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- Olofsson Bagge, Roger, 1978, et al.
(author)
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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)
- 2023
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In: Journal of Clinical Oncology. - : American Society of Clinical Oncology (ASCO). - 0732-183X .- 1527-7755. ; 41:16, s. 3042-50
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Journal article (peer-reviewed)abstract
- PURPOSEAbout 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.METHODSIn 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.RESULTSNinety-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.CONCLUSIONIHP 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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- Eriksson, A, et al.
(author)
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Effect of antisecretory factor in ulcerative colitis on histological and laborative outcome: a short period clinical trial.
- 2003
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In: Scandinavian journal of gastroenterology. - 0036-5521. ; 38:10, s. 1045-9
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Journal article (peer-reviewed)abstract
- BACKGROUND: The antisecretory factor (AF) is a 41 kD endogenously produced protein capable of mediating protection against diarrhoea diseases and intestinal inflammation. High concentrations of AF-like proteins are present in egg yolk, and AF can consequently be administrated in the form of egg yolk drinks. In this study, performed in patients suffering from acute onset of ulcerative colitis (UC), we evaluate the influence of orally administrated AF on the histological and clinical laboratory outcome. METHODS: A total of 20 patients fulfilled this prospective, double-blind and randomized protocol. The intake of AF was used as an additive treatment to conventional UC medication. Patient registrations were extended to two outward visits, performed 2-4 and 8-12 weeks after hospital discharge. RESULTS: During AF treatment, a reduction in the histological severity from mucosal biopsies received from the mid-rectum was found. In addition, a lowering in the inflammatory blood parameters ESR, CRP and orosomucoid was demonstrated. CONCLUSION: In the AF-treated group a late and significant lowering of various inflammatory parameters combined with a histological recovery was demonstrated. These findings suggest that administration of AF mediates a long-lasting anti-inflammatory effect in cases of acute UC.
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- McCulloch, Sofia, et al.
(author)
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The diagnostic value of a change in bowel habit for colorectal cancer within different age groups
- 2020
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In: United European Gastroenterology Journal. - : Wiley. - 2050-6406 .- 2050-6414. ; 8:2, s. 211-219
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Journal article (peer-reviewed)abstract
- Background Change in bowel habit as a sole alarm symptom for colorectal cancer is disputed. Objective We investigated the diagnostic value of change in bowel habit for colorectal cancer, particularly as a single symptom and within different age groups. Methods This retrospective cohort study examined colorectal cancer fast track referrals and outcomes across four Swedish hospitals (April 2016-May 2017). Entry criteria constituted one or more of three alarm features: anaemia, visible rectal bleeding, or change in bowel habit for more than 4 weeks in patients over 40 years of age. Patients were grouped as having only change in bowel habit, change in bowel habit plus anaemia/bleeding or anaemia/bleeding only. Results Of 628 patients, 22% were diagnosed with colorectal cancer. There were no cases of colorectal cancer in the only change in bowel habit group under 55 years, while this was 6% for 55-64 years, 8% for 65-74 years and 14% for 75 years and older. Among subjects under 55 years, 2% with anaemia/bleeding had colorectal cancer, this increased to 34% for 55 years and older (P < 0.0001). Change in bowel habit plus anaemia/bleeding gave a colorectal cancer prevalence of 16% in under 55 years and increased to 30% for 55 years and older (P = 0.07). Conclusion Change in bowel habit as the only alarm feature has a low diagnostic yield for colorectal cancer in patients under 55 years.
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- Olofsson Bagge, Roger, et al.
(author)
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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)
- 2023
-
In: Journal of Clinical Oncology. - : American Society of Clinical Oncology (ASCO). - 0732-183X .- 1527-7755. ; 41:16, s. 3042-3050
-
Journal article (peer-reviewed)abstract
- 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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