Table 2.
Event | Doses Below the MTD (all schedules pooled; n = 21) |
Schedule 1* MTD (1.88 mg/kg; n = 43) |
Schedule 2† MTD (1.5 mg/kg; n = 6) |
Schedule 3‡ MTD (1.0 mg/kg; n = 15) |
Doses Above the MTD (all schedules pooled; n = 32) |
|||||
---|---|---|---|---|---|---|---|---|---|---|
All Grades | Grade 3 or Higher | All Grades | Grade 3 or Higher | All Grades | Grade 3 or Higher | All Grades | Grade 3 or Higher | All Grades | Grade 3 or Higher | |
Nonhematologic toxicity | ||||||||||
Rash | 14 | — | 74 | 30 | 67 | — | 67 | 33 | 81 | 22 |
Fatigue | 14 | — | 65 | 7 | 67 | 17 | 53 | 13 | 63 | 13 |
Pruritus | 10 | — | 63 | — | 33 | — | 47 | 7 | 59 | 3 |
Alopecia | — | — | 65 | — | 33 | — | 33 | — | 41 | — |
Diarrhea | 10 | — | 47 | 2 | 67 | — | 20 | — | 38 | 6 |
Neuropathy | 5 | — | 33 | 7 | 33 | 17 | 60 | 27 | 34 | 3 |
Nausea | 5 | — | 35 | — | 50 | — | 7 | — | 41 | — |
Anorexia | — | — | 40 | — | 33 | — | 13 | — | 28 | 3 |
Dysgeusia | — | — | 33 | — | 33 | — | 13 | — | 16 | — |
Constipation | — | — | 30 | — | 17 | — | 20 | — | 16 | — |
Vomiting | 5 | — | 14 | — | 17 | — | 13 | — | 25 | — |
Myalgia | — | — | 12 | — | — | — | 27 | 13 | 19 | 6 |
Dry skin | — | — | 12 | — | 33 | — | 13 | — | 9 | — |
Pyrexia | — | — | 19 | — | — | — | — | — | 13 | — |
Pain in extremity | — | — | 14 | 5 | 17 | — | 13 | — | 6 | — |
Arthralgia | — | — | 7 | — | 17 | — | 7 | 7 | 16 | 6 |
Mucosal inflammation | — | — | 14 | — | — | — | 7 | — | 9 | 6 |
Palmar-plantar erythrodysesthesia syndrome | — | — | 5 | — | — | — | 7 | — | 13 | 6 |
Hyperglycemia | — | — | — | — | — | — | — | — | 6 | 6 |
Hematologic toxicity | ||||||||||
Neutropenia | 5 | 5 | 28 | 19 | 33 | 17 | 13 | 13 | 22 | 19 |
Thrombocytopenia | — | — | 5 | 2 | — | — | — | — | 6 | 3 |
Leukopenia | 5 | 5 | 2 | 2 | — | — | — | — | — | — |
NOTE. Data are shown as the percentage of patients experiencing the event. Listed are events that occurred at any severity in > 10% of patients or at grade 3 or higher severity in ≥ 2% of patients.
Abbreviations: MTD, maximum-tolerated dose.
Schedule 1: once every 3 weeks.
Schedule 2: once per week for 2 of 3 weeks.
Schedule 3: once per week.