Monotherapy with pixantrone in histologically confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a phase III trial.
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.
St George's University of London, London, UK.
Ruth
R
Pettengell
Leon Bérard Cancer Centre, Lyon, France.
Catherine
C
Sebban
Institute of Haematology "Le A Seràgnoli", University of Bologna, Bologna, Italy.
Pier Luigi
PL
Zinzani
Städt Klinikum, Frankfurt-Hoeschest, Klinik für Innere Medizin III, Frankfurt am Main, Germany.
Hans Gunter
HG
Derigs
Chemotherapy and Intensive Treatment of Haematology Diseases, Haematology Scientific Centre Ministry of Health RF, Moscow, Russia.
Sergey
S
Kravchenko
Cell Therapeutics Inc Life Sciences, London, UK.
Jack W
JW
Singer
Cell Therapeutics Inc, Seattle, WA, USA.
Panteli
P
Theocharous
Cell Therapeutics Inc, Seattle, WA, USA.
Lixia
L
Wang
Institut de Recherches Internationales Servier, Suresnes, France.
Mariya
M
Pavlyuk
Institut de Recherches Internationales Servier, Suresnes, France.
Kahina M
KM
Makhloufi
Centre Hospitalier Lyon Sud, Pierre-Benite, France.|Claude Bernard University of Lyon 1, Lyon, France.
Bertrand
B
Coiffier
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage*; D016393:Lymphoma, B-Cell / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D000069283:Rituximab / Q000627:therapeutic use; D016879:Salvage Therapy / Q000379:methods*; D059005:Topoisomerase II Inhibitors / Q000008:administration & dosage
D007546:Isoquinolines; D059005:Topoisomerase II Inhibitors; D000069283:Rituximab; C086548:pixantrone
B-cell non-Hodgkin lymphoma; pixantrone; post hoc study; rituximab; salvage therapy