Treatment-related adverse events (>10% of patients or grade >3) and laboratory abnormalities regardless of relationship, in patients with advanced endometrial cancer treated at the recommended dose: doxorubicin 40 mg/m2 and lurbinectedin 2.0 mg/m2 on day one every 3 weeks
| Expansion cohort (n=19 patients) | ||||||||
| NCI-CTCAE grade | ||||||||
| 1/2 | 3 | 4 | Total*† | |||||
| N | % | N | % | N | % | N | % | |
| Treatment-related adverse events ‡ | ||||||||
| Fatigue | 10 | 52.6 | 5 | 26.3 | – | – | 15 | 78.9 |
| Nausea | 13 | 68.4 | – | – | – | – | 13 | 68.4 |
| Alopecia | 10 | 52.6 | – | – | – | – | 10 | 52.6 |
| Constipation | 8 | 42.1 | – | – | – | – | 8 | 42.1 |
| Diarrhea | 4 | 21.1 | 1 | 5.3 | – | – | 5 | 26.3 |
| Mucositis | 5 | 26.3 | – | – | – | – | 5 | 26.3 |
| Vomiting | 5 | 26.3 | – | – | – | – | 5 | 26.3 |
| Decreased appetite | 4 | 21.1 | – | – | – | – | 4 | 21.1 |
| Dysgeusia | 4 | 21.1 | – | – | – | – | 4 | 21.1 |
| Febrile neutropenia | – | – | 2 | 10.5 | 2 | 10.5 | 4 | 21.1 |
| Myalgia | 3 | 15.8 | – | – | – | – | 3 | 15.8 |
| Dyspepsia | 2 | 10.5 | – | – | – | – | 2 | 10.5 |
| Epistaxis | 2 | 10.5 | – | – | – | – | 2 | 10.5 |
| Pain in extremity | 2 | 10.5 | – | – | – | – | 2 | 10.5 |
| Palmar-plantar erythrodysesthesia syndrome | 2 | 10.5 | – | – | – | – | 2 | 10.5 |
| Palpitations | 2 | 10.5 | – | – | – | – | 2 | 10.5 |
| Peripheral edema | 2 | 10.5 | – | – | – | – | 2 | 10.5 |
| Peripheral sensory neuropathy | 2 | 10.5 | – | – | – | – | 2 | 10.5 |
| Acute renal failure | – | – | 1 | 5.3 | – | – | 1 | 5.3 |
| Lower respiratory tract infection | – | – | 1 | 5.3 | – | – | 1 | 5.3 |
| Neutropenic infection | – | – | 1 | 5.3 | – | – | 1 | 5.3 |
| Laboratory abnormalities | ||||||||
| Anemia | 13 | 68.4 | 6 | 31.6 | – | – | 19 | 100.0 |
| Neutropenia | 4 | 21.1 | 3 | 15.8 | 12 | 63.2 | 19 | 100.0 |
| Creatinine increased | 15 | 78.9 | – | – | 1 | 5.3 | 16 | 84.2 |
| Thrombocytopenia | 11 | 57.9 | 1 | 5.3 | 2 | 10.5 | 14 | 73.7 |
| AP increased | 10 | 52.6 | 1 | 5.3 | – | – | 11 | 57.9 |
| ALT increased | 8 | 42.1 | 2 | 10.5 | – | – | 10 | 52.6 |
| AST increased | 8 | 42.1 | – | – | – | – | 8 | 42.1 |
| Bilirubin increased | 2 | 10.5 | – | – | – | – | 2 | 10.5 |
*Adverse events and laboratory abnormalities ordered by incidence from higher to lower.
†No grade 5 adverse events were reported.
‡Including adverse events with unknown relationship.
AP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events, v4.