BENDAMUSTINE PLUS RITUXIMAB IN 65 YEAR AND ABOVE UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS
(Abstract release date: 05/19/16)
EHA Library. De La Fuente A. 06/09/16; 132631; E1082
Dr. Adolfo De La Fuente
Contributions
Contributions
Abstract
Abstract: E1082
Type: Eposter Presentation
Background
Frontline Chemoimmunotherapy with Bendamustine and Rituximab (BR) in Previously Untreated and Physically Fit Patients (pts) with Advanced Chronic Lymphocytic Leukemia (CLL) has been compared against the standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) and suggested as an option for elderly pts (Eichhorst el al ASH 2014). There is a lack of data regarding BR as CLL front line in routine clinical practice.
Aims
The aim of this study is to evaluate the toxic profile and effectiveness of BR as front line in 65 yr and above CLL patients in daily practice and to identify risk factors.
Methods
We performed the analysis of the 65yr and above patients included in the MDA-LLC-2015-02 study, which consisted of a retrospective study CLL patients from 12 Spanish sites treated with BR as front line (B 90 mg/m2 days 1 and 2 every 28 days and R 375 mg/m2 on day 1 of the first cycle and 500 mg/m2 on day 1 of the other cycles). We evaluate effectives as IWCLL, toxicity as CTCAE v4.0 of NCI, overall survival (OS) and progression free survival (PFS) (Kaplan-Meier). This study has been approved by the Spanish Medicines Agency AEMPS.
Results
Sixty two (male 46 pt/female 16 pt) out of 85 pt included in MDA-LLC-2015-02 study were 65 or older, median age 72 (65-84). Risk factors as follows, ECOG≥2: 6 pt, high LDH: 25 pt, high β2 microglobulin: 50 pt, Binet C: 22 pt, Creatinine >1.3 mg/dL: 8 pt. Toxicity: A total of 316 cycles were administered, median 6 per patient, grade 4 neutropenia: 9pt, hospitalization do adverse events 13 pt, all febrile neutropenia. No cases of treatment related mortality. Efficacy: ORR 90.2%, with a median follow up 36 months 19 pt required second line therapy and 10 pt died, 2 because of progression. Median OS 56 months and median PFS 45 months (3 year OS 85.5%). ECOG≥2 (p0.002, p0.008) and grade 4 neutropenia (p0.017, p0.006) predict OS and PFS. High LDH, high β2 microglobulin, Binet C, Creatinine >1.3 mg/dL, trisomy 12, del11q, del13q did not predict OS neither PFS.
Conclusion
This results confirms BR as an effective (ORR 90.2% and PFS 45 months) and safe (no cases of treatment related mortality) as first lines for 65 year old and above CLL patients.
Session topic: E-poster
Keyword(s): Bendamustine, Chronic lymphocytic leukemia, Elderly
Type: Eposter Presentation
Background
Frontline Chemoimmunotherapy with Bendamustine and Rituximab (BR) in Previously Untreated and Physically Fit Patients (pts) with Advanced Chronic Lymphocytic Leukemia (CLL) has been compared against the standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) and suggested as an option for elderly pts (Eichhorst el al ASH 2014). There is a lack of data regarding BR as CLL front line in routine clinical practice.
Aims
The aim of this study is to evaluate the toxic profile and effectiveness of BR as front line in 65 yr and above CLL patients in daily practice and to identify risk factors.
Methods
We performed the analysis of the 65yr and above patients included in the MDA-LLC-2015-02 study, which consisted of a retrospective study CLL patients from 12 Spanish sites treated with BR as front line (B 90 mg/m2 days 1 and 2 every 28 days and R 375 mg/m2 on day 1 of the first cycle and 500 mg/m2 on day 1 of the other cycles). We evaluate effectives as IWCLL, toxicity as CTCAE v4.0 of NCI, overall survival (OS) and progression free survival (PFS) (Kaplan-Meier). This study has been approved by the Spanish Medicines Agency AEMPS.
Results
Sixty two (male 46 pt/female 16 pt) out of 85 pt included in MDA-LLC-2015-02 study were 65 or older, median age 72 (65-84). Risk factors as follows, ECOG≥2: 6 pt, high LDH: 25 pt, high β2 microglobulin: 50 pt, Binet C: 22 pt, Creatinine >1.3 mg/dL: 8 pt. Toxicity: A total of 316 cycles were administered, median 6 per patient, grade 4 neutropenia: 9pt, hospitalization do adverse events 13 pt, all febrile neutropenia. No cases of treatment related mortality. Efficacy: ORR 90.2%, with a median follow up 36 months 19 pt required second line therapy and 10 pt died, 2 because of progression. Median OS 56 months and median PFS 45 months (3 year OS 85.5%). ECOG≥2 (p0.002, p0.008) and grade 4 neutropenia (p0.017, p0.006) predict OS and PFS. High LDH, high β2 microglobulin, Binet C, Creatinine >1.3 mg/dL, trisomy 12, del11q, del13q did not predict OS neither PFS.
Conclusion
This results confirms BR as an effective (ORR 90.2% and PFS 45 months) and safe (no cases of treatment related mortality) as first lines for 65 year old and above CLL patients.
Session topic: E-poster
Keyword(s): Bendamustine, Chronic lymphocytic leukemia, Elderly
Abstract: E1082
Type: Eposter Presentation
Background
Frontline Chemoimmunotherapy with Bendamustine and Rituximab (BR) in Previously Untreated and Physically Fit Patients (pts) with Advanced Chronic Lymphocytic Leukemia (CLL) has been compared against the standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) and suggested as an option for elderly pts (Eichhorst el al ASH 2014). There is a lack of data regarding BR as CLL front line in routine clinical practice.
Aims
The aim of this study is to evaluate the toxic profile and effectiveness of BR as front line in 65 yr and above CLL patients in daily practice and to identify risk factors.
Methods
We performed the analysis of the 65yr and above patients included in the MDA-LLC-2015-02 study, which consisted of a retrospective study CLL patients from 12 Spanish sites treated with BR as front line (B 90 mg/m2 days 1 and 2 every 28 days and R 375 mg/m2 on day 1 of the first cycle and 500 mg/m2 on day 1 of the other cycles). We evaluate effectives as IWCLL, toxicity as CTCAE v4.0 of NCI, overall survival (OS) and progression free survival (PFS) (Kaplan-Meier). This study has been approved by the Spanish Medicines Agency AEMPS.
Results
Sixty two (male 46 pt/female 16 pt) out of 85 pt included in MDA-LLC-2015-02 study were 65 or older, median age 72 (65-84). Risk factors as follows, ECOG≥2: 6 pt, high LDH: 25 pt, high β2 microglobulin: 50 pt, Binet C: 22 pt, Creatinine >1.3 mg/dL: 8 pt. Toxicity: A total of 316 cycles were administered, median 6 per patient, grade 4 neutropenia: 9pt, hospitalization do adverse events 13 pt, all febrile neutropenia. No cases of treatment related mortality. Efficacy: ORR 90.2%, with a median follow up 36 months 19 pt required second line therapy and 10 pt died, 2 because of progression. Median OS 56 months and median PFS 45 months (3 year OS 85.5%). ECOG≥2 (p0.002, p0.008) and grade 4 neutropenia (p0.017, p0.006) predict OS and PFS. High LDH, high β2 microglobulin, Binet C, Creatinine >1.3 mg/dL, trisomy 12, del11q, del13q did not predict OS neither PFS.
Conclusion
This results confirms BR as an effective (ORR 90.2% and PFS 45 months) and safe (no cases of treatment related mortality) as first lines for 65 year old and above CLL patients.
Session topic: E-poster
Keyword(s): Bendamustine, Chronic lymphocytic leukemia, Elderly
Type: Eposter Presentation
Background
Frontline Chemoimmunotherapy with Bendamustine and Rituximab (BR) in Previously Untreated and Physically Fit Patients (pts) with Advanced Chronic Lymphocytic Leukemia (CLL) has been compared against the standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) and suggested as an option for elderly pts (Eichhorst el al ASH 2014). There is a lack of data regarding BR as CLL front line in routine clinical practice.
Aims
The aim of this study is to evaluate the toxic profile and effectiveness of BR as front line in 65 yr and above CLL patients in daily practice and to identify risk factors.
Methods
We performed the analysis of the 65yr and above patients included in the MDA-LLC-2015-02 study, which consisted of a retrospective study CLL patients from 12 Spanish sites treated with BR as front line (B 90 mg/m2 days 1 and 2 every 28 days and R 375 mg/m2 on day 1 of the first cycle and 500 mg/m2 on day 1 of the other cycles). We evaluate effectives as IWCLL, toxicity as CTCAE v4.0 of NCI, overall survival (OS) and progression free survival (PFS) (Kaplan-Meier). This study has been approved by the Spanish Medicines Agency AEMPS.
Results
Sixty two (male 46 pt/female 16 pt) out of 85 pt included in MDA-LLC-2015-02 study were 65 or older, median age 72 (65-84). Risk factors as follows, ECOG≥2: 6 pt, high LDH: 25 pt, high β2 microglobulin: 50 pt, Binet C: 22 pt, Creatinine >1.3 mg/dL: 8 pt. Toxicity: A total of 316 cycles were administered, median 6 per patient, grade 4 neutropenia: 9pt, hospitalization do adverse events 13 pt, all febrile neutropenia. No cases of treatment related mortality. Efficacy: ORR 90.2%, with a median follow up 36 months 19 pt required second line therapy and 10 pt died, 2 because of progression. Median OS 56 months and median PFS 45 months (3 year OS 85.5%). ECOG≥2 (p0.002, p0.008) and grade 4 neutropenia (p0.017, p0.006) predict OS and PFS. High LDH, high β2 microglobulin, Binet C, Creatinine >1.3 mg/dL, trisomy 12, del11q, del13q did not predict OS neither PFS.
Conclusion
This results confirms BR as an effective (ORR 90.2% and PFS 45 months) and safe (no cases of treatment related mortality) as first lines for 65 year old and above CLL patients.
Session topic: E-poster
Keyword(s): Bendamustine, Chronic lymphocytic leukemia, Elderly
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