Table 1.
Patient characteristics
| Pt | Age | Sex | PS | BSA (m2) | Diagnosis | Frequency | Dosage | AUC Day 28 | Toxicity ≥ G3-4 | Best response (TTP, days) | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| (mg/m2) | (mg/day)a | ||||||||||
| 1 | 54 | F | 1 | 1.75 | Cervical ca. | b.i.d. | 200 | 800 | 32.8 | – | NC (162) |
| 2 | 54 | M | 1 | 1.66 | NSCLC | b.i.d. | 200 | 800 | 33.4 | – | NC (64) |
| 3 | 31 | F | 1 | 1.43 | Parotid ca. | b.i.d. | 200 | 400 | 30.4 | – | PD |
| 4 | 72 | F | 0 | 1.37 | SCLC | b.i.d. | 400 | 1,200 | – | G3 (DLT) | NC (29+) |
| 5 | 55 | F | 1 | 1.34 | NSCLC | b.i.d. | 400 | 1,200 | – | – (DLT) | NE |
| 6 | 50 | F | 1 | 1.43 | Unknown | b.i.d. | 400 | 1,200 | 54.8 | – | PD |
| 7 | 53 | M | 1 | 1.78 | NSCLC | b.i.d. | 400 | 1,600 | 54.0 | – | PD |
| 8 | 47 | M | 1 | 1.71 | Cholecystis ca. | b.i.d. | 400 | 1,200 | 21.6 | – | NC (61) |
| 9 | 47 | M | 1 | 1.68 | NSCLC | b.i.d. | 400 | 1,200 | 17.1 | – | NC (29+) |
| 10 | 60 | F | 1 | 1.48 | Colon ca. | b.i.d. | 500 | 1,600 | 61.2 | – | PD |
| 11 | 63 | F | 1 | 1.67 | Colon ca. | b.i.d. | 500 | 1,600 | 44.6 | – | PD |
| 12 | 66 | F | 1 | 1.37 | NSCLC | b.i.d. | 500 | 1,200 | 23.8 | – | PD |
| 13 | 46 | M | 1 | 1.59 | Colon ca. | t.i.d. | 200 | 1200 | 25.3 | – | PD |
| 14 | 51 | F | 1 | 1.31 | Soft tissue sa. | t.i.d. | 200 | 600 | 19.0 | – | NC (254+) |
| 15 | 57 | M | 1 | 1.60 | Rectal ca. | t.i.d. | 200 | 1,200 | 51.0 | – | PD |
| 16 | 50 | F | 1 | 1.77 | Colon ca. | t.i.d. | 200 | 1,200 | 24.0 | – | PD |
| 17 | 62 | M | 1 | 1.70 | NSCLC | t.i.d. | 200 | 1,200 | 16.6 | – | NC (65) |
| 18 | 60 | M | 1 | 1.70 | Colon ca. | t.i.d. | 200 | 1,200 | 12.5 | – | PD |
| 19 | 56 | M | 1 | 2.26 | NSCLC | t.i.d. | 400 | 2,400 | 9.9 | G4 (DLT) | NC (28+) |
| 20 | 54 | F | 1 | 1.51 | Colon ca. | t.i.d. | 400 | 1,800 | 46.8 | – | NC (217+) |
| 21 | 64 | M | 1 | 1.91 | Colon ca. | t.i.d. | 400 | 2,400 | 27.8 | – | PD |
| 22 | 51 | M | 1 | 1.68 | Gastric ca. | t.i.d. | 400 | 1,800 | 21.3 | – | PD |
| 23 | 59 | F | 1 | 1.37 | Colon ca. | t.i.d. | 400 | 1,800 | 30.7 | – | NC (28+) |
| 24 | 55 | M | 0 | 1.68 | Esophagus ca. | t.i.d. | 400 | 1,800 | 53.4 | – | PD |
PS performance status, BSA body surface area, AUC area under the curve, G grade, NC no change, PD progressive disease, ca cancer, sa sarcoma, NSCLC non-small-cell lung cancer, DLT dose-limiting toxicity, TTP time to progression, b.i.d. TSU-68 administration of twice-daily, t.i.d. TSU-68 administration of thrice-daily
aOne tablet: 200 mg