Adriamycin (doxorubicin) is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA) to treat several types of cancer but not mesothelioma. Doctors may prescribe doxorubicin for mesothelioma patients, particularly in combination with other drugs. Doxorubicin has some serious risks and side effects but can help manage the disease.
What Is Doxorubicin?
Doxorubicin is the generic name of a drug used to treat several types of cancer.[1] This chemotherapy drug is administered through intravenous infusion and is often combined with other drugs to attack cancer from multiple angles.
Is Adriamycin the Same as Doxorubicin?
The most commonly known brand name is Adriamycin. It is notable for its deep red color. A newer formulation has also been created that stays in the body for longer, called Doxil (pegylated liposomal doxorubicin).[2]
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.
Is Doxorubicin FDA Approved?
In 1974, the first FDA approval for doxorubicin was awarded to Pharmacia and Upjohn.[3] The FDA has since approved changes in dosing, generic forms made by other pharmaceutical companies, and new uses that have proven to be effective and relatively safe.
How Doxorubicin Kills Cancer Cells
Doxorubicin is a chemotherapeutic agent that is a type of antibiotic classified as an anthracycline.[1] This class of agents includes drugs derived from Streptomyces bacteria.
Although they are antibiotics, anthracyclines are useful in treating cancers. Because anthracyclines damage DNA, they can be 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.
What Is Doxorubicin Used For?
The FDA approval for doxorubicin includes a limited number of specific types of cancer:
- Doxorubicin has been approved for the 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. Despite the lack of FDA approval, it has been used in several clinical trials for mesothelioma.
Physicians may prescribe the drug for unapproved or “off-label” uses. Some of the common off-label uses for doxorubicin include:[1]
- Bladder cancer
- Breast cancer
- Hodgkin’s lymphoma
- Lung cancer
- Non-Hodgkin’s lymphoma
- Neuroblastoma
- Stomach cancer
Can Doxorubicin Be Used to Treat Mesothelioma?
Although it is not specifically FDA-approved for mesothelioma, oncologists can and do use doxorubicin as part of treatment for some mesothelioma patients. Doctors are allowed to use drugs for non-FDA-approved purposes at their professional discretion.
How Is Doxorubicin Administered?
Like most types of chemotherapy, mesothelioma patients receive intravenous injections of doxorubicin. This is a systemic administration of chemotherapy, meaning the drug circulates through the body. It is not targeted specifically at tumors.
Patients usually receive doxorubicin and other systemic chemotherapies in cycles. You might need a few cycles over the course of several weeks of treatment.
What Are the Side Effects of Doxorubicin?
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.[1]
Doxorubicin may also cause hand and foot syndrome, a skin reaction on the palms of the hands and the soles of the feet.[2] 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.[4] 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:
- 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. The FDA includes a black box warning, its most serious, for more severe side effects.
- 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.[2]
How Effective Is Doxorubicin in Treating Mesothelioma?
The FDA has not approved doxorubicin for treating mesothelioma. However, doctors and researchers have been trying it with mesothelioma patients for years. Several studies indicate it may be a promising course of treatment.
Doxorubicin Case Study With Mesothelioma Patient
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.
Doctors gave the patient 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.[5]
Doxorubicin to Treat Peritoneal Mesothelioma
In another study, sixty-seven 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 twelve years. A smaller study confirmed these results by combining cisplatin with other chemotherapy drugs. The best results were seen with cisplatin combined with doxorubicin.[6]
Overcoming Doxorubicin Resistance
Other studies have found that asbestos, which causes mesothelioma, can make cells resistant to doxorubicin. The researchers believe that increasing iron intake might reverse these results, making the drug more effective.[7]
Mesothelioma Clinical Trials with Doxorubicin
Doxorubicin is not a standard chemotherapy drug for mesothelioma, although it is sometimes used. Researchers continue to investigate how it might help patients through clinical trials:
- In a completed phase II trial, researchers recruited mesothelioma patients to determine the effectiveness of a combination of doxorubicin with valproate. The patients involved had no or limited success with standard cisplatin chemotherapy.[8]
- In another completed trial, researchers tested the efficacy of an inhaled form of doxorubicin. They recruited patients with tumors related to the lungs, including pleural mesothelioma.[9]
- Another trial tested a trimodal approach to treating pleural mesothelioma with chemotherapy, surgery, and radiation therapy. The goal was to get good results while using a less radical surgery that spared the diseased lung. The researchers used cisplatin, pemetrexed, and doxorubicin for chemotherapy.[10]
Mesothelioma is a difficult cancer to treat. Although doxorubicin is not approved for mesothelioma treatment, it can help 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.
