The drug is taken orally, on an empty stomach, not. less than 1 hour before meals. The prescribed dose should be taken using the lowest possible number of capsules. Capsules can not be opened or chewed, they should be swallowed whole, washed down with a glass of water.
The newly discovered multiform glioblastomaTreatment of adult patients (over 18 years): primary treatment conduct in combination with. radiation therapy. The drug Temozolomide is used in a dose of 75 mg / m2 daily for 42 days at the same time as radiation therapy (30 fractions in a total dose of 60 Gy). Dose reduction is not recommended, but the drug may be interrupted depending on the tolerability. Renewal of the drug is possible during the entire 42-day period of combined treatment and up to 49 days, but only subject to all the conditions listed below:
-absolute number of neutrophils is not less than 1500 / μl,
-the number of platelets - not less than 100,000 / μl,
-the general toxicity criterion (common toxicity criteria - CTC) not higher than 1 degree (except for alopecia, nausea and vomiting).
During treatment, a blood test should be performed weekly, counting the number of cells.
Recommendations for dose reduction or withdrawal of Temozolomide during the combined phase of treatment are given in Table 1.
Table 1. Recommendations for dose reduction or drug cancellation Temozolomide when combined with radiotherapy | Criterion of toxicity | Break in taking Temozolomide * | Termination of admission preparation Temozolomide | | Absolute number of neutrophils | > 500 / μL, but <1500 / μl | <500 / μL | | Platelet count | > 10000 / μL, but <100,000 / μL | <10000 / μL | | CTC non-hematological toxicity (with the exception of alopecia, nausea and vomiting) | 2 degree | 3 or 4 degree | |
|
| * Resumption of taking the drug Temozolomide it is possible if all the conditions listed below are met: the absolute number of neutrophils is not less than 1500 / μl, the number of platelets is not less than 100,000 / μl, the general toxicity criterion (CTC) is not higher than 1 degree (except for alopecia, nausea and vomiting). | |
Adjuvant therapy is appointed 4 weeks after the completion of the combination therapy and is performed in the form of 6 additional cycles.
1- th cycle: the drug Temozolomide is used in a dose of 150 mg / m2 for 5 days followed by a 23-day interruption in treatment.
2- th cycle: the dose of Temozolomide can be increased to 200 mg / m2 per day, provided that during the first treatment cycle, the severity of non-hematologic toxicity (in accordance with the STS toxicity scale) did not exceed 2 degrees (except for alopecia, nausea and vomiting) at. this absolute number of neutrophils was not less than 1500 / μl, and the number of platelets was not less than 100,000 / μl. If the dose of Temozolomide was not increased in the second cycle, it should not be increased even in subsequent cycles. If in the 2nd cycle the dose was 200 mg / m2, in the same daily dose the drug is prescribed for subsequent cycles (in the absence of toxicity). In each cycle, the preparation of Temozolomide is administered for 5 consecutive days with a subsequent 23-day break. Recommendations for dose reduction in the adjuvant phase of treatment are given in Tables 2 and 3.
On the 22nd day of treatment (21 days after taking the first dose of Thymozolomide), a blood test should be performed to count the number of cells.
Abolition or reduction of the dose of the drug Temozolomide should be carried out, guided by Table 3.
Table 2. Dose levels of the preparation Temozolomide with adjuvant therapy
| Step | Dose (mg / m / day) | Note | | -1 | 100 | Dose reduction taking into account previous toxicity (see Table 3) | | 0 | 150 | Dose during the 1st cycle | | 1 | 200 | The dose during 2-6 cycles (in the absence of toxicity) | |
Table 3. Recommendations for dose reduction or withdrawal of the drug Temozolomide with adjuvant therapy | Criterion of toxicity | Reduce the dose of the drug Temozolomide for 1 step (see Table 2) | Termination of admission preparation Temozolomide |
| Absolute number of neutrophils | <1000 / μL | * |
| Platelet count | <50000 / μL | * |
| CTC non-hematological toxicity (with the exception of alopecia, nausea and vomiting) | 3 degree | 4 degree * |
| * A drug Temozolomide should be abolished if a dose reduction of <100 mg / m2, and also in case of recurrence of non-hematological toxicity of the 3rd degree (except for alopecia, nausea and vomiting) after dose reduction. |
Progressive or recurrent malignant glioma in the form of multiform glioblastoma or anaplastic astrocytoma (treatment of adults and children over 3 years old). A common metastatic malignant melanoma (treatment of adults).
Patients who had not previously undergone chemotherapy, the drug Temozolomide is prescribed in a dose of 200 mg / m2 1 time per day for 5 consecutive days with a subsequent break in taking the drug. for 23 days (the total duration of one treatment cycle is 28 days). For patients who had previously undergone chemotherapy, the initial dose is 150 mg / m2 1 per day; in the second cycle, the dose can be increased to 200 mg / m2 per day for 5 days, provided that on the 1st day of the next cycle the absolute number of neutrophils is not less than 1500 / μl, and the number of platelets is not less than 100,000 / μl.
Recommendations for modifying the dose of the drug Temozolomide in the treatment of progressive or recurrent. malignant glioma or malignant melanoma
Start drug treatment Temozolomide it is possible only with an absolute number of neutrophils> 1500 / μL and platelets> 100,000 / μL. A complete clinical blood test should be performed on the 22nd day (the 21st day after taking, the first dose), but not later than 48 hours after that day; further - weekly, until the absolute number of neutrophils becomes youwe 1500 / mkl, and the number of platelets does not exceed 100,000 / μL. At an absolute number of neutronssludges less than 1000 / μL or. platelets less than 50,000 / μl during any treatment cycle, the dose in the next cycle should be reduced by one step. Possible doses: 100 mg / m2, 150 mg / m2 and 200 mg / m2. The minimum recommended dose is 100 mg / m2.
Duration of treatment is maximum 2 years. When there are signs of progression of the disease, the drug treatment Temozolomide should be discontinued.