bsolute neutrophil count greater than or equal to 1.5 × 109 /L; platelet count greater than or equal to 100 × 109 /L; CTC nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, vomiting).
Absolute Neutrophil Count greater than or equal to 0.5 and less than 1.5 × 109 /L less than 0.5 × 109 /L
Platelet Count greater than or equal to 10 and less than 100 × 109 /L less than 10 × 109 /L
CTC Nonhematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 2 CTC Grade 3 or 4
TMZ = temozolomide; CTC = Common Toxicity Criteria.
* Treatment with concomitant TMZ could be continued when all of the following conditions were met: absolute neutrophil count greater than or equal to 1.5 × 109 /L; platelet count greater than or equal to 100 × 109 /L; CTC nonhematological toxicity less than or equal to Grade 1 (except for alopecia, nausea, vomiting).
Absolute Neutrophil Count greater than or equal to 0.5 and less than 1.5 × 109 /L less than 0.5 × 109 /L
Platelet Count greater than or equal to 10 and less than 100 × 109 /L less than 10 × 109 /L
CTC Nonhematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 2 CTC Grade 3 or 4
Maintenance Phase Treatment Schedule
Four weeks after completing the TEMODAR + RT phase, TEMODAR is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment. At the start of Cycle 2, the dose is escalated to 200 mg/m2 , if the CTC nonhematologic toxicity for Cycle 1 is Grade less than or equal to 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is greater than or equal to 1.5 × 109 /L, and the platelet count is greater than or equal to 100 × 109 /L. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
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. Dose reductions during the next cycle should be based on the lowest blood counts and worst nonhematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 3 and 4.
TABLE 3: Temozolomide Dose Levels for Maintenance Treatment Dose Level Dose (mg/m2 /day) Remarks
−1 100 Reduction for prior toxicity
0 150 Dose during Cycle 1
1 200 Dose during Cycles 2–6 in absence of toxicity
TABLE 4: Temozolomide Dose Reduction or Discontinuation During Maintenance Treatment Toxicity Reduce TMZ by 1 Dose Level * Discontinue TMZ
TMZ = temozolomide; CTC = Common Toxicity Criteria.
* TMZ dose levels are listed in Table 3.
† TMZ is to be discontinued if dose reduction to less than 100 mg/m2 is required or if the same Grade 3 nonhematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
Absolute Neutrophil Count less than 1.0 × 109 /L See footnote †
Platelet Count less than 50 × 109 /L See footnote †
CTC Nonhematological T |
