liposomal daunorubicin (DaunoXome)liposomal daunorubicin (DaunoXome)
DaunoXome is a new treatment for advanced AIDS-related Kaposi's sarcoma, or KS. KS is a type of cancer that people with HIV may develop. KS is more commonly seen in men than in women. Although KS mainly affects the skin, the mouth, and the lymph nodes, it can also involve the bowels and lungs. If it becomes severe, it may lead to swelling or breakdown of the skin. KS growths, called lesions or tumors, can show up in a wide range of colors, from pink to red-violet to brown to blue.
DaunoXome is a liposomal drug. Liposomal drugs are standard chemotherapy drugs used to treat KS that are put inside microscopic bubbles of fat called liposomes. When the drugs are used this way, it is hoped they will have fewer side effects and be more effective. DaunoXome is a liposomal version of the anti-cancer drug daunorubicin. DaunoXome is given intravenously, which means via a tube placed into your arm or chest, once every two weeks.
The current standard treatment for advanced KS is a combination of chemotherapy using the drugs Adriamycin, bleomycin and vincristine (ABV). These drugs can have severe side effects including damage to the heart, and also the bone marrow. Your bone marrow makes white blood cells. When you lose white blood cells, you are more likely to get bacterial infections. Additional side effects, such as hair loss and nausea, may impact quality of life during treatment.
DaunoXome has been approved as a first-line treatment for advanced KS. DaunoXome is also approved for people who can't take the standard treatments for KS because of side effects.
The largest study of DaunoXome enrolled 227 people. The study compared DaunoXome to the standard combination chemotherapy, ABV. Three people on DaunoXome and one on ABV had a complete response, defined as no detectable disease for at least four weeks. 26 people on DaunoXome and 30 on ABV had a partial response, which was a 50% or greater decrease in disease for at least four weeks. The majority of people in the study, 72 on DaunoXome and 64 on ABV, had stable disease.
The side effects of fatigue, neuropathy (pain in the hands and feet), hair loss, nausea and diarrhea were seen more often in people taking ABV than those taking DaunoXome. Only 13% of people on DaunoXome had neuropathy, compared to 41% of people on ABV. Hair loss occurred in 8% of people on DaunoXome compared to 36% of people on ABV. However, leukopenia and/or neutropenia (low levels of certain important white blood cells) was seen in over a third of people in both the DaunoXome and ABV groups. Forty-five people taking DaunoXome and twenty-nine people taking ABV developed a new opportunistic infection during the study. The side effect of neutropenia can be reduced by treatment with G-CSF, also known as Neupogen.
There was a small indication that survival may have been slightly better on DaunoXome compared to ABV, although it was not considered a significant difference.
Other side effects of treatment with DaunoXome can be hot flushes, tightness in the chest, difficulty breathing or swallowing and back pain. These side effects usually occur during the first five minutes of the infusion, and can often be stopped if the infusion is interrupted and then started again at a slower rate. DaunoXome can also cause heart problems, and people taking DaunoXome should be closely monitored for any sign of toxicity to the heart. The manufacturer, NeXstar, has been advised by the Food and Drug Administration that they must not make advertising claims that the drug has little or no toxicity to the heart.
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