{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T21:38:58Z","timestamp":1761514738084,"version":"3.41.2"},"reference-count":39,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2021,3,11]],"date-time":"2021-03-11T00:00:00Z","timestamp":1615420800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004543","name":"China Scholarship Council","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004543","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Oncol."],"abstract":"<jats:p><jats:bold>Background:<\/jats:bold> To identify the maximum tolerated dose (MTD) of hyperthermic intraperitoneal cisplatin at 43\u00b0C among gynecological cancer patients.<\/jats:p><jats:p><jats:bold>Methods:<\/jats:bold> In this Phase I dose-finding trial, Bayesian optimal interval (BOIN) design was used. We sought to explore the MTD with a target dose-limiting toxicity (DLT) rate of 20%, 4 prespecified doses (70 mg\/m<jats:sup>2<\/jats:sup>, 75 mg\/m<jats:sup>2<\/jats:sup>, 80 mg\/m<jats:sup>2<\/jats:sup> and 85 mg\/m<jats:sup>2<\/jats:sup>), and 30 patients.<\/jats:p><jats:p><jats:bold>Results:<\/jats:bold> Between 2019 and 2020, 30 gynecologic cancer patients were enrolled. No patients received bevacizumab in subsequent treatment. The most common adverse events related to cisplatin were nausea and vomiting (100%), followed by tinnitus (26.7%) and kidney injury (23.3%). Of the seven patients with kidney injury, four had persistent renal impairment, and finally progressed into chronic kidney injury. DLTs were noted only in the dose level 4 group (85 mg\/m<jats:sup>2<\/jats:sup>) and included acute kidney injury, pulmonary embolism, anemia, and neutropenia. When cisplatin was given at dose level four (85 mg\/m<jats:sup>2<\/jats:sup>), the isotonic estimate of the DLT rate (22%) was closest to the target DLT rate of 20%. Therefore, 85 mg\/m<jats:sup>2<\/jats:sup> was selected as the MTD, with a 51% probability that the toxicity probability was greater than the target DLT rate.<\/jats:p><jats:p><jats:bold>Conclusions:<\/jats:bold> For gynecological cancer patients who received HIPEC for peritoneal metastases, the MTD of cisplatin in HIPEC at 43\u00b0C was 85 mg\/m<jats:sup>2<\/jats:sup>. Our findings apply to patients who do not receive bevacizumab (ChiCTR1900021555).<\/jats:p>","DOI":"10.3389\/fonc.2021.616264","type":"journal-article","created":{"date-parts":[[2021,3,11]],"date-time":"2021-03-11T07:23:13Z","timestamp":1615447393000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":12,"title":["A Dose-Finding Trial for Hyperthermic Intraperitoneal Cisplatin in Gynecological Cancer Patients Receiving Hyperthermic Intraperitoneal 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