title: Thalidomide arm of Total Therapy 2 improves complete remission duration and survival in myeloma patients with metaphase cytogenetic abnormalities.
abstract: Total Therapy 2 examined the clinical benefit of adding thalidomide up-front to a tandem transplant regimen for newly diagnosed patients with multiple myeloma. When initially reported with a median follow-up of 42 months, complete response rate and event-free survival were superior among the 323 patients randomized to thalidomide, whereas overall survival was indistinguishable from that of the 345 patients treated on the control arm. With further follow-up currently at a median of 72 months, survival plots segregated 5 years after initiation of therapy in favor of thalidomide (P = .09), reaching statistical significance for the one third of patients exhibiting cytogenetic abnormalities (CAs; P = .02), a well-recognized adverse prognostic feature. The duration of complete remission was also superior in the cohort presenting with CAs such that, at 7 years from onset of complete remission, 45% remained relapse-free as opposed to 20% on the control arm (P = .05). These observations were confirmed when examined by multivariate analysis demonstrating that thalidomide reduced the hazard of death by 41% among patients with CA-positive disease (P = .008). Because two thirds of patients without CAs have remained alive at 7 years, the presently emerging separation in favor of thalidomide may eventually reach statistical significance as well.
authors.affiliation: Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, USA. barlogiebart@uams.edu
authors.forename: Bart
authors.initials: B
authors.lastname: Barlogie
authors.forename: Mauricio
authors.initials: M
authors.lastname: Pineda-Roman
authors.forename: Frits
authors.initials: F
authors.lastname: van Rhee
authors.forename: Jeff
authors.initials: J
authors.lastname: Haessler
authors.forename: Elias
authors.initials: E
authors.lastname: Anaissie
authors.forename: Klaus
authors.initials: K
authors.lastname: Hollmig
authors.forename: Yazan
authors.initials: Y
authors.lastname: Alsayed
authors.forename: Sarah
authors.initials: S
authors.lastname: Waheed
authors.forename: Nathan
authors.initials: N
authors.lastname: Petty
authors.forename: Joshua
authors.initials: J
authors.lastname: Epstein
authors.forename: John D
authors.initials: JD
authors.lastname: Shaughnessy
authors.forename: Guido
authors.initials: G
authors.lastname: Tricot
authors.forename: Maurizio
authors.initials: M
authors.lastname: Zangari
authors.forename: Jerome
authors.initials: J
authors.lastname: Zeldis
authors.forename: Sol
authors.initials: S
authors.lastname: Barer
authors.forename: John
authors.initials: J
authors.lastname: Crowley
mesh_terms: D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D002869:Chromosome Aberrations; D003582:Cytogenetics; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D008677:Metaphase; D009101:Multiple Myeloma / Q000235:genetics* / Q000378:metabolism*; D015999:Multivariate Analysis; D011379:Prognosis; D012074:Remission Induction; D013792:Thalidomide / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D013792:Thalidomide