Frontiers in Drug Discovery: Erythropoietic Stimulating Agents - Volume 1
Patients also reported nausea and injection site—related complications. Azacitidine was next explored in a phase III trial in which higher-risk patients with MDS were randomized to receive azacitidine at the dose used in the registration study or to conventional care, including best supportive care; low-dose cytarabine; or intensive, AML-type induction chemotherapy, as selected by investigators prior to randomization.
With a median follow-up of The superior activity of azacitidine, compared with both conventional care and previous azacitidine studies, has been credited to an appropriately selected population of higher-risk patients with MDS and to a median duration of therapy of over 9 months. The phase III registration trial for all MDS subtypes randomized 89 patients to receive the drug, compared with 81 managed with supportive care. As with 5-azacytidine, major toxicities were hematologic. Unlike with azacitidine, there was not a significant delay in transformation to AML or death in this study.
As the two drugs are considered by most to be clinically equivalent and biologically similar, this difference has been attributed to different patients enrolled to each study with more patients with early MDS in the decitabine study and to an inadequate number of cycles of decitabine given with a median of 2. Notably, patients received a median of only 4 cycles of decitabine. It is unknown whether shorter duration of therapy, subsequent therapies off-study, differences in patient populations, or true differences in drug activity account for the survival advantage for one DNA methyltransferase inhibitor over the other.
Another newer single-agent treatment approach for higher-risk patients with MDS that borrows from the acute leukemia model is clofarabine. Extended dosing schedules are being evaluated in a phase II study. Most agree that the next frontier in the treatment of MDS lies in combination therapies. Finally, this chapter would not be complete without a mention of the need for pharmacoeconomic evaluations of our treatment approach to MDS. The median age at diagnosis of MDS in the US is 71 years, implying that the majority of patients receive Social Security and Medicare, and may be dependent on these alone for healthcare costs, including drugs and co-pays.
At the time of this writing, cost-of-living adjustments will be eliminated for Social Security in , leaving seniors more vulnerable to depleting life savings to pay for healthcare.
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Some Things Old. Some Things New. Some Things Borrowed. Some Other Things New. Article Navigation. Myelodysplastic Syndromes January 1, Sekeres Mikkael A. Sekeres 1. This Site. Google Scholar. Table 1. Table 2. Survival improvement mainly in patients with low transfusion needs. Differences remained significant in multivariate analyses controlling for baseline characteristic differences. Table 3. Treatment-related cytopenias shown to correlate with response; cytogenetic CRs in some patients with complex karyo types.
Did not meet primary endpoint due to low median cycles given and mixed MDS population. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B. J Clin Oncol. Decitabine improves patient outcomes in myelodysplastic syndromes: results of a phase III randomized study. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med. Effect of romiplostim in patients pts with low or intermediate risk myelodysplastic syndrome MDS receiving azacytidine [abstract].
Characteristics of US patients with myelodysplastic syndromes: results of six cross-sectional physician surveys.
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