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Table 4 Best objective tumor response (investigator assessment) in Study 1199 by primary KIT mutational status, and in the overall ITT population of Study 1036

From: Correlation of KIT and PDGFRA mutational status with clinical benefit in patients with gastrointestinal stromal tumor treated with sunitinib in a worldwide treatment-use trial

Response parameter

Study 1199

1036 ITT (N = 1124)

Exon 9 (n = 42)

Exon 11 (n = 143)

Best confirmed tumor response,a n (%)

   

 CR

2 (5)

0

10 (1)

 PR

6 (14)

9 (6)

78 (7)

 Stable disease

29 (69)

86 (60)

639 (57)

 PD

4 (10)

31 (22)

237 (21)

 Not evaluable

0

1 (1)

2 (<1)

 Missing

1 (2)

16 (11)

158 (14)

Confirmed objective responses,b n (%)

8 (19)

9 (6)

88 (8)

 95 % exact CI, %

9−34

3−12

6−10

Difference in ORR: exon 9 vs. exon 11, %

13

NA

 95 % CI

<1−25

NA

P-value (two-sided Pearson χ2)

0.012

NA

  1. CI confidence interval, CR complete response, ITT intent-to-treat, NA not applicable, PD progressive disease, PR partial response
  2. aTumor assessment data obtained ≤28 days after last dose of study drug
  3. bCR  + PR