Debra L. Richardson, MD
In a phase II trial reported in JAMA Oncology by Debra L. Richardson, MD, of Stephenson Cancer Center, Oklahoma University Health Science Center, and colleagues, the addition of pazopanib (Votrient) to paclitaxel did not improve progression-free survival among women with persistent or recurrent ovarian cancer.
In the double-blind study from 26 U.S. study sites, 106 women with persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who had received 1 to 3 prior regimens were randomized between December 2011 and April 2013. They were treated with paclitaxel at 80 mg/m2 on days 1, 8, and 15 every 28 days plus or pazopanib at 800 mg daily (n = 54) or placebo (n = 52).
Median follow-up at the time of analysis was 17.7 months. Median progression-free survival was 7.5 months in the combination group vs 6.2 months with paclitaxel alone (hazard ratio [HR] = 0.84, P = .20). Objective response was observed in 31.8% vs 22.7% of evaluable patients. Median overall survival was 20.7 vs 23.3 months (HR = 1.04, P = .90).
Treatment was discontinued due to adverse events in 37% of the pazopanib group and 10% of the placebo group (P = .001), with the most common causes being neutropenia and neuropathy. Vascular adverse events were more common in the pazopanib group, including severe hypertension (risk ratio = 12.0, 95% confidence interval = 1.6–88.8); no patients in the pazopanib group discontinued treatment due to hypertension. Grade 3 bowel perforation occurred in two patients treated with pazopanib.
The investigators concluded: “The combination of pazopanib plus paclitaxel is not superior to paclitaxel in women with recurrent ovarian cancer.” ■