SGO 2020: Updated PAOLA-1 Data Support Maintenance Therapy for High-Grade Serous Ovarian Cancer
Posted: Friday, May 8, 2020
A maintenance regimen of the PARP inhibitor olaparib plus bevacizumab “improved outcomes compared with bevacizumab alone in patients with newly diagnosed advanced high-grade serous ovarian cancer regardless of the timing of surgery or residual disease status after surgery,” according to Christoph Grimm, MD, of the Medical University of Vienna, Austria, and colleagues. However, “the magnitude of the progression-free survival benefit [was] greatest when surgery achieved complete surgical debulking, particularly in the upfront setting.” Their findings were made available as part of the virtual platform of the 2020 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer (Abstract 34).
These conclusions emerged from the latest analyses of data from the PAOLA-1/ENGOT-ov25 trial. Previously, the team had reported that this maintenance regimen was better than bevacizumab alone (hazard ratio [HR] = 0.59) in these patients, who all had complete or partial response to first-line platinum-based chemotherapy plus bevacizumab. The researchers investigated further to see whether the timing of surgery or disease status impacted results.
In the phase III trial, 537 patients were randomly assigned to olaparib plus bevacizumab, and 269 received placebo plus bevacizumab, stratified by first-line treatment outcome and tumor BRCA-mutation status. Of the 93% of patients who had surgery, 51% and 42% of patients had upfront and interval surgery, respectively. In addition, 60% and 33% of patients had no residual and residual macroscopic disease, respectively, after surgery, regardless of its timing. The median follow-up was 22.9 months.
Progression-free survival results for the combination therapy versus placebo plus bevacizumab follow:
- HR = 0.52 (median 29.6 vs. 18.2 months): upfront surgery
- HR = 0.66 (median 21.4 vs. 16.7 months): interval surgery
- HR = 0.54 (median 29.6 vs. 19.3 months): no residual macroscopic disease after cytoreductive surgery
- HR = 0.63 (median 18.2 vs. 12.9 months): residual macroscopic disease after cytoreductive surgery
- HR = 0.47 (median 39.3 vs. 22.1 months): upfront surgery and no residual macroscopic disease.
Disclosure: The study authors’ disclosure information can be found sgo.confex.com.
