Overview
An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA.
Indication
For use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer.
Associated Conditions
- Breast Cancer
- Breast Cancer, Stage II
- Breast Cancer, Stage III
- Colorectal Cancer
- Hormone-Refractory Prostate Cancer
- Neoplasm of Stomach
- Non-Small Cell Lung Carcinoma
- Ovarian Cancer
- Papillary transitional cell carcinoma of bladder
- Recurrent Superficial Bladder Cancer
- Small Cell Lung Cancer (SCLC)
- Soft Tissue Sarcoma
- Carcinoma in situ of urinary bladder
Research Report
Epirubicin (DB00445): A Comprehensive Monograph
Executive Summary
Epirubicin is a semisynthetic anthracycline antibiotic that serves as a cornerstone agent in modern oncologic practice.[1] Classified as a small molecule, it is primarily employed as a cytotoxic chemotherapy drug, most notably in the adjuvant treatment of breast cancer in patients with axillary node involvement following surgical resection.[1] Its core mechanism of action is multifaceted, centered on its function as a topoisomerase II inhibitor and a potent DNA intercalator. By forming a stable complex with DNA and inhibiting key enzymatic processes, Epirubicin effectively disrupts DNA and RNA synthesis, leading to the programmed death of rapidly proliferating cancer cells.[1]
A defining characteristic of Epirubicin is its unique stereochemistry; it is the 4'-epi-isomer of the widely used anthracycline, doxorubicin.[1] This specific spatial orientation of a hydroxyl group on the daunosamine sugar moiety fundamentally alters its metabolic profile and pharmacokinetic disposition, resulting in faster systemic clearance and a comparatively more favorable toxicity profile.[4] This structural modification is particularly associated with reduced cardiotoxicity, a major dose-limiting factor for the anthracycline class.[4]
Despite its improved safety profile relative to doxorubicin, Epirubicin therapy is associated with significant and predictable toxicities that require diligent management. The principal dose-limiting toxicities are acute, reversible myelosuppression, manifesting as severe neutropenia and leukopenia, and a cumulative, dose-dependent cardiotoxicity that can lead to potentially fatal congestive heart failure months to years after treatment completion.[5] Furthermore, a recognized long-term risk is the development of secondary malignancies, including acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).[8]
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2017/09/05 | Phase 2 | Completed | |||
2017/04/21 | Phase 4 | UNKNOWN | Zhejiang University | ||
2017/01/30 | Phase 3 | Active, not recruiting | |||
2017/01/19 | Phase 2 | Recruiting | Groupe Hospitalier Diaconesses Croix Saint-Simon | ||
2017/01/16 | Not Applicable | UNKNOWN | Hebei Medical University Fourth Hospital | ||
2017/01/06 | Phase 3 | Completed | |||
2016/12/30 | Phase 3 | UNKNOWN | Shi Yanxia | ||
2016/12/08 | Phase 1 | UNKNOWN | |||
2016/11/22 | Phase 3 | UNKNOWN | Shanghai Zhongshan Hospital | ||
2016/10/31 | Phase 2 | UNKNOWN | Jinling Hospital, China |
FDA Drug Approvals
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EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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