TY - JOUR
T1 - Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
T2 - The ORCHARRD Study
AU - van Imhoff, Gustaaf W.
AU - McMillan, Andrew
AU - Matasar, Matthew J.
AU - Radford, John
AU - Ardeshna, Kirit M.
AU - Kuliczkowski, Kazimierz
AU - Kim, WonSeog
AU - Hong, Xiaonan
AU - Goerloev, Jette Soenderskov
AU - Davies, Andrew
AU - Caballero Barrigon, Maria Dolores
AU - Ogura, Michinori
AU - Leppa, Sirpa
AU - Fennessy, Michael
AU - Liao, Qiming
AU - van der Holt, Bronno
AU - Lisby, Steen
AU - Hagenbeek, Anton
PY - 2017/2/10
Y1 - 2017/2/10
N2 - PurposeWe compared the efficacy of ofatumumab (O) versus rituximab (R) in combination with cisplatin, cytarabine, and dexamethasone (DHAP) salvage treatment, followed by autologous stem-cell transplantation (ASCT) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).Patients and MethodsPatients with CD201 DLBCL age >= 18 years who had experienced their first relapse or who were refractory to first-line R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)-like treatment were randomly assigned between three cycles of R-DHAP or O-DHAP. Either O 1,000 mg or R 375 mg/m2 was administered for a total of four infusions (days 1 and 8 of cycle 1; day 1 of cycles 2 and 3 of DHAP). Patients who experienced a response after two cycles of treatment received the third cycle, followed by high-dose therapy and ASCT. Primary end point was progression-free survival (PFS), with failure to achieve a response after cycle 2 included as an event.ResultsBetween March 2010 and December 2013, 447 patients were randomly assigned. Median age was 57 years (range, 18 to 83 years); 17% were age >= 65 years; 63% had stage III and IV disease; 71% did not achieve complete response (CR) or experience response for, 1 year on first-line R-CHOP. Response rate for O-DHAP was 38% (CR, 15%) versus 42% (CR, 22%) for R-DHAP. ASCT on protocol was completed by 74 patients (33%) in the O arm and 83 patients (37%) in the R arm. PFS, event-free survival, and overall survival were not significantly different between O-DHAP versus R-DHAP: PFS at 2 years was 24% versus 26% (hazard ratio [HR], 1.12; 95% CI, 0.89 to 1.42; P = .33); event-free survival at 2 years was 16% versus 18% (HR, 1.10; P=.35); and overall survival at 2 years was 41% versus 38% (HR, 0.90; P=.38). Positron emission tomography negativity before ASCT was highly predictive for superior outcome.ConclusionNo difference in efficacy was found between O-DHAP and R-DHAP as salvage treatment of relapsed or refractory DLBCL. (C) 2016 by American Society of Clinical Oncology
AB - PurposeWe compared the efficacy of ofatumumab (O) versus rituximab (R) in combination with cisplatin, cytarabine, and dexamethasone (DHAP) salvage treatment, followed by autologous stem-cell transplantation (ASCT) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).Patients and MethodsPatients with CD201 DLBCL age >= 18 years who had experienced their first relapse or who were refractory to first-line R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)-like treatment were randomly assigned between three cycles of R-DHAP or O-DHAP. Either O 1,000 mg or R 375 mg/m2 was administered for a total of four infusions (days 1 and 8 of cycle 1; day 1 of cycles 2 and 3 of DHAP). Patients who experienced a response after two cycles of treatment received the third cycle, followed by high-dose therapy and ASCT. Primary end point was progression-free survival (PFS), with failure to achieve a response after cycle 2 included as an event.ResultsBetween March 2010 and December 2013, 447 patients were randomly assigned. Median age was 57 years (range, 18 to 83 years); 17% were age >= 65 years; 63% had stage III and IV disease; 71% did not achieve complete response (CR) or experience response for, 1 year on first-line R-CHOP. Response rate for O-DHAP was 38% (CR, 15%) versus 42% (CR, 22%) for R-DHAP. ASCT on protocol was completed by 74 patients (33%) in the O arm and 83 patients (37%) in the R arm. PFS, event-free survival, and overall survival were not significantly different between O-DHAP versus R-DHAP: PFS at 2 years was 24% versus 26% (hazard ratio [HR], 1.12; 95% CI, 0.89 to 1.42; P = .33); event-free survival at 2 years was 16% versus 18% (HR, 1.10; P=.35); and overall survival at 2 years was 41% versus 38% (HR, 0.90; P=.38). Positron emission tomography negativity before ASCT was highly predictive for superior outcome.ConclusionNo difference in efficacy was found between O-DHAP and R-DHAP as salvage treatment of relapsed or refractory DLBCL. (C) 2016 by American Society of Clinical Oncology
KW - MONOCLONAL ANTI-CD20 ANTIBODY
KW - CHEMOTHERAPY PLUS RITUXIMAB
KW - RANDOMIZED CONTROLLED-TRIAL
KW - ELDERLY-PATIENTS
KW - RESPONSE CRITERIA
KW - PROGNOSTIC VALUE
KW - TRANSPLANTATION
KW - CHOP
KW - THERAPY
KW - COMBINATION
U2 - 10.1200/JCO.2016.69.0198
DO - 10.1200/JCO.2016.69.0198
M3 - Article
C2 - 28029326
SN - 0732-183X
VL - 35
SP - 544
EP - 551
JO - Journal of clinical oncology : official journal of the American Society of Clinical Oncology
JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology
IS - 5
ER -