Breast cancer is a malignant disease when cells in the breast start to grow out of control, causing symptoms such as a breast lump or mass, swelling of all or part of a breast, skin irritation or dimpling, breast or nipple pain, nipple retraction, redness, scaliness, or thickening of the nipple or breast skin, and nipple discharge other than breast milk. Women are disproportionately affected by malignant breast cancer, with both invasive and non-invasive varieties diagnosed in about 291,000 women and 2,350 men in 2015 in the U.S., according to the American Breast Cancer Foundation.

Surgery and radiation therapy for breast cancer are classified as local treatments, since they are focused on treating the cancer without harming other parts of the body, while systemic treatments like chemotherapy, hormone therapy, targeted therapy, and bone-directed therapy are focused on the use of drugs to reach cancer cells anywhere in the body. Albumin-bound paclitaxel and docetaxel are the two most common types of chemotherapy drugs used for the treatment of breast cancer.

How Docetaxel (Taxotere) Works

Docetaxel is a chemotherapy drug described by the National Cancer Institute (NCI) Drug Dictionary as a “semi-synthetic, second-generation taxane derived from a compound found in the European yew tree Taxus baccata. Docetaxel displays potent and broad antineoplastic properties; it binds to and stabilizes tubulin, thereby inhibiting microtubule disassembly, which results in cell-cycle arrest at the G2/M phase and cell death. This agent also inhibits pro-angiogenic factors such as vascular endothelial growth factor (VEGF) and displays immunomodulatory and pro-inflammatory properties by inducing various mediators of the inflammatory response.”

The drug is used either alone or in combination with other drugs for the treatment of breast cancer; advanced adenocarcinoma of the stomach or gastroesophageal junction; non-small cell lung cancer in patients whose cancer is locally advanced or has metastasized; metastasized prostate cancer that is hormone-refractory; and locally advanced squamous cell carcinoma of the head and neck that cannot be treated with surgery.

Despite being widely used, it can cause side effects like a low white blood cell count, anemia, bruising, fatigue, hair loss, fluid build-up, rash, discolored fingernails, soreness, redness and peeling on the palms of the hands and soles of the feet, sore mouth, diarrhea, numbness and tingling in the hands and feet, allergic reactions, and watery eyes.

Docetaxel (Taxotere) for Breast Cancer

Docetaxel was approved by the U.S. Food and Drug Administration (FDA) in 2004, and it is commercialized under the brand name Taxotere by Aventis Pharmaceuticals. The injectable drug is indicated for the adjuvant treatment of women with operable node-positive breast cancer in combination with the drugs doxorubicin and cyclophosphamide. The approval was based on an international, multicenter, randomized trial with 1,491 female patients who suffered from node-positive operable breast cancer, who were randomly administered with either docetaxel 75 mg/m2 one hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm).

All of the patients were treated in six cycles for three weeks. “The primary endpoint, disease free survival (DFS), included local and distant recurrences, contralateral breast cancer, and deaths from any cause. At a median follow up of 55 months, results from a second interim analysis showed that the TAC regimen has significantly longer DFS than FAC, with an overall reduction in risk of relapse of 25.7 percent. At the time of this interim analysis, based on 219 deaths, overall survival was longer for TAC than FAC,” according to the National Cancer Institute. “The approved dose of docetaxel for the adjuvant treatment of operable node-positive breast cancer is 75 mg/m2 administered one-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every three weeks for six cycles.”

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