{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,11]],"date-time":"2026-01-11T01:46:20Z","timestamp":1768095980590,"version":"3.49.0"},"reference-count":28,"publisher":"Wiley","issue":"20","license":[{"start":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T00:00:00Z","timestamp":1761004800000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004737","name":"National Health Research Institutes","doi-asserted-by":"publisher","award":["NHRI\u2010114A1\u2010CACO\u201013252502"],"award-info":[{"award-number":["NHRI\u2010114A1\u2010CACO\u201013252502"]}],"id":[{"id":"10.13039\/501100004737","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of nanoliposomal irinotecan (nal\u2010IRI) plus 5\u2010fluorouracil (5\u2010FU) and leucovorin (LV) in patients with platinum\u2010refractory or intolerant head and neck squamous cell carcinoma (HNSCC) and esophageal squamous cell carcinoma (ESCC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this multicenter, phase 2 study (NCT03712397), patients with advanced HNSCC (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200943) or ESCC (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200916) who had failed or were intolerant to platinum\u2010based chemotherapy received biweekly nal\u2010IRI 80\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      (equivalent to 70\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      of irinotecan base), LV 400\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      , and 5\u2010FU 2400\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      until progression or unacceptable toxicity. The primary endpoint was the objective response rate (ORR).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In the intent\u2010to\u2010treat analysis, the ORR and disease control rate were 8.5% and 59.3% for the entire group. In the HNSCC subgroup, ORR and disease control rate were 11.6% and 65.1%, with a median progression\u2010free survival (PFS) of 2.7\u2009months and an overall survival (OS) of 8.1\u2009months. By contrast, no objective responses were observed in ESCC (ORR 0%, disease control rate 43.8%, median OS 4.2\u2009months). The most common grade 3\/4 toxicities were lymphopenia (50.8%), neutropenia (42.4%), leukopenia (33.9%), anemia (28.8%), and anorexia (8.5%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Nal\u2010IRI\/5\u2010FU\/LV demonstrates modest activity with acceptable safety profiles in patients with platinum\u2010refractory or intolerable advanced HNSCC. The exploratory findings warrant confirmation in larger, randomized studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      : NCT03712397\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cam4.71307","type":"journal-article","created":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T18:22:37Z","timestamp":1761070957000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Nanoliposomal Irinotecan in Combination With 5\u2010Fluorouracil and Leucovorin for Advanced Head and Neck and Esophageal Squamous Cell Carcinoma After Prior Platinum\u2010Based Chemotherapy or Chemoradiotherapy: A Multicenter Phase\n                    <scp>II<\/scp>\n                    Trial"],"prefix":"10.1002","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7722-9506","authenticated-orcid":false,"given":"Muh\u2010Hwa","family":"Yang","sequence":"first","affiliation":[{"name":"Department of Oncology Taipei Veterans General Hospital  Taipei Taiwan"},{"name":"Institute of Clinical Medicine National Yang Ming Chiao Tung University  Taipei Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shang\u2010Yin","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Oncology National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I\u2010Wei","family":"Ho","sequence":"additional","affiliation":[{"name":"Department of Oncology Taipei Veterans General Hospital  Taipei 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