Serum miRNA biomarkers are currently investigational tools that we are exploring to try to identify patients who may be at risk of recurrence, as well as a tool to monitor for disease recurrence. The miRNAs are small proteins that may interfere with the normal functioning of a cell, and can often be isolated in tumors as well as in the blood. We are investigating several miRNAs that may help predict the risk of recurrence of a primary melanoma. Circulating miRNAs may become melanoma "tumor markers", and an increase in these levels may signal a tumor recurrence. Research studies have identified miR-221 as a potential biomarker for melanoma, as its’ levels have been shown to fall after removal of a melanoma, and then rise with tumor recurrence. Research is also exploring ways to develop therapies against miR-221 that will target and block melanoma cells that over-express miR-221, and potentially help to control the disease.
The most common BRAF mutation is the V600E mutation that occurs in approximately 50% of all metastatic melanomas. It is important to note that these are mutations that occur within the tumor only; they are not genetic mutations that can be transmitted to family members. The other BRAF mutations, V600K,V600D and V600R occur with significantly less frequency (less than 10%). One clinical trial for BRAF mutated metastatic melanoma patients allowed V600E and V600K mutations. This trial demonstrated that patients with "other" BRAF mutations may respond to BRAF inhibitors, but the response rates and duration of response may not be as high as in patients with the V600E mutation.
A KIT mutation is another genetic alteration that can occur within certain melanoma tumors. The frequency of KIT mutations is low, usually about 15-20%. These mutations can be found in patients with acral melanoma (melanoma that starts on either the palms of hands or soles of feet), mucosal melanoma (melanomas that originate in the sinus, anus, and vagina) as well as some skin melanomas that occur in areas of solar elastosis (a finding that signifies severe and chronic sun damage to the skin). This can be useful information for when a patient with a KIT mutated melanoma develops metastatic disease, a specific treatment that "targets" this mutation may then be considered. There are clinical trials with agents that target KIT that are currently open to enrollment.
MEK inhibitors are still investigational. Based on the combination trial of a BRAF inhibitor and a MEK inhibitor for patients with BRAF mutated melanoma, as well as a single agent trial of the MEK inhibitor versus chemotherapy, the MEK inhibitor that was used in the trial may be approved by the FDA (Federal Drug Administration) this year. Since the combination of the BRAF and MEK inhibitor appears to be superior to a BRAF inhibitor alone, this may be approved for use as a single agent as well as in combination with a BRAF inhibitor in BRAF mutated metastatic melanoma patients. MEK inhibitors may also be useful agents for treating metastatic ocular melanoma. A clinical trial with a MEK inhibitor in this population has been completed and the results are pending.
The number and size of brain metastases will determine treatment options. If there is only one brain metastasis, it will be managed either by gamma knife or resection of the metastasis. If there are a few (usually 5 or less) metastases that are small (less than 3 cm each), the patient will be referred for a gamma knife procedure. This procedure consists of 200 individual beams of radiation that is focused only on the tumor and does not affect the entire brain. If there are numerous metastases that are very small, there may be clinical trials available in which the metastases will be treated with medications. If there is not a clinical trial available, or there are brain metastases that are too numerous or large in size, then whole brain radiation may be recommended.
If a brain metastasis is found on a CT scan of the brain, then the patient should undergo an MRI of the brain with contrast. The MRI is much more sensitive in identifying smaller brain metastases, so it is not unusual to find other metastases on the MRI which were not seen on the CT scan. Management will depend on the number and size of brain metastases seen. In addition, if the patient has not had the rest of their body imaged, this should also be done to determine if there is new disease anywhere else.
I discuss the response rates, impact on survival, and general side effects with a patient before starting treatment. I provide them with "take home" information to read, so they can fully understand the treatment they are about to begin. On the first day of treatment, I try to answer all questions they may have after having read the educational information. My nurse practitioners also routinely spend 20-30 minutes with the patient reviewing potential side effects and providing advice on how to best manage them.
The frequency of oncologist visits depends on many variables. If a patient with metastatic melanoma is participating in a clinical trial,they are seen according to pre-determined protocol visits, and of course, any time they are not feeling well. If the patient has metastatic disease and is receiving a type of standard therapy, they are seen every 3-4 weeks depending on the treatment regimen. Some metastatic melanoma patients can be rendered free of disease, are not receiving any active therapy, and can often be seen on a monthly basis;furthermore, this interval may increase as more time passes from the time the patient has been determined to be disease free. The time spent with each patient is dependent on the patient’s needs during that visit. In general, patients on treatment who are doing well usually have a visit that lasts about 20 minutes; whereas, a sick patient may require 45 minutes to an hour to be assessed and have their problems addressed.
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