Real-world evidences on adjuvant Pembrolizumab for renal cell carcinoma: results from the multicenter real-world ARON-1 study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F25%3A10505287" target="_blank" >RIV/00179906:_____/25:10505287 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11130/25:10505287 RIV/00216208:11140/25:10505287 RIV/00669806:_____/25:10505287 RIV/00064203:_____/25:10505287
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=nu0acD2iPg" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=nu0acD2iPg</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1007/s00262-025-04230-w" target="_blank" >10.1007/s00262-025-04230-w</a>
Alternative languages
Result language
angličtina
Original language name
Real-world evidences on adjuvant Pembrolizumab for renal cell carcinoma: results from the multicenter real-world ARON-1 study
Original language description
BACKGROUND: Pembrolizumab has demonstrated efficacy in improving disease-free survival (DFS) and overall survival (OS) as adjuvant therapy in clear cell renal cell carcinoma (ccRCC) at a higher risk of recurrence. However, real-world data on its effectiveness and safety remain limited. This study evaluates DFS, OS and severe adverse events (SAEs) associated with adjuvant pembrolizumab in a multicenter international cohort. METHODS: This retrospective analysis included 311 ccRCC patients treated with adjuvant pembrolizumab across 40 hospitals in 12 countries from the ARON-1 dataset. Eligible patients had histologically confirmed ccRCC with high relapse risk and received up to 17 cycles of pembrolizumab. The primary objective was DFS, with OS and safety as secondary objectives. Kaplan-Meier survival estimates, Cox proportional hazards models and log-rank tests were used for statistical analysis. RESULTS: At a median follow-up of 15.4-month, 2-year OS and DFS rates were 95% and 69%, respectively. Recurrence occurred in 20% of patients, primarily in the lungs (11%) and bones (5%). DFS was significantly impaired in patients < 65 years (HR 2.14, p = 0.005), N1 disease (HR 5.42, p = 0.004) and sarcomatoid dedifferentiation (HR 2.54, p = 0.007). SAEs led to 19% treatment discontinuation, with colitis (4%), hypertransaminasemia (4%) and nephritis (3%) as the most common events. The study's retrospective nature and short follow-up limit long-term outcome assessments. CONCLUSIONS: This large real-world study confirms pembrolizumab's effectiveness and manageable safety profile in the adjuvant setting for intermediate-high and high-risk ccRCC. Further research is needed to refine patient selection strategies and evaluate long-term outcomes.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30204 - Oncology
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Cancer Immunology, Immunotherapy
ISSN
0340-7004
e-ISSN
1432-0851
Volume of the periodical
74
Issue of the periodical within the volume
12
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
374
UT code for WoS article
001616348800001
EID of the result in the Scopus database
2-s2.0-105021794208