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
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.
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) |
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