{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T05:36:56Z","timestamp":1787809016342,"version":"build-2784847793"},"reference-count":32,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Med Oncol"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Nanoliposomal irinotecan with fluorouracil and folinic acid (NFF) is a standard second- or later-line regimen for unresectable or recurrent pancreatic cancer (urPC). However, validated prognostic biomarkers are lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>In this study, we aimed to identify clinical predictors of progression-free survival (PFS) in patients receiving NFF and to develop a nomogram for early prediction of therapeutic efficacy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>This was a pre-planned analysis of a prospective, multicenter observational study conducted across 17 hospitals in Japan.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We enrolled 150 patients with urPC who received NFF between 2021 and 2023. Prognostic factors independently associated with PFS were identified using multivariable Cox proportional hazards regression analysis. Based on these factors, we constructed a nomogram to estimate the probabilities of 2-, 4-, and 6-month PFS. Finally, we performed risk stratification according to total nomogram scores and validated this model using an independent retrospective cohort.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      The median overall survival was 7.8\u2009months, and the median PFS was 3.7\u2009months. Multivariable analysis identified a longer duration of previous chemotherapy (hazard ratio (HR), 0.52; 95% confidence interval (CI), 0.38\u20130.71;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.01) as a favorable prognostic factor; third-line treatment (vs second-line; HR, 1.67; 95% CI, 1.04\u20132.67,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.03) and higher C-reactive protein\/albumin ratio (CAR; HR, 1.14; 95% CI, 1.01\u20131.29,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.04) were associated with unfavorable PFS. In risk stratification, median PFS in the low-, moderate-, and high-risk groups was 5.9\u2009months (reference), 3.9\u2009months (HR, 1.78; 95% CI, 1.16\u20132.71;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.01), and 2.2\u2009months (HR, 2.30; 95% CI, 1.51\u20133.50;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.01), respectively. Significant risk stratification was also confirmed in an independent retrospective cohort.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>The duration of previous chemotherapy, treatment line, and the CAR are useful predictors of PFS in patients with urPC receiving NFF. The proposed nomogram and risk stratification system may facilitate individualized treatment planning and support clinical decision-making.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17588359261442386","type":"journal-article","created":{"date-parts":[[2026,4,21]],"date-time":"2026-04-21T07:52:38Z","timestamp":1776757958000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Predictors of prolonged progression-free survival in patients with unresectable or recurrent pancreatic cancer treated with nanoliposomal irinotecan with fluorouracil and folinic acid (NAPOLEON-2 study)"],"prefix":"10.1177","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-7756-2462","authenticated-orcid":false,"given":"Yasunori","family":"Kawaguchi","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Asakura Medical Association Hospital, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kohei","family":"Hayashi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mototsugu","family":"Shimokawa","sequence":"additional","affiliation":[{"name":"Clinical Research Institute, National Kyushu Cancer Center, Fukuoka, Japan"},{"name":"Department of Biostatistics, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taiga","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Minato Medical Clinic, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junichi","family":"Nakazawa","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Kagoshima City Hospital, Kagoshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hozumi","family":"Shimokawa","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan"},{"name":"Department of Medical Oncology, Hamanomachi Hospital, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yudai","family":"Shinohara","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Futa","family":"Koga","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noriko","family":"Oza","sequence":"additional","affiliation":[{"name":"Department of Hepatobiliary and Pancreatology, Saga Medical Center Koseikan, Saga, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisanobu","family":"Oda","sequence":"additional","affiliation":[{"name":"Division of Integrative Medical Oncology, Saiseikai Kumamoto Hospital, Kumamoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigeyuki","family":"Takeshita","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiho","family":"Arima","sequence":"additional","affiliation":[{"name":"Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuji","family":"Arita","sequence":"additional","affiliation":[{"name":"Department of Chemotherapy, Miyazaki Prefectural Miyazaki Hospital, Miyazaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuo","family":"Nishikawa","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Otsu","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroki","family":"Taguchi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Imamura General Hospital, Kagoshima, Japan"},{"name":"Department of Gastroenterology, Kagoshima City Hospital, Kagoshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Jikuya","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Imamura General Hospital, Kagoshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsunori","family":"Sakai","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, NHO Kumamoto Medical Center, Kumamoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yujiro","family":"Ueda","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Sakae","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Saiseikai Sendai Hospital, Kagoshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norimasa","family":"Araki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Saiseikai Sendai Hospital, Kagoshima, Japan"},{"name":"Department of Gastroenterology, Izumi General Medical Center, Kagoshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hironori","family":"Sawase","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, National Hospital Organization Saga Hospital, Saga, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Ide","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, National Hospital Organization Saga Hospital, Saga, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Machiko","family":"Kawahira","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Kagoshima Kouseiren Hospital, Kagoshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenta","family":"Nio","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hamanomachi Hospital, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9317-8216","authenticated-orcid":false,"given":"Tsuyoshi","family":"Shirakawa","sequence":"additional","affiliation":[{"name":"Clinical Hematology Oncology Treatment Study Group, 1-14-6 Muromi-gaoka, Nishi-ku, Fukuoka-shi, Fukuoka 819-0030, Japan"},{"name":"Medical Checkup Center, Eikoh Hospital, 3-8-15 Befu-nishi, Shime-machi, Kasuya-gun, Fukuoka 811-2232, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiko","family":"Mizuta","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Fujikawa Hospital, Saga, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Mitsugi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Sasebo Kyosai Hospital, Nagasaki, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,4,21]]},"reference":[{"key":"e_1_3_4_2_2","unstructured":"Cancer Statistics. Cancer mortality from vital statistics in Japan (1958\u20132023) tabulated by Cancer Information Service. National Cancer Center Japan. https:\/\/ganjoho.jp\/reg_stat\/statistics\/data\/dl\/en.html (2025 accessed 15 October 2025)."},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21834"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)62307-0"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1097\/MPA.0b013e318258055c"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2021.0017"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1011923"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1304369"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)01366-1"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00986-1"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-024-63172-y"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmogo.2025.100150"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2016.05.016"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1499-3872(15)60344-7"},{"key":"e_1_3_4_15_2","doi-asserted-by":"publisher","DOI":"10.1159\/000542137"},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-147-8-200710160-00010"},{"key":"e_1_3_4_17_2","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2288-14-75"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30098-6"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-021-09139-y"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.3390\/cancers11081068"},{"key":"e_1_3_4_21_2","doi-asserted-by":"publisher","DOI":"10.1111\/jgh.14926"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1177\/10732748251333040"},{"key":"e_1_3_4_23_2","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjc.6604528"},{"key":"e_1_3_4_24_2","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djx037"},{"key":"e_1_3_4_25_2","doi-asserted-by":"publisher","DOI":"10.1177\/1758835919875568"},{"key":"e_1_3_4_26_2","doi-asserted-by":"publisher","DOI":"10.1038\/nrclinonc.2015.53"},{"key":"e_1_3_4_27_2","doi-asserted-by":"publisher","DOI":"10.3390\/ijms20184504"},{"key":"e_1_3_4_28_2","doi-asserted-by":"publisher","DOI":"10.1038\/nature07205"},{"key":"e_1_3_4_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)70263-3"},{"key":"e_1_3_4_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70218-7"},{"key":"e_1_3_4_31_2","doi-asserted-by":"publisher","DOI":"10.1093\/ajcn\/82.3.531"},{"key":"e_1_3_4_32_2","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-09-1525"},{"key":"e_1_3_4_33_2","doi-asserted-by":"publisher","DOI":"10.1177\/17588359251320768"}],"container-title":["Therapeutic Advances in Medical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17588359261442386","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17588359261442386","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17588359261442386","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T22:34:25Z","timestamp":1777588465000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17588359261442386"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4]]},"references-count":32,"alternative-id":["10.1177\/17588359261442386"],"URL":"https:\/\/doi.org\/10.1177\/17588359261442386","relation":{},"ISSN":["1758-8359","1758-8359"],"issn-type":[{"value":"1758-8359","type":"print"},{"value":"1758-8359","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4]]},"article-number":"17588359261442386"}}