653 diarrhea was comparable between the two arms (3.0% vs 6.9%). This subgroup analysis confirms nal\u2010IRI+5\u2010FU\/LV as an efficacious treatment option that improves survival in Asian patients with mPDAC that progressed after gemcitabine\u2010based therapy, with a safety profile agreeing with previous findings. The nal\u2010IRI+5\u2010FU\/LV regimen should represent a new standard of care for these patients in Asia. (Clinicaltrials.gov: NCT01494506)<\/jats:p>","DOI":"10.1111\/cas.14264","type":"journal-article","created":{"date-parts":[[2019,12,2]],"date-time":"2019-12-02T21:19:43Z","timestamp":1575321583000},"page":"513-527","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Liposomal irinotecan in metastatic pancreatic adenocarcinoma in Asian patients: Subgroup analysis of the NAPOLI\u20101 study"],"prefix":"10.1111","volume":"111","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6000-4597","authenticated-orcid":false,"given":"Yung\u2010Jue","family":"Bang","sequence":"first","affiliation":[{"name":"Seoul National University College of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chung\u2010Pin","family":"Li","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Department of Medicine Taipei Veterans General Hospital Taipei Taiwan"},{"name":"National Yang\u2010Ming University School of Medicine Taipei Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyung\u2010Hun","family":"Lee","sequence":"additional","affiliation":[{"name":"Seoul National University Hospital Cancer Research Institute Seoul National University College of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chang\u2010Fang","family":"Chiu","sequence":"additional","affiliation":[{"name":"China Medical University Hospital Taichung Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joon Oh","family":"Park","sequence":"additional","affiliation":[{"name":"Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan\u2010Shen","family":"Shan","sequence":"additional","affiliation":[{"name":"Department of Surgery National Cheng Kung University Hospital Tainan Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun Suk","family":"Kim","sequence":"additional","affiliation":[{"name":"Korea University Guro Hospital Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9756-3974","authenticated-orcid":false,"given":"Jen\u2010Shi","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Hematology\u2010Oncology Linkou Chang Gung Memorial Hospital and Chang Gung University Tao\u2010Yuan Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyun\u2010Jeong","family":"Shim","sequence":"additional","affiliation":[{"name":"Chonnam National University Hwasun Hospital Gwangju Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kun\u2010Ming","family":"Rau","sequence":"additional","affiliation":[{"name":"Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hye Jin","family":"Choi","sequence":"additional","affiliation":[{"name":"Severance Hospital Yonsei University Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Do\u2010Youn","family":"Oh","sequence":"additional","affiliation":[{"name":"Seoul National University Hospital Cancer Research Institute Seoul National University College of Medicine Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce","family":"Belanger","sequence":"additional","affiliation":[{"name":"Ipsen Bioscience, Inc Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3250-7167","authenticated-orcid":false,"given":"Li\u2010Tzong","family":"Chen","sequence":"additional","affiliation":[{"name":"National Institute of Cancer Research National Health Research Institutes (NHRI) Tainan Taiwan"},{"name":"Department of Internal Medicine National Cheng Kung University Hospital National Cheng Kung University Tainan Taiwan"},{"name":"Department of Internal Medicine Kaohsiung Medical University Hospital Kaohsiung Medical University Kaohsiung Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,20]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx033"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12029-015-9724-1"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-14-0155"},{"key":"e_1_2_8_5_1","volume-title":"Global Cancer Observatory: Cancer Today","author":"Ferlay J"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2018.07.005"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1011923"},{"key":"e_1_2_8_8_1","unstructured":"NCCN.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines\u00ae) 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