In myeloma, there are numerous choices for therapy. We recommend treatments based on the risk level of the disease. Patients are divided into two groups, standard risk and high risk. In most centers, risk categorization is an important consideration when deciding the best course of treatment. Assessing risk typically involves the underlying health and age of the patient, the extent of disease, and genetic abnormalities within the cells. The standard system to classify extent or "stage" is called the International Staging System or “ISS.” The standard method to assess genetic abnormalities is called FISH (fluorescent in situ hybridization).
However, research has shown that genes associated with aggressive disease behavior wreak their havoc by causing myeloma cells in the body to proliferate, or increase in number. This suggests that instead of using genetic information, directly measuring the rate at which myeloma cells divide might provide more meaningful data about who is at high risk.
Research dating back to the late 1980s has confirmed that directly measuring myeloma cell growth by the "PCLI" (plasma cell labeling index) accurately predicts disease behavior. However, due to technical limitations, a widely-available laboratory method did not exist for routine clinical use.
For these reasons, the team at Weill Cornell Medicine, lead by pathologist Dr. Scott Ely, developed the "SynKii" assay, a validated instrument used to determine the proliferation rate of myeloma cells in a patient biopsy. Along with Drs. Ruben Niesvizky and Tomer Mark, Dr. Ely has now performed three studies, showing that myeloma cell growth, as assessed by SynKii, accurately predicts overall survival and progression-free disease.
On Monday, June 6, 2016 the Weill Cornell Medicine team presented this data at the American Society for Clinical Oncology (ASCO) annual meeting. This data demonstrated that SynKii predicts outcomes in newly-diagnosed patients and in patients undergoing bone marrow transplantation after myeloma relapse. SynKii also shows that that increased proliferation at relapse correlates with shorter progression free and overall survival times in the non-transplant setting.
The study also compared three methods for risk assessment and the cost associated with each one. According to U.S. government data, ISS costs an average of $29 per patient. SynKii can be used in conjunction with ISS staging, to show how fast the myeloma cells are proliferating. SynKii costs $136. By comparison, genetic analysis costs an additional $910 to $3,500. However, according to the data presented at ASCO 2016, genetic testing provides no additional, accurate prognostic information over and above the data already provided by staging and proliferation. This brings into question the cost-effectiveness of genetic analysis for myeloma. The Weill Cornell Medicine Myeloma Center recommends that SynKii be performed on all biopsies so that myeloma patients and their physicians will know how fast their cancer is growing in order to recommend the best possible treatment approach.