Table 6.
Phase II studies with pegylated liposomal doxorubicin as single agent
| Author | Dose, schedule | Clinical setting | RR (%) | PFS (Median) months | Grade 3/4 toxicity/patient |
|||
|---|---|---|---|---|---|---|---|---|
| Hgb | Neu | PLT | HFS | |||||
| Muggia65 | 50 mg/m2, q21 | RES 35 | 25.7 | 5.7 | – | – | – | – |
| Gordon66 | 50 mg/m2, q21 | ALL 89 | 16.8 | 4.8 | 20.2 | 15.7 | 2.2 | 20.2 |
| RES 82 | 18.3 | 4.4 | ||||||
| Rose67 | 50 mg/m2, q28 | RES 37 | 13.5 | 4.0 | – | – | – | – |
| 40 mg/m2, q28 | RES 39 | 7.7 | 4.0 | |||||
| Arcuri68 | 50 mg/m2, q28 | ALL 30 | 26.6 | – | – | 23.3 | – | 10.0 |
| Katsumata69 | 50 mg/m2, q28 | RES 63 | 20.9 | 5.6 | 17.6 | 67.5 | 6.9 | 16.2 |
| SEN 11 | 27.3 | 5.3 | ||||||
| Gorumlu70 | 50 mg/m2, q28 | RES 17 | 17.0 | 3.7 | – | 12.0 | – | 6.0 |
| Steppan71 | 45 mg/m2, q28 | RES 29 | 30.5 | – | – | – | – | – |
| Chou72 | 45 mg/m2, q28 | RES 29 | 23.1 | 5.4 | – | – | – | – |
| Markman73 | 40 mg/m2, q28 | RES 44 | 9.1 | – | – | 2.0 | 0 | 0 |
| Campos74 | 40 mg/m2, q28 | ALL 72 | 27.0 | 5.3 | 11 | 2 | 1 | – |
| RES 29 | 29.0 | |||||||
| SEN 43 | 25.6 | |||||||
| Wilailak75 | 40 mg/m2, q21 | RES 14 | 23.0 | 6.0 | 0 | 14.3 | 0 | 2.0 |
| Lorusso76 | 35 mg/m2, q21 | ALL | 13.5 | 7.2 | 0 | 10.8 | 0 | 2.7 |
| RES 17a | 18.9 | – | ||||||
| SEN 20 | 10.0 | – | ||||||
| Strauss77 | 20 mg/m2, q15 | RES 50 | 40 | 4.1 | 0 | 4 | 0 | 2.0 |
| Oskay-Oezcelik78 | 20 mg/m2, q15 | RES 7 | 0 | 2.3 | 5 | 0 | 0 | 5.0 |
| SEN 13 | 7.7 | 4.1 | ||||||
| Sehouli79 | 20 mg/m2, q15 | ALL 64 | 10.9b | 4.3 | 4.7 | 0 | 1.6 | 4.7 |
| RES 21 | – | – | ||||||
| SEN 43 | – | – | ||||||
Abbreviations: ALL, ; HFS, hand–foot syndrome; Hgb, anemia; PFS, progression-free survival; RR, response rate; RES, platinum-resistant recurrent disease; Neu, neutropenia, PLT, platelet toxicity; SEN, platinum-sensitive recurrent disease; q, every; d, day.
a
Platinum sensitivity according to the cut-off of 12-month platinum free interval;
b
In assessed patients (n = 44).