Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström’s Macroglobulinemia

A randomized trial comparing ibrutinib plus rituximab with rituximab alone in patients with Waldenström’s macroglobulinemia showed significantly higher rates of progression-free survival and overall response with the addition of ibrutinib.

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Bibliographic Details
Published inThe New England journal of medicine Vol. 378; no. 25; pp. 2399 - 2410
Main Authors Dimopoulos, Meletios A, Tedeschi, Alessandra, Trotman, Judith, García-Sanz, Ramón, Macdonald, David, Leblond, Veronique, Mahe, Beatrice, Herbaux, Charles, Tam, Constantine, Orsucci, Lorella, Palomba, M. Lia, Matous, Jeffrey V, Shustik, Chaim, Kastritis, Efstathios, Treon, Steven P, Li, Jianling, Salman, Zeena, Graef, Thorsten, Buske, Christian
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 21.06.2018
Subjects
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Arthralgia
Atrial Fibrillation - chemically induced
B-cell lymphoma
Bone marrow
Cancer
CXCR4 protein
Diarrhea
Disease-Free Survival
Female
Fibrillation
Hemoglobin
Hemoglobins - analysis
Hemorrhage
Hospitals
Humans
Hypertension
Immunoglobulin M
Immunoglobulin M - blood
Immunotherapy
Infusions, Intravenous - adverse effects
Inhibitor drugs
Lymphocytes B
Macroglobulinemia
Male
Medical research
Middle Aged
Monoclonal antibodies
MyD88 protein
Nausea
Patients
Pyrazoles - administration & dosage
Pyrazoles - adverse effects
Pyrimidines - administration & dosage
Pyrimidines - adverse effects
R&D
Research & development
Response rates
Rituximab
Rituximab - administration & dosage
Rituximab - adverse effects
Survival Analysis
Targeted cancer therapy
Waldenstrom Macroglobulinemia - blood
Waldenstrom Macroglobulinemia - drug therapy
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Abstract A randomized trial comparing ibrutinib plus rituximab with rituximab alone in patients with Waldenström’s macroglobulinemia showed significantly higher rates of progression-free survival and overall response with the addition of ibrutinib.
AbstractList A randomized trial comparing ibrutinib plus rituximab with rituximab alone in patients with Waldenström’s macroglobulinemia showed significantly higher rates of progression-free survival and overall response with the addition of ibrutinib.
Background Single-agent ibrutinib has shown substantial activity in patients with relapsed Waldenström's macroglobulinemia, a rare form of B-cell lymphoma. We evaluated the effect of adding ibrutinib to rituximab in patients with this disease, both in those who had not received previous treatment and in those with disease recurrence. Methods We randomly assigned 150 symptomatic patients to receive ibrutinib plus rituximab or placebo plus rituximab. The primary end point was progression-free survival, as assessed by an independent review committee. Key secondary end points were response rates, sustained hematologic improvement from baseline, and safety. The mutational status of MYD88 and CXCR4 was assessed in bone marrow samples. Results At 30 months, the progression-free survival rate was 82% with ibrutinib-rituximab versus 28% with placebo-rituximab (hazard ratio for progression or death, 0.20; P<0.001). The benefit in the ibrutinib-rituximab group over that in the placebo-rituximab group was independent of the MYD88 or CXCR4 genotype. The rate of major response was higher with ibrutinib-rituximab than with placebo-rituximab (72% vs. 32%, P<0.001). More patients had sustained increases in hemoglobin level with ibrutinib-rituximab than with placebo-rituximab (73% vs. 41%, P<0.001). The most common adverse events of any grade with ibrutinib-rituximab included infusion-related reactions, diarrhea, arthralgia, and nausea. Events of grade 3 or higher that occurred more frequently with ibrutinib-rituximab than with placebo-rituximab included atrial fibrillation (12% vs. 1%) and hypertension (13% vs. 4%); those that occurred less frequently included infusion reactions (1% vs. 16%) and any grade of IgM flare (8% vs. 47%). The major hemorrhage rate was the same in the two trial groups (4%). Conclusions Among patients with Waldenström's macroglobulinemia, the use of ibrutinib-rituximab resulted in significantly higher rates of progression-free survival than the use of placebo-rituximab, both among those who had received no previous treatment and among those with disease recurrence. Atrial fibrillation and hypertension were more common with ibrutinib-rituximab, whereas infusion reactions and IgM flare were more common with placebo-rituximab. (Funded by Pharmacyclics and Janssen Research and Development; ClinicalTrials.gov number, NCT02165397.)
Single-agent ibrutinib has shown substantial activity in patients with relapsed Waldenström's macroglobulinemia, a rare form of B-cell lymphoma. We evaluated the effect of adding ibrutinib to rituximab in patients with this disease, both in those who had not received previous treatment and in those with disease recurrence.BACKGROUNDSingle-agent ibrutinib has shown substantial activity in patients with relapsed Waldenström's macroglobulinemia, a rare form of B-cell lymphoma. We evaluated the effect of adding ibrutinib to rituximab in patients with this disease, both in those who had not received previous treatment and in those with disease recurrence.We randomly assigned 150 symptomatic patients to receive ibrutinib plus rituximab or placebo plus rituximab. The primary end point was progression-free survival, as assessed by an independent review committee. Key secondary end points were response rates, sustained hematologic improvement from baseline, and safety. The mutational status of MYD88 and CXCR4 was assessed in bone marrow samples.METHODSWe randomly assigned 150 symptomatic patients to receive ibrutinib plus rituximab or placebo plus rituximab. The primary end point was progression-free survival, as assessed by an independent review committee. Key secondary end points were response rates, sustained hematologic improvement from baseline, and safety. The mutational status of MYD88 and CXCR4 was assessed in bone marrow samples.At 30 months, the progression-free survival rate was 82% with ibrutinib-rituximab versus 28% with placebo-rituximab (hazard ratio for progression or death, 0.20; P<0.001). The benefit in the ibrutinib-rituximab group over that in the placebo-rituximab group was independent of the MYD88 or CXCR4 genotype. The rate of major response was higher with ibrutinib-rituximab than with placebo-rituximab (72% vs. 32%, P<0.001). More patients had sustained increases in hemoglobin level with ibrutinib-rituximab than with placebo-rituximab (73% vs. 41%, P<0.001). The most common adverse events of any grade with ibrutinib-rituximab included infusion-related reactions, diarrhea, arthralgia, and nausea. Events of grade 3 or higher that occurred more frequently with ibrutinib-rituximab than with placebo-rituximab included atrial fibrillation (12% vs. 1%) and hypertension (13% vs. 4%); those that occurred less frequently included infusion reactions (1% vs. 16%) and any grade of IgM flare (8% vs. 47%). The major hemorrhage rate was the same in the two trial groups (4%).RESULTSAt 30 months, the progression-free survival rate was 82% with ibrutinib-rituximab versus 28% with placebo-rituximab (hazard ratio for progression or death, 0.20; P<0.001). The benefit in the ibrutinib-rituximab group over that in the placebo-rituximab group was independent of the MYD88 or CXCR4 genotype. The rate of major response was higher with ibrutinib-rituximab than with placebo-rituximab (72% vs. 32%, P<0.001). More patients had sustained increases in hemoglobin level with ibrutinib-rituximab than with placebo-rituximab (73% vs. 41%, P<0.001). The most common adverse events of any grade with ibrutinib-rituximab included infusion-related reactions, diarrhea, arthralgia, and nausea. Events of grade 3 or higher that occurred more frequently with ibrutinib-rituximab than with placebo-rituximab included atrial fibrillation (12% vs. 1%) and hypertension (13% vs. 4%); those that occurred less frequently included infusion reactions (1% vs. 16%) and any grade of IgM flare (8% vs. 47%). The major hemorrhage rate was the same in the two trial groups (4%).Among patients with Waldenström's macroglobulinemia, the use of ibrutinib-rituximab resulted in significantly higher rates of progression-free survival than the use of placebo-rituximab, both among those who had received no previous treatment and among those with disease recurrence. Atrial fibrillation and hypertension were more common with ibrutinib-rituximab, whereas infusion reactions and IgM flare were more common with placebo-rituximab. (Funded by Pharmacyclics and Janssen Research and Development; ClinicalTrials.gov number, NCT02165397 .).CONCLUSIONSAmong patients with Waldenström's macroglobulinemia, the use of ibrutinib-rituximab resulted in significantly higher rates of progression-free survival than the use of placebo-rituximab, both among those who had received no previous treatment and among those with disease recurrence. Atrial fibrillation and hypertension were more common with ibrutinib-rituximab, whereas infusion reactions and IgM flare were more common with placebo-rituximab. (Funded by Pharmacyclics and Janssen Research and Development; ClinicalTrials.gov number, NCT02165397 .).
Single-agent ibrutinib has shown substantial activity in patients with relapsed Waldenström's macroglobulinemia, a rare form of B-cell lymphoma. We evaluated the effect of adding ibrutinib to rituximab in patients with this disease, both in those who had not received previous treatment and in those with disease recurrence. We randomly assigned 150 symptomatic patients to receive ibrutinib plus rituximab or placebo plus rituximab. The primary end point was progression-free survival, as assessed by an independent review committee. Key secondary end points were response rates, sustained hematologic improvement from baseline, and safety. The mutational status of MYD88 and CXCR4 was assessed in bone marrow samples. At 30 months, the progression-free survival rate was 82% with ibrutinib-rituximab versus 28% with placebo-rituximab (hazard ratio for progression or death, 0.20; P<0.001). The benefit in the ibrutinib-rituximab group over that in the placebo-rituximab group was independent of the MYD88 or CXCR4 genotype. The rate of major response was higher with ibrutinib-rituximab than with placebo-rituximab (72% vs. 32%, P<0.001). More patients had sustained increases in hemoglobin level with ibrutinib-rituximab than with placebo-rituximab (73% vs. 41%, P<0.001). The most common adverse events of any grade with ibrutinib-rituximab included infusion-related reactions, diarrhea, arthralgia, and nausea. Events of grade 3 or higher that occurred more frequently with ibrutinib-rituximab than with placebo-rituximab included atrial fibrillation (12% vs. 1%) and hypertension (13% vs. 4%); those that occurred less frequently included infusion reactions (1% vs. 16%) and any grade of IgM flare (8% vs. 47%). The major hemorrhage rate was the same in the two trial groups (4%). Among patients with Waldenström's macroglobulinemia, the use of ibrutinib-rituximab resulted in significantly higher rates of progression-free survival than the use of placebo-rituximab, both among those who had received no previous treatment and among those with disease recurrence. Atrial fibrillation and hypertension were more common with ibrutinib-rituximab, whereas infusion reactions and IgM flare were more common with placebo-rituximab. (Funded by Pharmacyclics and Janssen Research and Development; ClinicalTrials.gov number, NCT02165397 .).
Author Trotman, Judith
Treon, Steven P
Herbaux, Charles
Tam, Constantine
Li, Jianling
Orsucci, Lorella
Salman, Zeena
Buske, Christian
Macdonald, David
Tedeschi, Alessandra
García-Sanz, Ramón
Palomba, M. Lia
Mahe, Beatrice
Graef, Thorsten
Leblond, Veronique
Shustik, Chaim
Dimopoulos, Meletios A
Matous, Jeffrey V
Kastritis, Efstathios
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  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
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  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
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  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
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  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
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  givenname: Veronique
  surname: Leblond
  fullname: Leblond, Veronique
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
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  givenname: Beatrice
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  fullname: Mahe, Beatrice
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
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  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
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  givenname: Constantine
  surname: Tam
  fullname: Tam, Constantine
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 10
  givenname: Lorella
  surname: Orsucci
  fullname: Orsucci, Lorella
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 11
  givenname: M. Lia
  surname: Palomba
  fullname: Palomba, M. Lia
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 12
  givenname: Jeffrey V
  surname: Matous
  fullname: Matous, Jeffrey V
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 13
  givenname: Chaim
  surname: Shustik
  fullname: Shustik, Chaim
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 14
  givenname: Efstathios
  surname: Kastritis
  fullname: Kastritis, Efstathios
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 15
  givenname: Steven P
  surname: Treon
  fullname: Treon, Steven P
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 16
  givenname: Jianling
  surname: Li
  fullname: Li, Jianling
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 17
  givenname: Zeena
  surname: Salman
  fullname: Salman, Zeena
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 18
  givenname: Thorsten
  surname: Graef
  fullname: Graef, Thorsten
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
– sequence: 19
  givenname: Christian
  surname: Buske
  fullname: Buske, Christian
  organization: From the National and Kapodistrian University of Athens School of Medicine, Athens (M.A.D., E.K.); ASST Grande Ospedale Metropolitano Niguarda, Milan (A.T.), and Città della Salute Hospital and University, Turin (L.O.) — both in Italy; Concord Hospital, University of Sydney, Concord, NSW (J.T.), and Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC (C.T.) — both in Australia; Hospital Universitario de Salamanca, Salamanca, Spain (R.G.-S.); Ottawa Hospital, University of Ottawa, Ottawa (D.M.), and Royal Victoria Hospital at McGill University Health Centre, Montreal (C.S.) — both in Canada; Département d’Hématologie, Hôpital Pitié-Salpêtrière, Assistance Publique–Hôpitaux de Paris, Université Pierre et Marie Curie, Paris (V.L.), Centre Hospitalier Universitaire de Nantes, Nantes (B.M.), and Centre Hospitalier Régional Universitaire de Lille, Institute of Hematolog-Tranfusion, Lille (C.H.) — all in France; Memorial Sloan Kettering Cancer Center, New York (M.L.P.); Colorado Blood Cancer Institute, Denver (J.V.M.); Dana–Farber Cancer Institute, Boston (S.P.T.); Pharmacyclics, Sunnyvale, CA (J.L., Z.S., T.G.); and Comprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany (C.B.)
BackLink https://www.ncbi.nlm.nih.gov/pubmed/29856685$$D View this record in MEDLINE/PubMed
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SSID ssj0000149
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Snippet A randomized trial comparing ibrutinib plus rituximab with rituximab alone in patients with Waldenström’s macroglobulinemia showed significantly higher rates...
Single-agent ibrutinib has shown substantial activity in patients with relapsed Waldenström's macroglobulinemia, a rare form of B-cell lymphoma. We evaluated...
Background Single-agent ibrutinib has shown substantial activity in patients with relapsed Waldenström's macroglobulinemia, a rare form of B-cell lymphoma. We...
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StartPage 2399
SubjectTerms Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Arthralgia
Atrial Fibrillation - chemically induced
B-cell lymphoma
Bone marrow
Cancer
CXCR4 protein
Diarrhea
Disease-Free Survival
Female
Fibrillation
Hemoglobin
Hemoglobins - analysis
Hemorrhage
Hospitals
Humans
Hypertension
Immunoglobulin M
Immunoglobulin M - blood
Immunotherapy
Infusions, Intravenous - adverse effects
Inhibitor drugs
Lymphocytes B
Macroglobulinemia
Male
Medical research
Middle Aged
Monoclonal antibodies
MyD88 protein
Nausea
Patients
Pyrazoles - administration & dosage
Pyrazoles - adverse effects
Pyrimidines - administration & dosage
Pyrimidines - adverse effects
R&D
Research & development
Response rates
Rituximab
Rituximab - administration & dosage
Rituximab - adverse effects
Survival Analysis
Targeted cancer therapy
Waldenstrom Macroglobulinemia - blood
Waldenstrom Macroglobulinemia - drug therapy
Title Phase 3 Trial of Ibrutinib plus Rituximab in Waldenström’s Macroglobulinemia
URI https://nejm.org/doi/full/10.1056/NEJMoa1802917
https://www.ncbi.nlm.nih.gov/pubmed/29856685
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Volume 378
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