Eastern Spanish experience with nivolumab in metastatic renal cell carcinoma

• J. F. M. José ^[1] ; M. Jose ^[12] ; R. Silverio ^[13] ; V. Federico ^[2] ; C. Isabel ^[14] ; O. A. Martin ^[15] ; B. Inmaculada ^[3] ; C. Cristina ^[4] ; H. C. Julia ^[5] ; T. M. Dolores ^[6] ; G. Jose ^[7] ; P. Paola ^[8] ; del P. Nieves ^[9] ; A. Vicent ^[16] ; B. Sara ^[10] ; M. Sara ^[11] ; L. Julián ^[17] ; S. Manuel ^[18] ; M. M. del Carmen ^[1] ; C. M. Ángel ^[1] ; G. Vicente ^[1]
  1. [1] Instituto Valenciano de Oncologia

     Instituto Valenciano de Oncologia

     Valencia, España

     
  2. [2] Hospital General Universitario de Elche

     Hospital General Universitario de Elche

     Elche, España

     
  3. [3] Hospital Morales Meseguer

     Hospital Morales Meseguer

     Murcia, España

     
  4. [4] Hospital General Universitario de Valencia

     Hospital General Universitario de Valencia

     Valencia, España

     
  5. [5] Hospital Xàtiva Lluis Alcanyis

     Hospital Xàtiva Lluis Alcanyis

     Játiva, España

     
  6. [6] Hospital Universitario Doctor Peset

     Hospital Universitario Doctor Peset

     Valencia, España

     
  7. [7] Hospital Universitario Arnau de Vilanova

     Hospital Universitario Arnau de Vilanova

     Lérida, España

     
  8. [8] Hospital General Universitario Santa Lucía

     Hospital General Universitario Santa Lucía

     Cartagena, España

     
  9. [9] Hospital Universitario del Vinalopó

     Hospital Universitario del Vinalopó

     Elche, España

     
  10. [10] Hospital de Sagunto

      Hospital de Sagunto

      Sagunto/Sagunt, España

      
  11. [11] Hospital de Manises

      Hospital de Manises

      Valencia, España

      
  12. [12] Hospital Universitario La Fe de Valencia, Valencia, Spain
  13. [13] Hospital Universitario Virgen de La Arrixaca, Murcia, Spain
  14. [14] Hospital Universitario Clínico de Valencia, Valencia, Spain
  15. [15] Consorcio Hospitalario Provincial de Castellón, Castellón, Spain
  16. [16] Hospital Universitario Francesc de Borja de Gandía, Valencia, Spain
  17. [17] Hospital Universitario de Alzira, Valencia, Spain
  18. [18] Hospital QuironSalud Torrevieja (España), Alicante, Spain

  Mostrar afiliaciones +
• Localización: Clinical & translational oncology, ISSN 1699-048X, Vol. 22, Nº. 9, 2020, págs. 1517-1523
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • 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 Oncol- ogy 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.