The MDS Beacon™

South Korean researchers have shown that myelodysplastic syndromes patients treated with Dacogen experienced fewer episodes of fever when given preventative antibiotic treatment.

“Preventative antibiotic treatment will reduce the infection risk of MDS patients receiving hypomethylating agents, especially during earlier treatment cycles and in the presence of severely low blood cell counts”, explained Dr. Je-Hwan Lee of the University of Ulsan College of Medicine and lead author of the study in an email to The MDS Beacon.

Dacogen (decitabine) is approved by the United States Food and Drug Administration for the treatment of all subgroups of myelodysplastic syndromes (MDS). It belongs to a class of drugs called hypomethylating agents, which work by removing methyl groups that are bound to DNA. Methyl groups are thought to interfere with the regulation of cell growth and cause uncontrolled cell division.

Some of the most common side effects associated with Dacogen are reduced blood cell counts and infections related to those low blood cell counts.  These infections often cause fevers.

General guidelines are available for the treatment of fever associated with low blood cell counts in MDS patients. These guidelines suggest the use of preventative antibiotic treatment for the prevention and management of fever associated with low blood cell counts.

However, the guidelines do not include guidance on preventative antibiotic treatment in MDS patients who receive hypomethylating agents.

The researchers therefore retrospectively analyzed data of 28 MDS patients who were treated with Dacogen to determine the effect of preventative antibiotic treatment on the occurrence of fever during Dacogen treatment.

The patients received Dacogen for five consecutive days every four weeks. In addition, the patients were given antibiotics and blood cell growth factors to fight infection and fever if the treating physician felt that it was necessary.

The researchers found that patients developed fevers between days 4 and 44 of Dacogen treatment with the median at day 19. Fevers that required hospitalization and intravenous antibiotics occurred in 11.5 percent of treatment cycles.

Of those fevers that required hospitalization, all occurred within the first five treatment cycles , and most (17.8 percent) occurred within the first cycle of treatment.

Patients who received preventative antibiotics or blood cell growth factors in addition to Dacogen experienced significantly fewer episodes of fever (7.4 percent) that caused hospitalization and the administration of intravenous antibiotics than those who were not treated with preventative antibiotics (22.2 percent).

When patients who were treated with antibiotics did need to be hospitalized due to fever, they were treated with intravenous antibiotics for shorter times (a median of 8 days) than those who were not treated with antibiotics (a median of 15.5 days).

Hospitalization due to Dacogen-related side effects was also less frequent in patients treated with preventative antibiotics or blood cell growth factors (9.5 percent versus 25 percent).

The researchers also found having low blood cell counts before the start of Dacogen treatment was associated with occurrence of fever.

According to Dr. Lee, “These results were expected because low white blood cell count could be directly related to infections causing fever.”

Patients’ sex, age, time since MDS diagnosis, and type of MDS, on the other hand, were not linked to fever resulting from Dacogen treatment.

For more information, please see the study in Leukemia Research (abstract).