Where are the sites of relapse after localized treatment of renal cell carcinoma ? SOPRANO (Sites Of relaPse Renal cArciNOma)

Objectif(s) de la recherche et intérêt pour la santé publique

Finalité de l'étude

Objectifs poursuivis

Domaines médicaux investigués

Bénéfices attendus

Ce projet s'inscrit dans le cadre de l'exécution d'une mission d'intérêt public dans le domaine de la santé. Le traitement des données de santé est nécessaire à des fins de recherche scientifique tel que prévu à l'article 9.2.j du RGPD.

Contexte : Kidney cancer is the seventh leading cause of cancer worldwide. In 2020, the incidence was 450,000 new cases worldwide and there were 179,000 deaths. At localized stage, the risk of recurrence after surgery is substantial, with rates varying from 20 to 50% at 5 years, depending on the stage. Surgical approach has been the cornerstone and standard of care for treating localized RCC. For many years, no perioperative treatment has improved patient survival. Recently, a number of randomised phase 3 trials have investigated different immunotherapy agents as adjuvant treatment in renal cell carcinoma. The CheckMate 914 trial, PROSPER trial and IMmotion010 trial did not improve DFS compared with placebo (4-5). These results contrast with the positive ones reported by the KEYNOTE-564 trial, which showed that pembrolizumab increases DFS and OS compared with placebo in patients at intermediate to high risk, high risk, and with resected metastasis with no evidence of disease (at 30·1 months' follow-up: HR 0·63, 95% CI 0·50–0·80). Seventeen (3,4%) patients had local recurrence in the Pembrolizumab group and 32 (6,4%) in the placebo group. Eighty-six (17,3%) had distant recurrence in the Pembrolizumab group and 117 (23,5%) in the placebo group. There are a lack of data on the number and the location of relapse sites and time to relapse after nephrectomy at the localized stage. We hypothesize that these data differ according to the characteristics of the disease at the localized stage. The aim of te present study is to describe the different patterns of relapse according to the characteristics of the disease at the localized stage

Objectifs Principal : Describe the different patterns of relapse according to the characteristics of the disease at the localized stage.
Objectifs Secondaires : Description of following criteria from:
- Adjuvant therapy : type, duration
- Median time to first recurrence
- Median time to development metastatic recurrence
- Recurrence during vs after completion adjuvant IT or TT
- Describe local and distant recurrence groups
- Description of relapse sites after localized treatment for RCC: Glandular recurrence vs other location recurrence sites.
The predictive factors for local recurrence can be explored in a second time and will be the subject of another publication

Critères de jugement : Relapse sites after localized nephrectomy for RCC : Loco-regional recurrence (homolateral, contralateral, nephrectomy box, homolateral adrenal gland, retroperitoneal adenopathy)/ oligometastatic recurrence (1-5 metastatic sites and size limit to 5cm) (7) / metastatic recurrence.

Hypothèse : Relapse sites differ according to median time to relapse and whether or not adjuvant therapy is used.

Critères d’inclusion : Patients are eligible for the study if they meet all of the following criteria :
- Age ≥18 years
- M0 and N0 at diagnosis
- Treated by nephrectomy
- Histologically confirmed localized clear cell renal cell carcinoma.
- Recurrence local or metastatic

If patients had participated in a randomised trial involving placebo, they were included if they had been unblinded at the time of RCC recurrence and confirmed to have received adjuvant IT.

Critères d’exclusion :
- Patient’s refusal to participate
- Multiple histologies
- Patient with recurrence at the site of ablative treatment
- VHL

Analyses statistiques :
Qualitative data will be described by their frequency, percentage and 95% confidence interval. Quantitative data will be described by their mean and standard deviation or median and interquartile range. For quantitative variables, means and standard deviations will be presented. The number of missing data will be presented. The Kaplan–Meier method will be used to create survival curves. Comparisons between survival curves will be performed using the Log rank test. Cox regression will be used to perform the multivariate analysis. Patients were followed until death or the data censorship date. A comparative analysis will be to performed between the nephrectomy alone group vs. nephrectomy + adjuvant treatment. A subgroup analysis on the type of surgery will be performed (NP vs NTE)

Résultats attendus : Descriptive analysis of recurrence sites after localized treatment for RCC. We would then like to look at relapse patterns as a function of adjuvant therapy.