TY - JOUR
T1 - Thalidomide arm of Total Therapy 2 improves complete remission duration and survival in myeloma patients with metaphase cytogenetic abnormalities
AU - Barlogie, Bart
AU - Pineda-Roman, Mauricio
AU - Van Rhee, Frits
AU - Haessler, Jeff
AU - Anaissie, Elias
AU - Hollmig, Klaus
AU - Alsayed, Yazan
AU - Waheed, Sarah
AU - Petty, Nathan
AU - Epstein, Joshua
AU - Shaughnessy, John D.
AU - Tricot, Guido
AU - Zangari, Maurizio
AU - Zeldis, Jerome
AU - Barer, Sol
AU - Crowley, John
PY - 2008/10/15
Y1 - 2008/10/15
N2 - 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 wellrecognized 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,
AB - 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 wellrecognized 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,
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U2 - 10.1182/blood-2008-03-145235
DO - 10.1182/blood-2008-03-145235
M3 - Article
C2 - 18492953
AN - SCOPUS:54049148621
SN - 0006-4971
VL - 112
SP - 3115
EP - 3121
JO - Blood
JF - Blood
IS - 8
ER -