title: Better quality of response to lenalidomide plus dexamethasone is associated with improved clinical outcomes in patients with relapsed or refractory multiple myeloma.
abstract: BACKGROUND
  This retrospective pooled analysis of two phase III trials (MM-009/MM-010) compared clinical outcomes of patients who achieved a complete response or very good partial response to treatment with lenalidomide plus dexamethasone with the outcomes of those who only achieved a partial response.
  
  
  METHODS
  Patients (n=353) received lenalidomide (25 mg/day for 21 days of each 28-day cycle) plus dexamethasone (40 mg on days 1-4, 9-12, and 17-20 for four cycles, and only on days 1-4 after the first four cycles). Time to response, duration of response, time-to-progression, overall survival, and adverse events were investigated for patients who had a complete or very good partial response and compared with those of patients who had a partial response.
  
  
  RESULTS
  At the time of unblinding, 32% of patients had achieved a complete or very good partial response and 28% had a partial response. Half (50.5%) of the patients who had a partial response as their initial response achieved a complete or very good partial response with further treatment. The probability of achieving a complete or very good partial response with continued lenalidomide treatment decreased with delayed achievement of a partial response (by cycle 4 versus later); however, it remained clinically significant. With an extended follow-up of 48 months, the median response duration, time-to-progression, and overall survival were longer in patients with a complete or very good partial response than in those with a partial response (24.0 versus 8.3 months, P<0.001; 27.7 versus 12.0 months, P<0.001; not reached versus 44.2 months, P=0.021, respectively). The benefit of a complete or very good partial response was independent of when it was achieved.
  
  
  CONCLUSIONS
  Continuing treatment with lenalidomide plus dexamethasone to achieve best response, in the absence of disease progression and toxicity, provided deeper remissions and greater clinical benefit over time for patients in this study.
authors.affiliation: Centre René Gauducheau, Bd. Jacques Monod, Nantes, St. Herblain, France. jl-harousseau@nantes.fnclcc.fr
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Harousseau
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: Michael
authors.initials: M
authors.lastname: Wang
authors.forename: Alessandro
authors.initials: A
authors.lastname: Corso
authors.forename: Christine
authors.initials: C
authors.lastname: Chen
authors.forename: Michel
authors.initials: M
authors.lastname: Attal
authors.forename: Andrew
authors.initials: A
authors.lastname: Spencer
authors.forename: Zhinuan
authors.initials: Z
authors.lastname: Yu
authors.forename: Marta
authors.initials: M
authors.lastname: Olesnyckyj
authors.forename: Jerome B
authors.initials: JB
authors.lastname: Zeldis
authors.forename: Robert D
authors.initials: RD
authors.lastname: Knight
authors.forename: Donna M
authors.initials: DM
authors.lastname: Weber
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D017326:Clinical Trials, Phase III as Topic; D003907:Dexamethasone / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D012189:Retrospective Studies; D016879:Salvage Therapy / Q000379:methods*; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide
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