Lenalidomide Plus Low-Dose Dexamethasone (Ld): Superior One and Two Year Survival Regardless of Age Compared to Lenalidomide Plus High-Dose Dexamethasone (LD)

Abstract Abstract 308 Introduction: The Eastern Cooperative Oncology Group (ECOG) has previously reported the superior 1 and 2 year survival of Ld versus LD as initial therapy in newly diagnosed symptomatic multiple myeloma (MM) (Rajkumar et al Lancet Oncol 2010; 11: 29–37). The 1 year and 2 year OS for Ld vs LD were 96% and 85% vs 88% and 78%, (p 65. In this analysis, we evaluated the impact of age on dexamethasone dose intensity and OS. Methods: 445 pts were randomly assigned: 223 to LD and 222 to Ld. Pts were analyzed on an intent-to-treat basis for OS. The pts were analyzed by age in 2 groups: 65 (the age corresponding to transplant eligibility outside the US). The pts > 65 were then further subdivided into >70 and > 75 yrs. Results are expressed as OS probability at 1 and 2 years post randomization. In addition, to eliminate the early death ‘penalty’ in the LD group in the original analysis, a landmark analysis was performed at 4 months. Results: Overall Survival Probability: Intent-to Treat Analysis LD Ld LD Ld LD Ld Age N/Events N/Events 1 yr 1 yr 2 yr 2 yr 104/16 108/19 .92 .96 .86 .92 >65 119/40 113/33 .84 .95 .72 .85 >70 76/30 71/18 .78 .96 .67 .89 >75 38/11 30/13 .76 .90 .60 .76 Overall Survival Probability: 4 month Landmark Analysis LD Ld LD Ld LD Ld Age N/Events N/Events 1 yr 1 yr 2 yr 2 yr 103/15 106/17 .93 .98 .86 .93 >65 109/30 113/33 .92 .96 .79 .86 >70 67/21 70/17 .88 .97 .76 .90 >75 34/14 29/12 .85 .93 .67 .79 Conclusions: As previously reported, OS in the trial at 1 and 2 years was superior with Ld. OS was not superior with LD compared with Ld in any age group despite a higher response rate. This was true even when using a landmark analysis to eliminate the 5% early deaths seen in the first 4 months of treatment. We conclude the following: 1) LD is not definitively superior to Ld in any age group; 2) Given the higher toxicity in the absence of a clear survival benefit with LD, Ld remains the best choice for all ages. This analysis confirms the original opinion that low-dose dexamethasone is the standard of care for all newly diagnosed MM pts, regardless of age. Disclosures: Vesole: Millennium Pharmaceuticals: Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Centorcor-Ortho-Biotech: Speakers Bureau. Off Label Use: Lenalidomide for front-line therapy in multiple myeloma. Abonour: Celgene: Speakers Bureau; Millennium Pharmaceuticals: Speakers Bureau. Callander: Millennium Pharmaceuticals: Research Funding. Fonseca: Amgen: Consultancy; Bristol-Myers Squibb: Consultancy; Celgene: Consultancy, Research Funding; Genzyme: Consultancy; Onyx: Research Funding; Otsuka: Consultancy; Medtronic: Consultancy; Intellikine: Consultancy. Siegel: Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Millennium Pharmaceuticals: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Merck: Membership on an entity's Board of Directors or advisory committees.