Table 3.
Clinical Toxicities
| Clinical Toxicities | Grade I toxicities No. (%) | Grade II and III toxicities No. (%) | Grade IV toxicities No. (%) |
|---|---|---|---|
| Cohort 1-4 (n=4) | |||
| Pain | 4 (100%) | ||
| Lymphedema | 3 (75%) | ||
| Erythoderma | 3 (75%) | ||
| Nausea | 1 (25%) | ||
| Maculopapular rash | 1 (25%) | ||
| Motor neuropathy | 1 (25%) | ||
| Cohort 5 (n=19) MTD | |||
| Pain | 8 (40%) | 3 (16%) | |
| Lymphedema | 8 (40%) | 5 (26%) | |
| Erythoderma | 7 (35%) | 3 (16%) | |
| Nausea | 6 (30%) | ||
| Maculopapular rash | 5 (25%) | ||
| Motor neuropathy | 4 (20%) | 1 (5%) | |
| CPK elevation* | 4 (20%) | 2 (10%) | 6 (32%) |
| Cohort 6 (n=5) MAD | |||
| Pain | 2 (33%) | 1 (17%) | |
| Lymphedema | 2 (33%) | ||
| Erythoderma | 3 (50%) | ||
| Nausea | |||
| Maculopapular rash | |||
| Motor neuropathy | 1 (17%) | 1 (17%) | |
| Muscle necrosis | 1 (37%) | 1 (37%) | |
| CPK elevation* | 1 (17%) | 3 (50%) |
*
serologic toxicity, a grade IV CPK lasting less than 7 days was not considered a DLT