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| |  Thalidomide Provides a Durable Response and Survival Benefit Primarily in Patients With Low-Risk Myelodysplastic Disease: Presented at MDS By Alison Palkhivala FLORENCE, ITALY -- May 22, 2007 -- While any patient with myelodysplastic syndrome (MDS) may respond to thalidomide therapy, used alone or in combination with other agents, only those with low-risk disease are likely to obtain a sustained response and good overall survival, according to research presented here at the 9th International Symposium on Myelodysplastic Syndromes (MDS). Thalidomide has been chosen for clinical trials in MDS for 3 important effects: antitumour necrosis factor effect, anti-angiogenic effect, and immunomodulatory effect, write the investigators in a poster presented on May 18th. "Apart from the response rate, an important question relates to the long-term effects of thalidomide (± other agents) on the survival of MDS patients, especially those who have responded to these therapies. Are these therapies only providing short-term palliation, or is there an improvement in the survival of responders?" the researchers asked. To find out, the researchers, led by Anna Candoni, MD, division of haematology and bone marrow transplantation, University Hospital, Udine, Italy, evaluated the outcomes of 248 symptomatic patients with MDS who received thalidomide alone (n = 83) or in combination with other agents (n = 165). They evaluated response to the drug using International Working Group (IWG) criteria. Overall, 21% of patients achieved a haematological response to thalidomide, and these responses were primarily restricted to the erythroid series. Most patients who responded to thalidomide had refractory anaemia (RA) or RA with ringed sideroblasts (RARS). While the response rate to thalidomide was 25% in patients with refractory anaemia with excess blasts (RAEB) or RAEB in transformation as well as in patients with RA or RARS, the response was more durable in patients with RA/RARS. Based on a log-rank test, the 52 patients who responded to thalidomide therapy had a superior survival outcome than the nonresponders (P =.0002). The best survival rates occurred in patients who received thalidomide and etanercept, but these patients may have had lower-risk disease, the authors pointed out. Multilineage haematological responses were observed when thalidomide was combined with arsenic trioxide, particularly in patients with inv(3)(q21q26.2) and/or high pretherapy EV11 expression. Based on these results, the authors concluded in their poster that about 20% to 25% of MDS patients with any French-American-British score or International Prognostic Scoring System (IPSS) classification score can achieve a response to thalidomide alone or in combination. However, they noted that only patients with a low IPSS score or with low-grade MDS (RARS or RA) are able to maintain this response and can achieve a better survival. Patients with RAEB and RAEB in transformation have shorter response duration and no clear advantage with respect to survival.
[Presentation title: Thalidomide Alone or in Combination With Other Agents for the Treatment of Myelodysplastic Syndrome (MDS). Poster P144]
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