Table 1.
Baseline characteristics of all patients.
| Characteristic | Phase I (n=14) |
Phase II (n=30) |
Total (n=44) |
|---|---|---|---|
| Age, years | |||
| Median | 78 | 78 | 78 |
| Range | 72–84 | 71–91 | 71–91 |
| Male | 8 (57.1%) | 17 (56.7%) | 25 (56.8%) |
| Female | 6 (42.9%) | 13 (43.3%) | 19 (43.3%) |
| ECOG performance status | |||
| 0 | 5 (35.7%) | 12 (40%) | 17 (38.6%) |
| 1 | 9 (64.3%) | 16 (53.3%) | 25 (56.8%) |
| 2 | 0 | 2 (6.7%) | 2 (4.5%) |
| Ethnicity | |||
| African American | 0 | 1 (3.3%) | 1 (2.3%) |
| Caucasian | 14 (100%) | 29 (97.7%) | 43 (97.7%) |
| Histology | |||
| Adenocarcinoma | 10 (71.4%) | 16 (53.3%) | 26 (59.1%) |
| Squamous cell | 2 (14.3%) | 5 (16.7%) | 7 (15.9%) |
| Bronchoalveolar | 0 | 4 (13.3%) | 4 (9.1%) |
| Adenocarcinoma/bronchoalveolar | 0 | 1 (3.3%) | 1 (2.3%) |
| Unspecified | 2 (14.3%) | 4 (13.3%) | 6 (13.6%) |
| Stage IIIB | 1 (7.1%) | 0 | 1 (2.3%) |
| Stage IV | 13 (92.9%) | 30 (100%) | 43 (97.7%) |
| Metastatic sites | |||
| Liver | 2 (14.3%) | 5 (16.7%) | 7 (15.9%) |
| Bone | 4 (28.6%) | 7 (23.3%) | 11 (25.0%) |
| Brain | 0 | 3 (10.0%) | 3 (16.8%) |
| Adrenal gland | 4 (28.6%) | 3 (10.0%) | 7 (15.9%) |
| Pleural | 0 | 2 (6.7%) | 2 (4.5%) |
| Skin | 0 | 3 (10.0%) | 3 (6.8%) |
| Prior cancer-related therapy | |||
| Chemotherapy | 0 | 0 | 0 |
| Surgery | |||
| Early stage disease | 4 (28.6%) | 9 (30.0%) | 13 (29.5%) |
| Advanced stage disease | 0 | 0 | 0 |
| Radiotherapy | |||
| Early stage disease | 1 (7.1%) | 0 | 1 (2.3%) |
| Advanced stage disease | 2 (14.3%) | 11 (36.7%) | 13 (29.5%) |
| Surgery and radiotherapy | 2 (14.3%) | 4 (13.3%) | 6 (13.6%) |
| Gefitinib | 1 (7.1%) | 0 | 1 (2.3%) |
| Treatment site | |||
| UWCCC | 4 (28.6%) | 13 (43.3%) | 17 (38.6%) |
| WON | 10 (71.4%) | 17 (56.7%) | 27 (61.4%) |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; UWCCC, University of Wisconsin Paul P. Carbone Comprehensive Cancer Center; WON, Wisconsin Oncology Network.