Table 2.
Hematologic and nonhematologic toxicities occurring during any treatment cyclea
| Events/Patients |
|||
|---|---|---|---|
| Hematologic toxicities | Grade 2b | Grade 3 | Grade 4 |
| Anemia | 24/13 | 1/1 | 0/0 |
| Leukopenia | 46/20 | 29/13 | 6/3 |
| Lymphopenia | 43/12 | 18/11 | 1/1 |
| Neutropenia | 33/20 | 33/15 | 15/10 |
| Thrombocytopenia | 50/24 | 19/12 | 9/6 |
| Events/Patients |
|||
|---|---|---|---|
| Nonhematologic toxicities | Grade 2b | Grade 3 | Grade 4 |
| Anorexia | 16/12 | ||
| CD4 lymphocytes decreased | 1/1 | 0/0 | |
| Dehydration | 3/3 | 0/0 | |
| Diarrhea | 33/20 | 9/9 | 0/0 |
| Esophagitis | 1/1 | 0/0 | |
| Fatigue | 53/27 | 8/7 | 0/0 |
| Febrile neutropenia | 2/2 | 0/0 | |
| Hypoglycemia | 2/1 | 0/0 | |
| Hypotension | 1/1 | 0/0 | |
| Infection: blood (normal ANC) | 0/0 | 1/1 | |
| Infection: peripheral nerve (zoster)c | 2/2 | 0/0 | |
| Mucosal Infection | 1/1 | 0/0 | |
| Mucositis oral/pharyngeal | 1/1 | 0/0 | |
| Muscle weakness LE | 1/1 | 0/0 | |
| Myalgia | 1/1 | 0/0 | |
| Nausea | 10/9 | 1/1 | 0/0 |
| Neuropathy: sensory | 11/9 | 5/5 | 1/1 |
| Neuropathy: motor | 1/1 | 0/0 | |
| Oral dysesthesia | 1/1 | 0/0 | |
| Pain: Abdomen | 1/1 | 0/0 | |
| Pain: Back | 1/1 | 0/0 | |
| Pain: Bone | 1/1 | 0/0 | |
| Pain: Extremity | 3/3 | 0/0 | |
| Pain: Kidney | 1/1 | 0/0 | |
| Pain-neuralgia/peripheral nerve | 3/2 | 0/0 | |
| Pneumonia | 1/1 | 0/0 | |
| Syncope | 1/1 | 0/0 | |
| Tumor Lysis Syndrome | 1/1 | 0/0 | |
| Weight loss | 1/1 | 0/0 | |
a
Only those toxicities deemed possibly, probably, or definitely related to the treatment are included in the table.
b
Only grade 2 toxicities that occurred in at least 20% of the patients are reported.
c
Cases appeared prior to a protocol amendment dated Jan 2005, which included use of prophylactic antiviral treatment for herpes zoster.