{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T02:28:54Z","timestamp":1790389734427,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"24","license":[{"start":{"date-parts":[[2020,10,25]],"date-time":"2020-10-25T00:00:00Z","timestamp":1603584000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100011725","name":"Servier","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100011725","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2020,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In the NAPOLI\u20101 phase 3 trial, liposomal irinotecan (nal\u2010IRI)\u00a0+5\u2010fluorouracil\/leucovorin (5\u2010FU\/LV) significantly increased mPFS versus 5\u2010FU\/LV (3.1 vs. 1.5\u00a0months [unstratified HR\u00a0=\u00a00.56, <jats:italic>p<\/jats:italic>\u00a0=\u00a00.0001]) in patients with mPAC that progressed on prior gemcitabine\u2010based therapy. This randomized phase 2 trial evaluated nal\u2010IRI+5\u2010FU\/LV tolerability (Part 1), safety, and efficacy (Part 2; outcomes reported here) in Japanese patients with mPAC that progressed on gemcitabine\u2010based therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients were randomized 1:1 and stratified by KPS (70 and 80 vs. \u226590) and baseline albumin (\u22654.0\u00a0g\/dl vs. &lt;4.0\u00a0g\/dl). Primary endpoint was PFS; secondary endpoints were ORR, DCR, OS, TTF, CA19\u20109 response, and QoL. The ITT population comprised all randomized patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Patient characteristics differed between nal\u2010IRI+5\u2010FU\/LV (n\u00a0=\u00a040) and 5\u2010FU\/LV (n\u00a0=\u00a039) arms, including baseline hepatic lesions (63% vs. 51%), stage IV disease at diagnosis (78% vs. 51%), and post\u2010study anticancer therapy (55% vs. 72%). Investigator\u2010assessed mPFS increase with nal\u2010IRI+5\u2010FU\/LV was clinically meaningful and statistically significant versus 5\u2010FU\/LV (2.7 vs. 1.5\u00a0months, HR\u00a0=\u00a00.60). Independently assessed mPFS showed similar trends (1.7 vs. 1.6\u00a0months, HR\u00a0=\u00a00.79). mOS was 6.3\u00a0months with nal\u2010IRI+5\u2010FU\/LV and not reached with 5\u2010FU\/LV. ORR increased significantly with nal\u2010IRI+5\u2010FU\/LV versus 5\u2010FU\/LV (18% vs. 0, rate difference 17.5). Commonly reported grade \u22653 treatment\u2010emergent AEs were decreased neutrophil count (37% vs. 3%), decreased white blood cell count (20% vs. 0), and diarrhea (17% vs. 3%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In conclusion, clinically meaningful and statistically significant gains in investigator\u2010assessed PFS and ORR were observed with nal\u2010IRI+5\u2010FU\/LV versus 5\u2010FU\/LV in Japanese patients, with no new or unexpected safety signals. (Clinicaltrials.gov ID: NCT02697058).<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.3558","type":"journal-article","created":{"date-parts":[[2020,10,25]],"date-time":"2020-10-25T08:59:06Z","timestamp":1603616346000},"page":"9396-9408","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":48,"title":["nal\u2010IRI+5\u2010FU\/LV versus 5\u2010FU\/LV in post\u2010gemcitabine metastatic pancreatic cancer: Randomized phase 2 trial in Japanese patients"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4480-0029","authenticated-orcid":false,"given":"Makoto","family":"Ueno","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division Kanagawa Cancer Center Yokohama\u2010shi Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoji","family":"Nakamori","sequence":"additional","affiliation":[{"name":"Department of Surgery NHO Osaka National Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuya","family":"Sugimori","sequence":"additional","affiliation":[{"name":"Gastroenterological Center Yokohama City University Medical Center Yokohama\u2010shi Kanagawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masashi","family":"Kanai","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Kyoto University Hospital Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masafumi","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital East Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Ozaka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Cancer Institute Hospital of JFCR Tokyo 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Kyorin University Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshito","family":"Komatsu","sequence":"additional","affiliation":[{"name":"Department of Cancer Chemotherapy Hokkaido University Hospital Cancer Center Hokkaido Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Ishii","sequence":"additional","affiliation":[{"name":"Clinical Research Center Chiba Cancer Center Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atsushi","family":"Sato","sequence":"additional","affiliation":[{"name":"Department of Oncology Hirosaki University Hospital Aomori Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Saitama Cancer Center Saitama 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