By: Sarah Tilyou
From: clinicaloncology.com
Maintenance therapy with olaparib can reduce the risk for ovarian cancer progression and related death by 70% at three years, according to results of the phase 3 SOLO-1 trial.
The findings, which were presented at the ESMO 2018 Congress (abstract LBA7_PR) and published in The New England Journal of Medicine (2018 Oct 21. [Epub ahead of print]), provide “the first large data set of prospectively collected outcomes for this population of women,” according to lead investigator Kathleen Moore, MD.
Dr. Moore and her coinvestigators evaluated patients with newly diagnosed FIGO stage III to IV, BRCA-mutated, high-grade serous or endometroid ovarian, primary peritoneal and/or fallopian tube cancer who had a complete or partial response to first-line platinum-based chemotherapy. During the trial, the patients were randomly assigned in a 2:1 ratio to receive 300 mg of olaparib (Lynparza, AstraZeneca) twice daily (n=260) or placebo (n=131) until progression was identified on imaging. At two years, patients with a complete response (no radiologic evidence of disease) discontinued treatment, but those with a partial response could continue receiving the treatment in a blinded manner. The primary end point was investigator-assessed progression-free survival (PFS) based on modified RECIST version 1.1.
The investigators found that after a median of 41 months of follow-up, median PFS was 13.8 months in the placebo group but was not reached in the olaparib group (hazard ratio, 0.30; 95% CI, 0.23-0.41; P<0.001). Of the olaparib-treated patients, 60% were progression-free for three years, compared with 27% of those in the placebo group.
Adverse events were mostly low grade and consistent with the known effects of olaparib. The most common grade 3 or higher toxicities in patients treated with olaparib during the trial were anemia (22%) and neutropenia (8%). Olaparib treatment did not adversely affect health-related quality of life.
The results “demonstrate the potential of [olaparib] maintenance therapy earlier in the treatment pathway and reinforce the importance of identifying a patient’s BRCA mutation status at the time of diagnosis,” noted Dr. Moore, the associate director for clinical research at the University of Oklahoma’s Stephenson Cancer Center, in Oklahoma City. “These results could change the way we treat women with advanced BRCA-mutated ovarian cancer.”
Commenting on the results for ESMO, Isabelle Ray-Coquard, MD, PhD, a professor of medicine at the Université Claude Bernard Lyon Est, in Lyon, France, noted that “now, two questions remain. Can we expand this benefit to all high-grade serous carcinomas? … Also, what is the best maintenance therapy? Standard first-line therapy in many countries is chemotherapy plus bevacizumab [Avastin, Genentech] maintenance for the majority of advanced disease, but the question remains whether maintenance with olaparib alone or in combination with bevacizumab is preferable.”
She suggested that the results of the upcoming PAOLA 1 trial (ClinicalTrials.gov Identifier: NCT02477644) that is further exploring olaparib versus placebo treatment will be available next year and may help to answer these questions.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.