Abstract
BackgroundThe treatment paradigm in advanced renal cell carcinoma (RCC) has changed in the recent years. Sunitinib has been established as a new standard for first-line therapy. We studied the prognostic significance of baseline characteristics and we compared the risk stratification with the established Memorial Sloan Kettering Cancer Center (MSKCC) model.MethodsThis is a retrospective analysis of patients treated in six Greek Oncology Units of HECOG. Inclusion criteria were: advanced renal cell carcinoma not amenable to surgery and treatment with Sunitinib. Previous cytokine therapy but no targeted agents were allowed. Overall survival (OS) was the major end point. Significance of prognostic factors was evaluated with multivariate cox regression analysis. A model was developed to stratify patients according to risk.ResultsOne hundred and nine patients were included. Median follow up has been 15.8 months and median OS 17.1 months (95% CI: 13.7-20.6). Time from diagnosis to the start of Sunitinib (<= 12 months vs. >12 months, p = 0.001), number of metastatic sites (1 vs. >1, p = 0.003) and performance status (PS) (<= 1 vs >1, p = 0.001) were independently associated with OS. Stratification in two risk groups ("low" risk: 0 or 1 risk factors; "high" risk: 2 or 3 risk factors) resulted in distinctly different OS (median not reached [NR] vs. 10.8 [95% confidence interval (CI): 8.3-13.3], p < 0.001). The application of the MSKCC risk criteria resulted in stratification into 3 groups (low and intermediate and poor risk) with distinctly different prognosis underlying its validity. Nevertheless, MSKCC model did not show an improved prognostic performance over the model developed by this analysis.ConclusionsStudies on risk stratification of patients with advanced RCC treated with targeted therapies are warranted. Our results suggest that a simpler than the MSKCC model can be developed. Such models should be further validated.
Highlights
The treatment paradigm in advanced renal cell carcinoma (RCC) has changed in the recent years
Retrospective analyses and the recently reported PERCY Quattro trial [6] identified certain characteristics, which allow for the selection of patients likely to benefit from this treatment: LDH, Karnofsky performance status (PS), nephrectomy, time from nephrectomy, calcium and hemoglobin levels have been associated with independent prognostic significance [6,7,8,9]
The median progression-free survival (PFS) of 8.9 months is similar to that reported for expanded access programs (EAP) for sunitinib [21,22], taking into consideration that our population included fewer patients of favorable prognosis, according to Memorial Sloan Kettering Cancer Center (MSKCC) criteria
Summary
The treatment paradigm in advanced renal cell carcinoma (RCC) has changed in the recent years. Retrospective analyses and the recently reported PERCY Quattro trial [6] identified certain characteristics, which allow for the selection of patients likely to benefit from this treatment: LDH, Karnofsky PS, nephrectomy, time from nephrectomy, calcium and hemoglobin levels have been associated with independent prognostic significance [6,7,8,9]. The combination of these factors led to the development of a prognostic model by the MSKCC including three patient groups with a statistically significant and, more importantly, clinically relevant difference in survival [8]. This model was subsequently validated independently [10] and proved valuable in selecting patients likely to benefit from cytokine therapy and in interpreting results of phase II and III studies
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