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Table 2 Best overall response in patients with laBCC receiving sonidegib 200 mg daily by central review

From: Assessment of various efficacy outcomes using ERIVANCE-like criteria in patients with locally advanced basal cell carcinoma receiving sonidegib: results from a preplanned sensitivity analysis

 

mRECIST criteria

ERIVANCE-like criteria

laBCC, all

n = 66

n = 66

 ORR, % (95% CI)

56.1 (43.3–68.3)

60.6 (47.8–72.4)

 CR, % (95% CI)

4.5 (0.9–12.7)

21.2 (12.1–33.0)

 PR, %

51.5

39.4

 SD, %

34.8

30.3

 PD, %

1.5

1.5

 Unknown, %

7.6

7.6

laBCC, aggressive histologya

n = 37

n = 37

 ORR, % (95% CI)

59.5 (42.1–75.2)

64.9 (47.5–79.8)

 CR, % (95% CI)

5.4 (0.7–18.2)

21.6 (9.8–38.2)

 PR, %

54.1

43.2

 SD, %

32.4

27.0

 PD, %

2.7

2.7

 Unknown, %

5.4

5.4

laBCC, nonaggressive histologyb

n = 29

n = 29

 ORR, % (95% CI)

51.7 (32.5–70.6)

55.2 (35.7–73.6)

 CR, % (95% CI)

3.4 (0.1–17.8)

20.7 (8.0–39.7)

 PR, %

48.3

34.5

 SD, %

37.9

34.5

 PD, %

0

0

 Unknown, %

10.3

10.3

  1. aIncludes basosquamous, micronodular infiltrative, multifocal, and sclerosing histological subtypes
  2. bIncludes nodular and superficial histological subtypes
  3. CI confidence interval, CR complete response, laBCC locally advanced basal cell carcinoma, mRECIST modified RECIST, ORR overall response rate, PD progressive disease, PR partial response, RECIST Response Evaluation Criteria in Solid Tumors, SD stable disease