Table 4 Efficacy in the test population determined on the basis of gene status

Complete response

1

0

0

Partial response

18

1

0

Stable disease

19

11

4

Progressive disease

11

9

8

Total

49

21

12

Response rate (%)

38.8

4.8

0

P = 0.006^* (All wild-type vs. Any other mutations)

Disease control rate (%)

77.6

57.1

33.3

P = 0.006^* (All wild-type vs. Any other mutations)

Progression-free survival [Median (95% CI) (months)]

6.1 (3.1, 9.2)

2.7 (1.2, 4.2)

1.6 (1.5, 1.7)

P < 0.0001^** (All wild-type vs. Any other mutations)

Overall survival [Median (95% CI) (months)]

13.8 (9.2, 18.4)

8.2 (5.7, 10.7)

6.3 (1.3, 11.3)

P < 0.0001^** (All wild-type vs. Any other mutations)

Relative dose intensity

Irinotecan [Median (range) (%)]

72.8 (13.0–100)

81.0 (38.4–100)

98.0 (49.3–100)

P = 0.108^***

Cetuximab [Median (range) (%)]

86.0 (35.7–100)

86.3 (11.1–100)

100 (80.0–100)

P = 0.042^***

Number of treatment cycles [Median (range)]

12 (1–86)

5 (1–23)

3 (1–12)

P < 0.0001^***