Skip to main content

Table 2 INV-assessed response, DOR, and PFS

From: Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study

Outcome Primary analysis (9 months after completion of accrual) Long-term analysis (39 months after completion of accrual)
mBCC laBCC mBCC laBCC
(n = 33) (n = 63) (n = 33) (n = 63)
Objective response, n (%)
[95% CI]
15 (45.5)
[28.1–62.2]
38 (60.3)
[47.2–71.7]
16 (48.5)
[30.8–66.2]
38 (60.3)
[47.2–71.7]
 Complete response 0 20 0 20
 Partial response 15 18 16 18
 Stable disease 15 15 14 15
 Progressive disease 2 6 2 6
Median DOR, mo
[95% CI]
 Number of responders
12.9
[5.6–12.9]
15
7.6
[7.4–NE]
38
14.8
[5.6–17.0]
16
26.2
[9.0–37.6]
38
Median PFS, mo
[95% CI]
 Number of events, n
9.2
[7.4–NE]
17
11.3
[9.5–16.8]
26
9.3
[7.4–16.6]
24
12.9
[10.2–28.0]
34
Median OS, mo
[95% CI]
 Number of events, n
NE
[13.9–NE]
7
NE
[17.6–NE]
6
33.4
[18.1–NE]
17
NE
[NE]
13
1-year survival rate, %
[95% CI]
75.5
[57.3–93.6]
91.6
[83.5–99.7]
78.7
[64.7–92.7]
93.2
[86.8–99.6]
2-year survival rate, %
[95% CI]
NE NE 62.3%
[45.4–79.3]
85.5%
[76.1–94.8]
  1. The 95% CI for response rate was calculated using the Blyth-Still-Casella method
  2. CI confidence interval, DOR duration of response, INV investigator, laBCC locally advanced basal cell carcinoma, mBCC metastatic basal cell carcinoma, NE not estimable, OS overall survival, PFS progression-free survival