Table 2 Cumulative response rates at any time on treatment in patients with Ph+ CP CML by age and comorbidities (overall and excluding patients with the respective baseline response).

From: Impact of age and comorbidities on the efficacy and tolerability of bosutinib in previously treated patients with chronic myeloid leukemia: results from the phase 4 BYOND study

 

By age

By comorbidities

% (95% CI)

<65 years

65–74 years

≥75 years

mCCI 2

mCCI 3

mCCI ≥ 4

Cytogenetic response

 All evaluable patients, n

90

30

23

90

25

28

 CCyR

85.6 (76.6–92.1)

66.7 (47.2–82.7)

82.6 (61.2–95.0)

87.8 (79.2–93.7)

72.0 (50.6–87.9)

67.9 (47.6–84.1)

 Evaluable patients without baseline CCyR, n

32

14

6

32

10

10

 CCyR

75.0 (56.6–88.5)

35.7 (12.8–64.9)

66.7 (22.3–95.7)

75.0 (56.6–88.5)

50.0 (18.7–81.3)

40.0 (12.2–73.8)

Molecular response

 All evaluable patients, n

91

31

27

95

27

27

 MMR

73.6 (63.3–82.3)

64.5 (45.4–80.8)

74.1 (53.7–88.9)

77.9 (68.2–85.8)

63.0 (42.4–80.6)

59.3 (38.8–77.6)

 MR4

59.3 (48.5–69.5)

51.6 (33.1–69.8)

66.7 (46.0–83.5)

62.1 (51.6–71.9)

55.6 (35.3–74.5)

51.9 (31.9–71.3)

 MR4.5

47.3 (36.7–58.0)

48.4 (30.2–66.9)

51.9 (31.9–71.3)

48.4 (38.0–58.9)

48.1 (28.7–68.1)

48.1 (28.7–68.1)

 Evaluable patients without baseline MMR, n

45

21

13

51

13

15

 MMR

66.7 (51.0–80.0)

47.6 (25.7–70.2)

53.8 (25.1–80.8)

66.7 (52.1–79.2)

46.2 (19.2–74.9)

46.7 (21.3–73.4)

 Evaluable patients without baseline MR4, n

65

26

21

70

22

20

 MR4

52.3 (39.5–64.9)

42.3 (23.4–63.1)

61.9 (38.4–81.9)

52.9 (40.6–64.9)

54.5 (32.2–75.6)

45.0 (23.1–68.5)

 Evaluable patients without baseline MR4.5, n

79

28

24

85

25

21

 MR4.5

41.8 (30.8–53.4)

42.9 (24.5–62.8)

45.8 (25.6–67.2)

42.4 (31.7–53.6)

44.0 (24.4–65.1)

42.9 (21.8–66.0)

  1. Evaluable population. To be considered a responder, the patient must have maintenance of baseline response while on treatment (CCyR only) or an improvement from baseline. MMR: BCR::ABL1 IS ≤ 0.1%; MR4: BCR::ABL1 IS ≤ 0.01%; MR4.5: BCR::ABL1 IS ≤ 0.0032%. Associated two-sided 95% CI based on the exact method by Clopper–Pearson.
  2. CCyR complete cytogenic response, CI confidence interval, CML chronic myeloid leukemia, CP chronic phase, IS international scale, mCCI Charlson Comorbidity Index without age component, MMR major molecular response, MR molecular response, Ph Philadelphia chromosome, TKI tyrosine kinase inhibitor.
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