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Doxorubicin is a chemotherapy drug used to treat several types of cancer. In use since the 1970s, doxorubicin is manufactured by multiple companies, but is most commonly known by the brand name of Adriamycin. Doxorubicin, though approved by the U.S. Food and Drug Administration (FDA) to treat several types of cancer, is not approved to treat mesothelioma.
While not officially approved for mesothelioma, doctors often prescribe doxorubicin for mesothelioma patients, particularly in combination with other drugs. Clinical trials keep improving our understanding of the drug’s effectiveness. Doxorubicin has some serious risks and side effects. However, when carefully combined with other drugs, doxorubicin can have a role in the treatment of mesothelioma.
What is Doxorubicin?
Doxorubicin is the generic name of a drug used to treat several types of cancer. This drug is administered through intravenous infusion and is often combined with other drugs to attack the cancer from multiple angles. The most commonly known brand name is Adriamycin, and it is known for being a deep red color. A newer formulation has also been created that stays in the body for longer, called Doxil (pegylated liposomal doxorubicin). Doxil and doxorubicin may both include the same medication, but the dosing and efficacy can be vastly different from each other. Doxorubicin is currently manufactured by Teva Pharmaceuticals, Janssen Pharmaceuticals, Pfizer, and Bedford Laboratories.
In 1974, the first FDA approval for doxorubicin was awarded to Pharmacia and Upjohn. The FDA has since approved changes in dosing, generic forms by various pharmaceutical companies, and new uses proven to be effective and relatively safe.
How it Works
Doxorubicin is a chemotherapeutic agent that is actually a type of antibiotic classified as an anthracycline. This class of agents includes drugs derived from Streptomyces bacteria. Although they are antibiotics, they are useful in treating cancers. Because anthracyclines damage DNA, they prove effective in killing cancer cells. As with many chemotherapy drugs, this cell-killing effect is not limited to cancer. Healthy cells can also be destroyed by anthracyclines often causing unpleasant side effects.
Uses for Doxorubicin
The FDA approval for doxorubicin includes a limited number of specific types of cancer. However, physicians may prescribe the drug for unapproved or “off label” uses, and they sometimes do so for mesothelioma. Doxorubicin has been approved for treatment of ovarian cancer after earlier treatment with a platinum-based drug has failed. Doxorubicin can also be used to treat multiple myeloma in combination with the drug bortezomib. It is also approved to treat Kaposi’s sarcoma after other chemotherapy combinations have failed. In spite of the lack of FDA approval, it has been used in several clinical trials for mesothelioma.
Because doxorubicin also kills non-cancerous cells, it can cause serious side effects. Many of these side effects are common to all chemotherapy drugs. The most common side effects include fatigue, hair loss, dizziness, eye pain, discolored urine and tears (orange/red), and increased thirst. Other common side effects include weight loss, loss of appetite, nausea, vomiting, fever, diarrhea, constipation, skin rash, mouth sores, and anemia. This drug can also lead to a weakened immune system resulting in a higher risk of serious infections.
Doxorubicin may also cause hand and foot syndrome, a skin reaction on the palms of the hands and the soles of the feet. This condition most commonly occurs a few weeks after starting chemotherapy. Symptoms of hand and foot syndrome include stinging in the hands or feet, cracked, dry, and peeling skin, thickened skin like a callus, redness, blistering, and swelling. Hand and foot syndrome can be painful and often restricts movement. Patients who experience this condition should report this to their doctor and consult with a dermatologist.
Black Box Warning and Serious Risks
Doxorubicin may also cause more severe reactions. The FDA includes a black box warning, its most serious, for more severe side effects. If the drug escapes the vein during administration, it could leak into surrounding tissues at the injection site, causing serious damage as well as pain, itching, blisters, and sores.
Doxorubicin may also cause life-threatening heart problems, even years after treatment has concluded. Potential heart problems include congestive heart failure. The risk of heart damage increases as the total dose administered increases, so there is a maximum lifetime limit and monitoring for damage. Patients taking doxorubicin may also be susceptible to serious infections caused by suppression of blood cell production. This suppression could potentially affect the production of white blood cells in bone marrow. Doxorubicin may cause liver damage and increase the chance of developing leukemia. Doctors should monitor patients before, during, and after treatment for these serious problems. Some patients with existing heart, liver, or immune system impairments may not be eligible for treatment with doxorubicin.
Studies of Doxorubicin to Treat Mesothelioma
Doxorubicin has not been approved by the FDA to treat mesothelioma. However, this lack of approval can be influenced by the rarity of this particular type of cancer. Doctors and researchers have been trying doxorubicin with mesothelioma patients for years. Several studies indicate it may be a promising course of treatment.
Some studies are very small, including a case study of just one patient published in 2012. In this study, a man with pleural mesothelioma was given a combination of chemotherapy drugs that included Doxil (pegylated liposomal doxorubicin). This form is thought to be absorbed less in healthy tissues, making it more specific to tumor cells. The patient was given this drug in combination with etoposide and paclitaxel. He responded very well to treatment and in 2012, nine years after receiving the doxorubicin combination, the patient was still living. This success far surpassed the expected results of this patient’s experimental treatment.
In another study, 67 patients with peritoneal mesothelioma were given doxorubicin along with paclitaxel and cisplatin into the peritoneal cavity after surgery to remove the tumor. The results of this trial were astounding, producing a median survival time of more than six years. One patient in the study survived 12 years. A smaller study confirmed these results by combining cisplatin with other chemotherapy drugs. The best results were seen with cisplatin combined with doxorubicin.
Mesothelioma is a difficult cancer to treat. Although doxorubicin is not approved for mesothelioma treatment, it can play a helpful role for some patients. Doxorubicin does have the potential to cause serious side effects. However, for patients with mesothelioma, these risks can be outweighed by the benefits.
Page Medically Reviewed and Edited by Kyle J. Becker, PharmD, MBA, BCOP
Kyle J. Becker, PharmD is certified by the Board of Pharmacy Specialties in Oncology Pharmacy. Dr. Becker earned his pharmacy degree from Shenandoah University and he currently serves as an oncology pharmacist at Parkview Cancer Institute.