Bendamustine with or without rituximab in the treatment of relapsed chronic lymphocytic leukaemia

March 10, 2011

BlankBendamustine with or without rituximab in the treatment of relapsed chronic

lymphocytic leukaemia: an Italian retrospective study.

E Iannitto, F Morabito, S Mancuso, M Gentile, A Montanini, A Augello, V

Bongarzoni, A D'Arco, N Di Renzo, R Fazzi, G Franco, R Marasca, A Mule, M Musso,

P Musto, E Pennese, A Piccin, D Rota-Scalabrini, G Visani, and L Rigacci

Br J Haematol, March 4, 2011; .

UO di Ematologia, AOUP Paolo Giaccone, Palermo UO di Ematologia, Azienda

Ospedaliera, Cosenza Dipartimento di Oncologia, Ematologia e Patologie

dell'Apparato Respiratorio, Universit? di Modena e Reggio Emilia, Modena UO

Ematologia, Azienda Ospedaliera 'San Giovanni-Addolorata', Roma UO Ematologia,

Nocera Inferiore UO Ematologia e Trapianto di cellule Staminali, P.O V. Fazzi,

Lecce UO Ematologia, Universit? di Pisa, Pisa UO Ematologia, A.O. Villa

Sofia-Cervello, Palermo UO Ematologia e Trapianto di Midollo, CDC 'La

Maddalena', Palermo UO di Ematologia e Trapianto di Cellule Staminali,

IRCCS-CROB, Rionero in Vulture UO Ematologia e TMO, Ospedale Regionale San

Maurizio, Bolzano IRCC-FPO Candiolo Ematologia e centro trapianto di midollo,

Ospedale San Salvatore, Pesaro Ematologia Azienda Ospedaliero Universitaria

Careggi, Firenze, Italy.

To retrospectively assess the efficacy of bendamustine alone and with rituximab

(R-, 109 patients with relapsed chronic lymphocytic leukaemia (CLL) were

enrolled in 24 Italian centres. The median age was 66 years (range 39-85).

Forty-three percent of patients had relapsed and 57% were resistant (median

previous therapies?=?3; range 1-8). Twenty-two patients received bendamustine

alone and 87 patients received R-B (median B dosage: 100?mg/m(2) per day, range

90-130?mg/m(2) per day). The overall response rate was 69?6% (complete response

28?6%; partial response 41%), and was significantly higher in patients treated

with R-B (P?=?0?014) and in those responsive to the previous treatment

(P?=?0?04). After a median follow-up of 7?9?months (range 1-148), the median

progression-free survival was 16?months and the median duration of response was

13?months. Median overall survival (OS) was 16?8?months for the whole cohort;

patients not responding to the treatment had a significantly worse outcome than

those who attained a response (P?=?0?0001). In multivariate analysis, only

resistant disease status at start of bendamustine treatment (HR 3?2, 95% CI

1?4-7?3, P?=?0?006) had an independent prognostic value for OS. Toxicity was

manageable and mostly haematological. In conclusion, in our experience R-B was

an effective and well-tolerated treatment for relapsed/refractory CLL patients,

producing a remarkable high CR rate and mild toxicity.

PMID: 21371003

Recommended Posts