Table 1.
Demographics and baseline characteristics (safety analysis set)
| Continuous regorafenib 60 mg plus cetuximab (n = 5) | Continuous regorafenib 100 mg plus cetuximab (n = 6) | Intermittent regorafenib 120 mg plus cetuximab (n = 8) | Intermittent regorafenib 160 mg plus cetuximab (n = 23) | Total (n = 42) | |
|---|---|---|---|---|---|
| Median age, years (range) | 63 (53–72) | 57 (40–65) | 57 (40–69) | 60 (23–79) | 60 (23–79) |
| Male, n (%) | 0 | 1 (17) | 7 (88) | 13 (57) | 21 (50) |
| Ethnicity, n (%) | |||||
| American Indian or Alaska Native | 0 | 0 | 1 (13) | 0 | 1 (2) |
| Black or African American | 0 | 0 | 0 | 2 (9) | 2 (5) |
| White | 4 (80) | 5 (83) | 7 (88) | 19 (83) | 35 (83) |
| Not reported | 1 (20) | 1 (17) | 0 | 2 (9) | 4 (10) |
| Median BMI, kg/m2 (range) | 21.6 (17.6–28.8) | 25.1 (19.3–30.4) | 26.2 (18.4–33.2) | 23.4 (18.4–35.1) | 23.6 (17.6–35.1) |
| Alcohol use, n (%) | |||||
| Abstinent | 3 (60) | 4 (67) | 2 (25) | 13 (57) | 22 (52) |
| Light | 2 (40) | 2 (33) | 5 (63) | 10 (43) | 19 (45) |
| Moderate | 0 | 0 | 1 (13) | 0 | 1 (2) |
| Smoking status, n (%) | |||||
| Never | 1 (20) | 5 (83) | 1 (13) | 13 (57) | 20 (48) |
| Former | 4 (80) | 1 (17) | 5 (63) | 9 (39) | 19 (45) |
| Current | 0 | 0 | 2 (25) | 1 (4) | 3 (7) |
| Cancer type, n (%) | |||||
| Colorectal cancer | 3 (60) | 4 (67) | 0 | 3 (13) | 10 (24) |
| Pancreatic adenocarcinoma | 1 (20) | 0 | 0 | 6 (26) | 7 (17) |
| Hepatocellular carcinoma | 0 | 0 | 1 (13) | 2 (9) | 3 (7) |
| Non‐small cell lung cancer | 0 | 0 | 2 (25) | 1 (4) | 3 (7) |
| Breast cancer | 0 | 0 | 0 | 2 (9) | 2 (5) |
| Bladder cancer | 0 | 0 | 2 (25) | 0 | 2 (5) |
| Other1 | 1 (20) | 2 (33) | 3 (38) | 9 (39) | 15 (36) |
| Histology, n (%) | |||||
| Adenocarcinoma 2 | 3 (60) | 5 (83) | 1 (13) | 14 (61) | 23 (55) |
| Hepatocellular carcinoma | 0 | 0 | 1 (13) | 2 (9) | 3 (7) |
| Squamous cell carcinoma | 1 (20) | 0 | 2 (25) | 0 | 3 (7) |
| Adenoid cystic carcinoma | 0 | 0 | 1 (13) | 1 (4) | 2 (5) |
| Neuroendocrine carcinoma | 0 | 0 | 1 (13) | 1 (4) | 2 (5) |
| Urothelial (transitional cell) carcinoma in situ | 0 | 0 | 2 (25) | 0 | 2 (5) |
| Small cell carcinoma, NOS | 0 | 1 (17) | 0 | 0 | 1 (2) |
| Carcinoma NOS | 0 | 0 | 0 | 1 (4) | 1 (2) |
| Other | 1 (20) | 0 | 0 | 4 (17) | 5 (12) |
| Median time since initial diagnosis, months (range) | 25 (17–49) | 26 (9–42) | 22 (10–54) | 37 (4–125) | 25 (4–125) |
| Any prior systemic anticancer therapy | |||||
| Yes | 5 (100) | 6 (100) | 8 (100) | 23 (100) | 42 (100) |
| No | 0 | 0 | 0 | 0 | 0 |
| Any prior radiotherapy | |||||
| Yes | 2 (40) | 3 (50) | 5 (63) | 12 (52) | 22 (52) |
| No | 3 (60) | 3 (50) | 3 (38) | 11 (48) | 20 (48) |
1
Other tumor types include adenoid cystic carcinoma, high‐grade neuroendocrine tumor, submandibular gland adenoid cystic carcinoma, cholangiocarcinoma, primary malignant neuroendocrine tumor of the pancreas, anal adenocarcinoma, metastatic basal cell carcinoma, prostate cancer, adenocarcinoma of the rectum, adenocarcinoma of the gastroesophageal junction and adenocarcinoma of the distal esophagus.
2
Adenocarcinoma includes adenocarcinoma, adenocarcinoma NOS, adenocarcinoma in situ NOS, adenocarcinoma of the distal esophagus (poorly differentiated), ductal adenocarcinoma and invasive, ductal adenocarcinoma.
Abbreviations: BMI, body mass index; NOS, not otherwise specified.