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Epirubicin (Epirubicin Hydrochloride) - Summary

 
 



WARNING: RISK OF TISSUE NECROSIS, CARDIAC TOXICITY, SECONDARY ACUTE MYELOGENOUS LEUKEMIA, AND MYELOSUPPRESSION

  1. Severe local tissue necrosis will occur if there is extravasation during administration. Epirubicin hydrochloride injection must not be given by the intramuscular or subcutaneous route [see Warnings and Precautions (5.9)].
  2. Cardiac toxicity, including fatal congestive heart failure (CHF), may occur either during therapy with epirubicin hydrochloride injection or months to years after termination of therapy. The probability of developing clinically evident CHF is estimated as approximately 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of epirubicin hydrochloride injection in excess of 900 mg/m2; this cumulative dose should only be exceeded with extreme caution. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Cardiac toxicity with epirubicin hydrochloride injection may occur at lower cumulative doses whether or not cardiac risk factors are present [see Warnings and Precautions (5.3)].
  3. Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including epirubicin. The occurrence of refractory secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The cumulative risk of developing treatment-related AML or myelodysplastic syndrome (MDS), in 7110 patients with breast cancer who received adjuvant treatment with epirubicin hydrochloride injection-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years [see Warnings and Precautions (5.4)].
  4. Severe myelosuppression may occur [see Warnings and Precautions (5.2)].
 

EPIRUBICIN SUMMARY

Epirubicin hydrochloride injection is an anthracycline cytotoxic agent, intended for intravenous administration.

Epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [ see Clinical Studies (14.1) ].


See all Epirubicin indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Epirubicin

Oncotype DX Impacts Chemotherapy Decisions in Breast Cancer
Source: Medscape Hematology-Oncology Headlines [2015.08.28]
A large cohort study demonstrated that Oncotype DX testing was associated with less frequent chemotherapy use in high-risk patients, but more frequent use in low-risk women.
Medscape Medical News

Medical News Today: Breast cancer relapse could be predicted with new blood test
Source: Featured Health News from Medical News Today [2015.08.27]
A new study reports that a so-called ‘mutation-tracking' blood test can pick up valuable signs of cancer’s potential return, offering hope to patients with the disease.

Breast cancer relapse could be predicted with new blood test
Source: Blood / Hematology News From Medical News Today [2015.08.27]
A new study reports that a so-called ‘mutation-tracking' blood test can pick up valuable signs of cancer’s potential return, offering hope to patients with the disease.

New 'mutation-tracking' blood test could predict breast cancer relapse months in advance
Source: Blood / Hematology News From Medical News Today [2015.08.27]
Scientists have developed a blood test for breast cancer able to identify which patients will suffer a relapse after treatment, months before tumours are visible on hospital scans.

21-gene recurrence score and receipt of chemotherapy in patients with breast cancer
Source: Breast Cancer News From Medical News Today [2015.08.27]
Use of the 21-gene recurrence test score was associated with lower chemotherapy use in high-risk patients and greater use of chemotherapy in low-risk patients compared with not using the test among...

more news >>

Published Studies Related to Epirubicin

Randomized, phase III trial of sequential epirubicin and docetaxel versus epirubicin alone in postmenopausal patients with node-positive breast cancer. [2011.08.20]
PURPOSE: The Docetaxel Epirubicin Adjuvant (DEVA) trial evaluated the efficacy and toxicity of incorporating docetaxel after epirubicin to create a sequential anthracycline-taxane regimen in early breast cancer... CONCLUSION: These results suggest, within a relatively small trial, that substitution of docetaxel for epirubicin for the last three cycles of chemotherapy results in improved outcome in postmenopausal women with node-positive, early breast cancer compared with six cycles of epirubicin monotherapy.

Epirubicin and paclitaxel with G-CSF support in first line metastatic breast cancer: a randomized phase II study of dose-dense and dose-escalated chemotherapy. [2011.07]
An increased dose-intensity can be achieved by either higher dose of chemotherapy per cycle (dose-escalation) or by shortening the interval between cycles (dose-dense). This multicenter randomized phase II study assessed the efficacy and safety of two different approaches: epirubicin 110 mg/m(2) combined with paclitaxel 200 mg/m(2) every 21 days and epirubicin 75 mg/m(2) combined with paclitaxel 175 mg/m(2) every 10 days, both supported with G-CSF...

Predictive and prognostic impact of TP53 mutations and MDM2 promoter genotype in primary breast cancer patients treated with epirubicin or paclitaxel. [2011.04.27]
CONCLUSION: TP53 and CHEK2 mutations were associated with lack of response to epirubicin monotherapy. In contrast, TP53 mutations and MDM2 309G allele status conferred poor disease-specific survival among patients treated with primary paclitaxel but not epirubicin monotherapy.

A multicenter prospective phase II randomized trial of epirubicin/vinorelbine versus pegylated liposomal doxorubicin/vinorelbine as first-line treatment in advanced breast cancer. A GOIM study. [2011.04.12]
BACKGROUND: To evaluate activity and tolerability of two anthracycline-containing regimens as first-line treatment for anthracycline-naive relapsed breast cancer patients... CONCLUSIONS: Both anthracycline- containing regimens evaluated in the present study seem to be active and with a satisfactory tolerability in anthracycline-naive relapsed breast cancer patients.

Docetaxel and epirubicin compared with docetaxel and prednisone in advanced castrate-resistant prostate cancer: a randomised phase II study. [2011.02.15]
BACKGROUND: This randomised phase II study compared the activity and safety of the combination docetaxel (D)/epirubicin (EPI) with the conventional treatment D/prednisone (P) in advanced castrate-resistant prostate cancer (CRPC) patients... CONCLUSION: The treatment of advanced CRPC with weekly D combined with weekly EPI was feasible and tolerable, and led to superior PFS than the treatment with 3-weekly D and oral P.

more studies >>

Clinical Trials Related to Epirubicin

Epirubicin and Vinorelbine in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer [Terminated]
RATIONALE: Drugs used in chemotherapy, such as epirubicin and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin together with vinorelbine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving epirubicin together with vinorelbine works in treating patients with stage II, stage III, or stage IV breast cancer.

A Phase I, Open-label, Study of Pazopanib in Combination With Epirubicin or Doxorubicin for Advanced Solid Tumors [Completed]
This is an open-label, four-arm, Phase I, dose escalation study to evaluate the safety and tolerability and to determine the optimal tolerated regimen (OTR) of pazopanib in combination with epirubicin or doxorubicin in patients with advanced solid tumors. Patients will be enrolled in cohorts of 3 to receive escalating doses of pazopanib and epirubicin or doxorubicin. Dose escalation schemas for each study arm are described in the protocol. For each arm, the OTR will be defined as the highest dose combination of the agents where no more than one out of six patients experiences a dose-limiting toxicity. Twelve additional patients in each arm will be studied with the OTR to evaluate toxicity and pharmacokinetics. This will allow an assessment of potential drug-drug interactions. Antitumor activity will be assessed using RECIST criteria.

Dinaciclib and Epirubicin Hydrochloride in Treating Patients With Metastatic Triple-Negative Breast Cancer [Active, not recruiting]
This phase I clinical trial studies the side effects and the best dose of dinaciclib when given together with epirubicin hydrochloride (epirubicin) in patients with metastatic (cancer that has spread to other parts of the body) triple-negative breast cancer. Dinaciclib is designed to stop cancer cells from dividing into new cancer cells. Epirubicin is designed to block the way cancer cells grow and divide and may slow or stop cancer cells from spreading throughout the body. Researchers want to find out what is the highest tolerable dose of the experimental drug dinaciclib that can be given in combination with epirubicin in patients with metastatic triple negative breast cancer.

Predictors for Response to Dose-dense Docetaxel and Epirubicin Breast Cancer [Recruiting]
Molecular markers predicting response to dose dense chemotherapy with epirubicin and docetaxel in sequence for locally advanced breast cancer Protocol summary. Principal Investigator Per E Lonning, Professor, Section of Oncology, Department of Medicine

Collaborators. Dept of Surgery - Responsible: Turid Aas, Consultant Surgeon Dept of

Molecular Biology - Responsible: Professor Johan Lillehaug Dept of Anatomy and Cellular

Biology - Responsible: Professor Rolf Bjerkvig

Participants. Dept of Oncology Gun Anker, Consultant Oncologist Stephanie Geisler, Consultant Oncologist Jurgen Geisler, Consultant Oncologist Type of Study Phase II, Translational research Scientific aims: Addressing factors predicting response to dose intensive epirubicin followed by docetaxel sequential therapy Treatment regimen: epirubicin 60 mg/m2 on a 2 weekly basis x 4 followed by docetaxel 100 mg/m2 2-weekly x 4. Patients: Breast cancer patients below 65 years of age suffering from large (>4 cm largest diameter, non-inflammatory and / or N2-N3) primary breast cancer. . Clinical aim: Assessing responsiveness to this dose intensive regimen.

Number of patients to be enrolled: 60 - 100

Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer [Completed]
In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

more trials >>

Reports of Suspected Epirubicin Side Effects

Neutropenia (25)Amenorrhoea (18)Dyspnoea (17)Febrile Neutropenia (16)Pyrexia (15)Nausea (12)Vomiting (10)Arthralgia (10)Leukopenia (10)Death (9)more >>


Page last updated: 2015-08-28

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