Zosia Chustecka

December 19, 2011

December 19, 2011 (San Diego, California) — A survey asking nearly 2000 hematology/oncology providers in the United States how they would treat patients with myelodysplastic syndrome (MDS) has revealed an education gap, according to a poster presentation here at the American Society of Hematology 53rd Annual Meeting.

The survey showed that information from clinical trials was filtering down to physicians who are seeing these patients and that their prescribing decisions were data-driven, but was one instance in which there was some confusion over the significance of a biomarker in this setting.

It appears that some of the information about a biomarker has been taken out of context and was not being considered within the clinical setting, said coauthor Michael Williams, MD, FACP, chief of the hematologic malignancies section at the University of Virginia in Charlottesville. This resulted in patients receiving an expensive therapy with no proven benefit instead of a drug with a documented survival advantage, he told Medscape Medical News.

The reserachers looked at the prescribing preferences of 1960 American hematology/oncology providers from 2006 to 2010. The majority (around 80%) of these clinicians were in community practice; the remainder were in academic or teaching hospitals. They were all seeing newly diagnosed MDS patients annually — 17% to 20% of physicians estimated that they saw 5 or fewer new MDS patients each year, 39% to 44% saw 5 to 10 patients, 21% to 24% saw 11 to 15 patients, and 14% to 21% saw more than 15 new MDS patients annually.

Hypothetical Patients

In the survey, physicians were presented with hypothetical MDS patients and asked how they would treat them.

The researchers, led by James Foran, MD, FRCPC, from the division of hematology/oncology at the Mayo Clinic in Jacksonville, Florida, found that over the 4 years of the study, there was a significant change in the first-line treatment preferences for patients with higher-risk MDS. From 2007 to 2010, there was a progressive increase (from 40% to 78%) in physicians who would choose azacitidine (Vidaza, Celgene) as first-line treatment for patients with high risk MDS (and no Del5q mutation).

This change in prescribing reflected new data from a phase 3 trial of azacitidine (Lancet Oncol. 2009;10;223-232), which showed a survival benefit for the drug in this high-risk MDS patient population, said Dr. Foran. Azacitidine was first approved for use in high-risk MDS in 2004.

Azacitidine was chosen as the first-line treatment by only 40% of responders in 2007, but by 59% in 2008, 72% in 2009, and 78% in 2010.

The other drug choices were decitabine (Dacogen, Eisai) and lenalidomide (Revlimid, Celgene).

Decitabine was approved by the US Food and Drug Administration for use in MDS in 2006, but a recent trial with decitabine in a population similar to that in the azacitidine trial failed to show a significant survival benefit (J Clin Oncol. 2011;29:1987-1996), the researchers note.

Lenalidomide was approved in 2005, but is only indicated for use in the treatment of anemia in lower-risk patients with MDS and the Del5q mutation. The researchers point out that there are no phase 3 data testing the impact of lenalidomide on survival in higher-risk MDS, and the National Comprehensive Cancer Network does not include lenalidomide in its recommendations for the first-line treatment of higher-risk MDS.

Clinicians took this information on board. By 2010, only 2% of those surveyed said they would prescribe lenalidomide as a first-line treatment to a patient with higher-risk MDS (and no Del5q mutation). Another 17% said they would prescribe decitabine, but the majority (78%) said they would prescribe azacitidine.

Azacitidine would be the most appropriate choice in this patient population because it has documented survival advantage, so this choice is "data-driven," Dr. Foran said.

Choice Not Evidence-Based

However, when the same physicians were presented with a slightly different scenario — the hypothetical MDS patient was still higher risk but had a Del5q mutation — the results were somewhat surprising.

The same physicians were far more likely to prescribe lenalidomide as first-line therapy. In 2008, 17% of those surveyed chose lenalidomide and 30% chose azacitidine; in 2009, 49% chose lenalidomide and 39% azacitidine. In 2010, the distribution was evenly split, with 42% choosing lenalidomide and 42% choosing azacitidine.

"It appears that these physicians were having a knee-jerk reaction, choosing lenalidomide when they heard Del5q," said Dr. Foran. However, lenalidomide is approved for use in low-risk MDS with Del5q; these hypothetical patients had high-risk MDS and Del5q.

In this clinical setting, the choice of lenalidomide is not appropriate — these patients should be on azacitidine, Dr. Foran noted. "Lenalidomide is not approved for this use and it is not in the treatment guidelines," he explained.

"These findings suggest that there are important education gaps," the researchers conclude, adding that "efforts to address this gap with evidence-based approaches are warranted."

Dr. Foran reports being a consultant to Celgene. Dr. Williams reports being a consultant to Celgene and receiving honoraria from Xcenda Consulting Services.

American Society of Hematology (ASH) 53rd Annual Meeting: Abstract 3816. Presented December 12, 2011.

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