RT Journal Article
SR Electronic
T1 18 Efficacy of maintenance olaparib plus bevacizumab by biomarker status in clinical higher- and lower-risk patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1 trial
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP A13
OP A14
DO 10.1136/ijgc-2020-IGCS.18
VO 30
IS Suppl 3
A1 Harter, P
A1 Petran, D
A1 Scambia, G
A1 Ortega, E
A1 Tsibulak, I
A1 Nagao, S
A1 Vergote, I
A1 Meunier, J
A1 Priou, F
A1 Sverdlin, R
A1 Milenkova, T
A1 Ray-Coquard, I
A1 Ray-Coquard, I
YR 2020
UL http://ijgc.bmj.com/content/30/Suppl_3/A13.abstract
AB Introduction In the Phase III PAOLA-1/ENGOT-ov25 trial (NCT02477644), adding maintenance olaparib to bevacizumab improved progression-free survival (PFS) in patients with advanced ovarian cancer in response after first-line platinum-based chemotherapy plus bevacizumab (HR 0.59; 95% CI 0.49–0.72) (Ray-Coquard et al. NEJM 2019). Outcomes in patients classified by clinical risk according to biomarker status are unknown.Methods Patients were classified as higher-risk (stage III patients with upfront surgery and residual disease or who received neoadjuvant chemotherapy, or stage IV patients) or lower-risk (stage III patients with upfront surgery and no residual disease). This exploratory analysis evaluated PFS in higher-risk and lower-risk patients, including by biomarker status: homologous recombination deficiency (HRD)-positive, HRD-negative/unknown and tumour BRCA mutation (BRCAm)-positive.Results Of 806 randomized patients, 74% were higher risk and 26% were lower risk, with median follow-up of 22.4 and 23.8 months, respectively. PFS significantly favoured olaparib plus bevacizumab versus placebo plus bevacizumab in higher-risk and lower-risk patients. In both higher- and lower-risk patients, the greatest PFS benefit was seen with olaparib plus bevacizumab versus bevacizumab alone in the HRD-positive subgroup (figures 1 and 2) and the subgroup with a tumour BRCAm (figure 2). Outcomes in the higher- and lower-risk HRD-negative/unknown subgroups are shown in figure 2.Abstract 18 Figure 1 Kaplan-Meier estimates of investigator-assessed PFS in higher-risk and lower-risk HRD-positive patients*Abstract 18 Figure 2 Analysis of investigator-assessed PFS in higher-risk* and lower-risk† patients, including in biomarker subgroupsConclusions In PAOLA-1, maintenance olaparib plus bevacizumab provided a substantial PFS benefit over bevacizumab alone in higher-risk and lower-risk patients, especially in the HRD-positive and BRCAm populations.