Anti-EGFR Therapy: Mechanism and Advances in Clinical Efficacy in Breast Cancer
Table 4
Part A. Patient response rate:
Lapatinib dose cohort comparison adapted from Gomez et al. [30]. Stable disease
patients who had a best response of stable disease (i.e., stable disease documented for a
minimum of 7 weeks). Clinical benefit response rates
include only patients with a best response of CR, PR, or stable disease for at
least 24 weeks. Disease status was assessed by an independent panel using response
evaluation. Criteria in solid tumors (see
Section 3.3). CR: Complete response; PR: Partial response. Part B. Patients with drug-related
adverse events that occurred in >10% of patients receiving Lapatinib, Adapted
from Gomez et al. [30].
(a)
Dosing regimen
1500 mg once daily
500 mg twice daily
All patients
(n = 69)
(n = 69)
(N = 138)
Patient response
No.
%
No.
%
No.
%
Best response
CR
0
0
0
0
0
0
PR
15
22
18
26
33
24
Stable
disease
40
58
31
45
71
51
Progressive
disease
8
12
16
23
24
17
Unknown
6
9
4
6
10
7
Response rate: CR or PR, %
21.7
26.1
23.9
95% CI
12.7 to 33.3
16.3 to 38.1
17.1 to 31.9
Odds ratio
0.8
95% CI
0.3 to 1.9
P
.691
(b)
Dosing regimen
1500 mg once daily
500 mg twice daily
All patients
(n = 69)
(n = 69)
(N = 138)
Adverse event*
No.
%
No.
%
No.
%
Diarrhea
24
35
25
36
49
36
Grade
1-2
23
33
22
32
45
33
Grade 3
1
1
3
4
4
3
Rash
19
29
18
26
37
27
Grade
1-2
19
29
17
25
36
26
Grade 3
0
0
1
1
1
1
Pruritus
14
20
11
16
25
18
Grade
1-2
14
20
11
16
25
18
Grade 3
0
0
0
0
0
0
Nausea
9
13
5
7
14
10
Grade
1-2
9
13
4
6
13
9
Grade 3
0
0
1
1
1
1
*No grade 4 adverse events occurred for these conditions.
