Table 2.
Patient characteristics in the DS-7423 study
| US cohort | Japanese cohort | Total | |||||
|---|---|---|---|---|---|---|---|
| (n = 42) | (n = 27) | (n = 69) | |||||
| Characteristics | n | % | n | % | n | % | |
| Age (years) [mean (range)] | 60.4 (18–87) | 61.5 (40–73) | |||||
| Sex | Male | 19 | 45.2 | 14 | 51.9 | 33 | 47.8 |
| Female | 23 | 54.8 | 13 | 48.1 | 36 | 52.2 | |
| Performance status (ECOG) | 0 | 15 | 35.7 | 9 | 33.3 | 24 | 34.8 |
| 1 | 27 | 64.3 | 18 | 66.7 | 45 | 65.2 | |
| Prior antineoplastic regimens | 42 | 100 | 25 | 92.6 | 67 | 97.1 | |
| No. of prior regimens | Median | 4 | 3 | ||||
| Range | 1–15 | 0–9 | |||||
| Patients with ≥3 prior regimens | 33 | 78.6 | 15 | 55.6 | 48 | 69.6 | |
| Tumour type | Colorectal | 10 | 23.8 | 3 | 11.1 | 13 | 18.8 |
| Breast | 3 | 7.1 | 3 | 11.1 | 6 | 8.7 | |
| Oesophageal | 0 | 0 | 6 | 22.2 | 6 | 8.7 | |
| Non-small cell lung | 4 | 9.5 | 1 | 3.7 | 5 | 7.3 | |
| Thymic cancer or thymoma | 0 | 0 | 4 | 14.8 | 4 | 5.8 | |
| Cholangiocarcinoma | 3 | 7.1 | 1 | 3.7 | 4 | 5.8 | |
| Ovarian | 2 | 4.8 | 2 | 7.4 | 4 | 5.8 | |
| Pancreatic | 3 | 7.1 | 0 | 0 | 3 | 4.4 | |
| Squamous cell carcinoma | 3 | 7.1 | 0 | 0 | 3 | 4.4 | |
| Mesothelioma | 1 | 2.4 | 2 | 7.4 | 3 | 4.4 | |
| Carcinoid | 0 | 0 | 2 | 7.4 | 2 | 2.9 | |
| Prostate | 2 | 4.8 | 0 | 0 | 2 | 2.9 | |
| Gastric | 0 | 0 | 2 | 7.4 | 2 | 2.9 | |
| Othersa | 11 | 26.2 | 1 | 3.7 | 12 | 17.4 | |
| Race | White | 38 | 90.5 | 0 | 0 | 38 | 55.1 |
| African-American | 2 | 4.8 | 0 | 0 | 2 | 2.9 | |
| Asian | 2 | 4.8 | 0 | 0 | 2 | 2.9 | |
| Japanese | 0 | 0 | 27 | 100 | 27 | 39.1 | |
| Body weight (kg) [mean ± SD (range)] | 79.23 ± 23.88 (38.2–141.4) | 56.7 ± 10.84 (33.3–72) | |||||
| BMI (kg/m2) [mean ± SD (range)] | 27.68 ± 6.875 (14.0–46.1) | 21.6 ± 3.4 (14.7–27.7) | |||||
| BSAb ± SD | 1.88 ± 0.292 | 1.59 ± 0.181 | |||||
| Creatinine clearancec (ml/min) [mean ± SD] | 94.88 ± 52.954 | 86.7 ± 27.31 | |||||
ECOG Eastern Cooperative Oncology Group, SCC squamous cell carcinoma, BSA body surface area, BMI body mass index, SD standard deviation.
a One patient each with acrospiroma (not a cancer), adenoid cystic carcinoma, bladder, endometrial, large cell carcinoma of lung, laryngeal, melanoma, renal, sarcoma, small bowel carcinoma, thyroid carcinoma, and peritoneal carcinoma.
b BSA was calculated using the formula of Du Bois
c Cockcroft and Gault’s formula