Eastern Spanish experience with nivolumab in metastatic renal cell carcinoma.
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Immunological
/ therapeutic use
Carcinoma, Renal Cell
/ drug therapy
Drug Resistance, Neoplasm
Female
Follow-Up Studies
Humans
Kidney Neoplasms
/ drug therapy
Male
Middle Aged
Neoplasm Metastasis
Nivolumab
/ therapeutic use
Retrospective Studies
Spain
/ epidemiology
Survival Rate
Cancer
Experience
Nivolumab
Renal
Spanish
Journal
Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico
ISSN: 1699-3055
Titre abrégé: Clin Transl Oncol
Pays: Italy
ID NLM: 101247119
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
31
10
2019
accepted:
02
01
2020
pubmed:
13
2
2020
medline:
29
6
2021
entrez:
13
2
2020
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND (OR PURPOSE)
UNASSIGNED
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
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 32048159
doi: 10.1007/s12094-020-02288-9
pii: 10.1007/s12094-020-02288-9
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
Nivolumab
31YO63LBSN
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM