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Blood, 15 October 2008, Vol. 112, No. 8, pp. 3115-3121.
Prepublished online as a Blood First Edition Paper on May 20, 2008; DOI 10.1182/blood-2008-03-145235.
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Submitted March 14, 2008
Accepted April 17, 2008
Thalidomide arm of total therapy 2 improves complete remission duration and survival in myeloma patients with metaphase cytogenetic abnormalities
Bart Barlogie*, Mauricio Pineda-Roman, Frits van Rhee, Jeff Haessler, Elias Anaissie, Klaus Hollmig, Yazan Alsayed, Sarah Waheed, Nathan Petty, Joshua Epstein, John D. Shaughnessy Jr., Guido Tricot, Maurizio Zangari, Jerome Zeldis, Sol Barer, and John Crowley
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, United States
Cancer Research and Biostatistics, CRAB, Seattle, WA, United States
Celgene Corporation, Celgene Corporation, Summit, NJ, United States
* Corresponding author; email: barlogiebart{at}uams.edu.
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 42mo, 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 72mo, survival plots segregated 5 years after initiation of therapy in favor of thalidomide (p=0.09), reaching statistical significance for the one-third of patients exhibiting cytogenetic abnormalities (CA) (p=0.02), a well-recognized adverse prognostic feature. The duration of complete remission was also superior in the cohort presenting with CA such that, at 7 years from onset of complete remission, 45% remained relapse-free as opposed to 20% on the control arm (p=0.05). 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=0.008). As two-thirds of patients without CA have remained alive at 7 years, the presently emerging separation in favor of thalidomide may eventually reach statistical significance as well.
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