Renal cell carcinoma (RCC) is the 14th most common cancer worldwide. Surgery is the standard of care for localized RCC, however, the risk of recurrence varies widely among patients. Adjuvant pembrolizumab has been shown to improve outcomes after nephrectomy but is associated with substantial toxicity and high costs. This study uses real-world data from the French UroCCR-Chain registry to characterize the natural history, management, and outcomes of non-metastatic RCC in France, with the aim of informing adjuvant treatment decisions
Renal cell carcinoma (RCC) is the 14th most common malignant tumour worldwide, with 431,288 new cases reported in 2020. The standard treatment for localised and locally advanced renal tumours is partial or radical nephrectomy. However, 5-year postoperative recurrence-free survival rates vary widely, ranging from 10% to 95%. Currently, there is a lack of reliable, accurate, and up-to-date prognostic models to predict the risk of disease recurrence after surgery. Recently, the phase 3 clinical trial Keynote 564 demonstrated that adjuvant pembrolizumab, administered for one year following surgery, significantly improves disease-free survival (DFS) and overall survival (OS). Nevertheless, many patients experienced adverse effects, and the high cost of treatment remains a major concern. Therefore, precise postoperative risk assessment for progression in patients with localised or locally advanced RCC is essential. This enables clinicians to identify candidates most likely to benefit from adjuvant therapy, weigh the potential risks and benefits, and ensure cost-effective use of healthcare resources. In France, pembrolizumab has been available since December 2023-initially through early access programmes and subsequently via marketing authorisation-for patients identified as being at "high risk of recurrence." However, contemporary real-world data from France remain scarce regarding the accurate characterisation of these high-risk patients and the medical and economic impact of introducing this adjuvant therapy. The aim of this study is to expand current knowledge on the natural history, management, and clinical outcomes of non-metastatic RCC in France, particularly in the high-risk population, by leveraging data from UroCCR-Chain. This registry, derived from our kidney cancer-specific Health Data Warehouse (UroCCR), is referenced by both the French National Cancer Institute (INCa) and the French National Authority for Health (HAS), and is linked to the French National Health Data System (SNDS).
Study Type
OBSERVATIONAL
Enrollment
6,109
CHU Bordeaux
Bordeaux, France
RECRUITINGDescription of the natural evolution of the disease in the overall RCC population and in the ncRCC and cRCC subgroups according to the inclusion criteria of the KEYNOTE-564 study.
Assessment of time to first occurrence of the event of interest (disease-free survival, DFS, local recurrence-free survival, LRFS, or progression-free survival, PFS) or death from any cause (overall survival, OS), whichever occurs first.
Time frame: From 2014/01/01 to 2023/12/31
Description of the characteristics of the overall RCC population, the ncRCC and ccRCC subgroups, according to whether or not they met the Keynote-564 study eligibility criteria.
1. Number and proportion (%) of patients eligible for adjuvant therapy among those who underwent surgery for non-metastatic renal cell carcinoma, according to predefined eligibility criteria (ccRCC pT2 grade 4, pT3-T4 of any grade, pTany N1 of any grade, M0). 2. Proportion of high-risk patients relative to the annual incidence of surgically treated renal cell carcinoma. 3. Estimated size of the eligible population extrapolated to the national level (France).
Time frame: From 2014/01/01 to 2023/12/31
Description of the distribution of UroPredict 2 prognostic risk categories among patients with ccRCC, stratified according to fulfillment of the KEYNOTE-564 eligibility criteria.
Number and percentage (%) of patients classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
Time frame: From 2014/01/01 to 2023/12/31
Description the natural post-operative course of localised and locally advanced RCC (1)according to the UroPredict 2 classification in the total, ncRCC and ccRCC populations, according to fulfillment of the KEYNOTE-564 eligibility criteria (1)
Overall Survival (OS) is defined as the time from surgery to death from any cause. Patients will be classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
Time frame: From 2014/01/01 to 2023/12/31
Description the natural post-operative course of localised and locally advanced RCC according to the UroPredict 2 classification in the total, ncRCC and ccRCC populations, according to fulfillment of the KEYNOTE-564 eligibility criteria (2).
Disease Free Survival (DFS) is defined as the time from surgery until the first documented disease recurrence or death from any cause, whichever occurs first. Patients will be classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
Time frame: From 2014/01/01 to 2023/12/31
Description the natural post-operative course of localised and locally advanced RCC according to the UroPredict 2 classification in the total, ncRCC and ccRCC populations, according to fulfillment of the KEYNOTE-564 eligibility criteria. (3)
Local recurrence-free survival (LRFS) is defined as the time from surgery until the first documented local recurrence of the disease or death from any cause, whichever occurs first. Patients will be classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
Time frame: From 2014/01/01 to 2023/12/31
Description the natural post-operative course of localised and locally advanced RCC according to the UroPredict 2 classification in the total, ncRCC and ccRCC populations, according to fulfillment of the KEYNOTE-564 eligibility criteria.(4)
Progression-free survival (PFS) is defined as the time from surgery until the first documented disease progression, recurrence, or death from any cause, whichever occurs first. Patients will be classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2.
Time frame: From 2014/01/01 to 2023/12/31
Identification of the predictors of favorable response to immunotherapy among high-risk patients with ccRCC meeting the KEYNOTE-564 eligibility criteria who subsequently developed metachronous metastatic recurrence and were treated with immunotherapy.
Clinical, biological, anatomopathological and molecular factors associated with response to immunotherapy, defined by tumour response status (RC or RP vs SD or PD) in high-risk ccRCC patients according to Keynote 564 who have developed metachronous metastatic recurrence.
Time frame: From 2014/01/01 to 2023/12/31
Analyse of the care pathways for patients with non-metastatic RCC (total population, the ncRCC population and the ccRCC population)..
Hospital admissions related to RCC; Surgical procedures, radiotherapy and systemic treatments (including bisphosphonates and denosumab); Diagnostic and follow-up investigations: imaging, laboratory tests, consultations (oncology, urology and others).
Time frame: From 2014/01/01 to 2023/12/31
Assesment of healthcare resource utilization and associated costs before and after disease recurrence.
Total reimbursed healthcare costs associated with the management of patients with RCC, before and after disease recurrence.
Time frame: From 2014/01/01 to 2023/12/31
Estimation of the cost of adjuvant treatment in the high-risk RCC population (taking into account the results of the Keynote 564 trial and the cost of treatment).
Total cost of adjuvant immunotherapy (pembrolizumab or nivolumab/ipilimumab) in the high-risk RCC population, expressed on a per-patient basis and extrapolated to the target population, incorporating efficacy data from the KEYNOTE-564 trial.
Time frame: From 2014/01/01 to 2023/12/31
Assesment of the correlation between DFS and OS within the high-risk RCC population.
Comparison between DFS and OS in the high-risk RCC population.
Time frame: From 2014/01/01 to 2023/12/31
Assement of the the impact of long-term post-operative use of aspirin on the incidence of disease recurrence (total population, the ncRCC population and the ccRCC population). (1)
Overall Survival (OS) according to the use of long-term post-operative aspirin.
Time frame: From 2014/01/01 to 2023/12/31
Assement of the the impact of long-term post-operative use of aspirin on the incidence of disease recurrence (total population, the ncRCC population and the ccRCC population). (2)
Disease Free Survival (DFS) according to the use of long-term post-operative aspirin.
Time frame: From 2014/01/01 to 2023/12/31
Assement of the impact of the time to recurrence, as well as associated factors (site of recurrence, number of lesions), on OS.
OS according to the time to recurrence (early, intermediate or late) and associated factors (site of recurrence, number of lesions).
Time frame: From 2014/01/01 to 2023/12/31
Gaelle MARGUE, Dr
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