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Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study

BD. Cheson, N. Chua, J. Mayer, G. Dueck, M. Trněný, K. Bouabdallah, N. Fowler, V. Delwail, O. Press, G. Salles, JG. Gribben, A. Lennard, PJ. Lugtenburg, G. Fingerle-Rowson, F. Mattiello, A. Knapp, LH. Sehn,

. 2018 ; 36 (22) : 2259-2266. [pub] 20180327

Language English Country United States

Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc19045516

Purpose To perform an updated analysis of the randomized phase III GADOLIN trial in patients with rituximab-refractory indolent non-Hodgkin lymphoma treated with obinutuzumab (GA101; G) and bendamustine (B). Patients and Methods Patients with histologically documented, rituximab-refractory CD20+ indolent non-Hodgkin lymphoma received G 1,000 mg (days 1, 8, and 15, cycle 1; day 1, cycles 2 to 6) plus B 90 mg/m2/d (days 1 and 2, all cycles) or B 120 mg/m2/d monotherapy. Patients who did not experience disease progression with G-B received G maintenance (1,000 mg every 2 months) for up to 2 years. The primary end point was progression-free survival (PFS). Results Of 413 randomly assigned patients (intention-to-treat [ITT]: G-B, n = 204; B monotherapy, n = 209), 335 had follicular lymphoma (FL; G-B, n = 164; B monotherapy, n = 171). After a median follow-up of 31.8 months, median PFS in ITT patients was 25.8 months (G-B) and 14.1 months (B monotherapy; hazard ratio [HR], 0.57; 95% CI, 0.44 to 0.73; P < .001). Overall survival (OS) also was prolonged (HR, 0.67; 95% CI, 0.47 to 0.96; P = .027). PFS and OS benefits were similar in patients with FL. Grade 3 to 5 adverse events (AEs) were reported by 148 (72.5%) and 133 (65.5%) patients in the G-B and B monotherapy arms, respectively, most commonly neutropenia (G-B, 34.8%; B monotherapy, 27.1%), thrombocytopenia (10.8% and 15.8%), anemia (7.4% and 10.8%), and infusion-related reactions (9.3% and 3.4%). Serious AEs occurred in 89 G-B patients (43.6%) and 75 B monotherapy patients (36.9%); fatal AEs occurred in 16 (7.8%) and 13 (6.4%), respectively. Conclusion This updated analysis confirms the PFS benefit for G-B shown in the primary analysis. A substantial OS benefit also was demonstrated in the ITT population and in patients with FL. Toxicity was similar for both treatments.

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$a Cheson, Bruce D $u Bruce D. Cheson, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Neil Chua, University of Alberta, Edmonton, Alberta; Greg Dueck, British Columbia Cancer Agency, Kelowna; Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; Jiri Mayer, University Hospital and Masaryk University, Brno; Marek Trněný, Charles University General Hospital, Prague, Czech Republic; Kamal Bouabdallah, Centre Hospitalier Universitaire Haut-Leveque, Bordeaux; Vincent Delwail, Centre Hospitalier Universitaire de Poitiers, Poitiers; Gilles Salles, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France; Nathan Fowler, University of Texas, Houston, TX; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA; John G. Gribben, Queen Mary University of London, London; Anne Lennard, Newcastle University, Newcastle upon Tyne, United Kingdom; Pieternella J. Lugtenburg, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; and Günter Fingerle-Rowson, Federico Mattiello, and Andrea Knapp, F. Hoffmann-La Roche, Basel, Switzerland.
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$a Overall Survival Benefit in Patients With Rituximab-Refractory Indolent Non-Hodgkin Lymphoma Who Received Obinutuzumab Plus Bendamustine Induction and Obinutuzumab Maintenance in the GADOLIN Study / $c BD. Cheson, N. Chua, J. Mayer, G. Dueck, M. Trněný, K. Bouabdallah, N. Fowler, V. Delwail, O. Press, G. Salles, JG. Gribben, A. Lennard, PJ. Lugtenburg, G. Fingerle-Rowson, F. Mattiello, A. Knapp, LH. Sehn,
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$a Purpose To perform an updated analysis of the randomized phase III GADOLIN trial in patients with rituximab-refractory indolent non-Hodgkin lymphoma treated with obinutuzumab (GA101; G) and bendamustine (B). Patients and Methods Patients with histologically documented, rituximab-refractory CD20+ indolent non-Hodgkin lymphoma received G 1,000 mg (days 1, 8, and 15, cycle 1; day 1, cycles 2 to 6) plus B 90 mg/m2/d (days 1 and 2, all cycles) or B 120 mg/m2/d monotherapy. Patients who did not experience disease progression with G-B received G maintenance (1,000 mg every 2 months) for up to 2 years. The primary end point was progression-free survival (PFS). Results Of 413 randomly assigned patients (intention-to-treat [ITT]: G-B, n = 204; B monotherapy, n = 209), 335 had follicular lymphoma (FL; G-B, n = 164; B monotherapy, n = 171). After a median follow-up of 31.8 months, median PFS in ITT patients was 25.8 months (G-B) and 14.1 months (B monotherapy; hazard ratio [HR], 0.57; 95% CI, 0.44 to 0.73; P < .001). Overall survival (OS) also was prolonged (HR, 0.67; 95% CI, 0.47 to 0.96; P = .027). PFS and OS benefits were similar in patients with FL. Grade 3 to 5 adverse events (AEs) were reported by 148 (72.5%) and 133 (65.5%) patients in the G-B and B monotherapy arms, respectively, most commonly neutropenia (G-B, 34.8%; B monotherapy, 27.1%), thrombocytopenia (10.8% and 15.8%), anemia (7.4% and 10.8%), and infusion-related reactions (9.3% and 3.4%). Serious AEs occurred in 89 G-B patients (43.6%) and 75 B monotherapy patients (36.9%); fatal AEs occurred in 16 (7.8%) and 13 (6.4%), respectively. Conclusion This updated analysis confirms the PFS benefit for G-B shown in the primary analysis. A substantial OS benefit also was demonstrated in the ITT population and in patients with FL. Toxicity was similar for both treatments.
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$a Lennard, Anne $u Bruce D. Cheson, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Neil Chua, University of Alberta, Edmonton, Alberta; Greg Dueck, British Columbia Cancer Agency, Kelowna; Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; Jiri Mayer, University Hospital and Masaryk University, Brno; Marek Trněný, Charles University General Hospital, Prague, Czech Republic; Kamal Bouabdallah, Centre Hospitalier Universitaire Haut-Leveque, Bordeaux; Vincent Delwail, Centre Hospitalier Universitaire de Poitiers, Poitiers; Gilles Salles, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France; Nathan Fowler, University of Texas, Houston, TX; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA; John G. Gribben, Queen Mary University of London, London; Anne Lennard, Newcastle University, Newcastle upon Tyne, United Kingdom; Pieternella J. Lugtenburg, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; and Günter Fingerle-Rowson, Federico Mattiello, and Andrea Knapp, F. Hoffmann-La Roche, Basel, Switzerland.
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$a Lugtenburg, Pieternella J $u Bruce D. Cheson, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Neil Chua, University of Alberta, Edmonton, Alberta; Greg Dueck, British Columbia Cancer Agency, Kelowna; Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; Jiri Mayer, University Hospital and Masaryk University, Brno; Marek Trněný, Charles University General Hospital, Prague, Czech Republic; Kamal Bouabdallah, Centre Hospitalier Universitaire Haut-Leveque, Bordeaux; Vincent Delwail, Centre Hospitalier Universitaire de Poitiers, Poitiers; Gilles Salles, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France; Nathan Fowler, University of Texas, Houston, TX; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA; John G. Gribben, Queen Mary University of London, London; Anne Lennard, Newcastle University, Newcastle upon Tyne, United Kingdom; Pieternella J. Lugtenburg, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; and Günter Fingerle-Rowson, Federico Mattiello, and Andrea Knapp, F. Hoffmann-La Roche, Basel, Switzerland.
700    1_
$a Fingerle-Rowson, Günter $u Bruce D. Cheson, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Neil Chua, University of Alberta, Edmonton, Alberta; Greg Dueck, British Columbia Cancer Agency, Kelowna; Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; Jiri Mayer, University Hospital and Masaryk University, Brno; Marek Trněný, Charles University General Hospital, Prague, Czech Republic; Kamal Bouabdallah, Centre Hospitalier Universitaire Haut-Leveque, Bordeaux; Vincent Delwail, Centre Hospitalier Universitaire de Poitiers, Poitiers; Gilles Salles, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France; Nathan Fowler, University of Texas, Houston, TX; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA; John G. Gribben, Queen Mary University of London, London; Anne Lennard, Newcastle University, Newcastle upon Tyne, United Kingdom; Pieternella J. Lugtenburg, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; and Günter Fingerle-Rowson, Federico Mattiello, and Andrea Knapp, F. Hoffmann-La Roche, Basel, Switzerland.
700    1_
$a Mattiello, Federico $u Bruce D. Cheson, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Neil Chua, University of Alberta, Edmonton, Alberta; Greg Dueck, British Columbia Cancer Agency, Kelowna; Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; Jiri Mayer, University Hospital and Masaryk University, Brno; Marek Trněný, Charles University General Hospital, Prague, Czech Republic; Kamal Bouabdallah, Centre Hospitalier Universitaire Haut-Leveque, Bordeaux; Vincent Delwail, Centre Hospitalier Universitaire de Poitiers, Poitiers; Gilles Salles, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France; Nathan Fowler, University of Texas, Houston, TX; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA; John G. Gribben, Queen Mary University of London, London; Anne Lennard, Newcastle University, Newcastle upon Tyne, United Kingdom; Pieternella J. Lugtenburg, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; and Günter Fingerle-Rowson, Federico Mattiello, and Andrea Knapp, F. Hoffmann-La Roche, Basel, Switzerland.
700    1_
$a Knapp, Andrea $u Bruce D. Cheson, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Neil Chua, University of Alberta, Edmonton, Alberta; Greg Dueck, British Columbia Cancer Agency, Kelowna; Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; Jiri Mayer, University Hospital and Masaryk University, Brno; Marek Trněný, Charles University General Hospital, Prague, Czech Republic; Kamal Bouabdallah, Centre Hospitalier Universitaire Haut-Leveque, Bordeaux; Vincent Delwail, Centre Hospitalier Universitaire de Poitiers, Poitiers; Gilles Salles, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France; Nathan Fowler, University of Texas, Houston, TX; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA; John G. Gribben, Queen Mary University of London, London; Anne Lennard, Newcastle University, Newcastle upon Tyne, United Kingdom; Pieternella J. Lugtenburg, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; and Günter Fingerle-Rowson, Federico Mattiello, and Andrea Knapp, F. Hoffmann-La Roche, Basel, Switzerland.
700    1_
$a Sehn, Laurie H $u Bruce D. Cheson, Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC; Neil Chua, University of Alberta, Edmonton, Alberta; Greg Dueck, British Columbia Cancer Agency, Kelowna; Laurie H. Sehn, Centre for Lymphoid Cancer, British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada; Jiri Mayer, University Hospital and Masaryk University, Brno; Marek Trněný, Charles University General Hospital, Prague, Czech Republic; Kamal Bouabdallah, Centre Hospitalier Universitaire Haut-Leveque, Bordeaux; Vincent Delwail, Centre Hospitalier Universitaire de Poitiers, Poitiers; Gilles Salles, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France; Nathan Fowler, University of Texas, Houston, TX; Oliver Press, Fred Hutchinson Cancer Research Center, Seattle, WA; John G. Gribben, Queen Mary University of London, London; Anne Lennard, Newcastle University, Newcastle upon Tyne, United Kingdom; Pieternella J. Lugtenburg, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; and Günter Fingerle-Rowson, Federico Mattiello, and Andrea Knapp, F. Hoffmann-La Roche, Basel, Switzerland.
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