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Eastern Spanish experience with nivolumab in metastatic renal cell carcinoma

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Abstract

Background (or purpose)

Nivolumab has been shown to be effective for the treatment of second-line mRCC. The present study has investigated the effectiveness and safety of nivolumab in real-world Eastern Spanish patients with advanced mRCC at TKI progression.

Patients and methods

A retrospective review of mRCC patients treated with nivolumab as a second-line treatment was performed. Analyzed variables included age, sex, ECOG (quality of life scale designed by the Eastern Cooperative Oncology Group), histology, nephrectomy, location of metastases, number of metastasis locations, previous treatments, analytical data from the standard blood count and biochemistry, and response to treatment.

Results

98 patients from 18 sites in Spain were retrospectively reviewed. The majority of patients were male (75%), had ECOG 0–1 (90.6%), had no brain metastasis (91.4%), had undergone one prior systemic regimen (94.3%), and were current/former smokers (97.1%). Fourteen patients (13.1%) had non-clear cell histology, seven (7.1%) had poor-IMDC prognostic group characteristics, 13 patients (13.1%) had liver metastasis and 35 (35.7%) had bone lesions. All patients received prior systemic therapy (63.3% sunitinib, 34.7% pazopanib). During the study, a median of eight doses of nivolumab was given (range 2–62) and 11 patients received more than 12 doses. Eleven patients (11.2%) received nivolumab as a third or fourth line of treatment. Median duration of therapy was 3.6 months (range 0.5–29.3). Confirmed response rate was 25%. Median progression free survival was 7.8 months (range 1.2–12.1). Median overall survival was 16.3 months (range 1.7–29.3). After discontinuation of treatment, 27.58% of the patients received subsequent systemic cancer therapy. Side effects were mostly grade 1–2 (7.2% had hypothyroidism and 6.2% liver toxicity, 4% had nephritis and 2% hypophysitis). Two cases of grade 3–4 adverse events (2%) were reported.

Conclusion

Benefit/risk profile of nivolumab in Eastern-Spanish real-world population with mRCC after tyrosine-kinase inhibitors was consistent with prior real-life studies reported as well as pivotal study.

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Funding

This study has received no funding.

Author information

Authors and Affiliations

  1. Division Genitourinary Oncology, Fundación Instituto Valenciano de Oncología, Valencia, Spain

    J.-F. M. José, M. M. del Carmen, C. M. Ángel & G. Vicente

  2. Hospital Universitario La Fe de Valencia, Valencia, Spain

    M. Jose

  3. Hospital Universitario Virgen de La Arrixaca, Murcia, Spain

    R. Silverio

  4. Hospital General Universitario de Elche, Alicante, Spain

    V. Federico

  5. Hospital Universitario Clínico de Valencia, Valencia, Spain

    C. Isabel

  6. Consorcio Hospitalario Provincial de Castellón, Castellón, Spain

    O.-A. Martin

  7. Hospital General Universitario Morales Meseguer, Murcia, Spain

    B. Inmaculada

  8. Hospital General Universitario de Valencia, Valencia, Spain

    C. Cristina

  9. Hospital Lluís Alcanyís, Xativa, Spain

    H.-C. Julia

  10. Hospital Universitario Doctor Peset, Valencia, Spain

    T. M. Dolores

  11. Hospital Universitario Arnau de Vilanova de Valencia, Valencia, Spain

    G. Jose

  12. Hospital General Universitario Santa Lucía, Cartagena, Spain

    P. Paola

  13. Hospital Universitario del Vinalopó, Alicante, Spain

    del P. Nieves

  14. Hospital Universitario Francesc de Borja de Gandía, Valencia, Spain

    A. Vicent

  15. Hospital de Sagunto, Valencia, Spain

    B. Sara

  16. Hospital de Manises, Valencia, Spain

    M. Sara

  17. Hospital Universitario de Alzira, Valencia, Spain

    L. Julián

  18. Hospital QuironSalud Torrevieja (España), Alicante, Spain

    S. Manuel

Authors
  1. J.-F. M. José
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  2. M. Jose
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  3. R. Silverio
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  4. V. Federico
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  5. C. Isabel
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  6. O.-A. Martin
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  7. B. Inmaculada
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  8. C. Cristina
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  9. H.-C. Julia
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  10. T. M. Dolores
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  11. G. Jose
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  12. P. Paola
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  13. del P. Nieves
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  14. A. Vicent
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  15. B. Sara
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  16. M. Sara
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  17. L. Julián
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  18. S. Manuel
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  19. M. M. del Carmen
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  20. C. M. Ángel
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  21. G. Vicente
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Contributions

All authors contributed to the study conception and design. Material preparation and data collection were performed by all of them. Analysis of data was performed by the corresponding author. The first draft of the manuscript was written by MJJF, and all authors commented on previous and final versions of the manuscript. All authors read and approval the final manuscript.

Corresponding author

Correspondence to J.-F. M. José.

Ethics declarations

Conflict of interest

No organization has sponsored the research. The authors do not present a continuous financial relationship with the laboratory responsible for the drug referred to in the article. However, some of them have declared they have received fees for specific and punctual local talks (Dr Climent, Dra Marin, Dra Chirivella, Dr Sureda, Dr Ros, and Dr Juan).

Ethical approval

This study has been approved by the appropriate ethics committee and has been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

Informed consent

All alive persons gave their informed consent prior to their inclusion in the study.

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José, JF.M., Jose, M., Silverio, R. et al. Eastern Spanish experience with nivolumab in metastatic renal cell carcinoma. Clin Transl Oncol 22, 1517–1523 (2020). https://doi.org/10.1007/s12094-020-02288-9

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  • DOI: https://doi.org/10.1007/s12094-020-02288-9

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