Table A1.
Cycle 1 Toxicities of Cytotoxic and Molecular Agents in Patients With HGG and STS Enrolled Onto Phase I Oncology Studies
| Toxicity | Toxicity Grade (No. [%]) |
No. of DLTs | Cytotoxic Agents |
Molecular Agents |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1-2 | 3-4 | 5 | No. of Patients (glioma) | Rate per 1,000 Patients (glioma) | Rate per 1,000 Patients (solid tumors) | No. of Patients (glioma) | Rate per 1,000 Patients (glioma) | Rate per 1,000 Patients (solid tumors) | ||
| No. of patients | 105 | 575 | 222 | 1,345 | ||||||
| Constitutional | 89 (90.6) | 8 (1.4) | 8 | 3 | 28.6 | 45.2 | 5 | 22.5 | 53.5 | |
| Cardiovascular | 22 (3.8) | 1 (< 0.5) | 1 | 1 | 9.5 | 17.4 | 0 | 0 | 44.6 | |
| GI | 84 (14.8) | 2 (< 0.5) | 2 | 2 | 19.0 | 33 | 0 | 0 | 57.2 | |
| Respiratory | 4 (< 1) | 2 (< 0.5) | 2 | 2 | 19.0 | 5.2 | 0 | 0 | 7.4 | |
| Metabolic | 34 (6) | 3 (< 0.5) | 3 | 1 | 9.5 | 31.3 | 2 | 9.0 | 51.3 | |
| Dermatologic | 35 (6) | 6 (1) | 6 | 0 | 0 | 0 | 6 | 27.02 | 26 | |
| Neurologic | 35 (6) | 5 (< 1) | 5 | 0 | 0 | 1.7 | 5 | 22.5 | 5.9 | |
| Hematologic | ||||||||||
| WBC | 42 (7) | 12 (2) | 5 | 1 | 9.5 | 104.3 | 4 | 18.0 | 32.7 | |
| Hemoglobin | 73 (13) | 1 (0.8) | 0 | 0 | 0.6 | 0 | 0 | 0.7 | ||
| Platelets | 61 (11) | 12 (2) | 0 | 0 | 2.6 | 0 | 0 | 1.5 | ||
| Others | 29 (5) | 1 (< 1) | 1 | 1 | 9.5 | 26.1 | 0 | 0 | 17.8 | |
NOTE. Patients in HGG cohort only received single agents, whereas STS patients received single agents or a combination of drugs. Grade 3 or higher nonhematologic and grade 4 hematologic toxicities are calculated as a rate per 1,000 patients.
Abbreviations: DLT, dose-limiting toxicity; HGG, high-grade glioma; STS, solid tumor studies.