title: Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma.
abstract: BACKGROUND
  Thalidomide maintenance therapy after stem cell transplantation resulted in increased progression-free survival and overall survival in a few trials, but its role in non-transplant eligible patients with multiple myeloma remains unclear. This study assessed the impact of thalidomide-interferon in comparison to interferon maintenance therapy in elderly patients with multiple myeloma.
  
  
  METHODS
  Of 289 elderly patients with multiple myeloma who were randomized to thalidomide-dexamethasone or melphalan-prednisolone induction therapy, 137 finally completed 9 cycles of induction therapy with stable disease or better and thereby qualified for maintenance treatment. Of these, 128 have been randomized to either thalidomide-interferon or interferon alone. Primary study endpoints were progression-free survival and response rates; secondary endpoints were overall survival, toxicity and quality of life.
  
  
  RESULTS
  Thalidomide-interferon maintenance therapy led to a significantly longer progression-free survival compared to interferon (27.7 vs. 13.2 months, P=0.0068), but overall survival was similar in both groups (52.6 vs. 51.4 months, P=0.81) and did not differ between patients aged 75 years or older, or younger patients (P=0.39). Survival after disease progression tended to be shorter in patients on thalidomide-interferon maintenance therapy (P=0.056). Progression-free survival and overall survival tended to be shorter in patients with adverse cytogenetic (FISH) findings compared to the standard risk group but differences were not significant (P=0.084 and P=0.082, respectively). Patients on thalidomide-interferon presented with more neuropathy (P=0.0015), constipation (P=0.0004), skin toxicity (P=0.0041) and elevated creatinine (P=0.026).
  
  
  CONCLUSIONS
  Thalidomide plus interferon maintenance therapy increased progression-free survival but not overall survival and was associated with slightly more toxicity than maintenance with interferon alone. (ClinicalTrials.gov Identifier: NCT00205751).
authors.affiliation: Department of Medicine I, Center for Oncology and Hematology, Wilhelminenspital, Vienna, Austria. heinz.ludwig@wienkav.at
authors.forename: Heinz
authors.initials: H
authors.lastname: Ludwig
authors.forename: Zdenek
authors.initials: Z
authors.lastname: Adam
authors.forename: Elena
authors.initials: E
authors.lastname: Tóthová
authors.forename: Roman
authors.initials: R
authors.lastname: Hajek
authors.forename: Boris
authors.initials: B
authors.lastname: Labar
authors.forename: Miklós
authors.initials: M
authors.lastname: Egyed
authors.forename: Ivan
authors.initials: I
authors.lastname: Spicka
authors.forename: Heinz
authors.initials: H
authors.lastname: Gisslinger
authors.forename: Johannes
authors.initials: J
authors.lastname: Drach
authors.forename: Ingrid
authors.initials: I
authors.lastname: Kuhn
authors.forename: Axel
authors.initials: A
authors.lastname: Hinke
authors.forename: Niklas
authors.initials: N
authors.lastname: Zojer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007155:Immunologic Factors; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality*; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage*
chemical_list: D020533:Angiogenesis Inhibitors; D000970:Antineoplastic Agents; D007155:Immunologic Factors; D016898:Interferon-alpha; D013792:Thalidomide