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.
引用
收藏
页数:12
相关论文
共 50 条
  • [31] Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study
    Daniel Schöttle
    Wolfgang Janetzky
    Daniel Luedecke
    Elmar Beck
    Christoph U. Correll
    Klaus Wiedemann
    BMC Psychiatry, 18
  • [32] Effectiveness of aripiprazole once-monthly in schizophrenia patients pretreated with oral aripiprazole: a 6-month, real-life non-interventional study
    Schoettle, Daniel
    Janetzky, Wolfgang
    Luedecke, Daniel
    Beck, Elmar
    Correll, Christoph U.
    Wiedemann, Klaus
    BMC PSYCHIATRY, 2018, 18
  • [33] Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany
    Krueger, Klaus
    Burmester, Gerd R.
    Wassenberg, Siegfried
    Bohl-Buehler, Martin
    Thomas, Matthias H.
    BMJ OPEN, 2018, 8 (06):
  • [34] Opportunistic screening for atrial fibrillation in a real-life setting in general practice in Denmark - The Atrial Fibrillation Found On Routine Detection (AFFORD) non-interventional study
    Hald, Jonas
    Poulsen, Peter Bo
    Qvist, Ina
    Holm, Lisbeth
    Wedell-Wedellsborg, Dorte
    Dybro, Lars
    Frost, Lars
    PLOS ONE, 2017, 12 (11):
  • [35] A prospective multicentre, non-interventional, real-world study to assess the pattern of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study)
    Blockeel, C.
    Griesinger, G.
    Rago, R.
    Riviere, S.
    Larsson, P.
    Sonderegger, Y. L. Yip
    Laven, J. S. E.
    HUMAN REPRODUCTION, 2022, 37
  • [36] Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study)
    Blockeel, Christophe
    Griesinger, Georg
    Rago, Rocco
    Larsson, Per
    Sonderegger, Yum Lina Yip
    Riviere, Stephane
    Laven, Joop S. E.
    FRONTIERS IN ENDOCRINOLOGY, 2022, 13
  • [37] Effectiveness, safety, and tolerability of galcanezumab in a real-life setting in patients with migraine in Italy (the GARLIT study)
    Vernieri, Fabrizio
    Altamura, Claudia
    Aurilia, Cinzia
    Brunelli, Nicoletta
    Egeo, Gabriella
    Fofi, Luisa
    Costa, Carmelina Maria
    Fallacara, Adriana
    Favoni, Valentina
    Pierangeli, Giulia
    Aguggia, Marco
    Bertuzzo, Davide
    Albanese, Maria
    Di Fiore, Paola
    Frediani, Fabio
    Cevoli, Sabina
    Barbanti, Piero
    NEUROLOGICAL SCIENCES, 2020, 41 (SUPPL 2) : 487 - 488
  • [38] A prospective multicenter study assessing effectiveness and safety of secukinumab in a real-life setting in 158 patients
    Ortiz-Salvador, Jose-Maria
    Saneleuterio-Temporal, Martina
    Magdaleno-Tapial, Jorge
    Velasco-Pastor, Manel
    Pujol-Marco, Conrad
    Sahuquillo-Torralba, Antonio
    Mateu-Puchades, Almudena
    Pitarch-Bort, Gerard
    Mari-Ruiz, Juan-Ignacio
    Matabi-Diaz, Javier
    Montesinos-Villaescusa, Encarna
    Miralles-Botella, Julia
    Garcia-Fernandez, Laura
    Martorell-Calatayud, Antonio
    Belinchon-Romero, Isabel
    Sanchez-Carazo, Jose-Luis
    Perez-Ferriols, Amparo
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2019, 81 (02) : 427 - 432
  • [39] DIACEREIN POSTMARKETING ASSESSMENT: A PROSPECTIVE OBSERVATIONAL STUDY ON THE EFFECTIVENESS AND SAFETY OF DIACEREIN IN A REAL-LIFE SETTING
    Belyaeva, I. B.
    OSTEOPOROSIS INTERNATIONAL, 2021, 32 (SUPPL 1) : S360 - S360
  • [40] Effectiveness, safety, and tolerability of galcanezumab in a real-life setting in patients with migraine in Italy (the GARLIT study)
    Fabrizio Vernieri
    Claudia Altamura
    Cinzia Aurilia
    Nicoletta Brunelli
    Gabriella Egeo
    Luisa Fofi
    Carmelina Maria Costa
    Adriana Fallacara
    Valentina Favoni
    Giulia Pierangeli
    Marco Aguggia
    Davide Bertuzzo
    Maria Albanese
    Paola Di Fiore
    Fabio Frediani
    Sabina Cevoli
    Piero Barbanti
    Neurological Sciences, 2020, 41 : 487 - 488