TABLE 1.
Overview of relevant phase II trials investigating single‐agent pegylated liposomal doxorubicin in patients with metastatic breast cancer.
| Al‐Batran (2006) 13 | Al‐Batran (2006) 14 | Coleman (2006) 11 | Ranson (1997) 12 | Falandry (2013) 15 | |
|---|---|---|---|---|---|
| Number of patients | 46 | 79 | 116 | 71 | 60 |
| Treatment line | 2nd or 3rd | 2nd or later | 1st or 2nd | — | 1st |
| Inclusion criteria | |||||
| Performance status | ≥70% | ≥70% | ECOG≤2 | ≥60% | — |
| Age (years) | >18 | >18 | >65 | >60 | >70 |
| Receptor status | All | All | All | All | Her2‐ |
| Patient criteria | |||||
| Median age (years) | 60 | 58 | 69 | 57 | 77 |
| ≥3 sites of metastasis (%) | 35 | 35 | 58 | 39 | — |
| Her2‐positive (%) | 11 | 4 | — | — | 0 |
| HR‐positive (%) | 74 | 86 | 59 | — | 87 |
| Visceral disease (%) | — | 83 | — | 70 | 73 |
| Endocrine therapy (%) | 85 | 100 | 79 | 80 | 72 |
| Adjuvant (%) | — | — | 13 | — | — |
| Previously in MBC (%) | — | 100 | 33 | — | — |
| Prior chemotherapy (%) | — | 100 | 33 | — | 22 |
| Adjuvant (%) | — | — | 22 | — | 22 |
| In MBC (%) | 65 | 100 | 14 | 39 | — |
| Dosing (mg/m2) | 40, q4w | 50, q4w | 50/60, q4/6w | 45–60, q3‐4w | 40, q4w |
| Outcome measures | |||||
| ORR | 13% | 12.7% | 29%–31% | 31% | 20% |
| CBR | 48% | 40.5% | 63%–64% | 62% | 80% |
| PFS (months) | 3.3 | 3.6 | 5.4–5.8 | — | 6.1 |
| OS (months) | 10.7 | 12.3 | — | 7 | 15.7 |
Abbreviations: AT, anthracycline treatment; CBR, clinical benefit rate; ECOG, eastern cooperative oncology group performance status; Her2, human epidermal growth factor receptor 2; Her2‐, Her2 negative; HR, hormone receptor; HR‐, HR negative or endocrine resistant; m2, square meter; mg, milligram; ORR, objective response rate; OS, overall survival; PFS, progression‐free survival; q4w, every 4 weeks.