Landmark clinical research shows that a new drug can extend the lives of some women with advanced ovarian cancer by nearly two years.
Richard Moore, M.D., director of Wilmot’s Gynecologic Oncology program and a co-author of the study, said the research has the potential to transform the care for women newly diagnosed with stage 3 or stage 4 ovarian cancer.
“This opens up a whole new treatment regimen for women, on top of what we’re already doing now,” said Moore, who noted that Wilmot has been offering these types of groundbreaking clinical trials for four years.
The drug, known as niraparib (a daily pill), targets proteins in tumors known as PARP1 and PARP2, that cause DNA damage in cells and promote cancer cell growth.
The study evaluated whether niraparib was effective in newly diagnosed patients who had received chemotherapy and had achieved a complete or partial response to the chemo.
At that point, patients were randomly assigned, blindly, by a web-based system, to receive either a placebo pill or the niraparib as a maintenance drug. Doctors monitored the women closely, performing imaging tests every 12 weeks to assess the status of their cancer.
Results showed that cancer stayed away up to 21.9 months longer in the women who received niraparib, compared to the women who received standard care and a placebo. The last time a study of this significance was reported, it was several years ago when a new chemotherapy combination was shown to extend the lives of patients by 10 or 11 months, Moore said.
Another key finding about niraparib, Moore said, is that the drug appears to benefit patients with a variety of ovarian tumor types — including those with the signature BRCA gene and another gene, known as HRD. About 60 percent of ovarian cancer patients have one of those gene mutations, he said.
Niraparib is already being used in women whose cancer had recurred, but the latest study may allow doctors to begin using the drug as an up-front therapy to attack cancer earlier, he added.
This is important because 85 percent of women who are newly diagnosed with late-stage disease experience a relapse and have fewer treatment options. The study was conducted in 20 countries at 181 cancer centers and with more than 700 patient volunteers.
Ovarian cancer is a leading cause of death from gynecological cancers worldwide. Anemia was the most common adverse side effect, reported in about one-third of the patients who received niraparib. GlaxoSmithKline supported the study.