Assessment of the Role of Everolimus Therapy in Patients with Renal Cell Carcinoma Based on Daily Routine and Recent Research Results
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Everolimus is indicated for adults with metastatic renal cell carcinoma (mRCC) after failure of vascular endothelial growth factor receptor-tyrosine kinase inhibitors (TKI). Currently, the therapeutic applicability of EVE has been changing. Multicenter evaluation of efficacy and safety of everolimus in daily routine and definition of patient characteristics with favorable outcome. Data of 165 patients from 9 oncology institutes in Hungary were analyzed retrospectively. Everolimus therapy was used after one TKI in 10 mg starting dose. Physical and laboratory examinations and imaging tests were performed monthly and every 3 months, respectively. Median progression-free survival (PFS) was 5.4 months. Median overall survival (OS) was 16.2 months. PFS and OS results were more favorable in patients with ECOG 0–1 (pPFS = 0.033, pOS = 0.008) and after >9 months of TKI therapy (pPFS = 0.019, pOS = 0.045). Survival was longer in nonanemic patients with ECOG 0–1 than in anemic patients with ECOG 2–3, 30.9 and 7.7 months, respectively (p = 0.029). Dose reduction and treatment delay was required in 6.2% and 8.9% of patients, respectively. Common adverse events were exanthema, edema, stomatitis, anemia, and abnormal kidney functions and glucose levels. Results of this study show that everolimus is safe and efficacious in a real-world setting. Everyday practice showed that nonanemic patients with good performance status receiving TKI therapy for >9 months are favorable candidates for this treatment. Despite the efficiency of novel, registered drugs, everolimus still plays an important role during and after second-line therapy for mRCC when availability of modern remedies is limited.
KeywordsMetastatic kidney cancer mTOR inhibitor Everolimus Anemia ECOG RCC
We express our thanks to the doctors for their work and for the data they made available for this study: Csilla András, Krisztina Bíró, Anita Bokor, Zsófia Dankovics, Gergely Dombóvári, Andrea Gonda, Fruzsina Gyergyai, Attila Huszár, Balázs Juhász, Erika Kövér, Zsófia Küronya, Zsuzsanna Miszlai, Krisztián Nagyiványi, Hajnalka Németh, Ágota Petrányi, Tibor Solymosi, Éva Szilágyi, Éva Szekanecz, Judit Tóth, Miklós Wenczl and Judit Zsálek, and all members of their institutes who contributed to this study.
Compliance with Ethical Standards
Conflict of Interest
Anikó Maráz has received honoraria from Bayer, Bristol-Myers Squibb, and has served on advisory boards for Novartis.
András Csejtei has served on advisory boards for Novartis and Pfizer.
Judit Kocsis has received honoraria from Bayer and served as a member of advisory board: Novartis, Bristol-Myers Squibb and Pfizer.
Miklós Szűcs has received honoraria from Bayer, Novartis, Bristol-Myers Squibb and has served on advisory boards for Novartis and Pfizer.
Zsuzsanna Kahán has no actual or potential conflicts of interest to report.
György Bodoky has received honoraria from Bayer, Bristol-Myers Squibb and Pfizer and has served on advisory boards for Novartis and Pfizer.
Magdolna Dank has received honoraria from Bayer, Novartis and Pfizer and has served on advisory boards for Novartis and Pfizer.
László Mangel has received honoraria from Pfizer and has served on advisory boards for Novartis and Pfizer.
János Révész has served on advisory boards for Novartis and Pfizer.
Zoltán Varga has no actual or potential conflicts of interest to report.
Lajos Géczi has received honoraria from Bayer, Novartis, Bristol-Myers Squibb and Pfizer and has served on advisory boards for Bristol-Myers Squibb, Novartis and Pfizer.
All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. For this type of study no formal consent is required.
This was a non-sponsored study.
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