Xalkori Patient Management

Question 1

In the first line ALK study Xalkori -

Answer 1

Significantly prolonged PFS vs Chemotherapy

Question 2

Median PFS Xalkori vs Chemo (1st line study)

Answer 2

10.9 vs. 7.0

Question 3

Xalkori reduced the risk of disease progression by - % (1L)

Answer 3

55%

Question 4

% of patients with stable brain mets in 1L Xalkori vs. Chemo

Answer 4

26% vs. 27%

Question 5

Tumor responses based on IRR (1L)

Answer 5

75% vs. 45%

Question 6

Median Duration of Response (1L)

Answer 6

11.3 vs. 5.3

Question 7

Median time to response (1L)

Answer 7

Xalkori 1.4 months (.6-9.5)

Chemo 2.8 months (1.2-8.5)

Question 8

% of chemo patients that crossed to the Xalkori arm

Answer 8

70%

Question 9

Median duration of study treatment was

Answer 9

10.9 months vs. 4.1 months

Twice as long as chemo

Question 10

Majority of ARs associated with the Xalkori group were..

Answer 10

Grade 1 or 2

Question 11

Most common adverse reactions with Xalkori were (4)

Answer 11

Vision disorders
elevated transaminases
diarrhea
nausea

Question 12

Serious AE were reported in …%

Answer 12

34%

Question 13

The most frequent serious AE were (2)

Answer 13

Dyspnea (4.1%)

PE (2.9%)

Question 14

Fatal AE occurred in %

Answer 14

2.3%

septic shock, acute respiratory failure, diabetic ketoacidosis

Question 15

Permanent discontinuation due to AE %

Answer 15

8.2%
Elevated transaminases
hepatotoxicity
ILD

Question 16

Nausea %

Answer 16

56%

Question 17

Decreased appetite %

Answer 17

30%

Question 18

Fatigue %

Answer 18

29%

Question 19

Total number of patients across all trials included in safety analysis

Answer 19

1719

Question 20

Across all clinical trials the incidence of grade 4 visual field defect with vision loss was…

Answer 20

.2% (4/1719)

Question 21

Inform patients of …. (vision)

Answer 21

potential risk of severe vision loss

Question 22

DC is best corrected vision is …

Answer 22

less than 20/200 in one or both eyes

Question 23

% of 1719 with vision disorder

Answer 23

63%

Question 24

% of grade one visual disorders in the 1719 pts

Answer 24

95%

Question 25

Ros 1 study visual disorders %

Answer 25

92%

Question 26

Onset of visual disorders is usually

Answer 26

during the first week