Eastern Spanish experience with nivolumab in metastatic renal cell carcinoma


Por: Jose, J, Jose, M, Silverio, R, Federico, V, Isabel, C, Martin, O, Inmaculada, B, Cristina, C, Julia, H, Dolores, T, Jose, G, Paola, P, Nieves, D, Vicent, A, Sara, B, Sara, M, Julian, L, Manuel, S, del Carmen, M, Angel, C and Vicente, G

Publicada: 1 sep 2020 Ahead of Print: 1 feb 2020
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 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.

Filiaciones:
Jose, J:
 Fdn Inst Valenciano Oncol, Div Genitourinary Oncol, Valencia, Spain

Jose, M:
 Hosp Univ La Fe Valencia, Valencia, Spain

Silverio, R:
 Hosp Univ Virgen La Arrixaca, Murcia, Spain

:
 Hosp Gen Univ Elche, Alicante, Spain

Isabel, C:
 Hosp Univ Clin Valencia, Valencia, Spain

Martin, O:
 Consorcio Hosp Prov Castellon, Castellon De La Plana, Spain

Inmaculada, B:
 Hosp Gen Univ Morales Meseguer, Murcia, Spain

Cristina, C:
 Hosp Gen Univ Valencia, Valencia, Spain

:
 Hosp Lluis Alcanyis, Xativa, Spain

:
 Hosp Univ Doctor Peset, Valencia, Spain

:
 Hosp Univ Arnau Vilanova Valencia, Valencia, Spain

Paola, P:
 Hosp Gen Univ Santa Lucia, Cartagena, Spain

:
 Hosp Univ Vinalopo, Alicante, Spain

:
 Hosp Univ Francesc Borja Gandia, Valencia, Spain

:
 Hosp Sagunto, Valencia, Spain

Sara, M:
 Hosp Manises, Valencia, Spain

:
 Hosp Univ Alzira, Valencia, Spain

Manuel, S:
 Hosp QuironSalud Torrevieja Espana, Alicante, Spain

del Carmen, M:
 Fdn Inst Valenciano Oncol, Div Genitourinary Oncol, Valencia, Spain

Angel, C:
 Fdn Inst Valenciano Oncol, Div Genitourinary Oncol, Valencia, Spain

Vicente, G:
 Fdn Inst Valenciano Oncol, Div Genitourinary Oncol, Valencia, Spain
ISSN: 1699048X





CLINICAL & TRANSLATIONAL ONCOLOGY
Editorial
SPRINGER-VERLAG ITALIA SRL, VIA DECEMBRIO, 28, MILAN, 20137, ITALY, Italia
Tipo de documento: Article
Volumen: 22 Número: 9
Páginas: 1517-1523
WOS Id: 000516075300002
ID de PubMed: 32048159
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