| pathology | treatment | patient | Demonstrated benefit and harm | k | | | |
|---|
| advanced breast cancer (metastatic) | olaparib | not classified | versus olaparib superior to Physician s choice chemotherapy in terms of PFS in OlympiAD, 2017 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| OlympiAD, 2017 | olaparib vs Physician s choice chemotherapy | PFS 0.58 [0.43; 0.79] Demonstrated | | OS 0.90 [0.63; 1.29] |
| Trial | Treatments | Patients | Method |
|---|
| OlympiAD, 2017 | Olaparib (Olaparib tablet 300mg bd po) (n=205) vs. Physician's choice chemotherapy (Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21) (n=97) | women with human epidermal growth factor 2 (HER2)–negative metastatic breast cancer with a germline BRCA mutation | open label Sample size: 205/97 Primary endpoint: Progression Free Survival FU duration: 14.5 months |
|
| ovarian cancer | niraparib | not classified | versus No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ENGOT-OV16/NOVA gBRCA, 2017 | niraparib vs placebo | PFS 0.27 [0.17; 0.42] | | |
| Trial | Treatments | Patients | Method |
|---|
| ENGOT-OV16/NOVA gBRCA, 2017 | niraparib (300 mg) once daily as maintenance treatment (n=138) vs. placebo
(n=65) | patients with platinum-sensitive, recurrent ovarian cancer with germline BRCA mutation
| double-blind Parallel groups Sample size: 138/65 Primary endpoint: progression-free survival FU duration: |
|
| ovarian cancer | niraparib | not classified | versus placebo No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ENGOT-OV16/NOVA non-gBRCA | niraparib vs placebo | PFS 0.45 [0.33; 0.61] median 9.3 mo vs. 3.9 mo | | |
| Trial | Treatments | Patients | Method |
|---|
| ENGOT-OV16/NOVA non-gBRCA | niraparib (300 mg) once daily (n=138) vs. placebo (n=65) | patients with platinum-sensitive, recurrent ovarian cancer | double-blind Parallel groups Sample size: 138/65 Primary endpoint: progression-free survival FU duration: |
|
| ovarian cancer | olaparib | not classified | versus placebo No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Ledermann, 2012 | olaparid vs placebo | PFS 0.35 [0.25; 0.49] median 8.4 mo vs. 4.8 mo | | OS 0.94 [0.63; 1.40] | | SOLO2/ENGOT-Ov21 | olaparib vs placebo | PFS 0.30 [0.22; 0.41] median 19.1 months vs. 5.5 months | | |
| Trial | Treatments | Patients | Method |
|---|
| Ledermann, 2012 | olaparib, at a dose of 400 mg twice daily (n=136) vs. placebo (n=129) | patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer with or without BRCA1 or BRCA2 germline mutations, who had received two or more platinum-based regimens and had had a partial or complete response to their most recent platinum-based regimen | double-blind Sample size: 136/129 Primary endpoint: FU duration: phase 2 | | SOLO2/ENGOT-Ov21 | olaparib 300 mg in two 150 mg tablets, twice daily (n=196) vs. placebo (n=99) | patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation | double-blind Sample size: 196/99 Primary endpoint: investigator-assessed progression-free survival FU duration: |
|
