The Non-Interventional PAZOREAL Study to Assess the Effectiveness and Safety of Pazopanib in a Real-Life Setting: Reflecting a Changing mRCC Treatment Landscape

被引:1
|
作者
Doehn, Christian [1 ]
Boegemann, Martin [2 ]
Gruenwald, Viktor [3 ,4 ]
Welslau, Manfred [5 ]
Bedke, Jens [6 ]
Schostak, Martin [7 ]
Wolf, Thomas [8 ]
Ehness, Rainer [9 ]
Degenkolbe, Elisa [9 ]
Witecy, Stefanie [10 ]
Goebell, Peter J. [11 ]
机构
[1] Urol Lubeck, D-23566 Lubeck, Germany
[2] Univ Munster, Dept Urol, Med Ctr, D-48149 Munster, Germany
[3] Univ Hosp Essen, West German Canc Ctr, Dept Internal Med Tumor Res, D-45147 Essen, Germany
[4] Univ Hosp Essen, West German Canc Ctr, Dept Urol, D-45147 Essen, Germany
[5] Hamato Onkol Schwerpunktpraxis, Klinikum Aschaffenburg, D-63739 Aschaffenburg, Germany
[6] Univ Hosp Tubingen, Dept Urol, D-72076 Tubingen, Germany
[7] Univ Hosp Magdeburg, Dept Urol Urooncol Robot Assisted & Focal Therapy, D-39120 Magdeburg, Germany
[8] Outpatient Ctr Oncol, D-01307 Dresden, Germany
[9] Novartis Pharma GmbH, D-90429 Nurnberg, Germany
[10] APOGEPHA Arzneimittel GmbH, D-01309 Dresden, Germany
[11] Univ Hosp Erlangen, Dept Urol, D-91054 Erlangen, Germany
关键词
pazopanib; renal cell carcinoma; real-world data; non-interventional study; time on drug; nivolumab; everolimus; trial-eligibility; RENAL-CELL CARCINOMA; CLINICAL-PRACTICE GUIDELINES; DOUBLE-BLIND; PHASE-III; EVEROLIMUS; DIAGNOSIS; THERAPIES; SUNITINIB; SURVIVAL;
D O I
10.3390/cancers14225486
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Simple Summary Clinical trials have demonstrated the effectiveness of pazopanib as a primary treatment for metastatic renal cell carcinoma (mRCC). The approval of tyrosine kinase inhibitors and checkpoint-inhibitors represented further progress in the mRCC treatment landscape. Yet, with the recent changes in treatment options, there are scarce real-world data on these substances, including pazopanib. The PAZOREAL study investigated the effectiveness and safety of pazopanib (first-line), nivolumab (second-line), and everolimus (second- and third-line) in a real-life setting. This study included 376 mRCC patients who received first-line treatment with pazopanib and assessed the treatment's effectiveness, safety, and resultant quality of life. The median time on the drug for the study population was 10.0 months; for primary treatment with pazopanib, it was 6.3 months. The median overall survival (mOS) for the entire study population was 35.9 months. No new safety signals were detected. PAZOREAL provides valuable real-world data for the primary treatment of mRCC with pazopanib. The approval of tyrosine kinase inhibitors and checkpoint inhibitors represented a remarkable progression in the therapeutic landscape for the treatment of metastatic renal cell carcinoma (mRCC). Yet, in the ever-evolving landscape of mRCC treatment, real-world data on these agents, including pazopanib, are scarce. The non-interventional PAZOREAL study investigated the effectiveness and safety of pazopanib (first-line), nivolumab (second-line), and everolimus (second- and third-line) in a real-life setting. The multicentric study included 376 mRCC patients who received first-line treatment with pazopanib and assessed time on the drug (primary endpoint), overall survival, best responses, disease control rates, as well as safety signals and health-related quality of life. The median overall time on the drug was 10.0 months, with first-line pazopanib having a median time on drug of 6.3 months. The median overall survival was 35.9 months. The disease control rate for first-line pazopanib was 56.9%. No new safety signals were detected. PAZOREAL provides valuable real-world data for first-line treatment with pazopanib.
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页数:12
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