The MDS Beacon™

Dacogen (decitabine) is an effective and well-tolerated treatment for older myelodysplastic syndromes (MDS) patients, according to findings presented at the 51st Annual American Society of Hematology (ASH) meeting on December 6.

The risk of developing MDS increases with age, and older patients make up a large share of all MDS patients.  Older cancer patients, however, often find it particularly challenging to deal with the side effects of many cancer drugs.

For these reasons, physicians who treat MDS are particularly interested in knowing whether a potential MDS treatment is both effective and safe for older patients.

Dacogen is one of several drugs the U.S. Food and Drug Administration has approved in recent years for the treatment of MDS.

Dr. George F. Geils, the author of the findings presented at the ASH meeting, analyzed data from two recent clinical trials of Dacogen.  The goal of this analysis was to assess the efficacy and safety of Dacogen in two subgroups of older patients: patients aged 65 to 75 years, and patients aged 75 years and older.

The data from the two clinical trials were examined for overall response rate, duration of response, time to response, transfusion independence, and tolerability.

In one trial, patients were given Dacogen intravenously at 20 mg/m² for five consecutive days every four weeks.

In the other trial, patients received Dacogen intravenously at 15 mg/m² over three hours every eight hours for three consecutive days every six weeks.

In both trials, the overall response rate was higher for the 65 to 75 age group (38 percent and 16 percent) than for the 75 and older age group (23 percent and 9 percent).

More patients in the 65 to 75 age group achieved transfusion independence in both studies (39 percent and 43 percent, respectively) than patients in the 75 and older age group (15 percent and 21 percent, respectively).

However, patients aged 75 years and older responded more rapidly in both trials (72 days and 93 days, respectively) than patients aged 65 to 75 years (84 days and 101 days, respectively). In addition, the older patients showed a more durable response in both studies (554 days and 295, respectively) than their slightly younger counterparts (343 days and 226 days, respectively).

The most common side effects were moderate to severe anemia (low red blood cell levels), leukopenia (number of white blood cells outside of normal range), neutropenia (low white blood cell levels), and thrombocytopenia (low platelet levels). There were no reported cases of neutropenia in patients aged 75 years and above.

Dr. Geils, the author of the ASH study, concluded that Dacogen was effective and generally well-tolerated by both subgroups of older MDS patients. He further concluded that, based on his data analysis, physicians need not place undue weight on a patient’s age when considering whether or not Dacogen is an appropriate treatment.

Likewise, Dr. Geils believes the results of his study support further research into the efficacy and safety of Dacogen in elderly and other high-risk MDS patients.

For more information, please see abstract 2792 at the ASH Meeting Web site.