Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: The ORCHARRD Study

• DOI: 10.1200/jco.2016.69.0198
• Publication Date: 2017-02-24T11:56:50Z
• Authors: Gustaaf W. van Im...; Andrew McMillan; Matthew J. Matasar; John Radford; Kirit M. Ardeshna; Kazimierz Kuliczk...; WonSeog Kim; Xiaonan Hong; Jette Soenderskov...; Andrew Davies; María Dolores Cab...; Michinori Ogura; Sirpa Leppä; Michael Fennessy; Qiming Liao; Bronno van der Holt; Steen Lisby; Anton Hagenbeek
• Keywords: DHAP; Chemoimmunotherapy; Ofatumumab; Autologous stem-cell transplantation; Salvage therapy; Progression-free survival

Purpose We 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) patients relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients Methods CD20+ DLBCL age ≥ 18 years who had experienced their first relapse were to first-line R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)-like treatment randomly assigned between three cycles R-DHAP O-DHAP. Either O 1,000 mg R 375 mg/m2 was administered for a total four infusions (days 1 8 cycle 1; day 2 3 DHAP). response after two received third cycle, high-dose therapy ASCT. Primary end point progression-free survival (PFS), failure achieve included as an event. Results Between March 2010 December 2013, 447 assigned. Median 57 (range, 83 years); 17% 65 years; 63% stage III IV disease; 71% did not complete (CR) experience < year on R-CHOP. Response rate O-DHAP 38% (CR, 15%) 42% 22%) R-DHAP. ASCT protocol completed 74 (33%) arm (37%) arm. PFS, event-free survival, overall significantly different R-DHAP: PFS at 24% 26% (hazard ratio [HR], 1.12; 95% CI, 0.89 1.42; P = .33); 16% 18% (HR, 1.10; .35); 41% 0.90; .38). Positron emission tomography negativity before highly predictive superior outcome. Conclusion No difference found DLBCL.