Table 2.
Phase II–III single-agent studies
| Borchmann et al28 | Pettengell et al29 (pixantrone arm only in this table) | |
|---|---|---|
| Patient characteristics | ||
| Patients | 33 | 70 (only 68 treated) |
| Histotypes included, n (%) | DLBCL, 24 (73%) | DLBCL, 53 (76%) |
| MCL, 7 (21%) | Transformed, 10 (14%) | |
| Others, 2 (6%) | PTCL NOS, 3 (4%) Null ALCL, 3 (4%) FL grade III, 1 (1%) |
|
| Median age (range) | 66 (24–81) | 60 (18–80) |
| Sex (M/F) | 18/15 | 24/46 |
| Ann Arbor stage | ||
| I–II (%) | 8 (24%) | 19 (26%) |
| III–IV (%) | 25 (76%) | 51 (74%) |
| Median (range) previous lines of therapy | 2 (0–5) | 3 (2–9) |
| Prior treatment with anti-CD20 (%) | NA | 38 (54%) |
| Prior stem cell transplantation (%) | 2 (6%) | 11 (16%) |
| Median (range) prior equivalent dose of doxorubicin (mg/m2) | 300 (110–600) | 292.9 (51–472) |
| Median (range) time from last prior therapy | 123 days (6 days to 5 years) | 9 months (1–86 months) |
| Response | ||
| Median (range) number of cycles administered | 2 (1–6) | 4 (2–6) |
| Early treatment discontinuations (%) | 27 (82%) | 48 (71%) |
| CR (%) | 5 (15%) | 8 (11%) and 6 CRu (9%) |
| PR (%) | 4 (12%) | 12 (17.1%) |
| Median PFS | 106 days | 5.3 months |
| Median OS | NA | 10.2 months |
| Toxicities | ||
| Grade III–IV hematologic toxicities (%) | Neutropenia (58%) | Neutropenia (41%) |
| Thrombocytopenia (6%) | Thrombocytopenia (12%) | |
| Anemia (6%) | Anemia (6%) | |
| Grade III–IV nonhematologic toxicities (%) | Hepatobiliary disorders (3%) | Abdominal pain (7%) |
| Arthritis (3%) | Pneumonia (6%) | |
| Asthenia (3%) | Dyspnea (6%) | |
| Cardiac toxicity (%) | LVEF-D ≥10% (9%) | LVEF-D (19%) |
| LVEF-D CTC gr III–IV (2%) | ||
Abbreviations: n, number; M, male; F, female; CR, complete response; CRu, complete response unconfirmed; PR, partial response; DLBCL, diffuse large B-cell lymphoma; MCL, mantle cell lymphoma; PTCL NOS, peripheral T-cell lymphoma not otherwise specified; null ALCL, anaplastic large-cell lymphoma T/null-cell type; LVEF-D, left ventricle ejection fraction decrease; CTC gr, Common Toxicity Criteria grade; PFS, progression-free survival; OS, overall survival; NA, not available; FL, follicular lymphoma.