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| |  ASH: Velcade-Thalidomide-Dexamethasone Regimen Shows Treatment Potential for End-Stage Myeloma By Deanna M Green, PhD SAN DIEGO, CA -- December 12, 2003 -- Good response and survival rates are seen with a regimen of velcade, thalidomide and dexamethasone in patients with end-stage myeloma, according to a preliminary study presented here December 9th at the American Society of Hematology 45th Annual Meeting. Patients with cytogenetic abnormalities -- in particular a deletion at chromosome 13 -- however, show poorer event-free survival. Autologous transplantation is now considered standard therapy for myeloma. New strategies are still needed, however, particularly for high-risk groups who have shown poor prognosis or have failed traditional treatments. Preclinical studies have suggested a synergistic effect between 2 new myeloma-active immunomodulatory agents: velcade and thalidomide. This combination has not been tested clinically, however, and has a risk of neurologic toxicity. Maurizio Zangari, MD, and colleagues, Arkansas Cancer Research Center, University of Arkansas for Medical Sciences, Little Rock, United States, evaluated the safety and efficacy of velcade plus thalidomide in 56 patients with multiple myeloma who relapsed after autologous transplantation. The population chosen was a high-risk treatment group, as 78% had previous exposure and resistance to thalidomide, and 37% had more than 5 years of prior therapy. Furthermore, 76% of patients had abnormal cytogenetics, with half showing hypodiploidy at chromosome 13. Treatment consisted of velcade (1.0 or 1.3 mg/m2) and thalidomide (50-200 mg) on Days 1, 4, 8 and 11 of each cycle. Patients were also given dexamethasone if a partial response (defined as greater than or equal to 50% reduction in serum M protein or greater than or equal to 75% reduction of urine M protein) was not achieved by cycle 4. Dr. Zangari noted that "about 30% of patients showed some response after the first treatment cycle, and 70% of patients responded by the fourth cycle." Half of the patients showed a greater than or equal to 50% improvement after 4 cycles, and therefore did not require dexamethasone. Furthermore, 70% of patients had a greater than or equal to 25% improvement after 4 cycles. By the final treatment cycle, 22% of patients showed a complete response (greater than or equal to 99% improvement), and 70% showed at least a 25% improvement. Interestingly, the quality of response was not affected by velcade or thalidomide dose, and was independent of cytogenetic abnormalities. The event-free and overall survival rates, however, were affected by the presence and type of cytogenetic abnormalities. Survival rates were highest in patients who did not have abnormalities, and lowest in patients with hypodiploidy at chromosome 13. Specifically, the event-free survival at 1 year was 33% with hypodiploidy, 43% with other abnormalities, and 58% without abnormalities. About 20% of patients experienced cytopenia, and less than 10% had grade 3 or higher neurotoxicity. Dr. Zangari concluded that "the velcade-thalidomide-dexamethasone regimen is well-tolerated, and has excellent activity in a very high-risk population." He also notes the "there is a poor risk for patients with cytogenetic abnormalities -- particularly hypodiploidy at chromosome 13."
[Study Title: VTD Regimen Comprising Velcade (V) + Thalidomide (T) and Added DEX (D) for Non-responders to V + T Effects a 57% PR Rate Among 56 patients with Myeloma (M) Relapsing After Autologous Transplant. Abstract 830]
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