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Vidaza and Thalidomide Combination Therapy Is Safe And At Least As Effective As Vidaza Alone In Myelodysplastic Syndromes Patients

No Comment By Biblia Kim
Published: Jan 13, 2010 2:43 pm
Vidaza and Thalidomide Combination Therapy Is Safe And At Least As Effective As Vidaza Alone In Myelodysplastic Syndromes Patients

A combination treatment of Vidaza (azacitidine) and thalidomide (Thalomid) is considered to be safe and at least as effective as Vidaza alone in myelodysplastic syndromes (MDS) patients, according to recent research published in the journal Cancer.

Vidaza has been one of the main therapies for MDS since it was approved by the US Food and Drug Administration in 2004.  In August 2009, the National Comprehensive Cancer Network recommended Vidaza as the preferred drug for “treating MDS patients with progressing or relatively high-risk disease,” which includes patients most likely to progress to acute myeloid leukemia (see related Beacon news).

However, many MDS patients either do not respond or only have limited or brief responses to single-agent therapy like Vidaza. Researchers are therefore exploring potential combination therapies for the treatment of MDS.

Thalidomide is currently being investigated as a potential treatment for MDS patients due to evidence that it stabilizes blood cells by improving the bone marrow environment where blood cell development occurs (see related Beacon news). 

In this study, researchers tested Vidaza therapy in combination with thalidomide in 24 MDS and 16 acute myeloid leukemia (AML) patients. They received 75 mg/m2 Vidaza subcutaneously for five days every four weeks and 50 mg thalidomide per day, which was increased to 100 mg daily on day 8.  Of the 40 patients, 36 were evaluable for results.

Results showed that 58 percent of patients responded to the combination treatment. Seventeen percent of the patients achieved a complete remission (2 MDS and 4 AML patients).  Forty two percent experienced disease progression or did not show any improvements.

The median survival of the MDS patients was 18.5 months, compared to 13.2 months for AML patients.  Overall median survival of all evaluated patients was 17.8 months. 

The results also revealed that patients who did not improve through combination therapy possibly had genetic sequences that distinguished them from respondents. 

Side effects were mostly mild to moderate and consistent with the known side effects associated with the two drugs.

The study authors concluded that treating the MDS and AML patients with Vidaza and thalidomide was well tolerated and at least as effective as Vidaza alone. 

For more information, please see the related article in Cancer (full text).

The MDS Beacon will continue to follow research about Vidaza and thalidomide combination therapy from the recent 51st Annual American Society of Hematology Meeting and Exposition that took place in early December.  Other research and news articles about Vidaza and thalidomide can also be found on the Beacon.

Photo by Lee Nachtigal on Flickr – some rights reserved.
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