Table 4.
Summary of safety in phase III trials of PARP inhibitors maintenance therapy in frontline settings
| 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) |
AE Adverse event, PARP Poly (ADP-ribose) polymerase inhibitor
aData are reported only for the veliparib-throughout and control arms, excluding the veliparib combination-only arm
bExcludes grade 5 in SOLO-1 and VELIA
cIncludes anaemia, decreased haemoglobin level, decreased haematocrit, decreased red cell count, erythropenia, macrocytic anaemia, normochromic anaemia, normochromic normocytic anaemia and normocytic anaemia
dIncludes thrombocytopenia, decreased platelet production, decreased platelet count and decreased plateletcrit
eIncludes neutropenia, febrile neutropenia, neutropenic sepsis, neutropenic infection, decreased neutrophil count, idiopathic neutropenia, granulocytopenia, decreased granulocyte count and agranulocytosis