Ofatumumab Versus Rituximab Salvage Chemoimmunotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: The ORCHARRD Study
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) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patien...
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| Published in | Journal of clinical oncology Vol. 35; no. 5; pp. 544 - 551 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
10.02.2017
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| Online Access | Get full text |
| ISSN | 0732-183X 1527-7755 1527-7755 |
| DOI | 10.1200/JCO.2016.69.0198 |
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| Abstract | 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) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients and Methods Patients with CD20
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/m
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. Results Between 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. Conclusion No difference in efficacy was found between O-DHAP and R-DHAP as salvage treatment of relapsed or refractory DLBCL. |
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| AbstractList | 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) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients and Methods Patients with CD20+ 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. Results Between 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. Conclusion No difference in efficacy was found between O-DHAP and R-DHAP as salvage treatment of relapsed or refractory DLBCL.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) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients and Methods Patients with CD20+ 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. Results Between 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. Conclusion No difference in efficacy was found between O-DHAP and R-DHAP as salvage treatment of relapsed or refractory DLBCL. 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) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Patients and Methods Patients with CD20 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/m 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. Results Between 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. Conclusion No difference in efficacy was found between O-DHAP and R-DHAP as salvage treatment of relapsed or refractory DLBCL. |
| Author | van Imhoff, Gustaaf W. Matasar, Matthew J. Davies, Andrew Barrigón, María Dolores Caballero van der Holt, Bronno Goerloev, Jette Soenderskov Leppä, Sirpa Radford, John Lisby, Steen Liao, Qiming Kuliczkowski, Kazimierz Hagenbeek, Anton McMillan, Andrew Kim, WonSeog Ogura, Michinori Ardeshna, Kirit M. Hong, Xiaonan Fennessy, Michael |
| Author_xml | – sequence: 1 givenname: Gustaaf W. surname: van Imhoff fullname: van Imhoff, Gustaaf W. organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 2 givenname: Andrew surname: McMillan fullname: McMillan, Andrew organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 3 givenname: Matthew J. surname: Matasar fullname: Matasar, Matthew J. organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 4 givenname: John surname: Radford fullname: Radford, John organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 5 givenname: Kirit M. surname: Ardeshna fullname: Ardeshna, Kirit M. organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 6 givenname: Kazimierz surname: Kuliczkowski fullname: Kuliczkowski, Kazimierz organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 7 givenname: WonSeog surname: Kim fullname: Kim, WonSeog organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 8 givenname: Xiaonan surname: Hong fullname: Hong, Xiaonan organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 9 givenname: Jette Soenderskov surname: Goerloev fullname: Goerloev, Jette Soenderskov organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 10 givenname: Andrew surname: Davies fullname: Davies, Andrew organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 11 givenname: María Dolores Caballero surname: Barrigón fullname: Barrigón, María Dolores Caballero organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 12 givenname: Michinori surname: Ogura fullname: Ogura, Michinori organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 13 givenname: Sirpa surname: Leppä fullname: Leppä, Sirpa organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 14 givenname: Michael surname: Fennessy fullname: Fennessy, Michael organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 15 givenname: Qiming surname: Liao fullname: Liao, Qiming organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 16 givenname: Bronno surname: van der Holt fullname: van der Holt, Bronno organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 17 givenname: Steen surname: Lisby fullname: Lisby, Steen organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York – sequence: 18 givenname: Anton surname: Hagenbeek fullname: Hagenbeek, Anton organization: Gustaaf W. van Imhoff, University Medical Center, University of Groningen; Bronno van der Holt, University Medical Center, Rotterdam; Anton Hagenbeek, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Andrew McMillan, Nottingham University Hospital, Nottingham; John Radford and Kirit M. Ardeshna, Christie Hospital NHS Trust, Manchester; Andrew Davies, University of Southampton, Southampton, United Kingdom; Matthew J. Matasar, Memorial Sloan Kettering Cancer Center, New York |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28029326$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1200/JCO.2006.09.2403 10.1200/JCO.2006.08.2305 10.1056/NEJMoa011795 10.1016/S1470-2045(08)70002-0 10.1200/JCO.2005.09.137 10.1182/blood-2014-10-606939 10.1200/JCO.2005.05.1003 10.1200/JCO.1998.16.10.3264 10.1038/nrclinonc.2014.137 10.1056/NEJM199512073332305 10.1158/1078-0432.CCR-09-1624 10.1038/sj.onc.1206939 10.1200/JCO.2013.53.9593 10.1016/S1470-2045(06)70664-7 10.1182/blood-2012-12-472027 10.1182/blood-2007-10-117671 10.1200/JCO.2005.09.131 10.4049/jimmunol.177.1.362 10.1182/blood-2008-08-175208 10.3324/haematol.13440 10.1182/blood-2002-12-3837 10.1182/blood-2007-08-108415 10.1200/JCO.2010.28.1618 10.1182/blood-2007-09-111781 10.1111/j.1365-2141.2011.08966.x |
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