TY - JOUR
T1 - Thalidomide and hematopoietic-cell transplantation for multiple myeloma
AU - Barlogie, Bart
AU - Tricot, Guido
AU - Anaissie, Elias
AU - Shaughnessy, John
AU - Rasmussen, Erik
AU - Van Rhee, Frits
AU - Fassas, Athanasios
AU - Zangari, Maurizio
AU - Hollmig, Klaus
AU - Pineda-Roman, Mauricio
AU - Lee, Choon
AU - Talamo, Giampaolo
AU - Thertulien, Raymond
AU - Kiwan, Elias
AU - Krishna, Somashekar
AU - Fox, Michele
AU - Crowley, John
PY - 2006/3/9
Y1 - 2006/3/9
N2 - Background: High-dose therapy with melphalan can prolong survival among patients with multiple myeloma. We assessed whether the addition of thalidomide, which has activity against advanced and refractory myeloma, would further improve survival. Methods: Between October 1998 and February 2004, 668 patients with newly diagnosed multiple myeloma received two cycles of intensive melphalan-based chemotherapy, each supported by autologous hematopoietic stem-cell transplantation. A total of 323 were randomly assigned to receive thalidomide from the outset until disease progression or undue adverse effects, and 345 did not receive thalidomide. The primary end point was the five-year event-free survival rate. Secondary end points were complete response and overall survival. Results: After a median follow-up of 42 months among survivors, the thalidomide and control groups had rates of complete response of 62 percent and 43 percent, respectively (P<0.001), and five-year event-free survival rates of 56 percent and 44 percent (P=0.01). The five-year rate of overall survival was approximately 65 percent in both groups (P=0.90). Median survival after relapse was 1.1 years in the thalidomide group and 2.7 years in the control group (P=0.001). Severe peripheral neuropathy and deep-vein thrombosis occurred more frequently in the thalidomide group than in the control group. Conclusions: When incorporated into high-dose therapy for myeloma, thalidomide increased the frequency of complete responses and extended event-free survival at the expense of added adverse effects without improving overall survival.
AB - Background: High-dose therapy with melphalan can prolong survival among patients with multiple myeloma. We assessed whether the addition of thalidomide, which has activity against advanced and refractory myeloma, would further improve survival. Methods: Between October 1998 and February 2004, 668 patients with newly diagnosed multiple myeloma received two cycles of intensive melphalan-based chemotherapy, each supported by autologous hematopoietic stem-cell transplantation. A total of 323 were randomly assigned to receive thalidomide from the outset until disease progression or undue adverse effects, and 345 did not receive thalidomide. The primary end point was the five-year event-free survival rate. Secondary end points were complete response and overall survival. Results: After a median follow-up of 42 months among survivors, the thalidomide and control groups had rates of complete response of 62 percent and 43 percent, respectively (P<0.001), and five-year event-free survival rates of 56 percent and 44 percent (P=0.01). The five-year rate of overall survival was approximately 65 percent in both groups (P=0.90). Median survival after relapse was 1.1 years in the thalidomide group and 2.7 years in the control group (P=0.001). Severe peripheral neuropathy and deep-vein thrombosis occurred more frequently in the thalidomide group than in the control group. Conclusions: When incorporated into high-dose therapy for myeloma, thalidomide increased the frequency of complete responses and extended event-free survival at the expense of added adverse effects without improving overall survival.
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U2 - 10.1056/NEJMoa053583
DO - 10.1056/NEJMoa053583
M3 - Article
C2 - 16525139
AN - SCOPUS:33644833147
SN - 0028-4793
VL - 354
SP - 1021
EP - 1030
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 10
ER -