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Table 2 Efficacy end-point analysis (efficacy set population) in patients receiving a single dose of NEPA and dexamethasone

From: Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study

 

Overall period (days 1 to 5)

Acute period (day 1)

Delayed period (days 2 to 5)

N (%)

90% CI

N (%)

90% CI

N (%)

90% CI

Cycle 1 (N = 139)

 CR

98 (70.5) a

64.1; 76.9b

119 (85.6)

80.7; 90.5

101 (72.7)

66.4; 78.9

 NSN

80 (57.6)

50.7; 64.5

113 (81.3)

75.9; 86.7

85 (61.2)

54.4; 68.0

Cycle 2 (N = 139)

 CR

98 (70.5)

64.1; 76.9

118 (84.9)

79.9; 89.9

102 (73.4)

67.2; 79.6

 NSN

79 (56.8)

49.9; 63.7

101 (72.7)

66.4; 78.9

81 (58.3)

51.4; 65.2

Cycle 3 (N = 138)

 CR

100 (72.5)

66.2; 78.7

115 (83.3)

78.1; 88.6

104 (75.4)

69.3; 81.4

 NSN

85 (61.6)

54.8; 68.4

102 (73.9)

67.8; 80.1

88 (63.8)

57.0; 70.5

Cycle 4 (N = 136)

 CR

96 (70.6)

64.2; 77.0

106 (77.9)

72.1; 83.8

100 (73.5)

67.3; 79.8

 NSN

82 (60.3)

53.4; 67.2

95 (69.9)

63.4; 76.3

87 (64.0)

57.2; 70.7

  1. NEPA netupitant plus palonosetron, CI confidence interval, CR complete response (no vomiting and no use of rescue medication), NSN no clinically significant nausea (none to mild in severity)
  2. aPrimary efficacy end point
  3. bEfficacy hypothesis was demonstrated as the lower boundary of the 90% CI was greater than the preset cut-off of 64% which was assumed as the maximum response rate for a poor anti-emetic treatment in the study protocol