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. 2022 Jun 26;14(13):3127.
doi: 10.3390/cancers14133127.

RCC Real-World Data: Prognostic Factors and Risk Stratification in the Immunotherapy Era

Shira Sagie  1   2   3 , Michal Sarfaty  1   2 , Meital Levartovsky  1   2 , Hadas Gantz Sorotsky  1   2 , Raanan Berger  1   2 , Ruth Percik  1   2   4 , Moran Gadot  1   2
Affiliations

RCC Real-World Data: Prognostic Factors and Risk Stratification in the Immunotherapy Era

Shira Sagie et al. Cancers (Basel). .

Abstract

Immunotherapy has transformed the landscape of treatment in metastatic renal cell carcinoma (mRCC) in the last decade. Currently, prognostic risk stratification is based on the model developed in the era of vascular endothelial growth factor receptor inhibitors (VEGFRi) by Heng in 2009. Our study aims to find the most relevant risk criteria for mRCC patients treated with checkpoint inhibitors (CPI). In a retrospective cohort study, laboratory, pathology, demographic, and clinical data were retrieved from electronic medical records of consecutive mRCC patients treated with CPI in a tertiary center between 2015 and 2020. An unbiased multivariate analysis was performed to define predictive variables with a bootstrap validation step. We analyzed data on 127 patients with a median follow-up of 60 months. The median overall survival (OS) since the diagnosis of metastatic disease was 57 months. The response rate for CPI was 39%. Five risk factors were correlated with worse OS: intact primary kidney tumor (HR 2.33, p = 0.012), liver metastasis (HR 3.33, p = 0.001), <one year to treatment start (HR 1.98, p = 0.029), elevated platelets (HR 3.06, p = 0.015), and Karnofsky performance status <80% (HR = 3.42, p = 0.001). The model received a C-index of 70.7 compared with a score of 62.0 for the Heng’s model. When dividing patients into “low-risk” (0−1 risk factors) and “high-risk” (2−5 risk factors), there was good separation between the groups, with an HR of 5.9 (p < 0.0001). This study presents a new prognostic model for mRCC in the immunotherapy era with improved accuracy. Further research is needed to validate this model in larger cohorts.

Keywords: checkpoint inhibitors; renal cell carcinoma; risk prognostication.

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Conflict of interest statement

Shira Sagie declares no conflict of interest. Michal Sarfaty reports honoraria from BMS, Pfizer, Janssen, and MSD. Meital Levartovsky reports honoraria from MSD, BMS, Medison, Astellas, and Roche and advisory from Novartis. Hadas Gantz Sorotsky reports honoraria from Roche-Genentech, MSD, AstraZeneca, Takeda, Astella, and BMS. Raanan Berger reports honoraria from BMS, MSD, Astellas, Pfizer, Medison, Roche, Janssen, and AstraZeneca and advisory from BMS, MSD, Astellas, Pfizer, Medison, Roche, Janssen, and AstraZeneca. Ruth Percik reports honoraria from BMS, MSD, and Novartis and an advisory board of Novartis and Janssen. Moran Gadot reports honoraria from MSD, Medison, BMS, Novartis, Astellas, Janssen, AstraZeneca, Pfizer, and Bayer. The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Kaplan–Meier plots of overall survival of all patients (A) and by Heng risk groups (B). p-value calculated by a Cox proportional hazard regression model.
Figure 2
Figure 2
Kaplan–Meier plots of overall survival of patients divided by number of risk factors, by our new model (A) and by Heng’s criteria model (B). Separation of the patients into two risk groups, high risk (defined by having two or more risk factors) and low risk (fewer than two risk factors) of our new model (C) or Heng’s criteria model (D).
See this image and copyright information in PMC

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