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Epirubicin (Epirubicin Hydrochloride) - Summary

 



WARNING

  1. Severe local tissue necrosis will occur if there is extravasation during administration (See PRECAUTIONS). Epirubicin must not be given by the intramuscular or subcutaneous route.

  2. Myocardial toxicity, manifested in its most severe form by potentially fatal congestive heart failure (CHF), may occur either during therapy with epirubicin 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 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.

  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-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years and 0.55% at 8 years.

  4. Dosage should be reduced in patients with impaired hepatic function (see DOSAGE AND ADMINISTRATION).

  5. Severe myelosuppression may occur.

  6. Epirubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.

 

EPIRUBICIN SUMMARY

EPIRUBICIN HYDROCHLORIDE INJECTION
Rx only

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

Epirubicin 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 all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Epirubicin

Secretary Sebelius Statement On New Breast Cancer Recommendations
Source: Health News from Medical News Today [2009.11.19]
HHS Secretary Kathleen Sebelius issued the following statement today on new breast cancer screening recommendations from the U.S. Preventive Services Task Force: "There is no question that the U.S. Preventive Services Task Force Recommendations have caused a great deal of confusion and worry among women and their families across this country. I want to address that confusion head on. The U.S.


Breast Cancer Campaign: New Breast Cancer Research Funding For Belfast
Source: Health News from Medical News Today [2009.11.19]
Individualised radiotherapy treatment based on a person's genetic make up could soon become a reality, according to Breast Cancer Campaign. Professor Kevin Prise from Queen's University Belfast has been awarded a three year project grant by the charity to study how genes are involved in the effectiveness of radiotherapy treatment for breast cancer.


Some Physicians Say New Breast Cancer Screening Guidelines Unlikely To Alter Their Practices
Source: Health News from Medical News Today [2009.11.19]
One day after the release of new breast cancer screening guidelines, many physicians and some medical groups are saying that they do not plan to adopt the new recommendations -- which represent a drastic change -- the New York Times reports (Belluck, New York Times, 11/18). The guidelines, released by the U.S.


Radiation Breakthrough Gives Breast Cancer Patients Hope In Single Dose
Source: Breast Cancer News From Medical News Today [2009.11.19]
A radiation breakthrough to treat breast cancer patients in one day, as opposed to the current average of six weeks, has arrived at Cancer Treatment Centers of America(R) (CTCA) in Philadelphia. CTCA will become the first in the country to offer this treatment option using the Novac7 technology from Rome, Italy.

Breast Cancer Screening: New Fuel for an Old War of Words and Data
Source: MedPageToday.com - medical news plus CME for physicians [2009.11.19]
A controversy that has alternately simmered and boiled for more than 40 years reached a flash point this week when the U.S. Preventive Services Task Force published recommendations for breast cancer screening with mammography.

more news >>

Published Studies Related to Epirubicin

Randomized trial of cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil with node-positive breast cancer in Japan. [2009.07.03]
BACKGROUND: To compare the cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy and the anthracycline-containing regimen cyclophosphamide, epirubicin, and fluorouracil (CEF) to evaluate the efficacy and safety of the latter... CONCLUSION: Whereas CEF had a good trend compare with CMF, it could not be proven statistically significant. The principal cause of the failure seems to be insufficient power, that is, the dose intensity (EPI: 60 mg/m(2)) set 10 years ago, when the trial began, was low, and the number of trial subjects was small because of the background of the times, which made the accumulation of cases extremely difficult. However, the trial should be considered to be meaningful, as it was the first, formally conducted controlled trial on chemotherapy in Japan.

Comparison of 6 cycles versus 4 cycles of neoadjuvant epirubicin plus docetaxel chemotherapy in stages II and III breast cancer. [2009.06]
BACKGROUND: This phase III clinical study was designed to investigate whether 6 cycles of epirubicin plus docetaxel (ED) is more effective than 4 cycles of ED as neoadjuvant chemotherapy (NC) in patients with stage II or III breast cancer... CONCLUSION: Six cycles of ED enhanced the rates of pCR and BCS compared with 4 cycles without increasing treatment-related toxicities.

Long-term benefit of high-dose epirubicin in adjuvant chemotherapy for node-positive breast cancer: 15-year efficacy results of the Belgian multicentre study. [2009.02.10]
PURPOSE: The 4-year results of this trial demonstrated that a higher dose of epirubicin with cyclophosphamide (HEC) is superior to a lower dose of epirubicin, 60 mg/m(2) (EC), for event-free survival (EFS; 27% reduction), but is not superior to classical oral cyclophosphamide, methotrexate, and fluorouracil (CMF) in the adjuvant treatment of node-positive breast cancer. Herein we report the 15-year data on efficacy and long-term toxicity of this three-arm Belgian multicenter trial... CONCLUSION: Treatment with HEC demonstrated superior EFS when compared with lower-dose epirubicin. However, we do not recommend the use of HEC regimen in daily clinical practice, mainly because of the higher risk of cardiotoxicity related to the cumulative doses of epirubicin and the lack of superiority of anthracyclines over CMF in our study.

EPO in combination with G-CSF improves mobilization effectiveness after chemotherapy with ifosfamide, epirubicin and etoposide and reduces costs during mobilization and transplantation of autologous hematopoietic progenitor cells. [2009.02]
A successful stem cell harvest is a prerequisite for peripheral blood SCT. We investigated the number of CD34(+) cells mobilized, the number of leukaphereses needed and the expenses of treatment for 28 patients with multiple myeloma randomly assigned to receive either G-CSF alone or G-CSF+EPO for stem cell mobilization after chemotherapy with ifosfamide, epirubicin and etoposide...

Gemcitabine plus conventional-dose epirubicin versus gemcitabine plus cisplatin as first-line chemotherapy for stage IIIB/IV non-small cell lung carcinoma--a randomized phase II trial. [2008.12]
BACKGROUND: Epirubicin was effective for the treatment of non-small cell lung carcinoma (NSCLC). This study compared the efficacy and safety of gemcitabine plus conventional-dose epirubicin (GE) with gemcitabine-cisplatin (GC) as first-line chemotherapy for stage IIIB/IV NSCLC and evaluated the predictive value of nuclear expression of excision repair cross-complementing group 1 (ERCC1) and topoisomerase IIalpha (TopoIIalpha) on treatment outcome... CONCLUSION: GE regimen is effective and well-tolerated for NSCLC patients. Expression of both ERCC1 and TopoIIalpha may be associated with poor response to chemotherapy.

more studies >>

Clinical Trials Related to Epirubicin

Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer [Terminated]
The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.

Study of Docetaxel in Breast Cancer Patients [Completed]
Primary objectives:

- To compare the disease free survival (DFS) in patients treated with the sequential

epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin

Secondary objectives:

- To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and

CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen

- To evaluate the overall survival in each arm

- To evaluate the tolerability of a sequential intensified

epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)

- To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen

versus a standard sequential epidoxorubicin/CMF regimen (arm A)

Epirubicin and Cyclophosphamide Compared With Epirubicin and Paclitaxel in Treating Women With Metastatic Breast Cancer [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of epirubicin and cyclophosphamide with epirubicin and paclitaxel in treating women with metastatic breast cancer.

Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer [Terminated]
The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.

Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer [Active, not recruiting]
The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.

more trials >>

Page last updated: 2009-11-19

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