Study 1 (Profile 1007) Flashcards

1
Q

Study design

A

Randomized, multicenter, open label, active controlled study

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2
Q

Total number of patients

A

347

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3
Q

Patients had been previously treat with………

A

one platinum based chemotherapy regimen

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4
Q

Xalkori dose

A

250mg BID

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5
Q

of Xalkori pts

A

173

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6
Q

of chemo pts

A

174

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7
Q

Type of chemo used

A

Pemetrexed 500 (if naïve to it) or Docetaxil 75 intravenous every 21 days

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8
Q

OS

A

not reached

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9
Q

after progression ……….number and % of chemo patients received Xalkori

A

112 (64%)

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10
Q

ORR vs chemo

A

65% vs. 20%

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11
Q

Duration of response vs chemo

A

7.4 months vs. 5.6

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12
Q

Progression free survival vs. chemo

A

7.7 vs. 3.0

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13
Q

Eye disorder %

A

60%

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14
Q

Diarrhea %

A

60%

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15
Q

Nausea %

A

55%

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16
Q

Constipation %

A

42%

17
Q

Elevation of ALT any grade vs. chemo

A

76% vs. 38%

18
Q

Elevation of AST any grade vs. chemo

A

61% vs. 33%

19
Q

% of serious AE reported for Xalkori and Chemo

A

37.2% vs. 23.4%

20
Q

Most frequent serious AE’s with Xalkori (4)

A
  1. Pneumonia (4.1%)
  2. PE (3.5%)
  3. Dsypnea (2.3)
  4. ILD (2.9%(
21
Q

Fatal AE’s occurred in ….. Xalkori patients

A

9 (5%)