The MDS Beacon™

Higher-risk myelodysplastic syndromes (MDS) patients who achieve at least stable disease experience prolonged survival.  Additionally, for patients with stable disease, continued treatment with Vidaza (azacitidine) may lead to an improved response. These results were presented by Dr. Alan List of the Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, on June 7 at the American Society of Clinical Oncology (ASCO) annual meeting.

”Stable disease is a highly significant predictor for overall survival,” said Dr. List.

Previous research has shown that Vidaza significantly prolongs overall survival in higher-risk MDS patients compared to conventional care. Research has also indicated that first responses are achieved within six months of treatment and that the achievement of a complete response is not necessary to prolong overall survival.

However, little information is available on how to treat patients who achieved stable disease as their best response after being treated with six cycles of Vidaza.

Dr. List and other leading MDS specialists therefore analyzed the data from a previous Phase 3 trial to determine the relationship between disease status, response to treatment, and overall survival rate.

The trial enrolled 358 higher-risk MDS patients who received either Vidaza or conventional care regimens.  Conventional care regimens consisted of either intensive chemotherapy, low-dose cytarabine, or best supportive care.  Patient data were analyzed at three, six, and nine months.

Dr. List and his colleagues confirmed that patients who responded to Vidaza had a higher overall survival than patients who responded to conventional care.

The researchers found that patients who achieved stable disease as best response had a significant survival benefit over patients who showed disease progression.

They also found that patients with stable disease who received Vidaza were more likely to achieve improved blood cell counts than patients with stable disease who received conventional care.

Of the patients who had achieved stable disease after three months, 21 percent of patients who received Vidaza showed increased blood cell counts at six months compared to 14 percent of patients who received conventional care.

Of the patients with stable disease at six months, 14 percent of patients who received Vidaza achieved improved blood cell counts after nine months. No conventional care patients showed such progress.

“We are seeing evidence that you don’t necessarily need an objective response to get a clinical benefit,” said Dr. Jeffrey Lancet in a discussion session about Dr. List’s findings.

Based on these results, Dr. List suggested treating patients with stable disease for at least six months with Vidaza. After that, the decision on whether to continue Vidaza treatment should be made on an individual basis, since approximately 15 percent of patients may achieve a response that translates into a survival benefit.

For more information, please see abstract 6503 at the ASCO meeting website.