Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized,multicentre trial (PIX306) |
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| Authors: | Ruth Pettengell Monika D?ugosz-Danecka David Andorsky David Belada Pencho Georgiev Donald Quick Jack W Singer Simran B Singh Athanasios Pallis Anton Egorov Gilles Salles |
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| Institution: | 1. St. George's Hospital, London, UK;2. Department of Haematology, Jagiellonian University, Krakow, Poland;3. Rocky Mountain Cancer Centers, US Oncology Research, Boulder, CO, USA;4. Clinical Haematology, 4th Department of Internal Medicine, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic;5. Clinic of Oncology and Haematology, University Multiprofile Hospital for Active Treatment "Sveti Georgi" and Medical University, Plovdiv, Bulgaria;6. Joe Arrington Cancer Research Treatment Center, Lubbock, TX, USA;7. CTI Biopharma, Seattle, WA, USA
Elson S. Floyd School of Medicine, Washington State University, WA, USA;8. Institut de Recherches Internationales Servier, Suresnes, France;9. Haematology Department, Hospices Civils de Lyon, Université Claude Bernard Lyon-1, Pierre-Bénite, France |
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| Abstract: | PIX306 was a phase 3, randomised, single-blind, multicentre trial conducted in adult patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) grade 3 who relapsed after ≥1 rituximab-containing regimen and were not eligible for a stem cell transplant. Patients were randomised 1:1 to pixantrone 50 mg/m2 or gemcitabine 1000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, combined with rituximab 375 mg/m2 on day 1, for up to six cycles. Patients were followed for up to 96 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), complete response (CR) rate, overall response rate (ORR) and safety. Overall, 312 patients were randomised (median age 73·0 years). The study did not meet its primary endpoint. Median PFS 95% confidence interval (CI)] was 7·3 months (5·2–8·4) with pixantrone + rituximab (PIX + R) and 6·3 months (4·4–8·1) with gemcitabine + rituximab GEM + R; hazard ratio (HR): 0·85; 95% CI 0·64–1·14; P = 0·28]. Median OS was 13·3 (10·1–19·8) months with PIX + R and 19·6 (12·4–31·9) months with GEM + R (HR: 1·13; 95% CI 0·83–1·53). ORR was 61·9% and 43·9% respectively and CR rate 35·5% and 21·7%. The incidence of adverse events, including cardiac events, was not statistically significant different between PIX + R and GEM + R. |
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| Keywords: | DLBCL FL grade 3 gemcitabine pixantrone rituximab |
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