Profile 1014 Flashcards
1
Q
study design
A
randomized, multicenter, open label, active controlled phase 3 trial.
2
Q
number of patients
A
343
3
Q
patients had received ……….. previous systemic therapy
A
No
4
Q
Xalkori dose
A
250mg BID
5
Q
Platinum doublet therapy type and dose
A
pemetrexed plus cisplatin or carboplatin every 3 weeks for up to 6 cycles
6
Q
when published
A
December 2014
7
Q
what journal
A
New England Journal of Medicine
8
Q
PFS vs. doublet therapy
A
10.9 vs. 7 months
9
Q
Xalkori met its primary end point of …
A
statistically significant improvement in median PFS vs Chemo
10
Q
ORR vs chemo
A
74% vs. 45%
11
Q
Complete response vs. chemo
A
3% vs 2%
12
Q
Duration of response vs chemo
A
11.3 months vs. 5.3
13
Q
of pts that received Xalkori after progression
A
120 (70%)
14
Q
Discontinuation rate vs. chemo
A
12% vs. 14%
