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Risk factors and a model to predict toxicity-related treatment discontinuation in patients with metastatic renal cell carcinoma (mRCC) treated with vascular endothelial growth factor (VEGF)-targeted therapy

BJU Int. 2014 Oct;114(Suppl 4):11

BJU Int. 2014 Oct;114(Suppl 4):11

Abstract

Background: VEGF-targeted therapies are standard in advanced mRCC, however, toxicities that can lead to drug discontinuation can have a significant impact on patient outcomes. We aimed to identify risk factors for toxicity and develop the first model to predict toxicity-related treatment discontinuation in mRCC patients treated with VEGF-targeted therapies.

Methods:  Baseline characteristics and treatment outcome data were collected to identify 936 mRCC patients treated with first-line VEGFtargeted therapies as part of the IMDC. Toxicity-related treatment discontinuation was analyzed using a competing risk regression model for treatment discontinuation.

Results:  Treatment discontinuation occurred in 833 patients (89%), of which 198 (23.8%) were related to drug toxicity. Sunitinib was the most common (77%) VEGF-targeted agent in our series followed by sorafenib (18.4%). Median time on therapy was 4.4 months for patients who discontinued drug for toxicity. Most common toxicities leading to treatment discontinuation included fatigue, diarrhea and mucositis. On multivariate analysis, significant predictors for toxicity-related treatment discontinuation were age, baseline glomerular filtration rate (GFR), number of metastatic sites, and baseline sodium level. Unlike previous series (Van der veldt et al. Br J Cancer. 2008), female gender and body surface area were not found to be independent predictors of toxicity-related treatment discontinuation. A model was developed using the number of patient risk factors to predict the risk of toxicity-related treatment discontinuation (Table 1).

Conclusion:  In the largest series reported to date, age, GFR, number of metastatic sites, and baseline sodium level were found to be independent risk factors that predict toxicity-related treatment discontinuation in mRCC patients treated with VEGF-targeted agents. Based on the number of risk factors present, we built the first model to predict treatment-related drug discontinuation. This model can be used for treatment and frequency of monitoring considerations in clinical practice.

Comment from Henk van der Poel: TKI is currently standard of care in advanced renal cancer. In particular in clear cell cancers responses are impressive, delay in progression substantial, improvement in overall survival noticeable albeit without complete responses. TKI are not without toxicity. In this registry 198/833 (24%) of patients stopped treatment because of toxicity over a median of 4.4 months. Increased age and number of metastases as well as decreased renal function were among the stongest predictors of treatment cessation.

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