{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T19:35:08Z","timestamp":1791228908502,"version":"4.1.0"},"reference-count":25,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T00:00:00Z","timestamp":1740960000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T00:00:00Z","timestamp":1740960000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Blood &amp;amp; Cancer"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cisplatin is used to treat solid tumors but causes irreversible hearing loss. Pedmark, a formulation of sodium thiosulfate (STS), is approved to prevent cisplatin\u2010induced hearing loss (CIHL). Prior to approval, non\u2010Pedmark formulations of STS pentahydrate (STS\u2010P) were prescribed off\u2010label for otoprotection and continue to be used in the absence of data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Procedure<\/jats:title>\n                    <jats:p>This multicenter retrospective study examined tolerability, toxicity, and hearing outcomes of STS\u2010P used off\u2010label for otoprotection. Exploratory analyses compared toxicity and hearing data in patients receiving STS\u2010P versus the pre\u2010Pedmark investigational formulation (STS\u2010inv) tested in trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Fifty\u2010nine patients received STS\u2010P (16 or 20\u00a0g\/m\n                      <jats:sup>2<\/jats:sup>\n                      ). Infusion\u2010related reactions (IRR) occurred in 14% (8\/59), more commonly in patients receiving 20\u00a0g\/m\n                      <jats:sup>2<\/jats:sup>\n                      . No severe adverse events occurred. One patient (2%) discontinued STS\u2010P for IRR. The prevalence of CIHL (International Society of Paediatric Oncology [SIOP] Grade \u22652) at the end of therapy and at the most recent hearing assessment was 30% at both timepoints (12\/40 and 8\/27, respectively). In exploratory analyses comparing STS\u2010P with STS\u2010inv (\n                      <jats:italic>n<\/jats:italic>\n                      = 14), there was no difference in tolerance or toxicity. In multivariable analysis, a lower risk for CIHL at the end of therapy was found for age \u22655\u00a0years, higher dosing of 20\u00a0g\/m\n                      <jats:sup>2<\/jats:sup>\n                      , and received STS\u2010inv (odds ratio 0.02, 95% confidence interval: 0.0003\u20130.691,\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.01). No difference was present at the most recent exam.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>STS\u2010P off\u2010label for otoprotection following cisplatin was tolerable in a real\u2010world setting across age groups and cancer types. Formal testing in larger studies of different STS formulations is needed to explore possible differences in toxicity and CIHL prevention.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pbc.31631","type":"journal-article","created":{"date-parts":[[2025,3,11]],"date-time":"2025-03-11T16:54:39Z","timestamp":1741712079000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Real\u2010World Experience Using Sodium Thiosulfate Pentahydrate Off\u2010Label for Cisplatin Otoprotection in Children, Adolescents, and Young Adults"],"prefix":"10.1002","volume":"72","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4393-2927","authenticated-orcid":false,"given":"Julie","family":"Ma","sequence":"first","affiliation":[{"name":"Cancer and Blood Disease Institute Children's Hospital Los Angeles  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer H.","family":"Foster","sequence":"additional","affiliation":[{"name":"Texas Children's Cancer Center, Baylor College of Medicine  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shahrad R.","family":"Rassekh","sequence":"additional","affiliation":[{"name":"BC Children's Hospital University of British Columbia  Vancouver British Columbia Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jemily","family":"Malvar","sequence":"additional","affiliation":[{"name":"Cancer and Blood Disease Institute Children's Hospital Los Angeles  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yueh\u2010Yun","family":"Chi","sequence":"additional","affiliation":[{"name":"Cancer and Blood Disease Institute Children's Hospital Los Angeles  Los Angeles California USA"},{"name":"Keck School of Medicine University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2333-4364","authenticated-orcid":false,"given":"Hannah E.","family":"Sauer","sequence":"additional","affiliation":[{"name":"Texas Children's Cancer Center, Baylor College of Medicine  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Jeon","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Children's Hospital Los Angeles  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5280-990X","authenticated-orcid":false,"given":"David R.","family":"Freyer","sequence":"additional","affiliation":[{"name":"Cancer and Blood Disease Institute Children's Hospital Los Angeles  Los Angeles California USA"},{"name":"Keck School of Medicine University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"Rushing","sequence":"additional","affiliation":[{"name":"Cancer and Blood Disease Institute Children's Hospital Los Angeles  Los Angeles California USA"},{"name":"Department of Pharmacy Children's Hospital Los Angeles  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1487-6818","authenticated-orcid":false,"given":"Etan","family":"Orgel","sequence":"additional","affiliation":[{"name":"Cancer and Blood Disease Institute Children's Hospital Los Angeles  Los Angeles California USA"},{"name":"Keck School of Medicine University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,3]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.jmedchem.7b01653"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/OP.22.00710"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.29779"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tips.2013.05.006"},{"key":"e_1_2_9_6_1","unstructured":"\u201cCisplatin [package insert] \u201dU.S. Food and Drug Administration Revised February2019 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