Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer (PAOLA-1)

Disease site
  • Ovaries 
  • Fallopian tube
  • Primary peritoneal
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
Olaparib + bevacizumab Olaparib + placebo
Randomised(n) 537 267
PFS (months) 22.1 16.6
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
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. 

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