Table 9.
Randomized studies with pegylated liposomal doxorubicin (PLD) alone or in combinations in salvage setting
| Author | Pts (No.) | Drugs/dose | No. | RR (%) | PFS mts | OS mts | % Grade 3/4 toxicity/patient |
|||
|---|---|---|---|---|---|---|---|---|---|---|
| Hgb | Neu | PLT | HFS | |||||||
| O’Byrne106 | REC (214) | PLD (50 mg/m2) q28 vs | 107 | 17.8 | 5.4 | 11.4 | – | – | – | – |
| PTX (175 mg/m2) q21 | 107 | 22.4 | 6.0 | 14.0 | ||||||
| Gordon107,108 | RES (255) | PLD (50 mg/m2) d1, q28 vs | 130 | 12.3 | 2.3 | 8.9 | 5 | 12 | 1 | 23 |
| TPT (1.5 mg/m2) d1–5 q21 | 125 | 6.5 | 3.4 | 10.3 | 28 | 77 | 34 | 0 | ||
| SEN (219) | PLD (50 mg/m2) d1, q28 vs | 109 | 28.4 | 7.2 | 27 | |||||
| TPT (1.5 mg/m2) d1–5, q21 | 110 | 28.8 | 5.8* | 17.5* | ||||||
| Mutch109 | RESa (195) | PLD (50 mg/m2) d1, q28 vs | 96 | 8.3 | 3.6 | 12.7 | 2.1 | 18.7 | 5.2 | 10.4 |
| GEM (1,000 mg/m2) d1,8, q21 | 99 | 6.1 | 3.1 | 13.5 | 3.0 | 38.4 | 6.1 | 0 | ||
| Ferrandina110 | RESb (153) | PLD (40 mg/m2) q28 vs | 76 | 16 | 4.0 | 14 | 5 | 6 | 0 | 5 |
| GEM (1,000 mg/m2) d1,8,15 q28 | 77 | 29 | 5.0 | 12.7* | 7 | 23 | 5 | 0 | ||
| Vergote112 ASSIST-1 | RESc (461) | PLD (50 mg/m2) d1, q28 or TPT 1.5 mg/m2 d1–5 q21 vs |
229 | 10.9 | 4.3* | 13.5* | – | – | – | – |
| CAN (1,000 mg/m2) q21 | 232 | 4.3 | 2.3 | 8.5 | – | – | – | – | ||
| Vergote113 ASSIST-5 | RESc (125) | PLD (50 mg/m2) d1 CAN (1000 mg/m2) q28 vs |
65 | 12.3d | 5.6d | – | – | – | – | – |
| PLD (50 mg/m2) d1, q28 | 60 | 8.3 | 3.7 | – | – | – | – | – | ||
| Monk117 OVA-301 | ALL (672) | PLD (30 mg/m2) d1 TRAB (1.1 mg/m2) d1,q21 vs |
335 | 28.0* | 7.3* | 20.5e | 14.0 | 63.0 | 18.0 | 4.0 |
| PLD (50 mg/m2) q28 | 337 | 19.0 | 5.9 | 19.4 | 6.0 | 22.0 | 2.0 | 20.0 | ||
| SEN (430) | PLD (30 mg/m2) d1 TRAB (1.1 mg/m2) d1,q21 vs |
– | 35* | 9.2* | – | – | – | – | – | |
| PLD (50 mg/m2) q28 | – | 23 | 7.5 | – | – | – | – | – | ||
Abbreviations: CAN, canfosfamide; GEM, gemcitabine; HFS, hand–foot syndrome; Hgb, anemia; Neu, neutropenia; OS, overall survival; PFS, progression-free survival; PLT, platelet toxicity; PTX, paclitaxel; REC, not otherwise specified recurrent disease; RES, platinum-resistant recurrent disease; RR, response rate; SEN, platinum-sensitive recurrent disease; TRAB, trabectedin; q, every; d, day.
statistically significant.
up to 2 prior regimens allowed;
platinum resistance = recurrence/progression within 12 months from primary chemotherapy;
patients progressed on 2nd line treatment;
in the subgroup of platinum refractory/resistant (n = 75), the combination achieved a high response rate (15.0% vs 5.7%) and a longer PFS (median = 5.6 months vs 2.9 months) (HR = 0.55; P = 0.042);
results from interim analysis.