Sutent (sunitinib)
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Sutent® is an oral targeted therapy medication manufactured by Pfizer approved to treat carcinoid tumors and kidney cancer. This cutting-edge medication differs from chemotherapy. Sutent is designed to target certain enzymes in cancer cells and has been effective in treating kidney cancer, gastrointestinal stromal tumors, and pancreatic neuroendocrine tumors. It was first approved by the U.S. Food and Drug Administration (FDA) in 2006, and research continues today in numerous cancers.
Developed by Pfizer to target certain pathways in cancer cells, Sutent can cause potentially serious side effects. However, recent studies show this drug could help some patients struggling with mesothelioma. Continued research is needed to discover biomarkers that could determine which patients would benefit from Sutent.
What is Sutent?
Sutent is the brand name of a medication with the generic name of sunitinib. It was first approved by the FDA in 2006, and is used to treat advanced renal cell cancer, pancreatic neuroendocrine tumors in patients who are not candidates for surgery, and gastrointestinal stromal tumors that do not respond well to other treatments. Unlike many chemotherapy drugs, Sutent is taken as an oral tablet, making dosing more convenient for patients. Like traditional chemotherapy, Sutent is given in cycles. There is time allotted between cycles for the body to recover from treatment. Although Sutent is not approved for mesothelioma, studies are underway to determine if it could be used as an effective treatment.
How it Works
Sutent is a multi-receptor tyrosine kinase inhibitor. As such, it targets several cell receptors and kinases, which are enzymes on the surface of cells. These enzymes play an important role in how cancer grows and spreads. By targeting these enzymes, Sutent halts signaling inside the cell. Specifically, it inhibits the formation of new blood vessels required for tumor growth. It also inhibits the division of cancer cells and helps trigger cell death.
Some types of cancers are especially driven by mutations in receptor tyrosine kinases. This is why Sutent was first approved for a few very specific cancers. This is also the reason Sutent may work for some mesothelioma patients. Mesothelioma is a complex cancer and is different in every individual. In some patients, the receptor tyrosine kinases play an important role in how the cancer grows, while in other patients, they may not. Researchers are still investigating which patients can benefit from this targeted drug therapy.
Side Effects
Even with highly targeted drugs, there are potential side effects and adverse reactions. For Sutent, the most commonly reported side effects are fatigue, weakness, fever, nausea, diarrhea, vomiting, high blood pressure, abdominal pain, peripheral edema, constipation, skin rashes, skin discoloration, skin dryness, back pain, changes in taste, cough, shortness of breath, anorexia, and bleeding. Sutent can also cause hand and foot syndrome, resulting in cracked skin, stinging sensation, redness, swelling, thickening, and blistering on the palms of the hands and soles of the feet.
Black Box Warnings
The FDA reserves the black box warning for serious side effects and complications that may be severe or life threatening. For Sutent, there is a black box warning concerning liver toxicity. The drug has been shown to sometimes cause significant damage to the liver. This damage could be potentially severe and life threatening. Patients should be carefully screened for liver damage before using Sutent and should continue regular liver monitoring while taking it. Some patients with a history of liver disease or heavy alcohol use may not be good candidates for the drug. Patients should watch for signs of liver damage, including yellowing eyes and skin, itchiness, dark urine, and pain in the upper right abdominal area.
Sutent and Mesothelioma
Sutent is not approved by the FDA to treat mesothelioma. However, researchers are evaluating it as a possible treatment for this difficult cancer. Because Sutent is a targeted drug and the molecular makeup of cancer differs between each patient, some patients may respond well while others do not. Therefore, this drug will affect tumor growth in some patients and not others. This is in contrast to traditional chemotherapy drugs which are not very targeted and tend to work on any fast-growing cells, cancerous or healthy.
Preliminary results from a phase II clinical trial with Sutent show that as a single agent, this drug may not be useful in mesothelioma patients. Overall average survival time was just over eight months, which is not a great improvement over other treatments.
However, other studies have been more promising. One phase II clinical trial involving 53 mesothelioma patients who had previously undergone chemotherapy that did not slow disease progression showed some positive effect. In this study, 12 percent of patients had a reduction in tumor size and 65 percent saw stable disease. Only 22 percent of the patients saw no benefit. Researchers attempted to determine if certain biomarkers could indicate which patients would respond well to Sutent but were unsuccessful. They concluded that the drug should be used in mesothelioma patients, but that more work is necessary to pinpoint biomarkers to help determine which patients will respond favorably to the drug.
Sutent is a new targeted therapy with the potential to treat various types of cancer, possibly including mesothelioma. Targeted drugs like Sutent are making cancer treatment more individualized, with a hope of being more effective with fewer patients not responding to treatment. Currently, Sutent may have some value in treating mesothelioma, but not in all patients. As researchers discover more about the medication and disease, they hope to identify biomarkers that will indicate who will benefit from treatment with Sutent.
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.
