Addition of Pazopanib to Paclitaxel in Persistent or Recurrent Ovarian Cancer
In a phase II trial reported in JAMA Oncology, Richardson et al found that the addition of pazopanib to paclitaxel did not improve progression-free survival among women with persistent or recurrent ovarian cancer.
Study Details
In the double-blind study, 106 women from 26 U.S. study sites 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 to receive paclitaxel at 80 mg/m2 on days 1, 8, and 15 every 28 days plus either pazopanib at 800 mg daily (n = 54) or placebo (n = 52). Patients had a median age of 61 years, and 83% were white. Data were frozen as of August 2014.
Progression-Free Survival
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).
Adverse Events
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 2 patients treated with pazopanib.
The investigators concluded: “The combination of pazopanib plus paclitaxel is not superior to paclitaxel in women with recurrent ovarian cancer.”
The study was supported by grants from the National Cancer Institute.
Debra L. Richardson, MD, of Stephenson Cancer Center, Oklahoma University Health Science Center, is the corresponding author for the JAMA Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
