title: Predictive factors of survival after thalidomide therapy in advanced multiple myeloma: long-term follow-up of a prospective multicenter nonrandomized phase II study in 120 patients.
abstract: Thalidomide monotherapy has demonstrated consistent results in the treatment of advanced multiple myeloma. We report a 9-year follow-up of a French multicenter nonrandomized phase II study that evaluated the effect of oral thalidomide in 120 patients with advanced multiple myeloma. Independent predictors of survival were response to last therapy, performance status, serum β(2)-microglobulin level, platelet count, and response at day 60 of treatment.
  
  
  BACKGROUND
  Thalidomide monotherapy has demonstrated consistent results in the treatment of advanced multiple myeloma.
  
  
  METHODS
  We report the 9-year follow-up of a French multicenter, nonrandomized, phase II study that evaluated the effect of oral thalidomide in advanced multiple myeloma. Thalidomide was started at 200 mg/d and increased to 400 mg/d at day 15.
  
  
  RESULTS
  One hundred twenty patients were enrolled in 2 months at 33 centers. The overall response rate was 31.7% (38/120) on day 60. Overall survival rates were 47.5% (95% confidence interval [CI], 38.6-56.4), 25.0% (95% CI, 17.3-32.7), 11.7% (95% CI, 5.9-17.4), and 7.5% (95% CI, 2.8-12.2) at 1, 3, 6, and 9 years, respectively. Independent predictors of short survival at 1, 3, 6, and 9 years were multiple myeloma refractory to last therapy, performance status ≥ 2, serum β(2)-microglobulin level ≥ 3.5 mg/L, platelet count < 152 × 10(9)/L, and nonresponse at day 60 (Cox proportional hazards regression model).
  
  
  CONCLUSIONS
  Our study identified 5 independent unfavorable prognostic factors associated with short survival. These prognostic factors were very robust, allowing the prediction of patient survival not only during the first year but also during 3, 6, and even 9 years after the beginning of treatment.
authors.affiliation: Department of Internal Medicine, Rennes 1 University, Rennes University Hospital, Rennes, France. olivier.decaux@chu-rennes.fr
authors.forename: Olivier
authors.initials: O
authors.lastname: Decaux
authors.forename: Alain
authors.initials: A
authors.lastname: Renault
authors.forename: Véronique
authors.initials: V
authors.lastname: Sébille
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
authors.forename: Michel
authors.initials: M
authors.lastname: Attal
authors.forename: Laurent
authors.initials: L
authors.lastname: Voillat
authors.forename: Brigitte
authors.initials: B
authors.lastname: Pegourie
authors.forename: Mourad
authors.initials: M
authors.lastname: Tiab
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
authors.forename: Robert
authors.initials: R
authors.lastname: Zerbib
authors.forename: Bernard
authors.initials: B
authors.lastname: Grosbois
authors.forename: Eric
authors.initials: E
authors.lastname: Bellissant
mesh_terms: D000368:Aged; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D011379:Prognosis; D011446:Prospective Studies; D016019:Survival Analysis; D013792:Thalidomide / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide