Table 1.
NOVA Study Mirza et al. 2016 [12] |
PRIMA Study González-Martín et al. 2019 [13] |
NORA Study Wu et al. 2020 [14] |
||||||||
---|---|---|---|---|---|---|---|---|---|---|
gBRCAm (+) 203 Total n. of patients |
gBRCAm (−) 350 Total n. of patients |
HRD (+) 373 Total n. of patients |
Non-HRD(+) 249 Total n. of patients |
177 Total n. of patients | 88 Total n. of patients | |||||
Niraparib | Placebo | Niraparib | Placebo | Niraparib | Placebo | Niraparib | Placebo | Niraparib | Placebo | |
Number of patients | 138 | 65 | 234 | 116 | 247 | 126 | 240 | 120 | 177 | 88 |
Number of patients who discontinued treatment | 91 | 61 | 188 | 104 | 126 | 83 | 184 | 93 | 101 | 77 |
Number of patients receiving ongoing treatment at data cut off | 47 | 4 | 46 | 12 | 121 | 42 | 56 | 27 | 76 | 11 |
Median age, years | 57 | 58 | 63 | 61 | 58 | 58 | 66 | 66 | 53 | 55 |
Primary location tumor | ||||||||||
Ovary | 122 | 53 | 192 | 96 | 201 | 105 | 187 | 96 | 174 | 86 |
Other | 16 | 12 | 42 | 19 | 46 | 21 | 53 | 24 | 3 | 2 |
Response to platinum-based chemotherapy | ||||||||||
Complete | 71 | 33 | 117 | 60 | 185 | 93 | 152 | 79 | 121 | 60 |
Partial | 67 | 32 | 117 | 56 | 62 | 33 | 88 | 41 | 56 | 28 |
Number to previous platinum-based regiments | ||||||||||
1 | 1 | 0 | 0 | 0 | NR | NR | NR | NR | NR | NR |
2 | 70 | 30 | 155 | 77 | NR | NR | NR | NR | NR | NR |
≥3 | 67 | 35 | 79 | 38 | NR | NR | NR | NR | NR | NR |
n: number, NR: none reported, gBRCAm (+): germline BRCA mutated positive, gBRCAm (-): germline BRCA mutated negative, HRD (+): homologous recombination deficient positive, Non-HRD (+): non- homologous recombination deficient positive.