Combination therapies could help improve outcomes for patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), which belong to a spectrum of disorders associated with cytopenias, a high risk of transformation to acute myeloid leukemia (AML), and short survival times.
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“MDS are the most commonly diagnosed myeloid neoplasms in the United States, having an incidence rate of 4.6 in every 100,000 citizens,” says Mikkael Sekeres, MD, MS, Director of the Leukemia Program at Cleveland Clinic’s Taussig Cancer Institute. That means there are about 15,000 new diagnoses every year.
Patients with high-risk MDS have a median survival of nine months to two years with a 54 percent to 84 percent risk of transforming to AML during that period.
These disorders are typically treated with azacitidine (AZA) or decitabine monotherapy. “Once one of these drugs fails a patient, further treatment options are limited and survival time is less than six months,” Dr. Sekeres says.
Research conducted by Dr. Sekeres, the principal investigator of the North American Intergroup trial, and his team seeks to determine whether treating high-risk MDS and CMML with lenalidomide or vorinostat in combination with azacitidine will improve outcomes and response rates. This is the largest prospective trial conducted in the area of MDS therapeutics in North America, according to Dr. Sekeres. The results will be presented at the 2014 American Society of Hematology Annual Meeting.
Participant criteria and exclusions:
“Patients who met criteria were then randomized to receive azacitidine monotherapy or AZA in combination with either lenalidomide or vorinostat,” according to Dr. Sekeres.
Phase II, which included analysis of 276 patients (six ineligible patients were excluded), concluded that combination therapy may prove beneficial for certain MDS subgroups. “While overall response rates were similar among all three study arms, subgroups, such as patients with CMML, appeared to benefit from combination therapy. And those who remained on combination therapy appeared to have a DFS advantage compared to monotherapy,” says Dr. Sekeres.
Even with these promising observations for combination therapy in MDS subgroups, longer-term outcome data must be assessed before investigators can make further conclusions.
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