{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T13:35:38Z","timestamp":1793885738214,"version":"4.8.0"},"reference-count":33,"publisher":"Springer Science and Business Media LLC","issue":"8","license":[{"start":{"date-parts":[[2024,5,4]],"date-time":"2024-05-04T00:00:00Z","timestamp":1714780800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,5,4]],"date-time":"2024-05-04T00:00:00Z","timestamp":1714780800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ann Surg Oncol"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Uveal melanoma (UM) has a poor prognosis once liver metastases occur. The melphalan\/Hepatic Delivery System (melphalan\/HDS) is a drug\/device combination used for liver-directed treatment of metastatic UM (mUM) patients. The purpose of the FOCUS study was to assess the efficacy and safety of melphalan\/HDS in patients with unresectable mUM.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eligible patients with mUM received treatment with melphalan (3.0 mg\/kg ideal body weight) once every 6 to 8 weeks for a maximum of six cycles. The primary end point was the objective response rate (ORR). The secondary end points included duration of response (DOR), overall survival (OS), and progression-free survival (PFS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The study enrolled 102 patients with mUM. Treatment was attempted in 95 patients, and 91 patients received treatment. In the treated population (\n                      <jats:italic>n<\/jats:italic>\n                      = 91), the ORR was 36.3 % (95 % confidence interval [CI], 26.44\u201347.01), including 7.7 % of patients with a complete response. Thus, the study met its primary end point because the lower bound of the 95 % CI for ORR exceeded the upper bound (8.3 %) from the benchmark meta-analysis. The median DOR was 14 months, and the median OS was 20.5 months, with an OS of 80 % at 1 year. The median PFS was 9 months, with a PFS of 65 % at 6 months. The most common serious treatment-emergent adverse events were thrombocytopenia (15.8 %) and neutropenia (10.5 %), treated\u00a0mostly on an outpatient basis with observation. No treatment-related deaths were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Treatment with melphalan\/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1245\/s10434-024-15293-x","type":"journal-article","created":{"date-parts":[[2024,5,4]],"date-time":"2024-05-04T17:01:24Z","timestamp":1714842084000},"page":"5340-5351","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":56,"title":["Efficacy and Safety of the Melphalan\/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study"],"prefix":"10.1245","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6886-4468","authenticated-orcid":false,"given":"Jonathan S.","family":"Zager","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlana","family":"Orloff","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pier Francesco","family":"Ferrucci","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junsung","family":"Choi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David J.","family":"Eschelman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan S.","family":"Glazer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aslam","family":"Ejaz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. 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Education and Training grant through Delcath. Dr. Marlana Orloff\u2013Advisory Board: Delcath, Replimune. Consultant: Immunocore. Steering Committee: Ideaya. Speaker: Immunocore. Dr. David Eschelman\u2013Received <$5K consulting fees from Delcath. Dr. Evan Glazer\u2013My institution was a site for the clinical trial. I received no direct payment. Delcath paid for the clinical trial to my institution. Dr. J. Howard\u2013I was paid as a consultant to Delcath as a proctor for this trial\u00a0to ensure new\u00a0institutions adhered to protocol. Prof. Erika Richtig\u2013Medical University of Graz received payments for conducting the Phase 3 study. Dr. Sebastian Ochsenreither\u2013Advice: Immunocore, Delcath, Janssen. Speakers\u2019 bureau: Immunocore. Dr. Georgia Beasley\u2013Clinical trial funding paid to institution from Replimune, checkmate pharmaceuticals, Philogen, Delcath. Advisory board BMS 10.2023. Dr. Anja Gesierich\u2013University Hospital\u00a0W\u00fcrzburg received payments for conducting the Phase 3 study. Professor Reinhard Dummer\u2013intermittent, project focused consulting and\/or advisory relationships with Novartis, Merck Sharp & Dhome (MSD), Bristol-Myers Squibb (BMS), Roche, Amgen, Takeda, Pierre Fabre, Sun Pharma, Sanofi, Catalym, Second Genome, Regeneron, Alligator, T3 Pharma, MaxiVAX SA, Pfizer, Simcere and touchIME outside the submitted work. Dr. Ana Arance\u2013Consulting or advisory role: Pierre- Fabre, Novartis, Roche, BMS, MSD, Biontech. Speakers\u2019 Bureau: Pierre- Fabre, Novartis, Roche, BMS, MSD. Travel, Accommodations, Expenses: BMS, MSD. Mr. Stephen Fenwick\u2013Liverpool University Hospitals NHS Trust received support for conducting this Phase 3 study from the trial sponsor. Dr. Joseph Sacco\u2013I have been a paid member of advisory boards for Delcath, Replimune and Immunocore. I have received grant funding from Astra Zeneca and BMS (paid to institution). I have had travel and conference attendance paid for by MSD, BMS and Replimune. Dr. Matthew Wheater\u2013Institutional (University Hospital Southampton) funding for conducting a commercial trial. Personal funding for participation in advisory board for Delcath.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclosure"}}]}}