Everolimus as second-line therapy for metastatic renal cell carcinoma (mRCC) after one previous VEGF-targeted therapy: Final results of the noninterventional change study.

Authors

null

Peter J. Goebell

Department of Urology, Friedrich-Alexander University Erlangen, Erlangen, Germany

Peter J. Goebell , Ulrich Kube , Michael Staehler , Christian Doehn , Thomas Steiner , Manfred Kindler , Edwin Herrmann , Jan Janssen , Steffen Weikert , Michael Thomas Scheffler , Joerg Schmitz , Friedrich Overkamp , Gernot Guderian , Michael Albrecht , Lothar Bergmann

Organizations

Department of Urology, Friedrich-Alexander University Erlangen, Erlangen, Germany, Private Practice for Oncology, Chemnitz, Germany, Department of Urology, University of Munich, Munich, Germany, Urologikum Lübeck, Lübeck, Germany, Helios-Klinikum Erfurt, Klinik für Urologie, Erfurt, Germany, Private Practice for Oncology, Berlin, Germany, Department of Urology, University of Münster, Münster, Germany, Private Practice for Oncology, Westerstede, Germany, Charité Campus Mitte, Berlin, Germany, Praxis Dr. Scheffler, Zwickau, Germany, Kliniken der Stadt Köln Merheim, Cologne, Germany, Praxis und Tagesklinik für Internistische Onkologie, Recklinghausen, Germany, Novartis Pharma GmbH, Nuermberg, Germany, Department Drug Safety & Epidemiology, Novartis Pharma GmbH, Nuremberg, Germany, Klinikum der Johann-Wolfgang-Goethe Universität, Medizinische Klinik III, Tumorzentrum Rhein-Main,, Frankfurt/Main, Germany

Research Funding

No funding sources reported

Background: The mTOR inhibitor everolimus is approved for the treatment of mRCC following failure of VEGF-targeted therapy. To evaluate the effectiveness and tolerability of everolimus following the first VEGF-targeted therapy in routine clinical practice, we conducted the prospective, noninterventional CHANGE study in Germany. Methods: Patients (pts) with mRCC (any histology) were registered at the time of everolimus initiation, or within 90 days thereof, following treatment with either VEGFR-TKI or bevacizumab. Other previous systemic therapies (e.g., cytokines) were permitted. Pts received everolimus 10 mg/d according to the summary product characteristics until disease progression or intolerable toxicity. Study objectives included assessing treatment duration, time to progression (TTP), progression-free survival (PFS), Karnofsky performance status (KPS), and safety. Results: 334 pts were documented at 116 German sites between August 2009 and January 2012 (median age, 68 years; 75% male; median KPS, 80%; 88% clear cell histology). At the start of first-line therapy, MSKCC risk status was favorable in 35%, intermediate in 56%, and poor in 9%. Effectiveness results are shown in the table. In the safety population (n=318), median time to ≥10% deterioration in KPS was 8.4 months (95% CI, 6.1-10.1 months); the most common AEs (any grade) were dyspnea (17%), anemia (14%), and fatigue (12%). Treatment adherence was high, with <2% of patients per visit showing <50% intake of the expected doses. Conclusions: The CHANGE study demonstrates favorable effectiveness and tolerability for everolimus when given in routine clinical practice to pts with mRCC. Our data confirm the use of everolimus as a standard second-line therapy following VEGF-targeted treatment.

Effectiveness results.
Population (n) Median
treatment
duration
(95% CI), mo
Median TTP
(95% CI), mo
Median PFS
(95% CI), mo
Efficacy (280) 6.6 (5.0-8.5) 7.4 (6.1-9.1) 7.0 (5.4-8.8)
One previous VEGF-targeted therapy as
only prior systemic treatment (211)
6.6 (4.8-8.7) 7.1 (5.4-9.1) 6.9 (5.4-8.6)
Sunitinib as first-line therapy (188) 6.7 (5.0-8.9) 7.1 (6.1-9.1) 7.0 (5.4-8.8)

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2014 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session C: Renal Cancer

Track

Renal Cell Cancer

Sub Track

Renal Cell Cancer

Citation

J Clin Oncol 32, 2014 (suppl 4; abstr 469)

DOI

10.1200/jco.2014.32.4_suppl.469

Abstract #

469

Poster Bd #

F2

Abstract Disclosures