Malignant breast cancer is characterized by out-of-control growth of breast cells. The female breast is composed of glands that produce milk called lobules; ducts, which transport milk to the nipple; and stroma, which include both connective and fatty tissue surrounding the lymph nodes and blood vessels.
Patients may develop cancer in different parts of the breast, with symptoms that may include breast lumps or masses, swelling in all or part of the breast, skin irritation or dimpling, breast or nipple pain, nipple retraction, nipple discharge other than breast milk, or redness, scaliness, or thickening of the nipple or breast skin. The most common type of breast cancer begins in the ducts.
Breast cancer — both invasive and non-invasive — was diagnosed in about 291,000 women and 2,350 men in 2015 in the U.S., according to the American Breast Cancer Foundation.
Following diagnosis, patients with breast cancer discuss treatment options with a cancer care team. Breast cancer treatment is divided into two categories. Local treatments like surgery or radiation therapy are focused on treating the tumor without affecting the rest of the body, while systemic treatments are meant to reach cancer cells anywhere in the body, and include chemotherapy, hormone therapy, targeted therapy, and bone-directed therapy.
How Epirubicin Hydrochloride (Ellence) Works
Epirubicin hydrochloride, an anti-cancer and chemotherapy drug, is classified as an anthracyline antitumor antibiotic. Currently used only for the treatment of breast cancer and usually as part of adjuvant therapy, epirubicin hydrochloride is administered intravenously with a needle placed into the arm or directly in the chest via a port. This process needs to be carefully performed since epirubicin hydrochloride is also a vesicant, which means that it can extensively damage the tissue if it escapes from the vein.
The mechanism of action of epirubicin hydrochloride is similar to other anthracyclines like adriamycin, daunorubicin, Doxil, or mitoxantrone. The drug works by attacking and damaging the DNA in the cancer cells, making it unable to divide and reproduce and, consequently, resulting in the death of cancer cells.
According to the National Cancer Institute (NCI) Drug Dictionary, epirubicin hydrochloride is defined as: “The hydrochloride salt of the 4′-epi-isomer of the anthracycline antineoplastic antibiotic doxorubicin. Epirubicin intercalates into DNA and interacts with topoisomerase II, thereby inhibiting DNA replication and repair and RNA and protein synthesis. This agent also produces toxic free-radical intermediates and interacts with cell membrane lipids causing lipid peroxidation.”
The dosage of epirubicin hydrochloride is defined by the oncology medical team, depending on the patient’s height and weight, general health or other health problems, as well as the type of breast cancer and additional treatments recommended.
Epirubicin Hydrochloride (Ellence) for Breast Cancer
Epirubicin hydrochloride was approved by the U.S. Food and Drug Administration (FDA) in 1999, and is commercialized by Pharmacia & Upjohn under the brand name Ellence. It is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement for primary breast cancer, which means that it is used in breast cancer patients whose tumors have spread to the lymph nodes and have had surgery. In some cases, it can also be used instead of the drug doxorubicin.
The drug is provided as a sterile, translucent red solution and it is available in polypropylene vials with 50 and 200 mg of epirubicin hydrochloride as a preservative-free, ready-to-use solution.
The approval of epirubicin hydrochloride was based on the results from two randomized, open-label, multi-center studies known as MA-5 and GFEA-05. They included a total of 1,281 women with breast cancer and evaluated the use of ELLENCE Injection 100 to 120 mg/m 2 in combination with cyclophosphamide and fluorouracil for the adjuvant treatment of patients with axillary-node-positive breast cancer and no evidence of distant metastatic disease.
The same research revealed that epirubicin hydrochloride can cause gastrointestinal side effects like nausea, vomiting, diarrhea, and stomatitis, as well as potential neutropenic complications.
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