Toxicities observed during and after therapy with forodesine
Patient no. . | Dose, mg/m2 . | Grades 1-2 . | Grades 3-4 . |
|---|---|---|---|
| 1 | |||
| Course 1 | 40 | Hyperbilirubinemia, hypotension | Anasarca, dyspnea (increased pleural effusion), renal failure (irreversible), depressed level of consciousness, Gram-negative rod bacteremia, hypocalcemia* |
| 2 | |||
| Course 1 | 40 | Hypocalcemia,* headache,* nausea/vomiting,* constipation, orthostasis (autonomic), tremors | Hypoxemia (fluid overload),* neutropenia |
| Course 2 | 40 | Orthostasis (autonomic), tremors | Neutropenia |
| 3 | |||
| Course 1 | 40 | Headache,* nausea/vomiting* | |
| 4 | |||
| Course 1 | 40 | Headache,* constipation, elevation in ALT | Neutropenia, infection with neutropenia (catheter) |
| 5 | |||
| Course 1 | 40 | Stomatitis, peripheral neuropathy† | Neutropenia |
| Course 2 | 40 | Peripheral neuropathy,† orthostasis, (autonomic)† | Neutropenia |
| Course 3 | 60 | Peripheral neuropathy,† orthostasis, (autonomic)† | Neutropenia |
| Course 4 | 90 | Peripheral neuropathy,† orthostasis (autonomic)† | Neutropenia, fever without infection |
Patient no. . | Dose, mg/m2 . | Grades 1-2 . | Grades 3-4 . |
|---|---|---|---|
| 1 | |||
| Course 1 | 40 | Hyperbilirubinemia, hypotension | Anasarca, dyspnea (increased pleural effusion), renal failure (irreversible), depressed level of consciousness, Gram-negative rod bacteremia, hypocalcemia* |
| 2 | |||
| Course 1 | 40 | Hypocalcemia,* headache,* nausea/vomiting,* constipation, orthostasis (autonomic), tremors | Hypoxemia (fluid overload),* neutropenia |
| Course 2 | 40 | Orthostasis (autonomic), tremors | Neutropenia |
| 3 | |||
| Course 1 | 40 | Headache,* nausea/vomiting* | |
| 4 | |||
| Course 1 | 40 | Headache,* constipation, elevation in ALT | Neutropenia, infection with neutropenia (catheter) |
| 5 | |||
| Course 1 | 40 | Stomatitis, peripheral neuropathy† | Neutropenia |
| Course 2 | 40 | Peripheral neuropathy,† orthostasis, (autonomic)† | Neutropenia |
| Course 3 | 60 | Peripheral neuropathy,† orthostasis, (autonomic)† | Neutropenia |
| Course 4 | 90 | Peripheral neuropathy,† orthostasis (autonomic)† | Neutropenia, fever without infection |
All patients inevaluable for hematologic toxicity other than neutropenia owing to baseline cytopenias; patient no. 3. off-study day 10 of therapy for progression of disease and inevaluable for neutropenia owing to subsequent chemotherapy. Toxicities in patient no. 1 (renal failure, depressed level of consciousness) observed at day 21 and multifactorial in nature.
ALT indicates serum alanine aminotransferase.
During days of forodesine infusion
Present at baseline, progressed to grade 2 with course 2, then improved with subsequent courses, suspected related to prior vincristine