PAOLA-1 Study
Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer
Disease site
- Ovaries
- Fallopian tube
- Primary peritoneal
Pubmed link
Publication month/year
December 2019
Study question
Assessing the effects of Olaparib in combination with bevacizumab on disease progression
Type of study
Randomized control trial
Interventions compared
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
Control arm
Placebo tablets daily for 24 months plus 15mg/kg intravenous bevacizumab every 3 weeks for 15 months
Primary outcome
Progression-free survival
Secondary outcome
- Global health status–quality
- Adverse effects
Inclusion criteria
- 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
Exclusion criteria
None
Results
| Intervention arm | Control arm | |
|---|---|---|
|
Randomised (n) |
537 |
267 |
|
Received treatment |
Olaparib plus bevacizumab |
Olaparib plus placebo |
|
Progression-free survival (months) |
22.1
|
16.6
|
|
Progression-free survival (months) BRCA +ve |
37.2 |
21.7 |
|
Progression-free survival (months) BRCA -ve |
18.9 |
16 |
|
Progression-free survival (Months): HRD +ve /BRCA +ve: |
37.2 |
17.7 |
|
Progression-free survival (Months): HRD +ve /BRCA -ve: |
28.1 |
16.6 |
|
Progression-free survival (Months): HRD -ve |
16.9 |
16 |
HRD= Homologous Recombination Deficiency
Conclusions
- 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.
Study limitations
The study did not investigate Olaparib as monotherapy making it difficult to confirm its efficacy in HRD-positive tumors with negative BRCA mutations.