Treatment of portal vein thrombosis in cirrhosis: a multicenter real life cohort study (2023)

Type of publication:
Journal article

Author(s):
Mantaka A; Gatselis N; Triantos CK; *Thalheimer U; Leandro G; Zachou K; Konstantakis C; Saitis A; Thomopoulos K; Kouroumalis EA; Dalekos GN; Samonakis DN

Citation:
Minerva gastroenterology. 69(1):107-113, 2023 Mar.

Abstract:
BACKGROUND: Portal vein thrombosis (PVT) is a common complication of cirrhosis and can be a cause or consequence of liver disease progression. It is unclear whether PVT treatment is affecting clinical outcomes in cirrhotics. METHODS: This is a multicenter study of cirrhotics with PVT, initially retrospectively and thereafter prospectively registered in a data base. We studied the impact of PVT treatment on this population for efficacy, safety and the impact on survival. In survival analysis Mantel-Cox and Wilcoxon-Breslow-Gehan tests were used. A P value of <0.05, was considered significant. For statistical computations the STATA 12.1 was used.

RESULTS: Seventy-six patients were included (76% decompensated, median MELD score 12 and Child-Pugh score 7), 47% with concomitant HCC. Fifty-one patients with PVT were treated with Vitamin-K antagonists or Low-Molecular-Weight Heparin. Patients were followed up for at least 6 months after PVT diagnosis, or until death or transplantation. PV patency after 6 months was not  statistically different between patients receiving or not anticoagulation (complete-partial recanalization 27.4% of treated vs. 20% of untreated, P=0.21). Median survival was statistically worse between patients treated with anticoagulation than those untreated (10 vs. 15 months, P=0.036). Less portal hypertensive bleeding and less decompensation rates were found in treated cirrhotics vs. untreated (45.8% vs. 54.2%, P=0.003 and 78% vs. 80.9%, P=0.78, respectively). Patients with HCC had worse survival when treated vs. untreated (P=0.047).

CONCLUSIONS: In our cohort of cirrhotics with PVT, treatment was feasible with acceptable side effects, but without meaningful clinical benefits.

A prospective observational study of real-world treatment patterns and treatment outcomes in patients with advanced or metastatic renal cell carcinoma (mRCC) receiving pazopanib (2014)

Type of publication:
Conference abstract

Author(s):
Bamias A., Bono P., Procopio G., Herrmann E., Vazquez-Estevez S., Rodriguez Sanchez A., *Srihari N., Schrijvers D.L., Hawkins R.E., Vogelzang N.J., Sapunar F.J., Kothari D., Khan S., Mehmud F., Jonasch E., Schmidinger M.

Citation:
Journal of Clinical Oncology, May 2014, vol./is. 32/15 SUPPL. 1, 0732-183X (20 May 2014)

Abstract:
Background: Pazopanib is an oral, selective, multikinase inhibitor of VEGF receptors 1/2/3, PDGF receptors alpha/s, and stem cell factor receptor (c-Kit) that is approved for first-line treatment of patients with advanced renal cell carcinoma (RCC) and for patients who received prior cytokine therapy. The COMPARZ study of pazopanib versus sunitinib as first-line treatment demonstrated noninferiority of pazopanib for progression-free survival (PFS) in the intention-to-treat population, and pazopanib statistically favored health-related quality of life (HRQoL) in 11 of the 14 domains measured (NEJM 2013;369:722-31). The PISCES patient preference study demonstrated that significantly more patients preferred pazopanib over sunitinib due to overall better HRQoL and less fatigue (JCO 2012;30 suppl 15:CRA4502). The purpose of the PRINCIPAL study is to evaluate the real-world effectiveness and safety of pazopanib in patients with advanced or mRCC. Methods: This is a global, multicenter, prospective, observational study (VEG115232, NCT01649778 ) designed to enrol up to 700 patients. Primary endpoints include PFS, overall response rate, overall survival, relative dose intensity data, HRQoL data, and safety data. Additional treatment strategies for RCC will be obtained post-progression. Key inclusion criteria include a clinical decision to initiate treatment with pazopanib (before enrolment in the study), no prior systemic therapy for advanced or mRCC, and no participation in an interventional trial. The study has enroled 339 patients to date and is currently recruiting in 15 countries, including Europe, Asia, Latin America, and the United States. This study will determine patient outcomes with pazopanib in a real-world setting in terms of efficacy, safety, and patient compliance outside the normal parameters of a controlled trial. PRINCIPAL will also provide further data in patient groups that were under-represented in the controlled clinical trials to date, such as the elderly and patients with co-morbidities.

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