Lenalidomide plus dexamethasone versus thalidomide plus dexamethasone in newly diagnosed multiple myeloma: a comparative analysis of 411 patients

Abstract

The objective of this case-control study was to compare the efficacy and toxicity of lenalidomide plus dexamethasone (len/dex) versus thalidomide plus dexamethasone (thal/dex) as initial therapy for newly diagnosed myeloma. We retrospectively studied 411 newly diagnosed patients treated with len/dex (228) or thal/dex (183) at the Mayo Clinic. The differences were similar in a matched-pair analysis that adjusted for age, sex, transplantation status, and dexamethasone dose. The proportions of patients achieving at least a partial response to len/dex and thal/dex were 80.3% versus 61.2%, respectively (P < .001); very good partial response rates were 34.2% and 12.0%, respectively (P < .001). Patients receiving len/dex had longer time to progression (median, 27.4 vs 17.2 months; P = .019), progression-free survival (median, 26.7 vs 17.1 months; P = .036), and overall survival (median not reached vs 57.2 months; P = .018). A similar proportion of patients in the 2 groups experienced at least one grade 3 or 4 adverse event (57.5% vs 54.6%, P = .568). Main grade 3 or 4 toxicities of len/dex were hematologic, mainly neutropenia (14.6% vs 0.6%, P < .001); the most common toxicities in thal/dex were venous thromboembolism (15.3% vs 9.2%, P = .058) and peripheral neuropathy (10.4% vs 0.9%, P < .001). Len/dex appears well-tolerated and more effective than thal/dex. Randomized trials are needed to confirm these results.

Figure 1

TTP in the intention-to-treat population of patients treated with len/dex and thal/dex. (A) TTP in all patients, regardless of dexamethasone dose. (B) TTP in pair mates who received high-dose dexamethasone. Median TTP is provided in the figure. m indicates months.

Figure 2

PFS in the intention-to-treat population of patients treated with len/dex and thal/dex. (A) PFS in all patients, regardless of dexamethasone dose. (B) PFS in pair mates who received high-dose dexamethasone. Median PFS is provided in the figure. m indicates months.

Figure 3

OS in the intention-to-treat population of patients treated with len/dex and thal/dex. (A) OS in all patients, regardless of dexamethasone dose. (B) OS in pair mates who received high-dose dexamethasone. Median OS is provided in the figure. m indicates months.

Figure 4

Subgroup analysis of OS in the intention-to-treat population of patients treated with len/dex and thal/dex according to transplantation status. (A) OS in patients who received transplantation. (B) OS in patients in patients who did not receive transplantation. Median OS is provided in the figure. m indicates months.