Prognostic Factors for Overall Survival in Patients With Metastatic Renal Cell Carcinoma Treated With Vascular Endothelial Growth Factor–Targeted Agents: Results From a Large, Multicenter Study
- Study type
- Observational study
- Study name
- Heng et al. 2009
- Design
- Multicentre cohort study (3 cancer centres in the USA and 4 in Canada) to identify independent prognostic factors for overall survival using Cox proportional hazards regression and bootstrap validation
- Sample size
- 645 patients
- Source
- JCO · 2009
In plain words
This study looked at the records of 645 patients with advanced kidney cancer who had been treated with targeted drugs against VEGF. The researchers found six clinical and laboratory signs that were linked with a shorter life, including anaemia (low red blood cells), high calcium, poor general fitness (performance status), and high neutrophil and platelet counts. By counting these factors, patients can be placed in three risk groups, favourable, intermediate and poor, which gives a better prediction of how the disease will behave. This grouping helps the doctor assess the disease better, but on its own it does not decide what will happen to an individual patient.
Key results
Treatment arms and regimens
396 patients. Multicentre observational study; the drug was given according to each centre's clinical routine, and doses are not reported in the abstract.
200 patients. Multicentre observational study; the drug was given according to each centre's clinical routine, and doses are not reported in the abstract.
49 patients. Multicentre observational study; the drug was given according to each centre's clinical routine, and doses are not reported in the abstract.
Source of the regimen details: Abstract of the paper (observational study; the treatment regimen was not part of a study intervention)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with metastatic renal cell carcinoma (RCC) who had not previously received any VEGF-targeted therapy. Their baseline characteristics and outcomes were collected from three US cancer centres and four Canadian centres.
Endpoints
The aim of the study was to identify independent prognostic factors for overall survival (OS). The concordance index (C-index) of the model was also reported.
Safety and side effects
The abstract gives no information on treatment adverse events.
Clinical significance and place in guidelines
Based on the abstract, this model confirms the components of the MSKCC model and extends it by adding platelet and neutrophil counts, and it can be used both in patient care and in the design of clinical trials with VEGF-targeted agents. Its current adoption in clinical guidelines should be checked separately, as the abstract does not address it.
Limitations
The abstract refers to bootstrap validation and does not report external validation. A C-index of 0.73 indicates moderate predictive accuracy. The total number of patients in the three risk groups (586 patients) is lower than the overall population of 645, and the reason is not explained in the abstract. Patients treated with three drugs (sunitinib, sorafenib and bevacizumab) were studied, and the model was not evaluated for other treatments in the abstract. Comparing the effects of the drugs with each other was not an aim of this study.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.