Isolated Hepatic Perfusion With Melphalan for Patients With Isolated Uveal Melanoma Liver Metastases: A Multicenter, Randomized, Open-Label, Phase III Trial (the SCANDIUM Trial)

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Isolated Hepatic Perfusion With Melphalan for Patients With Isolated Uveal Melanoma Liver Metastases : A Multicenter, Randomized, Open-Label, Phase III Trial (the SCANDIUM Trial)

Olofsson Bagge, Roger (författare): Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Sahlgrenska Ctr Canc Res,Dept Surg, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Surg, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden.

Nelson, Axel (författare): Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Gothenburg, Sweden.,Univ Gothenburg, Sweden; Univ Western Australia, Australia

Shafazand, Amir (författare): Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden.;Alingsas Hosp, Dept Radiol, Alingsas, Sweden.

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All-Eriksson, Charlotta (författare): Sahlgrens Univ Hosp, Mölndal Hosp, Dept Ophthalmol, Gothenburg, Sweden.

Cahlin, Christian (författare): Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, Gothenburg, Sweden.

Elander, Nils (författare): Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Onkologiska kliniken US

Helgadottir, Hildur (författare): Karolinska Institutet,Karolinska Univ Hosp, Sweden

Kiilgaard, Jens Folke (författare): Copenhagen Univ Hosp Copenhagen, Dept Ophthalmol, Rigshosp, Copenhagen, Denmark. Skane Univ Hosp, Dept Oncol, Lund, Sweden. Umeå Univ Hosp, Dept Radiat Sci, Oncol, Umeå, Sweden.

Kinhult, Sara (författare): Department of Oncology, Skåne University Hospital, Lund, Sweden

Ljuslinder, Ingrid (författare): Department of Radiation Sciences, Oncology, Umeå University Hospital, Umeå, Sweden

Mattsson, Jan (författare): Sahlgrens Univ Hosp, Dept Surg, S-41345 Gothenburg, Sweden.

Rizell, Magnus (författare): Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, Gothenburg, Sweden.

Sternby Eilard, Malin (författare): Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, Gothenburg, Sweden.

Ullenhag, Gustav (författare): Uppsala universitet,Experimentell och klinisk onkologi,Science for Life Laboratory, SciLifeLab,Cancerimmunterapi,Department of Immunology, Genetics and Pathology (IGP), Science for Life Laboratories, Uppsala University, Uppsala, Sweden; Department of Oncology, Uppsala University Hospital, Uppsala, Sweden

Nilsson, Jonas A. (författare): Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Sahlgrenska Ctr Canc Res,Dept Surg, Gothenburg, Sweden.;Univ Western Australia, Harry Perkins Inst Med Res, Perth, WA, Australia.

Ny, Lars (författare): Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Gothenburg, Sweden.

Lindner, Per (författare): Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, Gothenburg, Sweden.

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Univ Gothenburg, Inst Clin Sci, Sahlgrenska Acad, Sahlgrenska Ctr Canc Res,Dept Surg, Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Surg, S-41345 Gothenburg, Sweden.;Univ Gothenburg, Wallenberg Ctr Mol & Translat Med, Gothenburg, Sweden. Univ Gothenburg, Sahlgrenska Univ Hosp, Inst Clin Sci, Dept Oncol,Sahlgrenska Acad, Gothenburg, Sweden. (creator_code:org_t)

American Society of Clinical Oncology (ASCO), 2023
2023
Engelska.
Ingår i: Journal of Clinical Oncology. - : American Society of Clinical Oncology (ASCO). - 0732-183X .- 1527-7755. ; 41:16, s. 3042-3050

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PURPOSE: About half of patients with metastatic uveal melanoma present with isolated liver metastasis, in whom the median survival is 6-12 months. The few systemic treatment options available only moderately prolong survival. Isolated hepatic perfusion (IHP) with melphalan is a regional treatment option, but prospective efficacy and safety data are lacking.METHODS: In this multicenter, randomized, open-label, phase III trial, patients with previously untreated isolated liver metastases from uveal melanoma were randomly assigned to receive a one-time treatment with IHP with melphalan or best alternative care (control group). The primary end point was overall survival at 24 months. Here, we report the secondary outcomes of response according to RECIST 1.1 criteria, progression-free survival (PFS), hepatic PFS (hPFS), and safety.RESULTS: Ninety-three patients were randomly assigned, and 87 patients were assigned to either IHP (n = 43) or a control group receiving the investigator's choice of treatment (n = 44). In the control group, 49% received chemotherapy, 39% immune checkpoint inhibitors, and 9% locoregional treatment other than IHP. In an intention-to-treat analysis, the overall response rates (ORRs) were 40% versus 4.5% in the IHP and control groups, respectively (P < .0001). The median PFS was 7.4 months versus 3.3 months (P < .0001), with a hazard ratio of 0.21 (95% CI, 0.12 to 0.36), and the median hPFS was 9.1 months versus 3.3 months (P < .0001), both favoring the IHP arm. There were 11 treatment-related serious adverse events in the IHP group compared with seven in the control group. There was one treatment-related death in the IHP group.CONCLUSION: IHP treatment resulted in superior ORR, hPFS, and PFS compared with best alternative care in previously untreated patients with isolated liver metastases from primary uveal melanoma.

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Av författaren/redakt...: Olofsson Bagge, ...; Nelson, Axel; Shafazand, Amir; All-Eriksson, Ch ...; Cahlin, Christia ...; Elander, Nils; visa fler...; Helgadottir, Hil ...; Kiilgaard, Jens ...; Kinhult, Sara; Ljuslinder, Ingr ...; Mattsson, Jan; Rizell, Magnus; Sternby Eilard, ...; Ullenhag, Gustav; Nilsson, Jonas A ...; Ny, Lars; Lindner, Per; visa färre...

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Isolated Hepatic Perfusion With Melphalan for Patients With Isolated Uveal Melanoma Liver Metastases : A Multicenter, Randomized, Open-Label, Phase III Trial (the SCANDIUM Trial)

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