Table 1

Baseline characteristics associated with long-term progression-free survival status in patients treated with niraparib

Long-term progression-free survival
status
<2 years (n=335)≥2 years (n=152)
Event counts for investigator-assessed progression-free survival, n (%)
Censored45 (13.4)110 (72.4)
Event290 (86.6)42 (27.6)
Demographic characteristics
Age, n (%)
<65 years201 (60.0)96 (63.2)
≥65 years134 (40.0)56 (36.8)
Body mass index, n (%)
<18.5 kg/m2 (underweight)5 (1.5)3 (2.0)
18.5–<25 kg/m2 (normal range)146 (43.6)68 (44.7)
25–30 kg/m2 (overweight)113 (33.7)48 (31.6)
≥30 kg/m2 (obese)71 (21.2)33 (21.7)
Clinical characteristics
ECOG performance status, n (%)
0222 (66.3)115 (75.7)
1113 (33.7)37 (24.3)
FIGO stage, n (%)
III207 (61.8)111 (73.0)
IV128 (38.2)41 (27.0)
Primary tumor location, n (%)
Ovarian259 (77.3)129 (84.9)
Primary peritoneal26 (7.8)8 (5.3)
Fallopian tube50 (14.9)15 (9.9)
Baseline target lesions, n (%)
0284 (84.8)143 (94.1)
≥151 (15.2)9 (5.9)
Baseline non-target lesions, n (%)*
0206 (61.5)125 (82.2)
171 (21.2)19 (12.5)
≥258 (17.3)8 (5.3)
BRCA/homologous recombination-deficiency status, n (%)
BRCA1 mutated/homologous recombination-deficient59 (17.6)46 (30.3)
BRCA2 mutated/homologous recombination-deficient15 (4.5)32 (21.1)
BRCA wild-type/not determined/homologous recombination-deficient63 (18.8)32 (21.1)
BRCA wild-type/homologous recombination-proficient/not determined198 (59.1)42 (27.6)
Type of debulking surgery, n (%)
Primary debulking surgery111 (33.1)47 (30.9)
Interval debulking surgery213 (63.6)103 (67.8)
No surgery11 (3.3)2 (1.3)
Residual disease status, n (%)
No visible residual disease145 (43.3)79 (52.0)
Visible residual disease162 (48.4)58 (38.2)
Missing/no surgery28 (8.4)15 (9.9)
Clinical response after platinum-based chemotherapy, n (%)
Complete response214 (63.9)123 (80.9)
Partial response121 (36.1)29 (19.1)
Prior chemotherapy cycles, n (%)
6226 (67.5)107 (70.4)
7–992 (27.5)32 (21.1)
Missing17 (5.1)13 (8.6)
Duration from end of chemotherapy to randomization, median (IQR), weeks8.14 (4.6)8.00 (4.3)
  • Receipt of neoadjuvant chemotherapy was not selected for evaluation because of high correlation with type of debulking surgery.

  • *Per the RECIST guidelines (version 1.1), when >1 measurable lesion is present at baseline, all lesions (≤5 total lesions and ≤2 lesions/organ) should be identified as target lesions. Excess lesions (>5) and non-measurable disease are designated as non-target lesions.20

  • ECOG, Eastern Cooperative Oncology Group; FIGO, International Federation of Gynecology and Obstetrics; RECIST, Response Evaluation Criteria in Solid Tumors.