Maintenance treatment with Lynparza (olaparib) after chemotherapy has been found to significantly extend progression-free survival in newly diagnosed patients with advanced ovarian cancer and a BRCA mutation, according to a recent phase 3 study.
Maintenance treatment with Lynparza (olaparib) after chemotherapy has been found to significantly extend progression-free survival (PFS) in newly diagnosed patients with advanced ovarian cancer and a BRCA mutation, according to a recent phase 3 study.
Known as the fifth most common cause of cancer deaths in women, ovarian cancer is the deadliest gynecologic cancer. When diagnosed in its early stages, it has a five-year survival rate of 90 percent.
However, as noted by the National Ovarian Cancer Coalition, only 20 percent of all diagnoses are made at stage 1 or 2 due to lack of early detection. And given that roughly 70 percent of patients will relapse, the researchers noted that these findings are particularly promising.
“The results of SOLO-1 herald a new era in treatment for women diagnosed with advanced ovarian cancer who carry a BRCA mutation,” said Dr. Kathleen Moore, associate professor at the Stephenson Cancer Center at the University of Oklahoma, when presenting the trial’s results at the ESMO 2018 Congress in Munich, Germany in October.
While Lynparza is already used to treat relapsed advanced ovarian cancer, this study was the first double-blind, randomized one of its kind to evaluate Lynparza in the frontline setting for maintenance therapy in patients with a BRCA1 or BRCA2 mutation who had already received platinum-based chemotherapy.
The study involved 391 patients who were randomly assigned to one of two groups: one that received Lynparza tablets (300mg) and another that received placebo. The group that received Lynparza contained twice as many patients as the placebo group.
The primary endpoint of the study was investigator-assessed PFS from the date of randomization. Overall survival (OS), quality of life and the time from patient randomization to the second progression event were all considered secondary outcomes.
Upon the median follow-up of 41 months, PFS in the Lynparza arm appeared was not yet reached, but was estimated to be about three years longer than the placebo group.
Moore explained, “While it is too early to say whether we have impacted the fraction of women who could be cured with their front-line therapy, the fact that it is estimated that over 50 percent of women on the olaparib arm were still progression free at four years as compared to only 11 percent for placebo speaks to this hope.”
Overall Lynparza was shown to be well tolerated among patients. Common grade 3 or higher side effects included anemia (22 percent of patients) and neutropenia (8 percent). No clinically relevant change in quality of life was reported between the two groups. Of those who discontinued treatment, the researchers noted that 12 percent of patients did so due to toxicity and not due to disease progression.