ESMO 2018: ‘Outstanding’ Results With Olaparib Maintenance in Advanced Ovarian Cancer
Posted: Wednesday, October 24, 2018
According to the results of the phase III SOLO-1 trial, 2-year maintenance therapy with the PARP inhibitor olaparib prolonged progression-free survival in newly diagnosed patients with advanced ovarian cancer who had a BRCA1/2 mutation. In fact, although the median progression-free survival in patients treated with olaparib was not reached, the study investigators indicate it may be about 3 years longer than that in those treated with placebo.
“The results of SOLO-1 herald a new era in treatment for women diagnosed with advanced ovarian cancer who carry a BRCA mutation,” announced Kathleen Moore, MD, of the Stephenson Cancer Center, University of Oklahoma, at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich (Abstract LBA7_PR). “This study demonstrates an outstanding improvement in progression-free survival over placebo, which is maintained even after olaparib is stopped at 2 years.”
In the first double-blind, randomized phase III trial evaluating front-line olaparib maintenance therapy after platinum-based chemotherapy in this patient population, nearly 400 women were assigned to either olaparib (n = 260) or placebo (n = 131). All of the patients had either a complete or partial response after chemotherapy.
At a median follow-up of 41 months, the median progression-free survival with placebo was 13.8 months compared with not yet reached with olaparib. As for the median time from randomization to second disease progression, again the outcome was better with olaparib: not yet reached versus 41.9 months (with placebo).
As for toxicity, the most common grade ≥ 3 toxicities with olaparib were anemia (22%) and neutropenia (8%). No clinically relevant change in quality of life between the two treatment groups was reported, and 12% of patients who received olaparib discontinued treatment due to toxicity—but not disease progression.
