Table 1.
Patient demographics and disease characteristics by treatment sequence
| Characteristic | Fed–fasted | Fasted–fed | Total |
|---|---|---|---|
| (n = 16) | (n = 15) | (N = 31) | |
| Age, years | |||
| Mean (SD) | 60.6 (8.1) | 62.5 (10.2) | 61.5 (9.1) |
| Median (range) | 59.5 (49–74) | 64.0 (42–77) | 61.0 (42–77) |
| Sex, n (%) | |||
| Male | 8 (50.0) | 4 (26.7) | 12 (38.7) |
| Female | 8 (50.0) | 11 (73.3) | 19 (61.3) |
| Race, n (%) | |||
| White | 12 (75.0) | 11 (73.3) | 23 (74.2) |
| Missing | 4 (25.0) | 4 (26.7) | 8 (25.8) |
| Body mass index, kg/m2a | |||
| Mean (SD) | 25.5 (2.9) | 28.4 (8.9) | 26.6 (5.9) |
| Median (range) | 26.0 (20.1–28.6) | 25.2 (20.5–45.0) | 26.0 (20.1–45.0) |
| ECOG performance status, n (%) | |||
| 0: normal activity | 7 (43.8) | 5 (33.3) | 12 (38.7) |
| 1: restricted activity | 9 (56.3) | 10 (66.7) | 19 (61.3) |
| Primary tumor location, n (%) | |||
| Biliary tract | 0 | 1 (6.7) | 1 (3.2) |
| Breast | 2 (12.5) | 0 | 2 (6.5) |
| Cervix uteri | 1 (6.3) | 0 | 1 (3.2) |
| Colon | 1 (6.3) | 0 | 1 (3.2) |
| Esophagus | 2 (12.5) | 0 | 2 (6.5) |
| Head and neck | 0 | 1 (6.7) | 1 (3.2) |
| Kidney | 0 | 2 (13.3) | 2 (6.5) |
| Left parotid | 1 (6.3) | 0 | 1 (3.2) |
| Lung | 2 (12.5) | 0 | 2 (6.5) |
| Ovary | 2 (12.5) | 4 (26.7) | 6 (19.4) |
| Pancreas | 1 (6.3) | 0 | 1 (3.2) |
| Penis | 0 | 1 (6.7) | 1 (3.2) |
| Rectum | 2 (12.5) | 2 (13.3) | 4 (12.9) |
| Renal pelvis | 0 | 1 (6.7) | 1 (3.2) |
| Right parotid | 0 | 1 (6.7) | 1 (3.2) |
| Skin | 0 | 1 (6.7) | 1 (3.2) |
| Uterus | 1 (6.3) | 1 (6.7) | 2 (6.5) |
| Uvea | 1 (6.3) | 0 | 1 (3.2) |
| Overall disease classification, n (%) | |||
| Metastaticb | 15 (93.8) | 14 (93.3) | 29 (93.5) |
| Locally advancedc | 6 (37.5) | 2 (13.3) | 8 (25.8) |
| Previous chemotherapy, n (%) | |||
| Yes | 15 (93.8) | 15 (100) | 30 (96.8) |
| No | 1 (6.3) | 0 | 1 (3.2) |
| Number of regimens, n (%) | |||
| 1 | 2 (13.3) | 2 (13.3) | 4 (12.9) |
| 2 | 3 (20.0) | 2 (13.3) | 5 (16.1) |
| 3 | 1 (6.7) | 5 (33.3) | 6 (19.4) |
| 4 | 4 (26.7) | 1 (6.7) | 5 (16.1) |
| 5 | 2 (13.3) | 2 (13.3) | 4 (12.9) |
| 6 | 1 (6.7) | 2 (13.3) | 3 (9.7) |
| 7 | 0 | 1 (6.7) | 1 (3.2) |
| 8 | 2 (13.3) | 0 | 2 (6.5) |
A patient may have more than one disease classification, depending on the number of affected anatomical sites. ECOG performance status and overall disease classification are based on assessments at baseline. Primary tumor location is based on assessments at primary diagnosis
aHeight and weight were determined for 16 and 30 patients, respectively. Body mass index was determined for nine patients in the fed–fasted and six patients in the fasted–fed treatment sequence, respectively
bMetastatic disease: patient has any metastatic site of disease
cLocally advanced: patient has any locally advanced site of disease