djusted according to nadir neutrophil and platelet counts in the previous cycle and at the time of initiating the next cycle.
How might the dose of TEMODAR be modified for Refractory Anaplastic Astrocytoma?
Dosage of TEMODAR must be adjusted according to nadir neutrophil and platelet counts in the previous cycle and neutrophil and platelet counts at the time of initiating the next cycle. The initial dose is 150 mg/m2 orally once daily for 5 consecutive days per 28-day treatment cycle. If both the nadir and day of dosing (Day 29, Day 1 of next cycle) absolute neutrophil counts (ANC) are greater than or equal to 1.5 × 109 /L (1500/µL) and both the nadir and Day 29, Day 1 of next cycle platelet counts are greater than or equal to 100 × 109 /L (100,000/µL), the TEMODAR dose may be increased to 200 mg/m2 /day for 5 consecutive days per 28-day treatment cycle. During treatment, a complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 109 /L (1500/µL) and the platelet count exceeds 100 × 109 /L (100,000/µL). The next cycle of TEMODAR should not be started until the ANC and platelet count exceed these levels. If the ANC falls to less than 1.0 × 109 /L (1000/µL) or the platelet count is less than 50 × 109 /L (50,000/µL) during any cycle, the next cycle should be reduced by 50 mg/m2 , but not below 100 mg/m2 , the lowest recommended dose (see Table 1 below).
TABLE 1: Dosing Modification Table for Refractory Anaplastic Astrocytoma
What is the TEMODAR Capsules treatment regimen?
TEMODAR is given for 5 consecutive days on a 28-day cycle. Patients should continue taking TEMODAR until their physician determines that their disease has progressed, up to 2 years, or until unacceptable side effects or toxicities occur. Physicians may alter the treatment regimen for a given patient.
Newly Diagnosed Concomitant Phase Treatment Schedule
TEMODAR is administered orally at 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions), followed by maintenance TEMODAR for 6 cycles. No dose reductions are recommended; however, dose interruptions may occur based on patient tolerance. The TEMODAR dose can be continued throughout the 42-day concomitant period up to 49 days if all of the following conditions are met: absolute neutrophil count greater than or equal to 1.5 × 109 /L, platelet count greater than or equal to 100 ×109 /L, common toxicity criteria (CTC) nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea and vomiting). During treatment a complete blood count should be obtained weekly. Temozolomide dosing should be interrupted or discontinued during concomitant phase according to the hematological and nonhematological toxicity criteria as noted in Table 2. Pneumocystis carinii pneumonia (PCP) prophylaxis is required during the concomitant administration of TEMODAR and radiotherapy, and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (CTC grade less than or equal to 1).
TABLE 2: Temozolomide Dosing Interruption or Discontinuation During Concomitant Radiotherapy and Temozolomide
Toxicity TMZ Interruption * TMZ Discontinuation
TMZ = temozolomide; CTC = Common Toxicity Criteria.
* Treatment with concomitant TMZ could be continued when all of the following conditions were met: a |
