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 - Funding Information:
Supported in part by Grant No. U01HL069294 from the National Heart, Lung, and Blood Institute and the National Cancer Institute, by the South-west Oncology Group, and by contributions from GlaxoSmithKline to the Blood and Marrow Transplant Clinical Trials Network.
Funding Information:
Supported in part by Grant No. U01HL069294 from the National Heart, Lung, and Blood Institute and the National Cancer Institute, by the Southwest Oncology Group, and by contributions from GlaxoSmithKline to the Blood and Marrow Transplant Clinical Trials Network.
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
VL - 31
SP - 1662
EP - 1668
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 13
ER -