Efficacy and safety of vascular endothelial growth factor receptor tyrosine kinase inhibitors in patients with metastatic renal cell carcinoma and poor risk features.

BACKGROUND: Temsirolimus is a standard of care in patients with metastatic renal cell carcinoma (mRCC) with poor risk factors. The role of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKI) remains poorly defined in this setting.

METHODS: Records of our center were examined to identify patients with mRCC and 3 or more poor prognosis factors, as determined in the Advanced Renal Cell Carcinoma (ARCC) trial, who had been treated with VEGFR TKIs. Their baseline characteristics, radiologic response, adverse events, and survival status were assessed.

RESULTS: The 88 patients who met our inclusion criteria had a median age of 56 years (range 17-83 years). We observed clear cell histology in 71 (81%) patients, and 52 (59%) underwent prior nephrectomy. Seventy-six patients (86%) were treated with sunitinib and 10 (11%) with sorafenib. Of 85 patients with measurable lesions, 19 (22%) showed objective response, with disease control achieved in 49 (56%). At a median follow-up of 29.6 months, the median time to progression was 5.0 months (95% CI, 3.5-6.5 months) and the median overall survival (OS) was 9.3 months (95% CI, 7.1-11.5 months). Neutrophil count (>ULN), bone metastasis, and lymph node metastasis were independent prognostic factors for OS, whereas prior nephrectomy was not.

CONCLUSIONS: VEGFR TKIs, especially sunitinib, are active and tolerated by mRCC patients with poor risk features.