sp;
Overall† 73 52 <0.001
OTHER PRESPECIFIED ENDPOINTS
Complete Response
Acute phase‡
Delayed phase§ 89
75 78
56 <0.001
<0.001
Complete Protection
Overall
Acute phase
Delayed phase 63
85
66 49
75
52 0.001
NS
<0.001
No Emesis
Overall
Acute phase
Delayed phase 78
90
81 55
79
59 <0.001
0.001
<0.001
No Nausea
Overall
Delayed phase 48
51 44
48 NS
NS#
No Significant Nausea
Overall
Delayed phase 73
75 66
69 NS
NS
Visual analogue scale (VAS) score range: 0 mm = no nausea; 100 mm = nausea as bad as it could be.
Table 2: Percent of Patients Receiving Highly Emetogenic Chemotherapy Responding by Treatment Group and Phase for Study 2 — Cycle 1 *
N: Number of patients (older than 18 years of age) who received cisplatin, study drug, and had at least one post-treatment efficacy eva luation.
Overall: 0 to 120 hours post-cisplatin treatment.
Acute phase: 0 to 24 hours post-cisplatin treatment.
Delayed phase: 25 to 120 hours post-cisplatin treatment.
Not statistically significant when adjusted for multiple comparisons.
Not statistically significant.
ENDPOINTS Aprepitant
Regimen
(N = 261)*
% Standard
Therapy
(N = 263)*
% p-Value
PRIMARY ENDPOINT
Complete Response
Overall† 63 43 <0.001
OTHER PRESPECIFIED ENDPOINTS
Complete Response
Acute phase‡
Delayed phase§ 83
68 68
47 <0.001
<0.001
Complete Protection
Overall
Acute phase
Delayed phase 56
80
61 41
65
44 <0.001
<0.001
<0.001
No Emesis
Overall
Acute phase
Delayed phase 66
84
72 44
69
48 <0.001
<0.001
<0.001
No Nausea
Overall
Delayed phase 49
53 39
40 NS
NS
No Significant Nausea
Overall
Delayed phase 71
73 64
65 NS
NS
Visual analogue scale (VAS) score range: 0 mm = no nausea; 100 mm = nausea as bad as it could be.
In both studies, a statistically significantly higher proportion of patients receiving the aprepitant regimen in Cycle 1 had a complete response (primary endpoint), compared with patients receiving standard therapy. A statistically significant difference in complete response in favor of the aprepitant regimen was also observed when the acute phase and the delayed phase were analyzed separately.
In both studies, the estimated time to first emesis after initiation of cisplatin treatment was longer with the aprepitant regimen, and the incidence of first emesis was reduced in the aprepitant regimen group compared with standard therapy group as depicted in the Kaplan-Meier curves in Figure 2.
Figure 2: Percent of Patients Receiving Highly Emetogenic Chemotherapy Who Remain Emesis Free Over Time – Cycle 1
Pati |
