BENDAMUSTINE COMBINED WITH RITUXIMAB (BR) IN ELDERLY FRAIL PATIENTS WITH NEWLY DIAGNOSED DLBCL
Author(s): ,
Sergio Storti
Affiliations:
Hematology,Università Cattolica - Fondazione Giovanni Paolo II,Campobasso,Italy;On behalf of,Fondazione Italiana Linfomi,FIL,Italy
,
Stefano Luminari
Affiliations:
Department of Diagnostic, Clinical and Public Health Medicine,University of Modena and Reggio Emilia,Modena,Italy
,
Flavia Salvi
Affiliations:
Division of Hematology,SS Antonio e Biagio Hospital,Alessandria,Italy
,
Francesco Passamonti
Affiliations:
Division of Hematology, Department of Medicine,Ospedale di Circolo e Fondazione Macchi,Varese,Italy
,
Alberto Fabbri
Affiliations:
Hematology,Azienda Ospedaliero Universitaria Le Scotte,Siena,Italy
,
Umberto Vitolo
Affiliations:
Hematology,6AO Città della Salute e della Scienza,Torino,Italy
,
Maria Giuseppina Cabras
Affiliations:
Ematologia e Centro Trapianti Midollo Osseo,ASL Cagliari,Cagliari,Italy
,
Maurizio Miglino
Affiliations:
Hematology and Oncology,IRCCS AOU San Martino -IST,Genova,Italy
,
Francesco Merli
Affiliations:
Hematology Unit,Arcispedale Santa Maria Nuova-IRCCS,Reggio Emilia,Italy
,
Pier Paolo Fattori
Affiliations:
Hematology Unit,Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRCCS,Meldola,Italy
,
Anna Marina Liberati
Affiliations:
Hematology,AO S.Maria Policlinico Monteluce, University of Perugia,Terni,Italy
,
Alfonso Zaccaria
Affiliations:
Hematology,Santa Maria delle Croci Hospital,Ravenna,Italy
,
Patrizia Tosi
Affiliations:
Hematology Unit,Rimini Hospital,Rimini,Italy
,
Rosanna Ciancia
Affiliations:
Medical Oncology,National Cancer Institute Aviano,Aviano,Italy
,
Emanuela Anna Pesce
Affiliations:
Department of Diagnostic, Clinical and Public Health Medicine,University of Modena and Reggio Emilia,Modena,Italy
Michele Spina
Affiliations:
Medical Oncology,National Cancer Institute Aviano,Aviano,Italy
EHA Learning Center. Storti S. Jun 12, 2015; 100572
Disclosure(s): Università Cattolica Roma
Hematology
Sergio Storti
Sergio Storti

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Abstract: P328

Type: Poster Presentation

Presentation during EHA20: From 12.06.2015 17:15 to 12.06.2015 18:45

Location: Poster area (Hall C)

Background
Rituximab (R) in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is currently the most widely used first-line therapy for Diffuse Large B-cell Lymphomas (DLBCL). However, many patients, including elderly and/or frail patients, may not tolerate the toxicities associated with this regimen. Recent data suggested that bendamustine plus rituximab (BR) was superior in effectiveness and tolerability compared to R-CHOP in the treatment of indolent and mantle cell lymphomas. Preliminary data have shown a promising activity in DLBCL, both in the relapsing and upfront setting. 

Aims

We investigated the safety and efficacy of BR combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.



Methods
Eligible patients were elderly patients (>70 years) with a newly diagnosed DLBCL not suitable for R-CHOP-based chemotherapy. All patients were evaluated by Comprehensive Geriatric Assessment (CGA) according to ADL, IADL and CIRS-G and were considered FRAIL if the following criteria were met: in patients aged 70-80 ADL<4 or IADL<5 or 1 grade 3 comorbidity or >8 grade 2 comorbidities; in patients older than 80 years ADL>5 or IADL>6 or 5-8 grade 2 comorbidities. Patients received bendamustine at a dose of 90 mg/m2 daily on days 1 and 2 of each 28-day cycle along with rituximab on day 1 for up to 6 cycles. The study evaluated the complete response rate (CRR), and treatment safety. Secondary end points included progression free survival (PFS) and overall survival (OS). 

Results
From February 2012 to February 2014, 49 patients were enrolled in 24 Italian centers. The majority (both 59%) were male and stage III-IV. The median age was 82. Overall, 83% (38) of the patients was older then 80 years and at CGA evaluation showed unfavourable 3 (68%, 26), 2 (26%, 10), and 1 (5%, 2) criteria. 25 patients completed all planned cycles of chemotherapy. The most frequent comorbidities were cardiovascular (37%) metabolic (11%) and respiratory diseases (7%). 24 patients discontinued the treatment (12 progressions of disease, 8 adverse events, 4 deaths). The adverse events that led to treatment discontinuation were: persistent cytopenia (3), worsening general condition (2), coronary acute syndrome (1), second tumor (1), febrile neutropenia associated to infection (1). Among four patients not receiving at least 2 courses of BR, 2 progressed. The overall response rate in 47 evaluable patients was 64%, with 26 patients (55%) achieving a complete response. At the last analysis performed with a median follow up of 10 months (1-31), 13 progressions and 4 relapse have been observed. The 2-years PFS and OS were 43% and 59%. 

 



Summary
Combination therapy with BR demonstrates low toxicity profile in this high risk population. The promising results on activity can encourage clinicians to considered BR for the treatment of FRAIL elderly patients with DLBCL not eligible for R-CHOP.  Disclosures: No relevant conflicts of interest to declare.

 



Keyword(s): Bendamustine, Elderly, Non-Hodgkin's lymphoma, Therapy

Session topic: Aggressive lymphoma -Therapy and Prognostication
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