{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T18:14:30Z","timestamp":1783448070919,"version":"3.55.0"},"reference-count":53,"publisher":"Bioscientifica","issue":"2","license":[{"start":{"date-parts":[[2026,2,17]],"date-time":"2026-02-17T00:00:00Z","timestamp":1771286400000},"content-version":"vor","delay-in-days":322,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003196","name":"Ministero della Salute","doi-asserted-by":"crossref","award":["Ricerca Corrente"],"award-info":[{"award-number":["Ricerca Corrente"]}],"id":[{"id":"10.13039\/501100003196","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.bioscientifica.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,4,1]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Little is known about sex differences in lenvatinib treatment safety and efficacy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Real-word retrospective Italian multicenter study enrolling patients with radioiodine-refractory differentiated thyroid cancer treated with lenvatinib.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 138 patients (64 females) were included, with a median follow-up of 26 months (2\u201372). More men performed physical activities (34% vs 17%, P = 0.024). The frequency of smoking and alcohol consumption was higher in men (58% vs 33%, P = 0.003; 45% vs 17%, P = 0.001). We did not find sex differences in lenvatinib dose reduction due to adverse events (AEs) (78% females vs 85% males). Ninety-nine percent of patients developed at least one adverse event (AE), with no sex difference in their number and the time to first AE. Severe AEs occurred in 74% of males and 66% of females (P = 0.398), with a mean dose of 18.2 mg (\u00b15.7), and a median time to the first serious AE of 9 weeks (1\u2013154). Stomatitis\/mucositis and hematological disorders were more frequent in females (48% vs 30%, P = 0.016; 17% vs 4%, P = 0.011). Gastrointestinal disorders were higher in males (15% vs 2%, P = 0.010). Eighty-seven patients interrupted lenvatinib due to AEs (median time: 3 months (0\u201348), mean dose: 17 mg \u00b15.5). Discontinuation occurred in 21 patients, five for severe AEs. No sex differences were found in progression-free survival, overall survival or disease control rate. Liver metastases were associated with disease progression (HR: 3.73, 95% CI: 1.06\u201313.12, P = 0.040) or death (HR: 4.82, 95% CI: 1.75\u201313.25, P = 0.002) only in females.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Lenvatinib is effective in both sexes and exhibits a good safety profile, with a sex difference in the frequencies of some adverse events.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1530\/etj-24-0386","type":"journal-article","created":{"date-parts":[[2025,4,8]],"date-time":"2025-04-08T13:32:43Z","timestamp":1744119163000},"update-policy":"https:\/\/doi.org\/10.1530\/crossmarkpolicy-17","source":"Crossref","is-referenced-by-count":0,"title":["Gender impact on safety and efficacy in lenvatinib treated patients with radioiodine-refractory differentiated thyroid cancer (GISEL study)"],"prefix":"10.1530","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2899-9146","authenticated-orcid":false,"given":"Giulia","family":"Puliani","sequence":"first","affiliation":[{"name":"Oncological Endocrinology Unit, IRCCS Regina Elena National Cancer Institute 1 , ,","place":["Rome, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-0685-5540","authenticated-orcid":false,"given":"Marta","family":"Bianchini","sequence":"additional","affiliation":[{"name":"Oncological Endocrinology Unit, IRCCS Regina Elena National Cancer Institute 1 , ,","place":["Rome, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5248-4436","authenticated-orcid":false,"given":"Carlotta","family":"Giani","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, Endocrine Unit, Pisa University Hospital 2 , ,","place":["Pisa, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7723-7020","authenticated-orcid":false,"given":"Laura","family":"Valerio","sequence":"additional","affiliation":[{"name":"Department of Clinical and Experimental Medicine, Endocrine Unit, Pisa University Hospital 2 , ,","place":["Pisa, Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9227-2075","authenticated-orcid":false,"given":"Alice","family":"Nervo","sequence":"additional","affiliation":[{"name":"Oncological Endocrinology; 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