Table 4 RECIST response according to ribociclib relative DI in patients receiving ribociclib with first-line endocrine treatment (FAS; investigator assessment).a,b

From: Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer

 

Ribociclib relative DI

 

0–71% relative DI (30th percentile)

72–96% relative DI (60th percentile)

97–100% relative DI (90th percentile)

 

n

% (95% CI)

n

% (95% CI)

n

% (95% CI)

Best overall response

 Complete response

7

2.9

5

2.0

14

4.3

 Partial response

108

44.6

90

36.0

109

33.4

 Stable disease

68

28.1

84

33.6

89

27.3

 Neither complete response nor progressive disease

49

20.2

44

17.6

64

19.6

 Progressive disease

7

2.9

22

8.8

20

6.1

 Unknown

3

1.2

5

2.0

30

9.2

 Overall responsec

115

47.5 (41.2–53.8)

95

38.0 (32.0–44.0)

123

37.7 (32.5–43.0)

 Clinical benefitd

212

87.6 (83.5–91.8)

192

76.8 (71.6–82.0)

240

73.6 (68.8–78.4)

  1. CI confidence interval, DI dose intensity, FAS full analysis set, RECIST Response Evaluation Criteria in Solid Tumours.
  2. aPooled data: patients from MONALEESA-2 (ribociclib plus letrozole group), MONALEESA-3 (ribociclib plus fulvestrant group), and MONALEESA-7 (ribociclib plus non-steroidal aromatase inhibitor group).
  3. bRelative DI = DI (mg/day)/planned DI (mg/day) × 100.
  4. cIncludes complete and partial responses.
  5. dIncludes complete and partial responses, stable disease lasting ≥24 weeks, and neither complete response nor progressive disease lasting ≥24 weeks.
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