Managed Care - July 2008 - (Page H14) FIGURE 2 Phase 3 trials of lenalidomide/dexamethasone in relapsed or refractory multiple myeloma Partial response 80 Total =61.0 (P<.001) 60 Response rate (%) Response rate, % 60 Near complete response 80 Complete response Total=60.2 (P<.001) 40 36.7 Total=60.2 (P<.001) 19.9* 10.2 14.1 18.2 1.1 0.6 40 35.8 Total =60.2 (P<.001) 24.0* 20 20 8.5 18.9 15.9 1.7 3.4 Len/Dex (n=176) Dex (n=175) 0 Len/Dex (n=177) Dex (n=176) 0 North Americaa Dex=dexamethasone, Len=lenalidomide. Sources: aWeber 2007, bDimopoulos 2007 Internationalb who received lenalidomide were exceptionally high (61 percent in the North American trial and 59 percent in the international trial). CR rates also were higher among patients who received lenalidomide with dexamethasone. Perhaps the most remarkable difference between the two treatment groups was with regard to TTP; the combination of lenalidomide and dexamethasone significantly extended the median TTP, from 4.7 months to 11.1 months in the North American study (P<.001), and from 4.7 months to 11.3 months in the international study (P<.001). This was the longest TTP observed to date in a phase 3 trial with previously treated patients. Although use of lenalidomide results in far less neuropathy than seen with thalidomide, greater myelosuppression occurs. In these two trials, patients had a high degree of grade 3/4 neutropenia (nearly 40 percent), but a low incidence of febrile neutropenia (less than 3 percent in both trials). Other adverse events reported with the combination of lenalidomide and dexamethasone were muscle cramps, constipation, nausea, tremor, and dizziness. These effects were manageable with dose adjustments. Another significant finding in these two trials was a remarkably high activity level in patients who had previously received thalidomide compared with those who had not (53 percent versus 63 percent). This response, even in patients previously exposed to the analogue of lenalidomide, was much higher than expected. This find- ing has created an interest in determining whether patients who fail treatment with lenalidomide will respond to thalidomide, and adds to the growing emphasis on determining the proper sequencing of agents in all treatment regimens. Clinical trials examining this issue are ongoing. Conclusion Although myeloma remains incurable, management of the disease has significantly improved with the introduction of novel agents. As various regimens continue to undergo testing, a major focus of ongoing trials will be determining the optimal combination and sequencing of novel and conventional therapies. In addition, insights into the role of the tumor microenvironment are expected to continue to generate newer targeted approaches. Considerable variations in the clinical manifestations of myeloma and in the patient response to treatment, together with the availability of an increasing number of treatment options, have led clinicians to adopt a more personalized approach to care. Decisions regarding treatment should begin with a long-term plan that incorporates both a patient’s prognosis and their QoL goals. References American Cancer Society. Cancer Facts and Figures 2008. «http://www.cancer.org/downloads/STT/ 2008CAFFfinalsecured.pdf.» Accessed June 3, 2008. Attal M, Harousseau JL. Role of autologous stem-cell transplanta- 14 MANAGED CARE / SUPPLEMENT http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf
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