Anorexia 14 (9) 1 (1)
Metabolic
Weight increase 8 (5) 0
Musculoskeletal System
Myalgia 8 (5)
Psychiatric Disorders
Anxiety 11 (7) 1 (1)
Depression 10 (6) 0
Reproductive Disorders
Breast pain, female 4 (6)
Resistance Mechanism Disorders
Infection viral 17 (11) 0
Respiratory System
Upper respiratory tract infection 13 (8) 0
Pharyngitis 12 (8) 0
Sinusitis 10 (6) 0
Coughing 8 (5) 0
Skin and Appendages
Rash 13 (8) 0
Pruritus 12 (8) 2 (1)
Urinary System
Urinary tract infection 12 (8) 0
Micturition increased frequency 9 (6) 0
Vision
Diplopia 8 (5) 0
Vision abnormal * 8 (5)
Blurred vision; visual deficit; vision changes; vision troubles
TABLE 9: Adverse Hematologic Effects (Grade 3 to 4) in the Anaplastic Astrocytoma Trial in Adults TEMODAR *
* Change from Grade 0 to 2 at baseline to Grade 3 or 4 during treatment.
Hemoglobin 7/158 (4%)
Lymphopenia 83/152 (55%)
Neutrophils 20/142 (14%)
Platelets 29/156 (19%)
WBC 18/158 (11%)
Change from Grade 0 to 2 at baseline to Grade 3 or 4 during treatment.
TEMODAR (Page 4 of 10)
By Merck Sharp & Dohme Corp. | Last revised: 30 June 2013
Refractory Anaplastic Astrocytoma:
Tables 8 and 9 show the incidence of adverse reactions in the 158 patients in the anaplastic astrocytoma study for whom data are available. In the absence of a control group, it is not clear in many cases whether these reactions should be attributed to temozolomide or the patients' underlying conditions, but nausea, vomiting, fatigue, and hematologic effects appear to be clearly drug-related. The most frequently occurring adverse reactions were nausea, vomiting, headache, and fatigue. The adverse reactions were usually NCI Common Toxicity Criteria (CTC) Grade 1 or 2 (mild to moderate in severity) and were self-limiting, with nausea and vomiting readily controlled with antiemetics. The incidence of severe nausea and vomiting (CTC Grade 3 or 4) was 10% and 6%, respectively. Myelosuppression (thrombocytopenia and neutropenia) was the dose-limiting adverse reaction. It usually occurred within the first few cycles of therapy and was not cumulative.
Myelosuppression occurred late in the treatment cycle and returned to normal, on average, within 14 days of nadir counts. The median nadirs occurred at 26 days for platelets (range: 21–40 days) and 28 days for neutrophils (range: 1–44 days). Only 14% (22/158) of patients had a neutrophil nadir and 20% (32/158) of patients had a platelet nadir, which may have delayed the start of the next cycle. Less than 10% of patients required hospitalization, blood transfusion, or discontinuation of therapy due to myelosuppression.
advertisementIn clinical trial experience with 110 to 111 women and 169 to 174 men (depending on measurements), there were higher rates of Grade 4 neutropenia (ANC less than 500 cells/µL) and thrombocytopenia (less than 20,000 cells/µL) in women than men in the first cycle of therapy (12% vs. 5% and 9% vs. 3%, respectively).
In the entire safety database for which hematologic data exist (N=932), 7% (4/61) and 9.5% (6/63) of patients over age 70 experienced Grade 4 neutropenia or thrombocytopenia in the first cycle, respectively. For patients less than or equ |
