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Table 1 MONALEESA-2 safety profile: all-grade adverse events across studies (≥ 30% of patients in any group)

From: Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial

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)

–

–

  1. AE adverse event, CT chemotherapy, ET endocrine therapy, L letrozole, Pbo placebo, Ribo ribociclib
  2. 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%)
  3. bFour patients in the Pbo + L group did not receive study treatment
  4. cOne patient in the Pbo + L arm was randomized but did not receive study treatment
  5. dNeutropenia also includes “neutrophil count decreased” and “granulocytopenia”
  6. eLeukopenia also includes “white blood cell count decreased”
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Breast Cancer Research

ISSN: 1465-542X

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