Table 1.
MONALEESA-2 safety profile: all-grade adverse events across studies (≥ 30% of patients in any group)
| AE, n (%) | Age < 65 years (n = 370) [17] |
Age ≥ 65 yearsa (n = 294) [17] |
Visceral metastases (n = 393) (Burris et al., 2016) |
Bone-only disease (n = 146) (Burris et al., 2016) |
De novo disease (n = 226) [21] |
Prior CT (n = 289) (Conte et al., 2017) | No prior CT (n = 375) (Conte et al., 2017) |
Prior ET (n = 344) (Conte et al., 2017) | No prior ET (n = 320) (Conte et al., 2017) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ribo + L (n = 184) | Pbo + L (n = 186)b | Ribo + L (n = 150) | Pbo + L (n = 144)b | Ribo + L (n = 197) | Pbo + L (n = 196) | Ribo + L (n = 69) | Pbo + L (n = 77) | Ribo + L (n = 114) | Pbo + L (n = 112)c | Ribo + L (n = 146) | Pbo + L (n = 143) | Ribo + L (n = 188) | Pbo + L (n = 187) | Ribo + L (n = 175) | Pbo + L (n = 169) | Ribo + L (n = 159) | Pbo + L (n = 161) | |
| Neutropeniad | 137 (75) | 10 (5) | 111 (74) | 7 (5) | 156 (79.2) | 10 (5.1) | 44 (63.8) | 4 (5.2) | 80 (70) | 5 (4) | 115 (79) | 8 (6) | 133 (71) | 9 (5) | 137 (78) | 11 (7) | 111 (70) | 6 (4) |
| Nausea | 92 (50) | 52 (28) | 80 (53) | 42 (29) | 111 (56.3) | 54 (27.6) | 32 (46.4) | 23 (29.9) | 55 (48) | 29 (26) | 79 (54) | 42 (29) | 93 (50) | 52 (28) | 97 (55) | 41 (24) | 75 (47) | 53 (33) |
| Fatigue | 67 (36) | 64 (34) | 55 (37) | 35 (24) | 71 (36.0) | 62 (31.6) | 27 (39.1) | 21 (27.3) | 48 (42) | 30 (27) | 43 (30) | 48 (34) | 79 (42) | 51 (27) | 56 (32) | 48 (28) | 66 (42) | 51 (32) |
| Leukopeniae | 64 (35) | 8 (4) | 46 (31) | 5 (4) | 70 (35.5) | 9 (4.6) | 21 (30.4) | 2 (2.6) | 36 (32) | 0 | 53 (36) | 9 (6) | 57 (30) | 4 (2) | 65 (37) | 11 (7) | – | – |
| Alopecia | 62 (34) | 26 (14) | 49 (33) | 25 (17) | 62 (31.5) | 31 (15.8) | 31 (44.9) | 7 (9.1) | 45 (39) | 17 (15) | 46 (32) | 24 (17) | 65 (35) | 27 (14) | 52 (30) | 25 (15) | 59 (37) | 26 (16) |
| Diarrhea | 56 (30) | 36 (19) | 61 (41) | 37 (26) | 66 (33.5) | 40 (20.4) | 28 (40.6) | 22 (28.6) | 32 (28) | 24 (21) | 48 (33) | 27 (19) | 69 (37) | 46 (25) | 70 (40) | 31 (18) | 47 (30) | 42 (26) |
| Arthralgia | 54 (29) | 55 (30) | 37 (25) | 40 (28) | – | – | 17 (24.6) | 24 (31.2) | 25 (22) | 37 (33) | – | – | 50 (27) | 61 (33) | – | – | 41 (26) | 55 (34) |
| Vomiting | 45 (29) | 24 (13) | 53 (35) | 27 (19) | – | – | – | – | 29 (25) | 17 (15) | 49 (34) | 24 (17) | – | – | 58 (33) | 24 (14) | – | – |
AE adverse event, CT chemotherapy, ET endocrine therapy, L letrozole, Pbo placebo, Ribo ribociclib
aAdditional AEs (≥ 15% in either group) in patients ≥ 65 years of age (ribociclib group vs placebo group): anemia (26% vs 6%), constipation (25% vs 16%), decreased appetite (23% vs 17%), cough (19% vs 19%), peripheral edema (19% vs 12%), hypertension (19% vs 19%), rash (19% vs 8%), urinary tract infection (19% vs 10%), headache (18% vs 15%), liver enzyme elevation (17% vs 6%), asthenia (17% vs15%), back pain (15% vs 21%), and hot flush (15% vs 19%)
bFour patients in the Pbo + L group did not receive study treatment
cOne patient in the Pbo + L arm was randomized but did not receive study treatment
dNeutropenia also includes “neutrophil count decreased” and “granulocytopenia”
eLeukopenia also includes “white blood cell count decreased”