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Samuel Oschin Comprehensive Cancer Institute
Cedars Sinai Medical Center
Los Angeles, CA, USA
by Lynne Lederman, PhD
Response criteria are important for evaluating therapy in myeloma, particularly as new agents continue to become available, and the goals in myeloma treatment evolve from trying to cure the disease to maximizing the duration of survival. It is difficult to use long term survival, not only because of the length of time needed for follow-up, but also because of the confounding issue of post-protocol treatment. Shorter term survival is an important early indicator of initial response and early relapse. Important markers for response include survival, adverse events contributing to death, and progressive disease. Dr. Durie reviewed several important studies showing improved response rates associated with the introduction of novel therapies. New response categories to consider include biochemical relapse and clinical relapse, based on CRAB criteria (development of bone disease, anemia, renal dysfunction, and hypercalcemia) as indicators for moving on to the next therapy; sequential therapy may be important in the absence of cure. However, cure and disease control may have similar endpoints, e.g., at least four years disease free or at least 10 years without relapse. New endpoint strategies are needed, including the incorporation of new molecular tests, to compare the results from different trials.
Accepted risk factors that are readily available, quantitative, cheap, and useful include age, performance status, beta-2-microglobulin, albumin, lactate dehydrogenase, C-reactive protein, and free light chains. Imaging techniques such as MRI and CT/PET, while accepted as identifying focal disease and relapse, are not readily available or cheap, and therefore not as useful. Risk factors that are less accepted for use in determining treatment or that are less available, less likely to be reimbursed, or more technically challenging include cytogenetics, FISH, GEP, SNP (single nucleotide polymorphism DNA analysis), and proteomics. However, it is probably too early to institute risk-adapted treatment for patients with myeloma.