TY - JOUR
T1 - Phase III Randomized Study of Rituximab/Carmustine, Etopo-side, Cytarabine, and Melphalan (BEAM) Compared With Iodine-131 Tositumomab/BEAM With Autologous Hematopoietic Cell Transplantation for Relapsed Diffuse Large B-Cell Lymphoma
T2 - Results From the BMT CTN 0401 Trial
AU - Vose, Julie M.
AU - Carter, Shelly
AU - Burns, Linda J.
AU - Ayala, Ernesto
AU - Press, Oliver W.
AU - Moskowitz, Craig H.
AU - Stadtmauer, Edward A.
AU - Mineshi, Shin
AU - Ambinder, Richard
AU - Fenske, Timothy
AU - Horowitz, Mary
AU - Fisher, Richard
AU - Tomblyn, Marcie
N1 - Publisher Copyright:
© 2013 by American Society of Clinical Oncology
PY - 2013/5/1
Y1 - 2013/5/1
N2 - Purpose This clinical trial evaluated standard-dose radioimmunotherapy with a chemotherapy-based transplantation regimen followed by autologous hematopoietic cell transplantation versus rituximab with the same regimen in patients with relapsed diffuse large B-cell lymphoma (DLBCL). Patients and Methods Patients with chemotherapy-sensitive persistent or relapsed DLBCL were randomly assigned to receive iodine-131 tositumomab (dosimetric dose of 5 mCi on day 19 and therapeutic dose of 0.75 Gy on day 12), carmustine 300 mg/m2 (day 6), etoposide 100 mg/m2 twice daily (days 5 to 2), cytarabine 100 mg/m2 twice daily (days 5 to 2), and melphalan 140 mg/m2 (day 1; B-BEAM) or rituximab 375 mg/m2 on days 19 and 12 and the same chemotherapy regimen (R-BEAM). Results Two hundred twenty-four patients were enrolled, with 113 patients randomly assigned to R-BEAM and 111 patients assigned to B-BEAM. Two-year progression-free survival (PFS) rates, the primary end point, were 48.6% (95% CI, 38.6% to 57.8%) for R-BEAM and 47.9% (95% CI, 38.2% to 57%; P .94) for B-BEAM, and the 2-year overall survival (OS) rates were 65.6% (95% CI, 55.3% to 74.1%) for R-BEAM and 61% (95% CI, 50.9% to 69.9%; P .38) for B-BEAM. The 100-day treatment-related mortality rates were 4.1% (95% CI, 0.2% to 8.0%) for R-BEAM and 4.9% (95% CI, 0.8% to 9.0%; P .97) for B-BEAM. The maximum mucositis score was higher in the B-BEAM arm (0.72) compared with the R-BEAM arm (0.31; P .001). Conclusion The B-BEAM and R-BEAM regimens produced similar 2-year PFS and OS rates for patients with chemotherapy-sensitive relapsed DLBCL. No differences in toxicities other than mucositis were noted.
AB - Purpose This clinical trial evaluated standard-dose radioimmunotherapy with a chemotherapy-based transplantation regimen followed by autologous hematopoietic cell transplantation versus rituximab with the same regimen in patients with relapsed diffuse large B-cell lymphoma (DLBCL). Patients and Methods Patients with chemotherapy-sensitive persistent or relapsed DLBCL were randomly assigned to receive iodine-131 tositumomab (dosimetric dose of 5 mCi on day 19 and therapeutic dose of 0.75 Gy on day 12), carmustine 300 mg/m2 (day 6), etoposide 100 mg/m2 twice daily (days 5 to 2), cytarabine 100 mg/m2 twice daily (days 5 to 2), and melphalan 140 mg/m2 (day 1; B-BEAM) or rituximab 375 mg/m2 on days 19 and 12 and the same chemotherapy regimen (R-BEAM). Results Two hundred twenty-four patients were enrolled, with 113 patients randomly assigned to R-BEAM and 111 patients assigned to B-BEAM. Two-year progression-free survival (PFS) rates, the primary end point, were 48.6% (95% CI, 38.6% to 57.8%) for R-BEAM and 47.9% (95% CI, 38.2% to 57%; P .94) for B-BEAM, and the 2-year overall survival (OS) rates were 65.6% (95% CI, 55.3% to 74.1%) for R-BEAM and 61% (95% CI, 50.9% to 69.9%; P .38) for B-BEAM. The 100-day treatment-related mortality rates were 4.1% (95% CI, 0.2% to 8.0%) for R-BEAM and 4.9% (95% CI, 0.8% to 9.0%; P .97) for B-BEAM. The maximum mucositis score was higher in the B-BEAM arm (0.72) compared with the R-BEAM arm (0.31; P .001). Conclusion The B-BEAM and R-BEAM regimens produced similar 2-year PFS and OS rates for patients with chemotherapy-sensitive relapsed DLBCL. No differences in toxicities other than mucositis were noted.
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U2 - 10.1200/JCO.2012.45.9453
DO - 10.1200/JCO.2012.45.9453
M3 - Article
C2 - 23478060
AN - SCOPUS:84884202033
SN - 0732-183X
VL - 31
SP - 1662
EP - 1668
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 13
ER -