From the Guidelines
The risk of poor outcomes in patients with metastatic renal cell carcinoma is best estimated using the International Metastatic RCC Database Consortium (IMDC) criteria, also known as Heng's model, which stratifies patients into favorable, intermediate, or poor risk groups based on six clinical factors. These factors include Karnofsky performance status <80%, time from diagnosis to treatment <1 year, hemoglobin below lower limit of normal, calcium above upper limit of normal, neutrophil count above upper limit of normal, and platelet count above upper limit of normal 1. The presence of 0 factors indicates favorable risk, 1-2 factors intermediate risk, and 3 or more factors poor risk.
Key Factors in Risk Assessment
- Karnofsky performance status <80%
- Time from diagnosis to treatment <1 year
- Hemoglobin below lower limit of normal
- Calcium above upper limit of normal
- Neutrophil count above upper limit of normal
- Platelet count above upper limit of normal
The IMDC criteria have been validated in an independent dataset and provide a useful tool for guiding treatment decisions, with combination immunotherapy often preferred for intermediate and poor-risk patients, while VEGF-targeted therapies may be considered for favorable-risk patients 1. The Memorial Sloan Kettering Cancer Center (MSKCC) criteria is another validated model that uses similar parameters, but the IMDC criteria are more widely used in clinical practice 1.
Clinical Application
Regular reassessment of risk factors is important as a patient's status may change over time, affecting treatment strategies and prognosis. These models provide objective measures to help clinicians and patients make informed decisions about treatment approaches and expected outcomes. The European Association of Urology guidelines also support the use of validated prognostic models, such as the IMDC criteria, to guide treatment decisions for patients with metastatic renal cell carcinoma 1.
Treatment Implications
The risk classification guides treatment decisions, with combination immunotherapy (ipilimumab plus nivolumab) often preferred for intermediate and poor-risk patients, while VEGF-targeted therapies like sunitinib or pazopanib may be considered for favorable-risk patients. The choice of treatment should be individualized based on the patient's risk classification, as well as other factors such as tumor histology and performance status.
From the FDA Drug Label
Patient distribution by International Metastatic Renal Cell Carcinoma Database (IMDC) risk groups was 21% favorable, 62% intermediate, and 16% poor
The Heng criteria are not explicitly mentioned in the provided drug labels. However, the IMDC (International Metastatic Renal Cell Carcinoma Database) risk criteria are mentioned, which can be used to estimate the risk of poor outcomes in patients with metastatic renal cell carcinoma.
- The IMDC risk criteria include factors such as performance status, hemoglobin, corrected calcium, neutrophil count, and platelet count.
- Patients are classified into three risk groups: favorable, intermediate, and poor.
- In the JAVELIN Renal 101 trial, the patient distribution by IMDC risk groups was 21% favorable, 62% intermediate, and 16% poor 2. However, without more information about the Heng criteria, no conclusion can be drawn about how to estimate the risk of poor outcomes according to Heng.
From the Research
RCC Risk Calculation According to Heng
To estimate the risk of poor outcomes in patients with metastatic renal cell carcinoma (mRCC), several models can be used, including the Heng criteria. The Heng model is a prognostic tool that stratifies patients into three risk groups: favorable, intermediate, and poor risk.
Key Factors in the Heng Model
The Heng model takes into account several key factors, including:
- Hemoglobin levels
- Lactate dehydrogenase (LDH) levels
- Calcium levels
- Karnofsky performance status (KPS)
- Time from diagnosis to treatment initiation
- Number of metastatic sites
Stratification of Patients
Using the Heng model, patients can be stratified into three risk groups:
- Favorable risk: 0-1 risk factors
- Intermediate risk: 2 risk factors
- Poor risk: 3 or more risk factors
Studies Supporting the Heng Model
Several studies have validated the Heng model as a prognostic tool in patients with mRCC. For example, a study published in The Lancet Oncology in 2012 found that the Heng model was able to stratify patients into three distinct risk groups with different overall survival curves 3. Another study published in Annals of Surgical Oncology in 2013 found that the Heng model had slightly better discriminatory ability than the MSKCC model in predicting overall survival in patients with mRCC treated with sunitinib 4.
Limitations and Future Directions
While the Heng model is a useful prognostic tool, it has some limitations. For example, it does not take into account other potential prognostic factors, such as C-reactive protein levels or hypertension status. Further studies are needed to validate the Heng model and to explore its potential applications in clinical practice.
Prognostic Factors
Some studies have identified additional prognostic factors that may be associated with overall survival in patients with mRCC, including: