Renal Cell Carcinoma
Conditions
Keywords
renal cell carcinoma (RCC) high-risk RCC, real life, UroCCR, UroCCR-Chain
Brief summary
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
Detailed description
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).
Interventions
Sponsors
University Hospital, Bordeaux
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients diagnosed with local RCC or high-risk locally advanced RCC, * Included in UroCCR register between 1st january 2014 and 31st december 2023, * Consenting to participate in UroCCR and UroCCR-Chain registers.
Exclusion criteria
* Patients with metastatic disease at inclusion, * Patients not linked between UroCCR and SNDS datasources, * Patients with hereditary RCC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description 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. | From 2014/01/01 to 2023/12/31 | 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. |
| 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. | From 2014/01/01 to 2023/12/31 | 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). |
| Description of the distribution of UroPredict 2 prognostic risk categories among patients with ccRCC, stratified according to fulfillment of the KEYNOTE-564 eligibility criteria. | From 2014/01/01 to 2023/12/31 | Number and percentage (%) of patients classified as 'Very low risk', 'Low risk', 'Medium risk' and 'High risk' according to UroPredict 2. |
| 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) | From 2014/01/01 to 2023/12/31 | 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. |
| 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). | From 2014/01/01 to 2023/12/31 | 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. |
| 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) | From 2014/01/01 to 2023/12/31 | 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. |
| 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) | From 2014/01/01 to 2023/12/31 | 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. |
| 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. | From 2014/01/01 to 2023/12/31 | 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. |
| Analyse of the care pathways for patients with non-metastatic RCC (total population, the ncRCC population and the ccRCC population).. | From 2014/01/01 to 2023/12/31 | 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). |
| Assesment of healthcare resource utilization and associated costs before and after disease recurrence. | From 2014/01/01 to 2023/12/31 | Total reimbursed healthcare costs associated with the management of patients with RCC, before and after disease recurrence. |
| 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). | From 2014/01/01 to 2023/12/31 | 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. |
| Assesment of the correlation between DFS and OS within the high-risk RCC population. | From 2014/01/01 to 2023/12/31 | Comparison between DFS and OS in the high-risk RCC population. |
| 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) | From 2014/01/01 to 2023/12/31 | Overall Survival (OS) according to the use of long-term post-operative aspirin. |
| 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) | From 2014/01/01 to 2023/12/31 | Disease Free Survival (DFS) according to the use of long-term post-operative aspirin. |
| Assement of the impact of the time to recurrence, as well as associated factors (site of recurrence, number of lesions), on OS. | From 2014/01/01 to 2023/12/31 | OS according to the time to recurrence (early, intermediate or late) and associated factors (site of recurrence, number of lesions). |
Countries
France
Contacts
CONTACTJean-Christophe BERNHARD, Pr
CONTACTGaelle MARGUE, Dr
PRINCIPAL_INVESTIGATORJean-Christophe BERNHARD, Pr
University Hospital, Bordeaux
Outcome results
None listed