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| |  Lenalidomide Plus Low-Dose Dexamethasone Improves Short-Term Survival in Newly Diagnosed Myeloma NEW YORK -- October 21, 2009 -- A study published online first and appearing in an upcoming issue of The Lancet Oncology, concludes that lenalidomide plus low-dose dexamethasone is associated with better short-term overall survival and with lower toxicity than lenalidomide plus high-dose dexamethasone in patients with newly diagnosed myeloma; and is thus a viable treatment option for these patients. S. Vincent Rajkumar, MD, Mayo Clinic, Rochester, Minnesota, and colleagues on behalf of the Eastern Cooperative Oncology Group (ECOG), randomised patients with untreated, symptomatic myeloma to receive lenalidomide 25 mg on days 1 to 21 plus dexamethasone 40 mg on days 1 to 4, 9 to 12, and on days 17 to 20 of a 28-day cycle (high dose), or lenalidomide given on the same schedule with dexamethasone 40 mg on days 1, 8, 15, and 22 of a 28-day cycle (low dose). After 4 cycles, patients could discontinue therapy to pursue stem-cell transplantation or continue treatment until disease progression. The primary endpoint was response rate after 4 cycles, assessed with European Group for Blood and Bone Marrow Transplant criteria. The researchers found that 79% of the 214 patients receiving high-dose therapy and 68% of the 205 patients on low-dose therapy had complete or partial response within 4 cycles. However, at the second interim analysis at 1 year, overall survival was 96% in the low-dose dexamethasone group compared with 87% in the high-dose group. As a result, the trial was stopped and patients on high dose therapy were crossed over to low-dose therapy. Of the patients on the high-dose regimen 117 (52%) had grade 3 or worse toxic effects in the first 4 months, compared with 76 (35%) of the 220 on the low-dose regimen for whom toxicity data were available. Twelve patients in the high-dose group and 1 patient in the low-dose group died in the first 4 months. The 3 most common grade 3 or higher toxicities in the high- and low-dose groups, respectively, were deep-vein thrombosis (26% vs 12%), infections including pneumonia (16% vs 9%), and fatigue (15% vs 9%). “High-dose dexamethasone in a community-setting seems more toxic than low-dose dexamethasone, with more early deaths in the first 4 months, increased risk of thromboembolic complications, and higher overall risk of serious adverse “This trial...shows that low-dose dexamethasone in conjunction with lenalidomide is an active regimen for newly diagnosed myeloma with acceptable toxicity and low early mortality.” They added that “The results of this trial show that the use of high-dose dexamethasone is not needed for the most part in the context of new active agents for myeloma, and as a result almost all current phase 3 trials have adopted low-dose dexamethasone as the standard in combination regimens.”
SOURCE: The Lancet Oncology
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