Table 2.
DLT and grade 3/4 toxicities of dose-escalation and expansion cohorts
| Cohort | Panobinostat days 1, 3, and 5a (mg) | N | DLTs | Grade (N): toxicity | Responses (N) |
|---|---|---|---|---|---|
| 1 | 20 | 3 | 0 | 3 (2): neutropenia, WBC | SD: melanoma, neuroblastoma |
| 2 | 30 | 3 | 0 | 3 (1): neutropenia | SD: ovarian |
| 3 (1): fatigue | |||||
| 3 | 40 | 3 | 0 | 3 (1): thrombocytopenia | |
| 3 (2): neutropenia, WBC | |||||
| 4 (1): neutropenia, WBC | |||||
| 4 | 50 | 7 | Atrial fibrillation | 3 (1): neutropenia, WBC | PR: breast (2) |
| 4 (2): neutropenia, WBC | SD: NSCLC | ||||
| 5 | 60 | 4 | Febrile neutropenia | 3 (4): neutropenia, WBC | PR: SCLC |
| Fatigue | 3 (2): fatigue | ||||
| Thrombocytopenia | |||||
| MTD | 50 | 20 | Febrile neutropenia | (see supplementary Table S1, available at Annals of Oncology online) | PR: liposarcoma |
| Neutropenia | SD: LMS, aveolar soft part, nerve sheath, chondrosarcoma, hemangioepithelioma, sarcamoid, synovial, liposarcoma (2), phyllodes (2) |
aEpirubicin (75 mg/m2) administered on day 5 every 21 days.
SD, stable disease ≥12 weeks; PR, partial response; NSCLC, non-small-cell lung cancer; SCLC, small-cell lung cancer; LMS, leiomyosarcoma; WBC, leukocytopenia.