Real-World Evidence Data on Metastatic Renal-Cell Carcinoma Treatment in Austria: The RELACS Study.


Journal

Clinical genitourinary cancer
ISSN: 1938-0682
Titre abrégé: Clin Genitourin Cancer
Pays: United States
ID NLM: 101260955

Informations de publication

Date de publication:
10 2019
Historique:
received: 19 03 2019
revised: 29 04 2019
accepted: 20 05 2019
pubmed: 27 6 2019
medline: 16 5 2020
entrez: 26 6 2019
Statut: ppublish

Résumé

Treatment decisions in routine clinical practice are based on reports of clinical trials, which represent highly selected populations. Limited studies reported real-world evidences representing routine clinical practices in patients with renal-cell carcinoma (RCC) in Europe. The aim of this retrospective, noninterventional chart review was to collect data on the treatment landscape for patients with advanced/metastatic RCC in routine clinical practice in a broader patient population in Austria. Patients with advanced/metastatic RCC receiving systemic treatment between June 2010 and June 2016 across 12 centers in Austria were included. Parameters were entered into an electronic case report form from the participating sites via the application Hermesoft electronic data capture system. Progression-free survival (PFS) and overall survival (OS) were the 2 primary end points. The median PFS and OS were 12 months and 44 months, respectively (first-line PFS was 14 months for pazopanib and 13 months for sunitinib; first-line OS was 44 months for pazopanib and 48 months for sunitinib). Factors influencing the OS were sex, with female patients at a significantly higher risk than male patients (hazard ratio = 1.719), Eastern Cooperative Oncology Group performance status > 0 increased the risk twice (hazard ratio = 2.048), and number of metastases > 3 before the first line doubled the risk compared to metastases (hazard ratio = 2.064). OS in this retrospective chart review was considerably longer than the previous reports in real-world patients, underlining the benefit of current RCC treatment options in routine clinical practice.

Sections du résumé

BACKGROUND
Treatment decisions in routine clinical practice are based on reports of clinical trials, which represent highly selected populations. Limited studies reported real-world evidences representing routine clinical practices in patients with renal-cell carcinoma (RCC) in Europe. The aim of this retrospective, noninterventional chart review was to collect data on the treatment landscape for patients with advanced/metastatic RCC in routine clinical practice in a broader patient population in Austria.
PATIENTS AND METHODS
Patients with advanced/metastatic RCC receiving systemic treatment between June 2010 and June 2016 across 12 centers in Austria were included. Parameters were entered into an electronic case report form from the participating sites via the application Hermesoft electronic data capture system. Progression-free survival (PFS) and overall survival (OS) were the 2 primary end points.
RESULTS
The median PFS and OS were 12 months and 44 months, respectively (first-line PFS was 14 months for pazopanib and 13 months for sunitinib; first-line OS was 44 months for pazopanib and 48 months for sunitinib). Factors influencing the OS were sex, with female patients at a significantly higher risk than male patients (hazard ratio = 1.719), Eastern Cooperative Oncology Group performance status > 0 increased the risk twice (hazard ratio = 2.048), and number of metastases > 3 before the first line doubled the risk compared to metastases (hazard ratio = 2.064).
CONCLUSION
OS in this retrospective chart review was considerably longer than the previous reports in real-world patients, underlining the benefit of current RCC treatment options in routine clinical practice.

Identifiants

pubmed: 31235275
pii: S1558-7673(19)30155-7
doi: 10.1016/j.clgc.2019.05.017
pii:
doi:

Substances chimiques

Antineoplastic Agents 0
Indazoles 0
Pyrimidines 0
Sulfonamides 0
pazopanib 7RN5DR86CK
Sunitinib V99T50803M

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e957-e967

Informations de copyright

Copyright © 2019. Published by Elsevier Inc.

Auteurs

Manuela Schmidinger (M)

Medical Oncology, Vienna General Hospital (AKH)-Medizinische Universität Wien, Vienna, Austria. Electronic address: manuela.schmidinger@meduniwien.ac.at.

Renate Pichler (R)

Department of Urology, Medical University Innsbruck, Innsbruck, Austria.

Wolfgang Loidl (W)

Department of Urology, Ordensklinikum Linz, Barmherzige Schwestern, Linz, Austria.

Thomas Bauernhofer (T)

Division of Oncology, Department of Internal Medicine, Medical University Graz, Graz, Austria.

Matthias Kretz (M)

Department of Urology, Salzkammergut-Klinikum Vöcklabruck, Voecklabruck, Austria.

Christoph Tinchon (C)

Department of Hematology and Medical Oncology, Landeskrankenhaus Leoben, Leoben, Austria.

Dora Niedersüß-Beke (D)

Department of Hematology and Oncology, Wilhelminenspital, Vienna, Austria.

Gottfried Pfleger (G)

Department of Urology, LKH Oberwart, Oberwart, Austria.

Clemens Georg Wiesinger (CG)

Department of Urology, Klinikum Wels-Grieskirchen, Wels, Austria.

Ursula Vogl (U)

Department of Oncology, St Joseph's Hospital, Vienna, Austria.

Michael Mitterberger (M)

Department of Urology, University Clinic Salzburg, Salzburg, Austria.

Herbert Stöger (H)

Division of Oncology, Department of Internal Medicine, Medical University Graz, Graz, Austria.

Gennadi Tulchiner (G)

Department of Urology, Medical University Innsbruck, Innsbruck, Austria.

Franz Kratochvill (F)

Novartis Pharma GmbH, Vienna, Austria.

Hanno Gerritsmann (H)

Novartis Pharma GmbH, Vienna, Austria.

Bernhard Mraz (B)

Novartis Pharma GmbH, Vienna, Austria.

Martin Marszalek (M)

Department of Urology and Andrology, Donauspital, Vienna, Austria.

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Classifications MeSH