Table 3.
EMBRACE study (n=508)
|
301 Study (n=544)
|
|||||
---|---|---|---|---|---|---|
Any grade% | Grade 3% | Grade 4% | Any grade% | Grade 3% | Grade 4% | |
Hematologic toxicities | ||||||
Neutropenia | 52 | 21 | 24 | 54 | 25 | 21 |
Leukopenia | 23 | 12 | 2 | 31 | 13 | 2 |
Anemia | 19 | 2 | <1 | 19 | 2 | 0 |
Thrombocytopenia | NR | NR | NR | 5 | <1 | 0 |
Nonhematologic toxicities | ||||||
Alopecia | 45 | – | – | 35 | – | – |
Nausea | 35 | 1 | 0 | 22 | < 1 | 0 |
Vomiting | 18 | 4 | <1 | 12 | < 1 | <1 |
Diarrhea | 18 | 0 | 0 | 14 | 1 | 0 |
Asthenia | 54 | 8 | 1 | 15 | 4 | <1 |
Peripheral neuropathy | 35 | 8 | <1 | 13 | 4 | 0 |
Febrile neutropenia | 5 | NR | NR | 2 | 2 | <1 |
Hypersensitivity | 1 | NR | NR | NR | NR | NR |
Abbreviations: NR, not reported; EMBRACE, the Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389.