Recently, encouraging results in terms of safety and efficacy have been obtained using bendamustine erituximab (BR) in untreated chronic lymphocytic leukaemia (CLL) patients enrolled in a phase II study. Here, we report a retrospective international multicenter study of CLL patients treated with BR as front-line therapy. The cohort included 279 patients with progressive CLL from 33 centers (29 Italian, 3 Israeli and 1 German) who received at least 1 cycle of BR as first-line treatment during the 2008 2014 period. The primary objective of this study was to evaluate the efficacy and safety of BR administered as front-line therapy, outside of controlled clinical trials. Median age was 70 years (range, 43e 86 years); 62.4% were males and 35.8% had Binet stage C. Forty-two patients (15.2%) were unfit (cumulative illness rating scale [CIRS] score 7), and 140 (50.2%) had creatinine clearance 70 ml/min. Fluorescentin situhybridisation analysis, available for 192 cases, showed that 21 (10.9%) had del11q and 18 (9.4%) del17p. The overall response rate (ORR) was 86.4%, with a complete remission rate of 28%. Patients with del17p had an ORR of 66.7%. After median follow-up of 24 months, the 2-year progression-free sur- vival (PFS) was 69.9%; CIRS 7, immunoglobulin heavy-chain variable-region ( IGHV ) unmu- tated status, del17p and BR dose intensity < 80% were independently associated with shorter PFS. Grade III or IV neutropenia, thrombocytopenia, and anaemia were observed in 25.9%, 15.4%, and 15.1% of patients, respectively. Twenty-four patients (8.6%) had severe infections. BR is also an effective and safe regimen for untreated CLL patients, outside of controlled

Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: Multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials / Gentile, Massimo; Zirlik, Katja; Ciolli, Stefania; Mauro, Francesca Romana; Di Renzo, Nicola; Mastrullo, Lucia; Angrilli, Francesco; Molica, Stefano; Tripepi, Giovanni; Giordano, Annamaria; Di Raimondo, Francesco; Selleri, Carmine; Coscia, Marta; Musso, Maurizio; Orsucci, Lorella; Mannina, Donato; Rago, Angela; Giannotta, Angela; Ferrara, Felicetto; Herishanu, Yair; Shvidel, Lev; Tadmor, Tamar; Scortechini, Ilaria; Ilariucci, Fiorella; Murru, Roberta; Guarini, Attilio; Musuraca, Gerardo; Mineo, Giuseppe; Vincelli, Iolanda; Arcari, Annalisa; Tarantini, Giuseppe; Caparrotti, Giuseppe; Chiarenza, Annalisa; Levato, Luciano; Villa, Maria Rosaria; De Paolis, Maria Rosaria; Zinzani, Pier Luigi; Polliack, Aaron; Morabito, Fortunato. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 60:(2016), pp. 154-165. [10.1016/j.ejca.2016.03.069]

Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: Multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials

MAURO, Francesca Romana;RAGO, ANGELA;
2016

Abstract

Recently, encouraging results in terms of safety and efficacy have been obtained using bendamustine erituximab (BR) in untreated chronic lymphocytic leukaemia (CLL) patients enrolled in a phase II study. Here, we report a retrospective international multicenter study of CLL patients treated with BR as front-line therapy. The cohort included 279 patients with progressive CLL from 33 centers (29 Italian, 3 Israeli and 1 German) who received at least 1 cycle of BR as first-line treatment during the 2008 2014 period. The primary objective of this study was to evaluate the efficacy and safety of BR administered as front-line therapy, outside of controlled clinical trials. Median age was 70 years (range, 43e 86 years); 62.4% were males and 35.8% had Binet stage C. Forty-two patients (15.2%) were unfit (cumulative illness rating scale [CIRS] score 7), and 140 (50.2%) had creatinine clearance 70 ml/min. Fluorescentin situhybridisation analysis, available for 192 cases, showed that 21 (10.9%) had del11q and 18 (9.4%) del17p. The overall response rate (ORR) was 86.4%, with a complete remission rate of 28%. Patients with del17p had an ORR of 66.7%. After median follow-up of 24 months, the 2-year progression-free sur- vival (PFS) was 69.9%; CIRS 7, immunoglobulin heavy-chain variable-region ( IGHV ) unmu- tated status, del17p and BR dose intensity < 80% were independently associated with shorter PFS. Grade III or IV neutropenia, thrombocytopenia, and anaemia were observed in 25.9%, 15.4%, and 15.1% of patients, respectively. Twenty-four patients (8.6%) had severe infections. BR is also an effective and safe regimen for untreated CLL patients, outside of controlled
2016
bendamustine; chronic lymphocytic leukaemia; rituximab; therapy; cancer research; oncology
01 Pubblicazione su rivista::01a Articolo in rivista
Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: Multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials / Gentile, Massimo; Zirlik, Katja; Ciolli, Stefania; Mauro, Francesca Romana; Di Renzo, Nicola; Mastrullo, Lucia; Angrilli, Francesco; Molica, Stefano; Tripepi, Giovanni; Giordano, Annamaria; Di Raimondo, Francesco; Selleri, Carmine; Coscia, Marta; Musso, Maurizio; Orsucci, Lorella; Mannina, Donato; Rago, Angela; Giannotta, Angela; Ferrara, Felicetto; Herishanu, Yair; Shvidel, Lev; Tadmor, Tamar; Scortechini, Ilaria; Ilariucci, Fiorella; Murru, Roberta; Guarini, Attilio; Musuraca, Gerardo; Mineo, Giuseppe; Vincelli, Iolanda; Arcari, Annalisa; Tarantini, Giuseppe; Caparrotti, Giuseppe; Chiarenza, Annalisa; Levato, Luciano; Villa, Maria Rosaria; De Paolis, Maria Rosaria; Zinzani, Pier Luigi; Polliack, Aaron; Morabito, Fortunato. - In: EUROPEAN JOURNAL OF CANCER. - ISSN 0959-8049. - 60:(2016), pp. 154-165. [10.1016/j.ejca.2016.03.069]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/868552
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