Table 1.
Patient Demographic and Clinical Characteristics
Characteristic | ITT |
MET Negative |
MET Positive |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Placebo Plus Erlotinib (n = 68) |
Onartuzumab Plus Erlotinib (n = 69) |
Placebo Plus Erlotinib (n = 31) |
Onartuzumab Plus Erlotinib (n = 31) |
Placebo Plus Erlotinib (n = 31) |
Onartuzumab Plus Erlotinib (n = 35) |
|||||||
No. | % | No. | % | No. | % | No. | % | No. | % | No. | % | |
Age, years | ||||||||||||
Median | 63 | 64 | 61 | 63 | 64 | 66 | ||||||
Range | 42-83 | 30-83 | 42-83 | 45-82 | 44-82 | 30-83 | ||||||
Sex* | ||||||||||||
Male | 42 | 62 | 40 | 58 | 17 | 55 | 20 | 65 | 20 | 65 | 18 | 51 |
Female | 26 | 38 | 29 | 42 | 14 | 45 | 11 | 35 | 11 | 35 | 17 | 49 |
Race* | ||||||||||||
White | 61 | 90 | 61 | 88 | 28 | 90 | 27 | 87 | 28 | 90 | 32 | 91 |
Black or African American | 5 | 7 | 4 | 6 | 3 | 10 | 3 | 10 | 1 | 3 | 1 | 3 |
Asian | 1 | 1 | 2 | 3 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 3 |
Other | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 |
Not available | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 3 | 1 | 3 | 0 | 0 |
ECOG PS* | ||||||||||||
0 | 21 | 31 | 22 | 32 | 9 | 29 | 8 | 26 | 10 | 32 | 13 | 37 |
1 | 45 | 66 | 43 | 62 | 22 | 71 | 20 | 65 | 19 | 61 | 21 | 60 |
2 | 2 | 3 | 4 | 6 | 0 | 0 | 3 | 10 | 2 | 6 | 1 | 3 |
Histology* | ||||||||||||
Adenocarcinoma | 41 | 60 | 40 | 58 | 17 | 55 | 12 | 39 | 21 | 68 | 26 | 74 |
Squamous cell | 20 | 29 | 20 | 29 | 12 | 39 | 14 | 45 | 5 | 16 | 5 | 14 |
Large cell | 3 | 4 | 6 | 9 | 1 | 3 | 4 | 13 | 2 | 6 | 2 | 6 |
Bronchioloalveolar | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 0 |
Other | 3 | 4 | 3 | 4 | 1 | 3 | 1 | 3 | 2 | 6 | 2 | 6 |
Smoking history* | ||||||||||||
Current/former | 60 | 88 | 59 | 86 | 30 | 97 | 29 | 93 | 25 | 81 | 28 | 80 |
Never-smoker† | 8 | 12 | 10 | 14 | 1 | 3 | 2 | 7 | 6 | 19 | 7 | 20 |
Line of therapy* | ||||||||||||
Second | 46 | 68 | 46 | 67 | 20 | 65 | 21 | 68 | 22 | 71 | 22 | 63 |
Third | 22 | 32 | 23 | 33 | 11 | 35 | 10 | 32 | 9 | 29 | 13 | 37 |
MET IHC status* | ||||||||||||
Positive | 31 | 46 | 35 | 51 | 0 | 0 | 0 | 0 | 31 | 100 | 35 | 100 |
Negative | 31 | 46 | 31 | 45 | 31 | 100 | 31 | 100 | 0 | 0 | 0 | 0 |
Unknown | 6 | 9 | 3 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
KRAS mutation* | ||||||||||||
Wild type | 43 | 63 | 43 | 62 | 21 | 68 | 19 | 61 | 20 | 65 | 24 | 69 |
Mutant | 13 | 19 | 13 | 19 | 7 | 23 | 6 | 19 | 6 | 19 | 7 | 20 |
Unknown | 12 | 18 | 13 | 19 | 3 | 10 | 6 | 19 | 5 | 16 | 4 | 11 |
EGFR mutation* | ||||||||||||
Wild type | 50 | 74 | 49 | 71 | 24 | 77 | 25 | 81 | 24 | 77 | 24 | 69 |
Mutant | 6 | 9 | 7 | 10 | 4 | 13 | 0 | 0 | 2 | 7 | 7 | 20 |
Unknown | 12 | 18 | 13 | 19 | 3 | 10 | 6 | 19 | 5 | 16 | 4 | 11 |
Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; IHC, immunohistochemistry; ITT, intent to treat.
Because of rounding, some percentages do not sum to 100.
Never-smokers defined as those who had never smoked or smoked < 100 cigarettes in lifetime.