Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.
TMZL(RT)-TMZL
Palliative
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
For the treatment of newly diagnosed glioblastoma multiforme, concurrently with radiation and post-radiation
temozolomide
ODB - General Benefit
(temozolomide)
Concurrently with Radiation:
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temozolomide 1 | 75 mg /m² | PO | Daily up to 6 weeks during radiotherapy |
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4 Weeks Post-Radiation: |
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temozolomide 1,2 | 150-200 mg /m² | PO | Daily for 5 days |
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(1) PO capsules available as outpatient prescription in multiples of 5mg, 20mg, 100mg, 140mg and 250mg. |
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Moderate – Consider prophylaxis daily (>75 mg/m2 OR ≤75 mg/m2/day + RT)
Low – No routine prophylaxis; PRN recommended (≤75 mg/m2/day)
Other Supportive Care:
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Antiemetic therapy is recommended prior to or following administration of temozolomide, especially for patients with emesis.
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Prophylaxis against Pneumocystis carinii pneumonia (PCP) required especially for patients during concomitant phase with radiotherapy.
Also refer to CCO Antiemetic Recommendations.
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.
Dosage with toxicity
Dose Modification for Newly Diagnosed-Concurrent RT:
- No specific dose reductions are recommended for concurrent RT phase.
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Table 1: Modifications during concurrent treatment |
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ANC (109/L) |
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Platelets (109/L) |
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Non-hematologic toxicity# |
Action during RT |
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≥0.5 to <1.5 |
OR |
≥10 to <100 |
OR |
Grade 2 |
Hold until recovery and then restart |
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< 0.5 |
OR |
<10 |
OR |
≥ Grade 3, including pneumonitis or severe rash |
Discontinue during RT |
| Hepatotoxicity | Assess risk/benefit before continuing treatment | ||||
| Hepatitis B | Discontinue if active disease or reactivation | ||||
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# except for alopecia, nausea, vomiting |
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- Dose levels are 200, 150 and 100 mg/m2
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Table 2: modifications for worst toxicity in previous cycle |
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ANC (109/L) |
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Platelets (109/L) |
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Non-hematologic toxicity# |
Dose for Next Cycle ** |
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<1
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OR
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< 50 |
OR
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Grade 3 |
Reduce by 1 dose level* |
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-
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OR
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-
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OR
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Grade 4 or Recurrent Grade 3 or pneumonitis or severe rash |
Discontinue
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| Hepatotoxicity | Assess risk/benefit before continuing treatment | ||||
| Hepatitis B | Discontinue if active disease or reactivation | ||||
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# except for alopecia, nausea, vomiting
* Discontinue if < 100mg/m2 ** New cycles of temozolomide should not be started until ANC is ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L and patient has recovered from ≥ grade 3 organ toxicity.
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Hepatic Impairment
No formal studies have been performed. Population pharmacokinetics appear unchanged in patients with mild to moderate hepatic impairment. Patients with severe hepatic impairment should be monitored closely and consideration given to dose modification.
Renal Impairment
No formal studies have been performed. Population pharmacokinetics appear unchanged in patients with mild-moderate renal impairment. Patients with severe renal impairment should be monitored closely and consideration given to dose modification.
Refer to temozolomide drug monograph(s) for additional details of adverse effects
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Most Common Side Effects |
Less Common Side Effects, but may be Severe or Life-Threatening |
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Refer to temozolomide drug monograph(s) for additional details
Recommended Clinical Monitoring
- CBC; Baseline then weekly for concurrent RT; Baseline then on day 1 and 22 (for q28d cycles)
- Liver function tests; Baseline then at mid-cycle (42-day cycle); Baseline then each cycle (28-day cycles)
- Hepatitis B screening; Baseline. If active, do not treat with temozolomide. If not active, monitor every 1-2 cycles for reactivation & continue for 6 months after treatment discontinuation.
- Clinical toxicity assessment including fatigue, constipation, infections (including opportunistic such as PCP and Hepatitis B), bleeding, nausea and vomiting, pneumonitis, hypersensitivity, thromboembolism, skin and respiratory toxicity; Regular
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Temozolomide drug monograph, Cancer Care Ontario, April 2015.
Stupp R, Mason WP, Van Den Bent MJ et al. Radiotherapy plus Concomitant and Adjuvant Temozolomide for Glioblastoma. NEJM. March 10 2005; 352; 987-96.
June 2021 temozolomide is ODB General Benefit
Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
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