Table 3.
Toxicity | Enzastaurin (n = 167)† |
Lomustine (n = 84)† |
||||||
---|---|---|---|---|---|---|---|---|
Grade 2 |
Grade 3 to 4 |
Grade 2 |
Grade 3 to 4 |
|||||
No. | % | No. | % | No. | % | No. | % | |
Nonhematologic toxicity | ||||||||
Fatigue | 5 | 3.0 | 6 | 3.6 | 5 | 6.0 | 0 | |
Anorexia | 2 | 1.2 | 0 | 0 | 0 | |||
Nausea | 1 | 0.6 | 0 | 2 | 2.4 | 0 | ||
GI | 2 | 1.2 | 0 | 0 | 0 | |||
Flatulence | 2 | 1.2 | 0 | 0 | 0 | |||
Edema | 7 | 4.2 | 2 | 1.2 | 2 | 2.4 | 0 | |
Infection | 1 | 0.6 | 2 | 1.2 | 1 | 1.2 | 3 | 3.6 |
Stomatitis | 2 | 1.2 | 0 | 2 | 2.4 | 0 | ||
Thrombosis | 1 | 0.6 | 3‡ | 1.8 | 0 | 0 | ||
Hematologic toxicity | ||||||||
Anemia | 1 | 0.6 | 0 | 3 | 3.6 | 2 | 2.4 | |
Neutropenia | 1 | 0.6 | 0 | 4 | 4.8 | 17 | 20.2 | |
Thrombocytopenia | 4 | 2.4 | 1 | 0.6 | 9 | 10.7 | 21 | 25.0 |
Lymphopenia | 0 | 0 | 2 | 2.4 | 0 | |||
Leukopenia | 2 | 1.2 | 0 | 3 | 3.6 | 6 | 7.1 |
Grade 2 or grade 3 to 4 toxicities in one or more patient in either arm.
15 patients (seven assigned to enzastaurin, eight assigned to lomustine) discontinued before receiving treatment and were not included in the safety analysis.
Two patients receiving enzastaurin had grade 4 thrombosis.