Table 4 Summary of safety in phase III trials of PARP inhibitors maintenance therapy in frontline settings
From: Maintenance therapy for newly diagnosed epithelial ovarian cancer– a review
Trial | PRIMA [55] (n = 728) | SOLO-1 [28] (n = 390) | PAOLA-1 [56] (N = 802) | VELIA [57] (N = 621) | ||||
|---|---|---|---|---|---|---|---|---|
Niraparib (n = 484) | Placebo (n = 244) | Olaparib (n = 260) | Placebo (n = 130) | Olaparib + Bevacizumab (n = 535) | Placebo (n = 267) | Velipariba (n = 310) | Placebo (n = 311) | |
Any grade, n (%) | 478 (99) | 224 (92) | 256 (98) | 120 (92) | 531 (99) | 256 (96) | 294 (95) | 290 (93) |
Grade > =3b, n (%) | 341 (70) | 46 (19) | 102 (39) | 24 (18) | 303 (57) | 136 (51) | 138 (45) | 99 (32) |
AE leading to treatment discontinuation, n (%) | 58 (12) | 6 (2) | 30 (12) | 3 (2) | 109 (20) | 15 (6) | 58 (19) | 3 (1) |
AE leading to dose reduction, n (%) | 343 (71) | 20 (8) | 74 (28) | 4 (3) | 220 (41) | 20 (7) | 74 (24) | 12 (4) |
Selected grade > =3, n (%) | ||||||||
Anaemia | 150 (31) | 4 (2) | 56 (22)c | 2 (2)c | 93 (17)c | 1 (< 1)c | 23 (7) | 3 (1) |
Thrombocytopenia | 139 (29) | 1 (< 1) | 2 (1)d | 2 (2)d | 9 (2)d | 1 (< 1)d | 20 (6) | 1 (< 1) |
Neutropenia | 62 (13) | 3 (1) | 22 (8)e | 6 (5)e | 32 (6)e | 8 (3)e | 16 (5) | 12 (4) |
Fatigue/asthenia | 9 (2) | 1 (< 1) | 10 (4) | 2 (2) | 28 (5) | 4 (1) | 19 (6) | 3 (1) |