Monotherapy with pixantrone in histologically confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a phase III trial.

Autor: Pettengell R; St George's University of London, London, UK., Sebban C; Leon Bérard Cancer Centre, Lyon, France., Zinzani PL; Institute of Haematology 'Le A Seràgnoli', University of Bologna, Bologna, Italy., Derigs HG; Städt Klinikum, Frankfurt-Hoeschest, Klinik für Innere Medizin III, Frankfurt am Main, Germany., Kravchenko S; Chemotherapy and Intensive Treatment of Haematology Diseases, Haematology Scientific Centre Ministry of Health RF, Moscow, Russia., Singer JW; Cell Therapeutics Inc Life Sciences, London, UK., Theocharous P; Cell Therapeutics Inc, Seattle, WA, USA., Wang L; Cell Therapeutics Inc, Seattle, WA, USA., Pavlyuk M; Institut de Recherches Internationales Servier, Suresnes, France., Makhloufi KM; Institut de Recherches Internationales Servier, Suresnes, France., Coiffier B; Centre Hospitalier Lyon Sud, Pierre-Benite, France.; Claude Bernard University of Lyon 1, Lyon, France.
Jazyk: angličtina
Zdroj: British journal of haematology [Br J Haematol] 2016 Sep; Vol. 174 (5), pp. 692-9. Date of Electronic Publication: 2016 Apr 26.
DOI: 10.1111/bjh.14101
Abstrakt: 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/m(2) pixantrone dimaleate (equivalent to 50 mg/m(2) 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.
(© 2016 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
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