Thalidomide arm of Total Therapy 2 improves complete remission duration and survival in myeloma patients with metaphase cytogenetic abnormalities.
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.
Barlogie
Bart
B
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, USA. barlogiebart@uams.edu
Pineda-Roman
Mauricio
M
van Rhee
Frits
F
Haessler
Jeff
J
Anaissie
Elias
E
Hollmig
Klaus
K
Alsayed
Yazan
Y
Waheed
Sarah
S
Petty
Nathan
N
Epstein
Joshua
J
Shaughnessy
John D
JD
Tricot
Guido
G
Zangari
Maurizio
M
Zeldis
Jerome
J
Barer
Sol
S
Crowley
John
J
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
D020533:Angiogenesis Inhibitors; D013792:Thalidomide