Comparison of toxicity between single-agent THAL and low-dose THAL-PRED therapy in MMM
| Toxicity . | No. of patients affected (%) . | ||
|---|---|---|---|
| THAL + PRED . | Grade 2/grade 3 or higher . | THAL,24 100-400 mg . | |
| Leukocytosis* | 8 (38) | 6/2 (29) | 2 (13) |
| Thrombocytosis | 4 (19) | 3/2 (14/10) | 3 (20) |
| Constipation | 8 (38) | 3 (14) | 9 (60) |
| Edema | 5 (24) | 2 (10) | 3 (20) |
| Visual disturbance | 4 (19) | 2 (10) | 2 (13) |
| Fatigue | 2 (10) | 2 (10) | 10 (67) |
| Thrombosis | 1 (5) | 1/1 (5/5) | 0 (0) |
| Paresthesias | 6 (29) | 1 (5) | 4 (33) |
| Sedation | 6 (29) | 1 (5) | 3 (20) |
| Neutropenia | |||
| Less than 1500/μL | 5 (24) | 1 (5) | 6 (40) |
| Less than 1000/μL | 4 (19) | 4 (19) | 4 (27) |
| Anxiety | 4 (19) | 0 (0) | 3 (20) |
| Rash | 3 (14) | 0 (0) | 4 (33) |
| Orthostatic symptoms | 0 (0) | 0 (0) | 5 (33) |
| Tremor | 0 (0) | 0 (0) | 3 (20) |
| Myeloproliferative reaction | 0 (0) | 0 (0) | 3 (20) |
| Dry mouth | 0 (0) | 0 (0) | 2 (13) |
| Sinus bradycardia | 0 (0) | 0 (0) | 2 (13) |
| Abdominal pain | 0 (0) | 0 (0) | 2 (13) |
| Decreased hearing | 0 (0) | 0 (0) | 2 (13) |
| Anorexia | 0 (0) | 0 (0) | 1 (7) |
| Confusion | 0 (0) | 0 (0) | 1 (7) |
| Dry eyes | 0 (0) | 0 (0) | 1 (7) |
| Depression | 0 (0) | 0 (0) | 1 (7) |
| Toxicity . | No. of patients affected (%) . | ||
|---|---|---|---|
| THAL + PRED . | Grade 2/grade 3 or higher . | THAL,24 100-400 mg . | |
| Leukocytosis* | 8 (38) | 6/2 (29) | 2 (13) |
| Thrombocytosis | 4 (19) | 3/2 (14/10) | 3 (20) |
| Constipation | 8 (38) | 3 (14) | 9 (60) |
| Edema | 5 (24) | 2 (10) | 3 (20) |
| Visual disturbance | 4 (19) | 2 (10) | 2 (13) |
| Fatigue | 2 (10) | 2 (10) | 10 (67) |
| Thrombosis | 1 (5) | 1/1 (5/5) | 0 (0) |
| Paresthesias | 6 (29) | 1 (5) | 4 (33) |
| Sedation | 6 (29) | 1 (5) | 3 (20) |
| Neutropenia | |||
| Less than 1500/μL | 5 (24) | 1 (5) | 6 (40) |
| Less than 1000/μL | 4 (19) | 4 (19) | 4 (27) |
| Anxiety | 4 (19) | 0 (0) | 3 (20) |
| Rash | 3 (14) | 0 (0) | 4 (33) |
| Orthostatic symptoms | 0 (0) | 0 (0) | 5 (33) |
| Tremor | 0 (0) | 0 (0) | 3 (20) |
| Myeloproliferative reaction | 0 (0) | 0 (0) | 3 (20) |
| Dry mouth | 0 (0) | 0 (0) | 2 (13) |
| Sinus bradycardia | 0 (0) | 0 (0) | 2 (13) |
| Abdominal pain | 0 (0) | 0 (0) | 2 (13) |
| Decreased hearing | 0 (0) | 0 (0) | 2 (13) |
| Anorexia | 0 (0) | 0 (0) | 1 (7) |
| Confusion | 0 (0) | 0 (0) | 1 (7) |
| Dry eyes | 0 (0) | 0 (0) | 1 (7) |
| Depression | 0 (0) | 0 (0) | 1 (7) |
Single-agent THAL treatment consisted of 200 mg/d or higher. The THAL dose in the combined therapy was 50 mg/d, plus prednisone in tapered doses as described in “Patients, materials, and methods.” All toxicities were graded according to the Common Toxicity Criteria Version 2.0 of the National Cancer Institute. For a diagnosis of thrombocytosis, the platelet increases must be above normal limits. For leukocytosis, the leukocyte increases must be above normal limits.
One patient transformed to acute myeloid leukemia.