title: 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.
authors.affiliation: Department of Internal Medicine, Division of Hematology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.
authors.forename: Francesca
authors.initials: F
authors.lastname: Gay
authors.forename: Suzanne R
authors.initials: SR
authors.lastname: Hayman
authors.forename: Martha Q
authors.initials: MQ
authors.lastname: Lacy
authors.forename: Francis
authors.initials: F
authors.lastname: Buadi
authors.forename: Morie A
authors.initials: MA
authors.lastname: Gertz
authors.forename: Shaji
authors.initials: S
authors.lastname: Kumar
authors.forename: Angela
authors.initials: A
authors.lastname: Dispenzieri
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Mikhael
authors.forename: P Leif
authors.initials: PL
authors.lastname: Bergsagel
authors.forename: David
authors.initials: D
authors.lastname: Dingli
authors.forename: Craig B
authors.initials: CB
authors.lastname: Reeder
authors.forename: John A
authors.initials: JA
authors.lastname: Lust
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Russell
authors.forename: Vivek
authors.initials: V
authors.lastname: Roy
authors.forename: Steven R
authors.initials: SR
authors.lastname: Zeldenrust
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Witzig
authors.forename: Rafael
authors.initials: R
authors.lastname: Fonseca
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kyle
authors.forename: Philip R
authors.initials: PR
authors.lastname: Greipp
authors.forename: A Keith
authors.initials: AK
authors.lastname: Stewart
authors.forename: S Vincent
authors.initials: SV
authors.lastname: Rajkumar
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016022:Case-Control Studies; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D012189:Retrospective Studies; D016879:Salvage Therapy / Q000379:methods; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide