• Bruce D Cheson, Neil Chua, Jiri Mayer, Greg Dueck, Marek Trněný, Kamal Bouabdallah, Nathan Fowler, Vincent Delwail, Oliver Press, Gilles Salles, John G Gribben, Anne Lennard, Pieternella J Lugtenburg, Günter Fingerle-Rowson, Federico Mattiello, Andrea Knapp, and Laurie H Sehn.
• 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.
• J. Clin. Oncol. 2018 Aug 1; 36 (22): 2259-2266.

AbstractPurpose 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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