BACKGROUND:High-dose chemotherapy combined with autologous stem-cell transplantation (ASCT) is the standard therapy for refractory/relapsed aggressive lymphoma. In the era of rituximab-containing frontline regimens, it is becoming more challenging to salvage patients in this setting, and novel approaches are required. This is a randomized study evaluating the safety and efficacy of standard-dose ibritumomab tiuxetan (Zevalin) combined with high-dose BEAM chemotherapy (Z-BEAM) and ASCT in refractory/relapsed aggressive lymphoma. METHODS:Forty-three patients with CD20(+) -aggressive lymphoma were randomized to a treatment arm (Z-BEAM, n = 22) or control arm (BEAM alone, n = 21). Ibritumomab tiuxetan was given at 0.4 mCi/kg on day -14 before ASCT. RESULTS:Patient characteristics, engraftment kinetics, and toxicity profile were similar between the 2 groups. Two-year progression-free survival (PFS) for all patients was 48% (95% confidence interval, 32%-64%): 59% and 37% after Z-BEAM and BEAM alone, respectively (P = .2). Multivariate analysis identified advanced age (hazard ratio [HR], 8.3; P = .001), high-risk disease (relapse within 12 months of diagnosis and/or secondary International Prognostic Index >2; HR, 2.8; P = .04), positive positron emission tomography-computed tomography pretransplant (HR, 2.4; P = .07), and BEAM alone (HR, 2.8; P = .03) as poor prognostic factors. Intermediate-risk patients with 1 or 2 risk factors had better PFS with Z-BEAM compared with BEAM: 69% and 29%, respectively (P = .07). Two-year overall survival was 91% and 62% after Z-BEAM and BEAM, respectively (P = .05). Similar prognostic factors determined survival. The HR for BEAM alone in the multivariate analysis was 8.1 (P = .01). CONCLUSIONS: Standard-dose ibritumomab tiuxetan combined with BEAM high-dose chemotherapy is safe and possibly more effective than BEAM alone as a conditioning regimen for ASCT in the era of rituximab-containing chemotherapy regimens.
RCT Entities:
BACKGROUND: High-dose chemotherapy combined with autologous stem-cell transplantation (ASCT) is the standard therapy for refractory/relapsed aggressive lymphoma. In the era of rituximab-containing frontline regimens, it is becoming more challenging to salvage patients in this setting, and novel approaches are required. This is a randomized study evaluating the safety and efficacy of standard-dose ibritumomab tiuxetan (Zevalin) combined with high-dose BEAM chemotherapy (Z-BEAM) and ASCT in refractory/relapsed aggressive lymphoma. METHODS: Forty-three patients with CD20(+) -aggressive lymphoma were randomized to a treatment arm (Z-BEAM, n = 22) or control arm (BEAM alone, n = 21). Ibritumomab tiuxetan was given at 0.4 mCi/kg on day -14 before ASCT. RESULTS:Patient characteristics, engraftment kinetics, and toxicity profile were similar between the 2 groups. Two-year progression-free survival (PFS) for all patients was 48% (95% confidence interval, 32%-64%): 59% and 37% after Z-BEAM and BEAM alone, respectively (P = .2). Multivariate analysis identified advanced age (hazard ratio [HR], 8.3; P = .001), high-risk disease (relapse within 12 months of diagnosis and/or secondary International Prognostic Index >2; HR, 2.8; P = .04), positive positron emission tomography-computed tomography pretransplant (HR, 2.4; P = .07), and BEAM alone (HR, 2.8; P = .03) as poor prognostic factors. Intermediate-risk patients with 1 or 2 risk factors had better PFS with Z-BEAM compared with BEAM: 69% and 29%, respectively (P = .07). Two-year overall survival was 91% and 62% after Z-BEAM and BEAM, respectively (P = .05). Similar prognostic factors determined survival. The HR for BEAM alone in the multivariate analysis was 8.1 (P = .01). CONCLUSIONS: Standard-dose ibritumomab tiuxetan combined with BEAM high-dose chemotherapy is safe and possibly more effective than BEAM alone as a conditioning regimen for ASCT in the era of rituximab-containing chemotherapy regimens.
Authors: Amrita Y Krishnan; Joycelynne Palmer; Auayporn P Nademanee; Robert Chen; Leslie L Popplewell; Ni-Chun Tsai; James F Sanchez; Jennifer Simpson; Ricardo Spielberger; Dave Yamauchi; Stephen J Forman Journal: Biol Blood Marrow Transplant Date: 2017-03-04 Impact factor: 5.742
Authors: Mark Hertzberg; Maher K Gandhi; Judith Trotman; Belinda Butcher; John Taper; Amanda Johnston; Devinder Gill; Shir-Jing Ho; Gavin Cull; Keith Fay; Geoff Chong; Andrew Grigg; Ian D Lewis; Sam Milliken; William Renwick; Uwe Hahn; Robin Filshie; George Kannourakis; Anne-Marie Watson; Pauline Warburton; Andrew Wirth; John F Seymour; Michael S Hofman; Rodney J Hicks Journal: Haematologica Date: 2016-11-10 Impact factor: 9.941
Authors: Javier Briones; Silvana Novelli; José A García-Marco; José F Tomás; Teresa Bernal; Carlos Grande; Miguel A Canales; Antonio Torres; José M Moraleda; Carlos Panizo; Isidro Jarque; Francisca Palmero; Miguel Hernández; Eva González-Barca; Dulce López; Dolores Caballero Journal: Haematologica Date: 2013-10-25 Impact factor: 9.941
Authors: L Bento; A Boumendil; H Finel; S Le Gouill; S Amorim; H Monjanel; R Bouabdallah; J O Bay; E Nicolas-Virelizier; G McQuaker; G Rossi; R Johnson; A Huynh; P Ceballos; A Rambaldi; E Bachy; R Malladi; K Orchard; D Pohlreich; H Tilly; F Bonifazi; X Poiré; F Guilhot; A Haenel; C Crawley; B Metzner; J Gribben; N H Russell; G Damaj; K Thomson; P Dreger; S Montoto Journal: Bone Marrow Transplant Date: 2017-05-22 Impact factor: 5.483
Authors: Javier Briones; Silvana Novelli; José A García-Marco; José F Tomás; Teresa Bernal; Carlos Grande; Miguel A Canales; Antonio Torres; José M Moraleda; Carlos Panizo; Isidro Jarque; Francisca Palmero; Miguel Hernández; Eva González-Barca; Dulce López; Dolores Caballero Journal: Haematologica Date: 2014-07 Impact factor: 9.941
Authors: Arne Kolstad; Anna Laurell; Mats Jerkeman; Kirsten Grønbæk; Erkki Elonen; Riikka Räty; Lone Bredo Pedersen; Annika Loft; Trond Velde Bogsrud; Eva Kimby; Per Boye Hansen; Unn-Merete Fagerli; Herman Nilsson-Ehle; Grete Fossum Lauritzsen; Anne Kristine Lehmann; Christer Sundstrom; Marja-Liisa Karjalainen-Lindsberg; Elisabeth Ralfkiaer; Mats Ehinger; Jan Delabie; Hans Bentzen; Jukka Schildt; Kamelia Kostova-Aherdan; Henrik Frederiksen; Peter de Nully Brown; Christian H Geisler Journal: Blood Date: 2014-03-20 Impact factor: 22.113