Related pages Cancer Drug Information 1 Approval Process for New Cancer Treatments 2 Access to Investigational Drugs 3

This page contains brief information about doxorubicin hydrochloride and a collection of links to more information about the use of this drug, related research results, and ongoing clinical trials.

US Brand Name(s):		Adriamycin RDF
		Adriamycin PFS
FDA Approved:		Yes

Doxorubicin hydrochloride is approved by the Food and Drug Administration (FDA) to treat the following types of cancer:

• Acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML).
• Breast cancer.
• Gastric cancer.
• Hodgkin lymphoma.
• Neuroblastoma.
• Non-Hodgkin lymphoma.
• Ovarian cancer.
• Small cell lung cancer.
• Soft tissue and bone sarcomas.
• Thyroid cancer.
• Transitional cell bladder cancer.
• Wilms tumor.

Doxorubicin hydrochloride is approved for use with other drugs as adjuvant therapy for breast cancer that has spread to the lymph nodes, including cancer that is HER-2 positive or has spread after surgery.

In addition to the uses that have been approved by the FDA, doxorubicin hydrochloride is sometimes used alone or with other drugs to treat other types of cancer. The drug continues to be studied in the treatment of many types of cancer.

Doxorubicin hydrochloride is also available in a different form called doxorubicin hydrochloride liposome. For more information, see the Drug Information Summary for Doxorubicin Hydrochloride Liposome ⁴.

Definition from the NCI Drug Dictionary ⁵ - Detailed scientific definition and other names for this drug.

Clinical Trial Results: Taxane Combinations Marginally Better than Anthracyclines for Metastatic Breast Cancer (05/21/2008) ⁶ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Anthracyclines Improve Survival for HER2-Positive, But Not HER2-Negative, Breast Cancer (01/30/2008) ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Positron Emission Tomography (PET) Can Strongly Predict Likelihood of Early Relapse in Hodgkin Lymphoma (08/10/2007) ⁸ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Less-Intense Chemotherapy Effective in Children with Intermediate-Risk Neuroblastoma (06/13/2007) ⁹ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Lower-Toxicity Treatment Effective in Some Cases of Early-Stage Hodgkin Lymphoma (07/10/2006) ¹⁰ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Rituximab Benefits Younger Lymphoma Patients with Good-Prognosis Diffuse Large-B-Cell Lymphoma (05/03/2006) ¹¹ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Age and Type of Chemotherapy Affect Women's Chances of Menstruating after Breast Cancer Treatment (02/27/2006) ¹² - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Chemotherapy Better than Whole-Abdominal Radiation for Advanced Endometrial Cancer (12/21/2005) ¹³ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Heart Risks of Doxorubicin Higher Than Previously Reported (05/28/2003) ¹⁴ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Additional Taxol, But Not Higher Dose of Doxorubicin, Helps with Early Breast Cancer (03/05/2003) ¹⁵ - Important clinical trial results for this drug, background information, and how the trial was done.

MedlinePlus Information on Doxorubicin Hydrochloride ¹⁶ - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This NLM patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Clinical Trials for Doxorubicin Hydrochloride ¹⁷ - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

An aggressive (fast-growing) type of leukemia (blood cancer) in which too many lymphoblasts (immature white blood cells) are found in the blood and bone marrow. Also called acute lymphocytic leukemia and ALL.

An aggressive (fast-growing) disease in which too many myeloblasts (immature white blood cells that are not lymphoblasts) are found in the bone marrow and blood. Also called acute myeloblastic leukemia, acute myeloid leukemia, acute nonlymphocytic leukemia, AML, and ANLL.

Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.

Cancer that forms in tissues of the bladder (the organ that stores urine). Most bladder cancers are transitional cell carcinomas (cancer that begins in cells that normally make up the inner lining of the bladder). Other types include squamous cell carcinoma (cancer that begins in thin, flat cells) and adenocarcinoma (cancer that begins in cells that make and release mucus and other fluids). The cells that form squamous cell carcinoma and adenocarcinoma develop in the inner lining of the bladder as a result of chronic irritation and inflammation.

Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.

Cancer that forms in tissues lining the stomach. Also called stomach cancer.

A protein involved in normal cell growth. It is found on some types of cancer cells, including breast and ovarian. Cancer cells removed from the body may be tested for the presence of HER2/neu to help decide the best type of treatment. HER2/neu is a type of receptor tyrosine kinase. Also called c-erbB-2, human EGF receptor 2, and human epidermal growth factor receptor 2.

A cancer of the immune system that is marked by the presence of a type of cell called the Reed-Sternberg cell. The two major types of Hodgkin lymphoma are classical Hodgkin lymphoma and nodular lymphocyte-predominant Hodgkin lymphoma. Symptoms include the painless enlargement of lymph nodes, spleen, or other immune tissue. Other symptoms include fever, weight loss, fatigue, or night sweats. Also called Hodgkin disease.

A drug preparation that contains the active drug inside very tiny, fat-like particles. This form is easier for the body to absorb and allows more drug to get to the target area of the body, such as a tumor. Liposomal drugs may have fewer side effects and work better than other forms of the drug.

A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called lymph gland.

Cancer that arises in immature nerve cells and affects mostly infants and children.

Any of a large group of cancers of lymphocytes (white blood cells). Non-Hodgkin lymphomas can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different types of non-Hodgkin lymphoma. These types can be divided into aggressive (fast-growing) and indolent (slow-growing) types, and they can be formed from either B-cells or T-cells. B-cell non-Hodgkin lymphomas include Burkitt lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma, follicular lymphoma, immunoblastic large cell lymphoma, precursor B-lymphoblastic lymphoma, and mantle cell lymphoma. T-cell non-Hodgkin lymphomas include mycosis fungoides, anaplastic large cell lymphoma, and precursor T-lymphoblastic lymphoma. Lymphomas that occur after bone marrow or stem cell transplantation are usually B-cell non-Hodgkin lymphomas. Prognosis and treatment depend on the stage and type of disease. Also called NHL.

Cancer that forms in tissues of the ovary (one of a pair of female reproductive glands in which the ova, or eggs, are formed). Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells).

A test result that reveals the presence of a specific disease or condition for which the test is being done.

A cancer of the bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue.

An aggressive (fast-growing) cancer that forms in tissues of the lung and can spread to other parts of the body. The cancer cells look small and oval-shaped when looked at under a microscope.

A cancer that begins in the muscle, fat, fibrous tissue, blood vessels, or other supporting tissue of the body.

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.

Cancer that forms in the thyroid gland (an organ at the base of the throat that makes hormones that help control heart rate, blood pressure, body temperature, and weight). Four main types of thyroid cancer are papillary, follicular, medullary, and anaplastic thyroid cancer. The four types are based on how the cancer cells look under a microscope.

Cancer that forms in transitional cells in the lining of the bladder, ureter, or renal pelvis (the part of the kidney that collects, holds, and drains urine). Transitional cells are cells that can change shape and stretch without breaking apart.

A disease in which malignant (cancer) cells are found in the kidney, and may spread to the lungs, liver, or nearby lymph nodes. Wilms tumor usually occurs in children younger than 5 years old.