Table 1.
Important clinical studies leading to the use of PARPi as monotherapy in the clinical setting.
| Study name (NCT number) | Treatment setting | Patient population | Drug name | PFS PARPi versus placebo (months) | HR (95% CI) |
|---|---|---|---|---|---|
| SOLO-1 (NCT01844986) 1 | First-line maintenance | BRCA1/2 mut | Olaparib | BRCA1/2 mut: 56.0 versus 13.8 | 0.33 (0.25–0.43) |
| PRIMA (NCT02655016) 2 | First-line maintenance | All comers | Niraparib | Overall: 13.8 versus 8.2 HRD: 21.9 versus 10.4 HRD test neg: 8.1 versus 5.4 |
0.62 (0.50–0.76) 0.43 (0.31–0.59) 0.68 (0.49–0.94) |
| VELIA (NCT0247058) 3 | In combo with first-line chemo then maintenance | All comers | Veliparib | Overall: 23.5 versus
17.3 BRCA1/2 mut: 34.7 versus 22 HRD: 31.9 versus 20.5 |
0.68 (0.56–0.83) 0.44 (0.28–0.68) 0.57 (0.43–0.76) |
| Study 19 (NCT00753545) 4 | PSR maintenance | All comers | Olaparib | Overall: 10.8 versus
5.4 BRCA1/2 mut: 11.2 versus 4.3 BRCA1/2 wt: 7.4 versus 5.5 |
0.35 (0.25–0.49) 0.18 (0.34–0.85) 0.54 (0.34–0.85) |
| SOLO-2 (NCT01874353) 5 | PSR maintenance | BRCA1/2 mut | Olaparib | BRCA1/2 mut: 19.1 versus 5.5 | 0.33 (0.24–0.44) |
| NOVA (NCT01847274) 6 | PSR maintenance | All comers | Niraparib | gBRCA1/2 mut: 21.0 versus
5.5 HRD & gBRCA1/2 wt: 12.9 versus 3.8 HRD test neg: 6.9 versus 3.8 |
0.27 (0.17–0.41) 0.38 (0.24–0.59) 0.58 (0.36–0.92) |
| ARIEL3 (NCT01968213) 7 | PSR maintenance | All comers | Rucaparib | Overall: 10.8 versus
5.4 BRCA1/2 mut: 16.6 versus 5.4 HRD: 13.6 versus 5.4 |
0.36 (0.30–0.45) 0.23 (0.16–0.34) 0.32 (0.24–0.42) |
BRCA1/2 mut, BRCA1/2 mutation carriers; CI, confidence interval; g, germline; HR, hazard ratio; HRD, homologous recombination deficient; PARPi, PARP inhibitors; PFS, progression-free survival; PSR, platinum-sensitive relapse; wt, wild-type.