title: Dose-dependent effect of thalidomide on overall survival in relapsed multiple myeloma.
abstract: OBJECTIVE
  Although thalidomide (Thal) was introduced successfully in the treatment of multiple myeloma (MM), the optimal Thal dosage and schedule are still controversial. The aim of this study was to analyze whether the effect of Thal in MM is dose dependent and whether the outcome might be improved when the Thal dosage is adjusted to parameters reflecting body size.
  
  
  METHODS
  From December 1998 to March 2001, 83 patients with relapsed MM were enrolled in a clinical Phase II trial and treated with a maximum Thal dosage of 400 mg daily. We performed a retrospective analysis and studied the effect of the cumulative 3-month Thal dosage on progression-free survival and overall survival (OS) together with age and the pretreatment levels of beta2-microglobulin, C-reactive protein, albumin, and hemoglobin in a Cox regression model.
  
  
  RESULTS
  After a median follow-up time of 17 months (range, 1-30 months), the estimated 12-month progression-free survival and OS were 45% (SE = 6%) and 86% (SE = 4%) for the whole patient group. After backward selection, hemoglobin (P = 0.002) and the cumulative 3-month Thal dosage (P = 0.002) were the remaining factors for OS. The effect on OS could not be improved when the cumulative 3-month Thal dosage was adjusted to parameters reflecting body size such as height, weight, body surface area, or body mass index in comparison with Thal alone.
  
  
  CONCLUSIONS
  Our retrospective analysis demonstrates that the cumulative 3-month Thal dosage is one of the major prognostic factors for OS, supporting the hypothesis of a dose-dependent effect of Thal in relapsed MM.
authors.affiliation: Department of Internal Medicine V, University of Heidelberg, 69115 Heidelberg, Germany. k.neben@dkfz.de
authors.forename: Kai
authors.initials: K
authors.lastname: Neben
authors.forename: Thomas
authors.initials: T
authors.lastname: Moehler
authors.forename: Axel
authors.initials: A
authors.lastname: Benner
authors.forename: Alwin
authors.initials: A
authors.lastname: Kraemer
authors.forename: Gerlinde
authors.initials: G
authors.lastname: Egerer
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Ho
authors.forename: Hartmut
authors.initials: H
authors.lastname: Goldschmidt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000096:biosynthesis; D001827:Body Height; D001835:Body Weight; D002097:C-Reactive Protein / Q000096:biosynthesis; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006454:Hemoglobins / Q000096:biosynthesis; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D011379:Prognosis; D016016:Proportional Hazards Models; D012008:Recurrence; D012189:Retrospective Studies; D013792:Thalidomide / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D001613:beta 2-Microglobulin / Q000097:blood
chemical_list: D000418:Albumins; D006454:Hemoglobins; D007166:Immunosuppressive Agents; D001613:beta 2-Microglobulin; D013792:Thalidomide; D002097:C-Reactive Protein