Barbara Buttin, MD, discusses the PAOLA-1 clinical trial and it impact on the first-line treatment of ovarian cancer.
Barbara Buttin, MD, a gynecologic oncologist at City of Hope Chicago, discusses the PAOLA-1 clinical trial and it impact on the first-line treatment of ovarian cancer.
PAOLA-1 was a randomized, double-blind, phase 3 study of the PARP inhibitor with chemotherapy and bevacizumab compared with placebo in patients with advanced FIGO stage IIIb-IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal cancer. In 2020, results from this study led to the FDA approval of olaparib plus bevacizumab for the treatment of ovarian, fallopian tube, or primary peritoneal cancers.
Initial results from PAOLA-1 were published in the New England Journal of Medicine and showed that olaparib and bevacizumab achieved 41% reduction in the risk of disease progression or death compared with placebo (HR, 0.59; 95% CI, 0.49-0.72; P <.001). The median progression-free survival (PFS) observed with olaparib plus bevacizumab was 22.1 months versus 16.6 months with bevacizumab.
0:09 | The PAOLA-1 trial was the international trial that showed us the benefit of using the combination of PARP and bevacizumab, specifically in the population of ovarian cancer patients with HRD. Again, we you know that our BRCA-positive patients have the best prognosis, and our BRCA-negative/HRD-negative patients have the worst prognosis in terms of progression-free and overall survival. PAOLA-1 showed us that PARP with bevacizumab improves outcomes in both groups, most importantly for the HRD-positive population, and that's where the indication was made.
1:05 | The post hoc analysis showed us that basically, progression while on olaparib, the PARP inhibitor and bevacizumab is a core prognostic sign, which of course, makes sense in that population. The from first to second progression in the patients who received PRAP vs placebo was significantly different in that group. It is worth pushing these patients towards the doublet in in terms of maintenance therapy to prolong that disease-free survival between recurrences as much as possible, and that's kind of what the takeaway was here.