Combination therapy in patients with metastatic renal cell carcinoma.

BE At the 2007 American Society of Clinical Oncology meeting, Merchan and colleagues presented results from the phase I portion of a trial that aimed to determine the maximum tolerated dose and dose-limiting toxicity of the combination of the mammalian target of rapamycin (mTOR) inhibitor temsirolimus (Torisel, Pfizer) and the anti-vascular endothelial growth factor (VEGF) monoclonal antibody bevacizumab (Avastin, Genentech). Study inclusion criteria were measurable stage IV clear cell RCC, Eastern Cooperative Oncology Group (ECOG) performance score between 0 and 2, and good organ function. Among the 12 patients in the study, the median age was 66 years [range, 50–77 years]). The combination of temsirolimus and bevacizumab was excellent, and the preliminary activity was very encouraging (65% response rate). These data provided the encouragement to conduct a phase II trial.