Women with ovarian cancer that has recurred after chemotherapy survived longer after treatment with cediranib, a biological therapy, according to research presented at the 2013 European Cancer Congress in Amsterdam, The Netherlands.
Cediranib, which is taken in pill form, is an inhibitor of a cell signalling process involved in formation of tumor blood vessels, which are essential for tumor growth. It is the first oral inhibitor of its kind to show an improvement in the time before patients’ disease progresses and in overall survival. The drug is a tyrosine kinase inhibitor, a type of biological therapy that blocks vascular endothelial growth factor (VEGF) receptors that control the development of blood vessels required for tumor growth.
Professor Jonathan Ledermann, Professor of Medical Oncology at UCL Cancer Institute, University College London, United Kingdom, presented these first results from ICON6, which is an international, randomized, double-blind, academic clinical phase III trial of cediranib.
“In women whose ovarian cancer had been treated with platinum-based chemotherapy together with cediranib given during and after the chemotherapy, we found that the time before the tumour started to grow again was extended by an average of 3.2 months. This sounds like a modest increase but represents about a 30% improvement, with overall survival also increased by a similar amount, to an average of 2.7 months over a 2-year period of follow-up,” he said.
A total of 456 patients whose ovarian cancer had recurred were enrolled in the trial in 63 centers from the United Kingdom, Canada, Australasia, and Spain. They were randomized to receive platinum-based chemotherapy together with a placebo (the reference arm of the trial), or cediranib 20 mg a day during chemotherapy followed by placebo for 18 months (concurrent arm of the trial), or cediranib 20 mg a day during chemotherapy followed by cediranib as a maintenance treatment (maintenance arm).
Previous studies with chemotherapy alone have shown that the time before patients experience disease progression following treatment for a relapse that is sensitive to platinum-based chemotherapy is an average of 8 to 9 months. These latest results show that cediranib in addition to chemotherapy increased the time before the disease progressed from 9.4 to 12.6 months over a period of 2 years, and extended overall survival from 17.6 to 20.3 months.
“These are ground-breaking data,” said Ledermann. “Cediranib is the first oral VEGF tyrosine kinase inhibitor that has been shown to delay tumour progression and improve overall survival in recurrent ovarian cancer. It is simple to give for a prolonged period and in most patients it is well-tolerated.” Adverse side effects included high blood pressure, diarrhea, and fatigue.
An increased survival time of nearly three months is significant in this group of patients. Ledermann said, “In previous ovarian cancer trials any improvement seen with each new treatment has been incremental… Trials showing an improvement in overall survival are uncommon. Cediranib produces an incremental improvement in progression-free survival and an incremental improvement in overall survival.”