Table 1.
Patient and disease characteristics at baseline
| Patient characteristic | Sunitinib + erlotinib (n = 65) | Placebo + erlotinib (n = 67) |
|---|---|---|
| Median age (range), years | 59 (37–79) | 61 (39–81) |
| Male, n (%) | 39 (60) | 45 (67) |
| Race, n (%)a | ||
| Caucasian | 63 (97) | 64 (96) |
| Asian | 1 (2) | 2 (3) |
| Other | 0 | 1 (1) |
| Smoking status, n (%)b | ||
| Current | 26 (40) | 24 (36) |
| Prior | 31 (48) | 33 (49) |
| Never | 7 (11) | 9 (13) |
| Unknown | 1 (2) | 1 (1) |
| Eastern Cooperative Oncology Group performance status (ECOG PS), n (%)c | ||
| 0 | 21 (32) | 21 (31) |
| 1 | 43 (66) | 45 (67) |
| Disease stage, n (%)a | ||
| IIIB | 1 (2) | 0 |
| IV | 63 (97) | 67 (100.0) |
| Histology, n (%)a | ||
| Adenocarcinoma | 36 (55) | 29 (43) |
| Squamous cell carcinoma | 15 (23) | 19 (28) |
| Large cell carcinoma | 6 (9) | 10 (15) |
| Bronchioloalveolar carcinoma | 0 | 2 (3) |
| Other/NOS | 7 (11) | 7 (10) |
| EGFR expression, n (%) | ||
| Positive | 29 (45) | 36 (54) |
| Negative | 19 (29) | 12 (18) |
| Unmeasuredd | 17 (26) | 19 (28) |
| EGFR gene copy number increased, n (%) | ||
| Positive | 0 | 1 (1) |
| Negative | 31 (48) | 28 (42) |
| Unmeasuredd | 34 (52) | 38 (57) |
| EGFR gene amplification, n (%) | ||
| No | 31 (48) | 29 (43) |
| Unmeasured | 34 (52) | 38 (57) |
| EGFR gene mutation, n (%) | ||
| Mutated | 4 (6) | 1 (1) |
| Wild type | 21 (32) | 19 (28) |
| Indeterminated | 40 (62) | 47 (70) |
| KRAS mutation status, n (%) | ||
| Mutated | 6 (9) | 4 (6) |
| Wild type | 22 (34) | 19 (28) |
| Indeterminated | 37 (57) | 44 (66) |
| Prior radiation therapy, n (%) | ||
| Neoadjuvant | 3 (5) | 3 (4) |
| Adjuvant | 6 (9) | 3 (4) |
| Palliative | 28 (43) | 29 (43) |
| Prior surgery (resection or exploratory thoracotomy), n (%) | 20 (31) | 15 (22) |
| Prior chemotherapy, n (%)a | ||
| 1 regimen | 39 (60) | 46 (69) |
| 2 regimens | 23 (35) | 21 (31) |
| ≥3 regimens | 1 (2) | 0 |
aData not collected from one subject in the sunitinib arm with no informed consent who was randomized in error.
bCurrent smoker includes subjects who stopped smoking <1 year before the first dose of study medication; prior smokers stopped smoking ≥1 year before the first dose of study medication.
cIn the erlotinib arm, 1 patient had ECOG PS of 2.
dIncludes patients where a tissue sample was not available (n = 14 for combination arm and n = 14 for erlotinib arm).
ECOG, Eastern Cooperative Oncology Group; NOS, not otherwise specified.