Dr. Sekeres on Combination Therapies With Azacitidine in CMML and MDS

Mikkael A. Sekeres, MD, MS
Published: Thursday, Jan 21, 2016



Mikkael A. Sekeres, MD, MS, professor of Medicine, director, Leukemia Program, Cleveland Clinic Taussig Cancer Institute, discusses a study examining azacitidine combined with lenalidomide or with vorinostat versus azacitidine monotherapy in higher-risk patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

The randomized phase II North American Intergroup SWOG S1117 study enrolled 277 patients. Results showed that the combination therapies in both groups of patients were well tolerated; there was no difference regarding neutropenia and fever. Patients who received lenalidomide/azacitidine were more likely to develop rash, while patients in the vorinostat/azacitidine arm were more likely to experience gastrointestinal toxicities. However, patients who received either combination regimens were significantly more likely to have dose-reductions not specified by protocol, Sekeres explains.

For patients with MDS who were in the lenalidomide/azacitidine arm, the overall response rate (ORR) was 49% compared with 38% with azacitidine monotherapy (P = .16). Patients who received vorinostat/azacitidine had a lower ORR versus azacitidine monotherapy.

However, in patients with CMML, ORR with azacitidine/lenalidomide was 68% compared with 29% for azacitidine monotherapy. These findings demonstrate that though there are no statistically significant findings in high-risk patients with MDS, it was found to be significant for patients with CMML, Sekeres adds.

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Mikkael A. Sekeres, MD, MS, professor of Medicine, director, Leukemia Program, Cleveland Clinic Taussig Cancer Institute, discusses a study examining azacitidine combined with lenalidomide or with vorinostat versus azacitidine monotherapy in higher-risk patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).

The randomized phase II North American Intergroup SWOG S1117 study enrolled 277 patients. Results showed that the combination therapies in both groups of patients were well tolerated; there was no difference regarding neutropenia and fever. Patients who received lenalidomide/azacitidine were more likely to develop rash, while patients in the vorinostat/azacitidine arm were more likely to experience gastrointestinal toxicities. However, patients who received either combination regimens were significantly more likely to have dose-reductions not specified by protocol, Sekeres explains.

For patients with MDS who were in the lenalidomide/azacitidine arm, the overall response rate (ORR) was 49% compared with 38% with azacitidine monotherapy (P = .16). Patients who received vorinostat/azacitidine had a lower ORR versus azacitidine monotherapy.

However, in patients with CMML, ORR with azacitidine/lenalidomide was 68% compared with 29% for azacitidine monotherapy. These findings demonstrate that though there are no statistically significant findings in high-risk patients with MDS, it was found to be significant for patients with CMML, Sekeres adds.




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