Monotherapy with pixantrone in histologically confirmed relapsed or refractory aggressive B‐cell non‐Hodgkin lymphoma: post‐hoc analyses from a phase III trial |
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| Authors: | Ruth Pettengell Catherine Sebban Pier Luigi Zinzani Hans Gunter Derigs Sergey Kravchenko Jack W. Singer Panteli Theocharous Lixia Wang Mariya Pavlyuk Kahina M. Makhloufi Bertrand Coiffier |
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| Affiliation: | 1. St George's University of London, London, UK;2. Leon Bérard Cancer Centre, Lyon, France;3. Institute of Haematology “Le A Seràgnoli”, University of Bologna, Bologna, Italy;4. St?dt Klinikum, Frankfurt‐Hoeschest, Klinik für Innere Medizin III, Frankfurt am Main, Germany;5. Chemotherapy and Intensive Treatment of Haematology Diseases, Haematology Scientific Centre Ministry of Health RF, Moscow, Russia;6. Cell Therapeutics Inc Life Sciences, London, UK;7. Cell Therapeutics Inc, Seattle, WA, USA;8. Institut de Recherches Internationales Servier, Suresnes, France;9. Centre Hospitalier Lyon Sud, Pierre‐Benite, France;10. Claude Bernard University of Lyon 1, Lyon, France |
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| Abstract: | This post hoc analysis of a phase 3 trial explored the effect of pixantrone in patients (50 pixantrone, 47 comparator) with relapsed or refractory aggressive B‐cell non‐Hodgkin lymphoma (NHL) confirmed by centralized histological review. Patients received 28‐d cycles of 85 mg/m2 pixantrone dimaleate (equivalent to 50 mg/m2 in the approved formulation) on days 1, 8 and 15, or comparator. The population was subdivided according to previous rituximab use and whether they received the study treatment as 3rd or 4th line. Median number of cycles was 4 (range, 2–6) with pixantrone and 3 (2–6) with comparator. In 3rd or 4th line, pixantrone was associated with higher complete response (CR) (23·1% vs. 5·1% comparator, P = 0·047) and overall response rate (ORR, 43·6% vs. 12·8%, P = 0·005). In 3rd or 4th line with previous rituximab (20 pixantrone, 18 comparator), pixantrone produced better ORR (45·0% vs. 11·1%, P = 0·033), CR (30·0% vs. 5·6%, P = 0·093) and progression‐free survival (median 5·4 vs. 2·8 months, hazard ratio 0·52, 95% confidence interval 0·26–1·04) than the comparator. Similar results were found in patients without previous rituximab. There were no unexpected safety issues. Pixantrone monotherapy is more effective than comparator in relapsed or refractory aggressive B‐cell NHL in the 3rd or 4th line setting, independently of previous rituximab. |
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| Keywords: | pixantrone salvage therapy B‐cell non‐Hodgkin lymphoma rituximab post hoc study |
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