Table 3.
Combination therapy studies
| Lim et al31 | Borchmann et al32 | Herbrecht et al33 (pixantrone arm) | |
|---|---|---|---|
| Response | |||
| Median number of cycles administered (range) | 4 (1–6) | 6 (1–6) | 8 (1–8) |
| CR (%) | 7 (37%) | 14 (47%) | 46 (75%) |
| PR (%) | 4 (21%) | 8 (26%) | 4 (7%) |
| Median PFS | TTP 5.7 months (I and II) | 8.2 months (II) | Not reached |
| Median OS | 14.7 months (I and II) | 17.9 months (II) | Not reached |
| Toxicities | |||
| Grade III–IV hematologic toxicities (%) | Neutropenia (68% gr. IV) | Neutropenia (I: 89%; II: 97%) | Neutropenia |
| Anemia (53% I and II) | Anemia (I: 14%; II: 30%) | Anemia | |
| Thrombocytopenia (95% I and II) | Thrombocytopenia (I: 14%; II: 20%) | Febrile neutropenia | |
| Febrile neutropenia (5% gr. IV) | Febrile neutropenia (I: 11%; II: 20%) | Thrombocytopenia | |
| Grade III–IV nonhematologic toxicities (%) | Metabolic (16% I and II) | Metabolic (I: 0%; II: 10%) | Metabolic (20%) |
| Gastrointestinal (11% I and II) | Gastrointestinal (I: 3%; II: 10%) | Gastrointestinal (17%) | |
| Fatigue (5% I and II) | Infectious (17%) | ||
| Deep vein thrombosis (5% I and II) | |||
| Cardiac toxicity (%) | LVEF-D ≥10% (37% I and II) | Any disorder (I: 37%; II: 27%) | LVEF-D ≥15% (17%) |
| LVEF-D ≥10% (I: 29%; II: 13%) | LVEF-D ≥20% (2%) | ||
| Troponin T increase (7%) | |||
Abbreviations: CRu, complete response unconfirmed; PR, partial response; TTP, time to progression; LVEF-D, left ventricle ejection fraction decrease; I, Phase I; II, Phase II; PFS, progression-free survival; OS, overall survival; gr., grade.