36MO Maintenance olaparib plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (OC): 5-year (y) progression-free survival (PFS) by molecular subgroup in the PAOLA-1/ENGOT-ov25 trial

The cost-effectiveness analysis of maintenance olaparib plus Bevacizumab in patients with advanced ovarian cancer: based on the final survival results from PAOLA-1 trial

“…A Markov model was designed using a hypothetical population of 806 patients with AOC based on the baseline data from patients enrolled in the PAOLA-1 trial [ 15 , 18 ]. These included 537 and 269 patients that were randomly assigned to olaparib plus bevacizumab and single-agent bevacizumab treatment groups, respectively, including HRD-positive patients [n = 255 (47.5%) and n = 132 (49.1%), respectively], BRCA mutations patients [n = 161 (30.0%) and n = 80 (29.7%), respectively], and were HRD-positive but BRCA mutation-negative patients [n = 97 (18.1%) and n = 55 (20.5%), respectively][ 15 , 16 ]. Per the PAOLA-1 trial protocols, enrolled patients received twice-daily oral olaparib (300 mg) treatment for a maximum 2 years, while bevacizumab was intravenously administered (15 mg/Kg) every 3 weeks for a maximum 15 months [ 15 , 16 ].…”

“…These included 537 and 269 patients that were randomly assigned to olaparib plus bevacizumab and single-agent bevacizumab treatment groups, respectively, including HRD-positive patients [n = 255 (47.5%) and n = 132 (49.1%), respectively], BRCA mutations patients [n = 161 (30.0%) and n = 80 (29.7%), respectively], and were HRD-positive but BRCA mutation-negative patients [n = 97 (18.1%) and n = 55 (20.5%), respectively][ 15 , 16 ]. Per the PAOLA-1 trial protocols, enrolled patients received twice-daily oral olaparib (300 mg) treatment for a maximum 2 years, while bevacizumab was intravenously administered (15 mg/Kg) every 3 weeks for a maximum 15 months [ 15 , 16 ]. These patients were assumed to have an of 60 years, with an average body weight and body surface area of 70 kg and 1.84 m 2 , respectively, and average serum creatinine levels of 1 mg/dL [ 15 , 16 , 19 , 20 ] (Table 1 ).…”

“…Per the PAOLA-1 trial protocols, enrolled patients received twice-daily oral olaparib (300 mg) treatment for a maximum 2 years, while bevacizumab was intravenously administered (15 mg/Kg) every 3 weeks for a maximum 15 months [ 15 , 16 ]. These patients were assumed to have an of 60 years, with an average body weight and body surface area of 70 kg and 1.84 m 2 , respectively, and average serum creatinine levels of 1 mg/dL [ 15 , 16 , 19 , 20 ] (Table 1 ). Computed tomography (CT) imaging studies of these patients were conducted every 24 weeks to detect progressive disease and to evaluate patient status [ 15 , 16 ].…”

“…These patients were assumed to have an of 60 years, with an average body weight and body surface area of 70 kg and 1.84 m 2 , respectively, and average serum creatinine levels of 1 mg/dL [ 15 , 16 , 19 , 20 ] (Table 1 ). Computed tomography (CT) imaging studies of these patients were conducted every 24 weeks to detect progressive disease and to evaluate patient status [ 15 , 16 ]. Patients underwent treatment with their assigned first-line maintenance therapies until developing progressive disease (PD) or experiencing adverse events (AEs) that were considered unacceptable, at which time 260 (48.4%) pateins in the combination group and 164 (61.0%) pateins in the bevacizumab single-agent group were treated using carboplatin plus paclitaxel in line with the guidelines of the PAOLA-1 trial (Table 1 )[ 21 , 22 ].…”

“…This combination regimen, however, failed to provide significant benefits in the overall AOC patient cohort (56.5 vs. 51.6 months; HR, 0.92; 95% CI, 0.76 to 1.12) or in patients with HRD-positive tumors negative for BRCA mutations (NR vs. 52; HR, 0.71; 95% CI, 0.45 to 1.13)[ 15 ]. In light of these promising results, the analysis was updated this 5-year PFS data for this trial were presented at the 2023 ESMO meeting, revealing that olaparib plus bevacizumab yielded significant median PFS benefits over those associated with bevacizumab alone in the overall AOC patient population (22.9 vs. 16.6 months; HR, 0.63; 95% CI, 0.53 to 0.74), HRD-positive patients (46.8 vs. 17.6 months; HR, 0.41; 95% CI, 0.32 to 0.54), BRCA mutations patients (60.7 vs. 21.7 months; HR, 0.45; 95% CI, 0.32 to 0.64), and HRD-positive BRCA mutation-negative patients (30.0 vs. 16.6 months; HR, 0.47; 95% CI, 0.32 to 0.70)[ 16 ]. Combination olaparib plus bevacizumab treatment received approval from the Food and Drug Administration (FDA) on May 8, 2020 as a therapeutic option for patients diagnosed with HRD-positiveadvanced epithelial ovarian, fallopian tube, or primary peritoneal carcinoma that exhibited partial or complete responses to first-line platinum-based chemotherapeutic regimens [ 17 ].…”