Temozolomide
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
- Temozolomide
- Pharmacist Assessment Report
- Temozolomide: From Glioma (Astrocytoma and Glioblastoma) to Cauda Equina Neoplasm
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Cytotoxicity
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Temozolomide: From Glioma (Astrocytoma and Glioblastoma) to Cauda Equina Neoplasm
One-Sentence Summary
Temozolomide is an oral alkylating chemotherapy drug. The knowledge graph records it for anaplastic astrocytoma, astrocytoma (excluding glioblastoma) and brain glioblastoma. The TxGNN model predicts it may be useful for cauda equina neoplasm, but there are no registered clinical trials and only 3 publications (all case reports, with just one directly relevant), so the evidence is very limited.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Anaplastic astrocytoma, astrocytoma (excluding glioblastoma) and brain glioblastoma (relations recorded in the knowledge graph; the Australian licence record contains no approved indication text) |
| Predicted New Indication | Cauda equina neoplasm |
| TxGNN Prediction Score | 0.9930 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. In general, temozolomide is an oral alkylating agent that methylates DNA (notably at O6-guanine), causing cytotoxic lesions and cell death. It is generally more active in tumours with low MGMT expression (for example, MGMT promoter methylation). This description comes from general pharmacological knowledge, not from the supplied record.
The TxGNN model (deep learning) gives cauda equina neoplasm a score of 0.9930. This score comes from the model and may reflect similarities the model learned between related diseases, not biological evidence.
The TxGNN score is a computational prediction only and does not replace clinical evidence. No MGMT status data for these tumours were available.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29270703 | 2018 | Case report | Eur Spine J | Temozolomide showed remarkable efficacy in a relapsed spinal myxopapillary ependymoma with multiple recurrences and cerebrospinal dissemination |
| 42760727 | 2026 | Case report | Medicine | Nasal NUT carcinoma managed with multimodal treatment including radiotherapy; not specific to cauda equina tumours |
| 18706663 | 2009 | Case report | Neuro-Chirurgie | Neuromeningeal cryptococcosis in a child treated for pontine glioma; not relevant to cauda equina tumours |
Note: The first case report concerns a spinal myxopapillary ependymoma, a tumour type that arises in the cauda equina region. It is a single case and does not directly study cauda equina neoplasm as a defined disease. The other two reports do not address this condition. For this reason the evidence level is capped at L5.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 10062N | APO-Temozolomide | Capsule 180 mg | Not stated in the licence record |
The listing is a single-ingredient oral product (1 valid entry).
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (alkylating agent) |
| Myelosuppression Risk | Please refer to the Product Information (PI) warnings and precautions. The knowledge graph lists blood-related conditions among its contraindication relations (see below). |
| Emetogenicity Classification | Please refer to the Product Information (PI) warnings and precautions |
| Monitoring Items | Haematological parameters (FBC with differential), liver function; confirm details in the PI |
| Handling Protection | Follow local cytotoxic drug handling requirements |
Safety Considerations
- Contraindication relations recorded in the knowledge graph (not label text): liver failure, thrombocytopenia, neutropenia, agranulocytosis, anaemia, macrocytic anaemia, pneumocystosis, pancytopenia, lymphopenia, myelodysplastic syndrome, idiopathic aplastic anaemia and aplastic anaemia.
- Drug Interactions: 100 interactions were found in the DDI database. The ones listed are mostly of unknown severity. The graded ones are naltrexone (Moderate) and levofloxacin (Minor). Others listed include pantoprazole, omeprazole, lansoprazole, metformin, morphine, prednisone, hydrocortisone and amphotericin B.
Please refer to the TGA-approved Product Information (PI) for authoritative warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is supported only by a computational score and a single case report in a related tumour type. There are no registered trials, and no cited study directly addresses cauda equina neoplasm as a disease, so the evidence level is L5. The safety profile also cannot be assessed here because label warnings are unavailable.
To proceed, the following is needed:
- Review of the TGA Product Information for warnings, contraindications and approved indications
- Mechanism of action data and, ideally, MGMT status data for cauda equina tumours
- Systematic literature review or case series of temozolomide in myxopapillary ependymoma and other cauda equina tumours
- A defined plan for blood count monitoring and for cytotoxic drug handling
- Registration of a prospective study or an expert-panel review before any clinical consideration
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.