Efficacy and safety of sequential use of everolimus in patients with metastatic renal cell carcinoma previously treated by bevacizumab with or without interferon therapy: Results from pooled analysis of AVATOR, CHANGE, and TRAIN studies.

Authors

null

Antoine Thiery- Vuillemin

Medical Oncology Unit, CHU Minjoz, Besançon, France

Antoine Thiery- Vuillemin , Aline Guillot , Thomas Steiner , Edwin Herrmann , Konstantinos N. Syrigos , Nadia Kelkouli , Agnese Cattaneo , Thierry Nguyen

Organizations

Medical Oncology Unit, CHU Minjoz, Besançon, France, Institut de Cancérologie de la Loire, Saint-Etienne, France, Helios-Klinikum Erfurt, Klinik für Urologie, Erfurt, Germany, Universitätsklinikum Münster, Münster, Germany, Sotiria General Hospital, Athens, Greece, Novartis, Rueil-Malmaison, France, Novartis Farma S.p.A., Origgio, Italy

Research Funding

No funding sources reported

Background: Everolimus is a mammalian target of rapamycin (mTOR) inhibitor. It gained approval based on the results of the RECORD-1 trial, which included patients with metastatic renal cell carcinoma (mRCC) whose disease progressed after receiving vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs). Bevacizumab is a monoclonal antibody targeting angiogenesis that is approved in patients (pts) with mRCC. AVATOR was the 1st study to explore the sequential use of bevacizumab followed by everolimus but with limited number of pts. Methods: In order to further explore this sequence pooled data from the AVATOR, CHANGE and TRAIN studies were analysed retrospectively. All pts had mRCC and were previously or currently treated with everolimus after failure of bevacizumab ± IFN. The primary end point was everolimus time to progression (TTP). Secondary end points were related to the overall survival (OS) of patients receiving the drug sequence, everolimus treatment and safety. Results: 89 pts were included in the analysis. Median age was 68 years [18-90]. At everolimus initiation ECOG was 0-1 for 72% pts and 16% were classified as poor prognosis from Heng classification. Exploring the duration of second-line everolimus treatment, 32% of patients received less than 3 months of everolimus and 35% received at least 6 months of treatment. At the time of data analysis, 20 pts (24%) were still receiving everolimus. Pts receiving everolimus after bevacizumab experienced a median TTP of 6 months [95%CI 4 - 14]. Median OS was not reached for everolimus second-line therapy. At 36 months after the start of first-line therapy, 60.4% of pts were still alive. All grades of common adverse events were consistent with the known safety profile of everolimus. Conclusions: The larger size of this cohort confirms the signal previously seen with AVATOR that the sequence of bevacizumab followed by everolimus displays interesting efficacy with not unexpected toxicity from everolimus and compares favourably with RECORD-1.

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Abstract Details

Meeting

2016 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session C: Renal Cell Cancer

Track

Renal Cell Cancer

Sub Track

Renal Cell Cancer

Citation

J Clin Oncol 34, 2016 (suppl 2S; abstr 585)

DOI

10.1200/jco.2016.34.2_suppl.585

Abstract #

585

Poster Bd #

H4

Abstract Disclosures