Table 1.
Phase I studies with pegylated liposomal doxorubicin as a single agent
| Author | No. pts | Type of tumor | MTD | DI mg/m2/week | DLTs |
|---|---|---|---|---|---|
| Bogner12 | 40 | Kaposi sarcomas | 20 mg/m2, q15 | 10 | neutropenia |
| James13 | 15 | Kaposi sarcomas | 20 mg/m2, q15 | 10 | hematologic |
| Uziely14 | 56 | Solid tumors | 60 mg/m2, q28 | 15 | stomatitis (doses ≥ 60 mg/m2) for a single dose HFS (interval < 28 d) |
| Jahanzeb15 | 24 | Solid tumors | 40–50 mg/m2, q28 | 10–12.5 | neutropenia |
| Gabizon16 | 22 | MBC | 50 mg/m2, q28 | 12.5 | stomatitis (doses > 60 mg/m2) HFS (interval < 21 d) |
| Caponigro17 | 24 | Head/neck | 45 mg/m2, q21 | 15 | stomatitis |
| Hamilton18 | 20 | MBC | 60 mg/m2, q42 | 10 | mucositis |
| Marina19 | 22 | Pediatric solid tumors | 60 mg/m2, q28 | 15 | mucositis |
Abbreviations: DI, dose intensity; DLT, dose limiting toxicity; HFS, hand–foot syndrome; MBC, metastatic breast cancer; MTD, maximum tolerated dose; q, every; d, day.