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Assessment of the Role of Everolimus Therapy in Patients with Renal Cell Carcinoma Based on Daily Routine and Recent Research Results

  • Original Article
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Pathology & Oncology Research

Abstract

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.

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Acknowledgments

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.

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Authors and Affiliations

  1. Department of Oncotherapy, University of Szeged, Korányi fasor 12, Szeged, 6720, Hungary

    Anikó Maráz, Zsuzsanna Kahán & Zoltán Varga

  2. Markusovszky Teaching Hospital, Markusovszky str. 5, Szombathely, Hungary

    András Csejtei

  3. Institute of Oncology, University of Debrecen, Nagyerdei krt. 98., Debrecen, Hungary

    Judit Kocsis

  4. Faculty of Medicine, Department of Urology and Urooncological Centre, Semmelweis University, Üllői str. 78/b, Budapest, Hungary

    Miklós Szűcs

  5. Department of Oncology, Integrated St. Istvan and St. Laszlo Hospital, Albert Flórián str. 5-7, Budapest, Hungary

    György Bodoky

  6. Faculty of Medicine, 1st Department of Internal Medicine, Division of Oncology, Semmelweis University, Tömő str.25-29, Budapest, Hungary

    Magdolna Dank

  7. Institute of Oncotherapy, University of Pécs, Édesanyák 17., Pécs, Hungary

    László Mangel

  8. Institute of Radiotherapy and Clinical Oncology, Borsod County Hospital and University Academic Hospital, Szentpéteri Kapu 72-76, Miskolc, Hungary

    János Révész

  9. National Institute of Oncology, Chemotherapy C and Clinical Pharmacology, Ráth György str. 7-9, Budapest, Hungary

    Lajos Géczi

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  1. Anikó Maráz
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  2. András Csejtei
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  8. László Mangel
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  10. Zoltán Varga
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  11. Lajos Géczi
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Corresponding author

Correspondence to Anikó Maráz.

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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.

Ethical Approval

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.

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This was a non-sponsored study.

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The authors are solely responsible for writing the manuscript and the decision to submit the manuscript for publication.

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Maráz, A., Csejtei, A., Kocsis, J. et al. Assessment of the Role of Everolimus Therapy in Patients with Renal Cell Carcinoma Based on Daily Routine and Recent Research Results. Pathol. Oncol. Res. 25, 149–156 (2019). https://doi.org/10.1007/s12253-017-0317-0

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  • DOI: https://doi.org/10.1007/s12253-017-0317-0

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