Table 2.
Patient demographics, other baseline characteristics, and disease history
| All patients |
|
|---|---|
| AMXT 1501 80-1800 mg o.d.; 400 or 600 mg b.i.d. | |
| DFMO 500-1000 mg b.i.d. | |
| N = 56 | |
| Age,a years | |
| Mean (standard deviation) | 58.1 (14.14) |
| Median | 58.5 |
| Minimum-maximum | 20-78 |
| Age groups, n (%) | |
| <65 years | 35 (63) |
| ≥65 years | 21 (38) |
| Sex, n (%) | |
| Male | 20 (36) |
| Female | 36 (64) |
| Ethnicity, n (%) | |
| Hispanic or Latino | 11 (20) |
| Not Hispanic or Latino | 42 (75) |
| Not reported | 3 (5) |
| Race,bn (%) | |
| American Indian or Alaska Native | 3 (5) |
| Asian | 2 (4) |
| Black or African American | 6 (11) |
| Native Hawaiian or Other Pacific Islander | 1 (2) |
| White or Caucasian | 36 (64) |
| Other | 2 (4) |
| Not reported | 7 (13) |
| Body mass index at baseline, kg/m2 | |
| n | 55 |
| Mean (standard deviation) | 28.65 (7.650) |
| Median | 27.07 |
| Minimum-maximum | 18.3-53.2 |
| ECOG PS at baseline,cn (%) | |
| 0 | 4 (7) |
| 1 | 52 (93) |
| Stage at baseline, n (%) | |
| IIIA | 2 (4) |
| IIIB | 1 (2) |
| IVA | 29 (52) |
| IVB | 21 (38) |
| Unknown | 3 (5) |
| Time since initial diagnosis of cancer to date of informed consent, yearsd | |
| n | 55 |
| Mean (standard deviation) | 6.23 (6.429) |
| Median | 4.71 |
| Minimum-maximum | 0.3-30.5 |
| Number of prior anticancer therapies | |
| Mean (standard deviation) | 10.9 (5.96) |
| Median | 10.0 |
| Minimum-maximum | 1-23 |
| Tumor type, n (%) | |
| Adenocarcinoma of pancreas | 1 (2) |
| Adenocarcinoma of rectosigmoid | 1 (2) |
| Adenocarcinoma of rectosigmoid junction | 1 (2) |
| Adenocarcinoma of stomach | 1 (2) |
| Adenocarcinoma, NOS of transverse colon | 1 (2) |
| Brainstem glioma | 1 (2) |
| Breast cancer | 1 (2) |
| Chondrosarcoma | 1 (2) |
| Colon cancer | 4 (7) |
| Colorectal adenocarcinoma | 1 (2) |
| Colorectal carcinoma | 1 (2) |
| Colorectal cancer | 6 (11) |
| Diffuse midline glioma with h3k27m | 1 (2) |
| Ductal breast cancer | 1 (2) |
| Extraskeletal myxoid chondrosarcoma | 1 (2) |
| Gastroesophageal junction adenocarcinoma to distant left supraclav | 1 (2) |
| Glioblastoma multiforme of brain | 1 (2) |
| Glioma | 1 (2) |
| Jejunum/small bowel adenocarcinoma | 1 (2) |
| Liposarcoma | 1 (2) |
| Metastatic melanoma | 1 (2) |
| Malignant epithelial tumor of ovary | 1 (2) |
| Malignant melanoma of vulva | 1 (2) |
| Malignant neoplasm of overlapping sites of cervix uteri | 1 (2) |
| Mesothelioma | 1 (2) |
| Metastatic adenocarcinoma of prostate | 1 (2) |
| Metastatic breast cancer | 1 (2) |
| Metastatic colorectal cancer | 1 (2) |
| Metastatic leiomyosarcoma | 1 (2) |
| Nasal angiosarcoma | 1 (2) |
| Non-small-cell lung cancer | 1 (2) |
| Ovarian cancer | 3 (5) |
| Pancreatic adenocarcinoma | 1 (2) |
| Pancreatic cancer | 1 (2) |
| Peritoneal serous carcinoma | 1 (2) |
| Primary malignant neoplasm of rectum | 1 (2) |
| Prostate cancer | 1 (2) |
| Rectal cancer | 2 (4) |
| Sigmoid colon cancer | 1 (2) |
| Squamous-cell carcinoma of cervix | 1 (2) |
| Squamous-cell carcinoma of gum | 1 (2) |
| Synovial sarcoma | 1 (2) |
| Uterine cancer | 1 (2) |
| Uterine sarcoma | 1 (2) |
| Not reported | 1 (2) |
b.i.d., twice daily; DFMO, difluoromethylornithine; NOS, not otherwise specified; o.d., once daily.
a
Age was calculated as the number of years between the date of birth and the date of signing the informed consent.
b
More than one response could be provided for race and, as such, the percentage may total more than 100%.
c
ECOG PS: Eastern Cooperative Oncology Group Performance Status: 0 = fully active; 1 = restricted in activity.
d
Time since initial diagnosis of cancer to date of informed consent was calculated as the number of years between the date of initial diagnosis and the date of informed consent.