A retrospective exploratory analysis of pooled efficacy data from more than 500 patients with metastatic renal cell carcinoma treated with sunitinib (Sutent) “support the hypothesis that hypertension may be a viable biomarker of antitumor efficacy in this patient population,” according to a report in the Journal of the National Cancer Institute. Patients with sunitinib-induced hypertension, defined by a maximum systolic blood pressure of 140 mm Hg or higher, had better outcomes than those without treatment-induced hypertension, including objective response rate (54.8% vs 8.7%); median progression-free survival (12.5 vs 2.5 months); and median overall survival (33.7 vs 7.2 months).
“The overall incidence of cardiovascular, cerebrovascular, and ocular adverse events was low, and it was similar between patients in both groups,” the authors reported, although patients with hypertension had more renal adverse events (5% vs 3%, and 3% vs 2% for grade 3 or higher). “These data and the potential for renovascular complications underscore the importance of monitoring patients with metastatic renal cell carcinoma for sunitinib-induced hypertension and treating them as necessary with antihypertensive medication, as recently recommended by an expert panel of the National Cancer Institute for patients receiving VEGF inhibitors,” the authors noted.
“Although several potential biomarkers have been recently investigated in renal cell carcinoma,” the authors pointed out, “none has been consistently associated with patient outcomes as demonstrated here.” If treatment-induced hypertension is prospectively validated, it “may best meet the criteria for a desirable biomarker in patients with advanced renal cell carcinoma treated with sunitinib,” they concluded. ■
Rini BI, et al: J Natl Cancer Inst 103:763-773, 2011.