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BENDAMUSTINE-RITUXIMAB IN PATIENTS WITH RELAPSED FOLLICULAR LYMPHOMA PREVIOUSLY EXPOSED TO RITUXIMAB. EXPERIENCE IN SEVEN HOSPITALS OF THE SPANISH GELTAMO GROUP
Author(s): ,
Juan Alfonso Soler Campos
Affiliations:
Hematology,Hospital Universitari Parc Tauli Sabadell,Sabadell,Spain
,
Montserrat Martinez
Affiliations:
Hematology,Hospital Universitari Parc Tauli Sabadell,Sabadell,Spain
,
Blanca Sanchez-Gonzalez
Affiliations:
Hematology,Hospital del Mar,Barcelona,Spain
,
Maria Belen Navarro
Affiliations:
Hematology,Hospital Univeristario Puerta de Hierro,Madrid,Spain
,
Silvana Novelli
Affiliations:
Hematology,Hospital de la Santa Creu i Sant Pau,Barcelona,Spain
,
Santiago Mercadal
Affiliations:
Hematology,ICO H. Duran i Reynals.,Bellvitge,Spain
,
Elena Perez Ceballos
Affiliations:
Hematology,Hospital Universitario Morales Messeguer,Murcia,Spain
,
Nicolas Kelleher
Affiliations:
Hematology,Hospital Josep Trueta,Girona,Spain
Antonio Asensio
Affiliations:
Hematology,Hospital Sant Camil,Sant Pere de Ribes,Spain
(Abstract release date: 05/18/17) EHA Library. Soler Campos J. 05/18/17; 182601; PB1887
Juan Alfonso Soler Campos
Juan Alfonso Soler Campos
Contributions
Abstract

Abstract: PB1887

Type: Publication Only

Background

Follicular lymphoma (FL) is characterized by a course of relapses and increasingly shorter responses to the consecutive treatments. In first relapse after immunochemotherapy, in patients who are not considered refractory to rituximab, there is no standard treatment. In Spain, bendamustine in association with rituximab (BR) has not been approved for this indication. Nevertheless this combination has shown high efficacy and excellent tolerance in patients previously treated with and without rituximab.

Aims
To evaluate the efficacy and safety of the bendamustine-rituximab association in a group of patients with follicular lymphoma previously exposed to rituximab.

Methods

Retrospective analysis of patients with relapsed FL treated with BR in 7 spanish hospitals on behalf of the Spanish Lymphoma Group (GELTAMO). The study was approved by the reference Ethic Committee and by all of the participating centres. All patients acceded to the treatment through the compassionate use program.

Results
41 patients were valid for analysis. Characteristics: 70% males with a mean age of 62 years (30-87). ECOG≤ 2 in 95% of cases, 73.2% in stages III-IV and FLIPI ≥ 3 in 48%. Bulky mass in 13% of patients, LDH and β2-microglobulin increased by 12% and 41.2% respectively and bone marrow involvement in 60%. 68% had received only one previous treatment, with an average of 1.7 (1-5) and the most frequent was CHOP-R in 66% followed by CVP-R in 11%. All patients had previously received rituximab and only 3 patients (7.3%) could be considered refractory. All patients received BR (B-90 mg / m2 D1-2, R-375mg / m2 D1). Median cycles 5.1 (1-6). Support with G-CSF was used in 27.5% of cycles. Maintenance with rituximab after obtaining a complete (CR) or partial remission (PR) was administered in 42% of patients. Response: The overall response rate was 95.1% (65.8% CR-iCR / 29.3% PR). With a median follow-up of 25 months (6-92) the median response duration was 41.9 months (32.8-51.1) and the median progression-free survival (PFS) was 57 months (27.4-86.5) with no impact neither by the number of previous treatments (1 vs ≥2) (P = 0.69) nor by the age (<70 vs ≥ 70) (P = 0.9). Patients who received maintenance with rituximab after BR had a significantly longer median PFS than without (NR vs 32) (p = 0.004). Toxicity: No treatment-related death was recorded. 42% and 36.6% of the patients presented G3-4 neutropenia and thrombocytopenia respectively, although only 2 patients were admitted due to febrile neutropenia. 43% received cotrimoxazole prophylaxis and 3 opportunistic infections were recorded (1 P. jirovecii pneumonia in a patient without prophylaxis).

Conclusion
BR has a high efficacy and a good safety profile in this series of patients with relapsed FL previously exposed to rituximab. The number of previous treatments (1 vs ≥ 2) and the age had no impact in the results.

Session topic: 19. Indolent Non-Hodgkin lymphoma - Clinical

Keyword(s): Follicular lymphoma

Abstract: PB1887

Type: Publication Only

Background

Follicular lymphoma (FL) is characterized by a course of relapses and increasingly shorter responses to the consecutive treatments. In first relapse after immunochemotherapy, in patients who are not considered refractory to rituximab, there is no standard treatment. In Spain, bendamustine in association with rituximab (BR) has not been approved for this indication. Nevertheless this combination has shown high efficacy and excellent tolerance in patients previously treated with and without rituximab.

Aims
To evaluate the efficacy and safety of the bendamustine-rituximab association in a group of patients with follicular lymphoma previously exposed to rituximab.

Methods

Retrospective analysis of patients with relapsed FL treated with BR in 7 spanish hospitals on behalf of the Spanish Lymphoma Group (GELTAMO). The study was approved by the reference Ethic Committee and by all of the participating centres. All patients acceded to the treatment through the compassionate use program.

Results
41 patients were valid for analysis. Characteristics: 70% males with a mean age of 62 years (30-87). ECOG≤ 2 in 95% of cases, 73.2% in stages III-IV and FLIPI ≥ 3 in 48%. Bulky mass in 13% of patients, LDH and β2-microglobulin increased by 12% and 41.2% respectively and bone marrow involvement in 60%. 68% had received only one previous treatment, with an average of 1.7 (1-5) and the most frequent was CHOP-R in 66% followed by CVP-R in 11%. All patients had previously received rituximab and only 3 patients (7.3%) could be considered refractory. All patients received BR (B-90 mg / m2 D1-2, R-375mg / m2 D1). Median cycles 5.1 (1-6). Support with G-CSF was used in 27.5% of cycles. Maintenance with rituximab after obtaining a complete (CR) or partial remission (PR) was administered in 42% of patients. Response: The overall response rate was 95.1% (65.8% CR-iCR / 29.3% PR). With a median follow-up of 25 months (6-92) the median response duration was 41.9 months (32.8-51.1) and the median progression-free survival (PFS) was 57 months (27.4-86.5) with no impact neither by the number of previous treatments (1 vs ≥2) (P = 0.69) nor by the age (<70 vs ≥ 70) (P = 0.9). Patients who received maintenance with rituximab after BR had a significantly longer median PFS than without (NR vs 32) (p = 0.004). Toxicity: No treatment-related death was recorded. 42% and 36.6% of the patients presented G3-4 neutropenia and thrombocytopenia respectively, although only 2 patients were admitted due to febrile neutropenia. 43% received cotrimoxazole prophylaxis and 3 opportunistic infections were recorded (1 P. jirovecii pneumonia in a patient without prophylaxis).

Conclusion
BR has a high efficacy and a good safety profile in this series of patients with relapsed FL previously exposed to rituximab. The number of previous treatments (1 vs ≥ 2) and the age had no impact in the results.

Session topic: 19. Indolent Non-Hodgkin lymphoma - Clinical

Keyword(s): Follicular lymphoma

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