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

Massimo Gentile, Katja Zirlik, Stefania Ciolli, F. R. Mauro, Nicola Di Renzo, Lucia Mastrullo, F. Angrilli, Stefano Molica, G. Tripepi, Annamaria Giordano, Francesco Di Raimondo, Carmine Selleri, Marta Coscia, Maurizio Musso, L. Orsucci, Donato Mannina, Angela Rago, Angela Giannotta, Felicetto Ferrara, Yair HerishanuLev Shvidel, Tamar Tadmor, Ilaria Scortechini, Fiorella Ilariucci, Roberta Murru, Attilio Guarini, Gerardo Musuraca, Giuseppe Mineo, Iolanda Vincelli, Annalisa Arcari, Giuseppe Tarantini, Giuseppe Caparrotti, Annalisa Chiarenza, Luciano Levato, M. R. Villa, M. Rosaria De Paolis, Pierluigi Zinzani, Aaron Polliack, Fortunato Morabito

Research output: Contribution to journalArticle

Abstract

Recently, encouraging results in terms of safety and efficacy have been obtained using bendamustine-rituximab (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, 43-86 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. Fluorescent in situ hybridisation 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 survival (PFS) was 69.9%; CIRS ≥7, immunoglobulin heavy-chain variable-region (IGHV) unmutated status, del17p and BR dose intensity

Original languageEnglish
Pages (from-to)154-165
Number of pages12
JournalEuropean Journal of Cancer
Volume60
DOIs
Publication statusPublished - Jun 1 2016

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Controlled Clinical Trials
B-Cell Chronic Lymphocytic Leukemia
Therapeutics
Safety
Immunoglobulin Heavy Chains
Fluorescence In Situ Hybridization
Multicenter Studies
Disease-Free Survival
Creatinine
Bendamustine Hydrochloride
Rituximab

Keywords

  • Bendamustine
  • Chronic lymphocytic leukaemia
  • Rituximab
  • Therapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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, F. R.; Di Renzo, Nicola; Mastrullo, Lucia; Angrilli, F.; Molica, Stefano; Tripepi, G.; Giordano, Annamaria; Di Raimondo, Francesco; Selleri, Carmine; Coscia, Marta; Musso, Maurizio; Orsucci, L.; 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, M. R.; De Paolis, M. Rosaria; Zinzani, Pierluigi; Polliack, Aaron; Morabito, Fortunato.

In: European Journal of Cancer, Vol. 60, 01.06.2016, p. 154-165.

Research output: Contribution to journalArticle

Gentile, M, Zirlik, K, Ciolli, S, Mauro, FR, Di Renzo, N, Mastrullo, L, Angrilli, F, Molica, S, Tripepi, G, Giordano, A, Di Raimondo, F, Selleri, C, Coscia, M, Musso, M, Orsucci, L, Mannina, D, Rago, A, Giannotta, A, Ferrara, F, Herishanu, Y, Shvidel, L, Tadmor, T, Scortechini, I, Ilariucci, F, Murru, R, Guarini, A, Musuraca, G, Mineo, G, Vincelli, I, Arcari, A, Tarantini, G, Caparrotti, G, Chiarenza, A, Levato, L, Villa, MR, De Paolis, MR, Zinzani, P, Polliack, A & Morabito, F 2016, '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', European Journal of Cancer, vol. 60, pp. 154-165. https://doi.org/10.1016/j.ejca.2016.03.069
Gentile, Massimo ; Zirlik, Katja ; Ciolli, Stefania ; Mauro, F. R. ; Di Renzo, Nicola ; Mastrullo, Lucia ; Angrilli, F. ; Molica, Stefano ; Tripepi, G. ; Giordano, Annamaria ; Di Raimondo, Francesco ; Selleri, Carmine ; Coscia, Marta ; Musso, Maurizio ; Orsucci, L. ; 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, M. R. ; De Paolis, M. Rosaria ; Zinzani, Pierluigi ; Polliack, Aaron ; Morabito, Fortunato. / 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. In: European Journal of Cancer. 2016 ; Vol. 60. pp. 154-165.
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AU - Gentile, Massimo

AU - Zirlik, Katja

AU - Ciolli, Stefania

AU - Mauro, F. R.

AU - Di Renzo, Nicola

AU - Mastrullo, Lucia

AU - Angrilli, F.

AU - Molica, Stefano

AU - Tripepi, G.

AU - Giordano, Annamaria

AU - Di Raimondo, Francesco

AU - Selleri, Carmine

AU - Coscia, Marta

AU - Musso, Maurizio

AU - Orsucci, L.

AU - Mannina, Donato

AU - Rago, Angela

AU - Giannotta, Angela

AU - Ferrara, Felicetto

AU - Herishanu, Yair

AU - Shvidel, Lev

AU - Tadmor, Tamar

AU - Scortechini, Ilaria

AU - Ilariucci, Fiorella

AU - Murru, Roberta

AU - Guarini, Attilio

AU - Musuraca, Gerardo

AU - Mineo, Giuseppe

AU - Vincelli, Iolanda

AU - Arcari, Annalisa

AU - Tarantini, Giuseppe

AU - Caparrotti, Giuseppe

AU - Chiarenza, Annalisa

AU - Levato, Luciano

AU - Villa, M. R.

AU - De Paolis, M. Rosaria

AU - Zinzani, Pierluigi

AU - Polliack, Aaron

AU - Morabito, Fortunato

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Recently, encouraging results in terms of safety and efficacy have been obtained using bendamustine-rituximab (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, 43-86 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. Fluorescent in situ hybridisation 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 survival (PFS) was 69.9%; CIRS ≥7, immunoglobulin heavy-chain variable-region (IGHV) unmutated status, del17p and BR dose intensity

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KW - Rituximab

KW - Therapy

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