Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer (PAOLA-1)
- Fallopian tube
- Primary peritoneal
Assessing the effects of Olaparib in combination with bevacizumab on disease progression
Type of study
Randomized control trial
Treatment with Olaparib and bevacizumab vs placebo and bevacizumab
Experimental arm (Intervention)
Olaparib 300 mg twice daily for 24 months plus 15mg/kg intravenous bevacizumab every 3 weeks for 15 months
Placebo tablets daily for 24 months plus 15mg/kg intravenous bevacizumab every 3 weeks for 15 months
- Global health status–quality
- Adverse effects
- Patients 18 years or older
- Newly diagnosed ovarian cancer FIGO stage III or IV
- high-grade serous or endometrioid ovarian cancer or germline BRCA1/2mutation.
- Complete or partial response with platinum- taxane chemotherapy in combination with bevacizumab
- Eastern Cooperative Oncology Group performance status of 1 or lower
|Olaparib + bevacizumab||Olaparib + placebo|
|PFS in BRCA +ve||37.2||21.7|
|PFS in BRCA -ve||18.9||16.0|
|PFS (HRD +ve/BRCA +ve)||37.2||17.7|
|PFS (HRD +ve/BRCA -ve)||28.1||16.6|
|PFS (HRD -ve/undetermined)||16.9||16.0|
- The combination of Olaparib and bevacizumab as maintenance therapy has shown significant prolongation of progression-free survival.
- Subgroup analysis confirmed increased progression-free survival specifically in BRCA and HRD-positive tumors.
- The experimental group showed higher incidence of hematological malignancies.
The study did not investigate Olaparib as monotherapy making it difficult to confirm its efficacy in HRD-positive tumors with negative BRCA mutations.