Temozolomide Dosing Interruption or Discontinuation During Concomitant Radiotherapy and Temozolomide
Toxicity TMZ Interruption a TMZ Discontinuation
Absolute Neutrophil Count >/=0.5 and <1.5 × 10 9 /L <0.5 × 10 9 /L
Platelet Count >/=10 and <100 × 10 9 /L <10 × 10 9 /L
CTC Non-hematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 2 CTC Grade 3 or 4
a Treatment with concomitant TMZ could be continued when all of the following conditions were met: absolute neutrophil count >/= 1.5 × 10 9 /L; platelet count >/= 100 × 10 9 /L; CTC non-hematological toxicity </= Grade 1 (except for alopecia, nausea, vomiting).
TMZ = temozolomide; CTC = Common Toxicity Criteria.
Maintenance Phase Cycle 1:
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/m 2 once daily for 5 days followed by 23 days without treatment.
Cycles 2-6:
At the start of Cycle 2, the dose is escalated to 200 mg/m 2 , if the CTC non-hematologic toxicity for Cycle 1 is Grade </= 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is >/= 1.5 × 10 9 /L, and the platelet count is >/= 100 × 10 9 /L. The dose remains at 200 mg/m 2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Dose reduction or discontinuation during maintenance:
Dose reductions during the maintenance phase should be applied according to Tables 6 and 7 .
During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TEMODAR) or within 48 hours of that day, and weekly until the ANC is above 1.5 × 10 9 /L (1500/µL) and the platelet count exceeds 100 × 10 9 /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 non-hematologic toxicity during the previous cycle. Dose reductions or discontinuations during the maintenance phase should be applied according to Tables 6 and 7 .
Table 6 Temozolomide Dose Levels for Maintenance Treatment
Dose Level Dose (mg/m 2 /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 7 Temozolomide Dose Reduction or Discontinuation During Maintenance Treatment
Toxicity Reduce TMZ by 1 Dose Level a Discontinue TMZ
Absolute Neutrophil Count <1.0 × 10 9 /L See footnote b
Platelet Count <50 × 10 9 /L See footnote b
CTC Non-hematological Toxicity (except for alopecia, nausea, vomiting) CTC Grade 3 CTC Grade 4 b
a TMZ dose levels are listed in Table 6 .
b TMZ is to be discontinued if dose reduction to <100 mg/m 2 is required or if the same Grade 3 non-hematological toxicity (except for alopecia, nausea, vomiting) recurs after dose reduction.
TMZ = temozolomide; CTC = Common Toxicity Criteria.
Patients with Re |
