Clinical Experience of Bendamustine Treatment for Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Spanish Registry.

Bendamustine (B) is a purine analog/alkylator hybrid that has demonstrated clinical activity in relapsed indolent non-Hodgkin lymphoma (NHL), including those refractory to other alkylating or purine analog agents, chronic lymphocytic leukemia (CLL) and multiple myeloma patients. Bendamustine is currently licensed in Germany and Switzerland for use in NHL and CLL, and in evaluation process by European Medication Agency (EMA) in other countries.

Retrospective analysis of efficacy and toxicity of bendamustine as a single-agent or in combination for NHL and CLL treatment in the setting of compassionate use in Spain. Retrospective analysis of efficacy and toxicity of bendamustine as a single-agent or in combination for NHL and CLL treatment in the setting of compassionate use in Spain. Retrospective analysis of efficacy and toxicity of bendamustine as a single-agent or in combination for NHL and CLL treatment in the setting of compassionate use in Spain.

Patients with relapsed or refractory NHL or CLL after at least 1 prior treatment regimen were eligible. Any bendamustine regimen was included.

91 patients(pts) from 18 institutions were included in the registry. The median age was 69 years (range: 36-88); male: 58%. Histology: 30 pts CLL; 16 pts aggressive NHL: pts (13 mantle cell lymphoma and 3 diffuse large B-cell lymphoma); 45 indolent NHL: (36 follicular lymphoma, 6 extranodal marginal zone B-cell lymphoma of MALT type and 3 lymphoplasmocytic lymphoma); ECOG/PS 0-1: 73%; Ann Arbor III-IV: 79% and IPI score >3: 48% in NHL, and Binnet B-C in CLL: 96%. Median time from diagnosis to Bendamustine treatment was 4,6 years (range 1-19,2) and median prior treatment regimens was 3 (range 1-11). 31 pts were refractory to prior treatment.

The most frequent used regimen was Rituximab plus B (RB) independently of the histology (see table 1).

Median number of Bendamustine cycles was 3 (range 1-7). 322 cycles of B were administered. 60% of de pts had adverse events grade 3-4, being hematologic toxicity the most frequent adverse event (54% neutropenia, 33% leucopenia, 29,7% thrombocytopenia, and 20% anemia). 15% cycles of B required pts admission in hospital. Sixty-nine pts were assessable for response at the time of analysis. Response rate are showed in table 1. 22 pts died (7 infection, 11 progression, 2 infection plus progression, 1 infection plus respiratory insufficiency and 1 isquemia). Table 1.

The most common regimen was Bendamustine at dose 90 mg/m² associated with rituximab. Treatment with B produced a high response rate, independently of the histology in this population of heavily pretreated NHL and CLL pts, including refractory to prior therapies. Treatment with B produced durable objective responses with acceptable toxicity in this population of heavily pretreated NHL and CLL pts, including refractory to prior therapies. Updated data will be presented at the meeting.

No relevant conflicts of interest to declare.