Epirubicin
| Evidence Level: L5 | Predicted Indications: 7 |
Table of Contents
Epirubicin: Primary pulmonary lymphoma
One-Sentence Summary
Epirubicin is an anthracycline chemotherapy drug that damages the DNA of rapidly dividing cancer cells. The TxGNN model predicts it may be useful for primary pulmonary lymphoma, but no clinical trials and no publications that directly study this use are currently available, so the prediction rests on the model alone (evidence level L5).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Primary pulmonary lymphoma |
| TxGNN Prediction Score | 0.9971 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the compiled data. Epirubicin is known as an anthracycline, a class that blocks topoisomerase II and inserts itself into DNA, which kills dividing cells. This activity is biologically plausible in lymphoid cancers, and anthracyclines appear in several lymphoma regimens.
However, the studies found do not test epirubicin in primary pulmonary lymphoma. They cover general epirubicin pharmacology, a diffuse large B-cell lymphoma regimen that uses doxorubicin rather than epirubicin, a pleural lymphoma case report, and retrospective or pilot series in other lymphomas. The standard doxorubicin-based regimen (R-CHOP) is already well established, so there is little reason to substitute epirubicin without direct evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
None of these publications studies epirubicin in primary pulmonary lymphoma. They are listed as background only.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 7686469 | 1993 | Review | Drugs | General review of epirubicin pharmacology and use in cancer chemotherapy; similar response and survival to doxorubicin regimens in several solid tumours |
| 40728626 | 2025 | Retrospective analysis | Annals of Hematology | Pola-R-CHP (contains doxorubicin) in 117 first-line DLBCL patients, including trial-ineligible and low-risk patients |
| 39192408 | 2024 | Retrospective cohort | Zhongguo Shi Yan Xue Ye Xue Za Zhi | Clinical features and prognostic factors of primary extranodal DLBCL in the rituximab era |
| 10526668 | 1999 | Cohort | The Cancer Journal from Scientific American | VEBEP plus radiotherapy in advanced Hodgkin’s disease |
| 36237246 | 2022 | Case report with review | Translational Cancer Research | Misdiagnosed primary MALT lymphoma of the pleura |
| 1866500 | 1991 | Case report | Revista de Investigación Clínica | A single case of non-Hodgkin lymphoma involving the lung |
India Market Information
At least 20 single-ingredient injectable licences are recorded, all valid; the list may be partial. Main examples:
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| 89381 | Farmorubicin RD 10mg Injection | Vial of 5 ml, injection | Pfizer Ltd |
| 82628 | Episar 10mg Injection | Vial of 1, injection | Sarabhai Chemicals Ltd |
| 11863 | Alrubicin 150mg Injection | Vial of 1, injection | Alkem Laboratories Ltd |
| 79984 | Epitero 10 Injection | Vial of 1, powder for injection | Hetero Drugs Ltd |
| 77804 | Epitaz 10mg Injection | Vial of 1, injection | Intas Pharmaceuticals Ltd |
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (anthracycline) |
| Myelosuppression Risk | High (neutropenia and thrombocytopenia are expected with anthracyclines) |
| Emetogenicity Classification | Moderate to high |
| Monitoring Items | Complete blood count with differential, liver and renal function, cardiac function (cumulative anthracycline dose) |
| Handling Protection | Follow cytotoxic drug handling regulations |
Safety Considerations
- Drug Interactions: 487 interactions were recorded. Major-level examples include cimetidine and dolasetron. Moderate-level examples include clarithromycin, levofloxacin, bupropion, famotidine and loperamide.
- Conditions of concern with this drug (from the data compiled for this report, not label text): liver failure and liver disease, kidney disease, thrombocytopenia, neutropenia, agranulocytosis, myocardial infarction, cardiomyopathy and other heart disorders, and stomatitis.
Please refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high, but no trial or publication tests epirubicin in primary pulmonary lymphoma, so the evidence level is L5. Doxorubicin-based R-CHOP is already the standard of care, and epirubicin carries cardiac and bone marrow risks.
To proceed, the following is needed:
- Direct clinical or retrospective data on epirubicin in primary pulmonary lymphoma
- Comparison with the standard doxorubicin-based regimen
- Mechanism of action data and package insert warnings and contraindications
- A cardiac and haematological monitoring plan
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.