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Ocular (uveal) melanoma (UM)
Uveal melanoma (UM), also known as ocular or choroidal melanoma, is the most common form of eye cancer. Uveal melanoma arises from the choroid, ciliary body or iris - all structures that are part of the "uveal tract".
Treatment Goals and Treatments
The main goals of treatment of uveal melanoma are to reduce the risk of metastasis, prevent local growth and destruction of ocular tissues and preserve vision to the extent possible.
Treatment of the primary eye tumor is highly effective. The most common treatment is plaque brachytherapy. Brachytherapy involves placing a temporary plaque (which will deliver targeted radiation) on the eye overlaying the area of the tumor. Proton beam irradiation and enucleation (removal of the eye) are also used. All three of these methods are highly effective at controlling the primary eye tumor.
The primary clinical issue in the management of ocular melanoma is accurately predicting risk of metastasis (spread of the tumor). Approximately half of uveal melanoma tumors will metastasize at some point prior to diagnosis of the primary eye tumor. However, at the time of diagnosis of the primary eye tumor, metastatic disease will only be detectable in about 3% of patients… an event known as 'micrometastasis'. The need for a tool to help physicians identify the population at high risk for having experienced this 'micrometastatic event' is what drove the discovery and development of the DecisionDx-UM gene expression profile test.
The Need for DecisionDx-UM
The DecisionDx-UM test accurately predicts the risk of metastasis.
Clinical medical records and the literature show that physicians and patients use the results of the DecisionDx-UM test to:
- Develop patient specific monitoring (also known as surveillance) plans. Patients identified as having a high risk of developing metastasis may receive a high intensity surveillance plan that may include more frequent monitoring with advanced imaging procedures such as CT, MRI, or PET scans. In contrast, patients at a low risk of developing metastasis may receive a less intensive surveillance plan – thus balancing the risks of radiation exposure associated with today's imaging with the patient's risk of metastasis;
- Initiate referral to a medical oncologist for treatment planning which may include adjuvant treatment; and
- Improve life-planning. Two different patient surveys were published in 2009 - both of which reported that 97% of patients wanted to know prognostic test results.
What is DecisionDx-UM?
The DecisionDx-UM test determines the molecular signature of a patient's tumor. The DecisionDx-UM test is also known as the gene expression profile test (GEP) for uveal melanoma. The results of the test provide knowledge regarding the risk of near term metastasis (5 years). Tumors with a Class 1 signature are associated with a good prognosis and a low potential to spread (or metastasize), while tumors with a Class 2 signature have a high potential to spread.
The DecisionDx-UM test was validated technically and clinically during the last decade. It has been available for clinical use since late 2009 and has been incorporated into the routine standard of care by the majority of ocular oncologists. The DecisionDx-UM gene expression profile test is recommended for use by the American Joint Committee on Cancer in January 2010 (AJCC, version 7) because the results were determined to be "clinically significant" for patient care.
The DecisionDx-UM test should not be mistaken for chromosome 3 (monosomy 3) testing. The DecisionDx-UM test has been compared to monosomy 3 testing in both accuracy and technical success. The DecisionDx-UM test was found to be more accurate in predicting metastasis than monosomy 3 testing in comparisons made in the same patients. Technically, the DecisionDx-UM test works more than 95% of the time while several reports indicate that monosomy 3 testing may only work 50-75% of the time.
The DecisionDx-UM test can only be ordered by a physician (most commonly an ocular oncologist, retinal specialist, or ophthalmologist) and requires a sample of the tumor.
For patients undergoing radiation therapy (brachytherapy or proton beam radiation), the sample needs to be taken before radiation is delivered to the tumor. Many ophthalmologists already take a tumor sample immediately prior to brachytherapy by fine needle aspirate biopsy (FNAB) in the operating room for diagnostic purposes. The DecisionDx-UM assay requires a single biopsy specimen.
For patients undergoing an enucleation procedure, the tumor specimen can be obtained with an FNAB at the time of enucleation or it can be obtained at a later date from the formalin fixed paraffin embedded slides that will be made from the enucleated globe.
Specific information regarding specimen collection can be found under the 'To Order DecisionDx-UM' tab above.