Contributions
Abstract: PB1885
Type: Publication Only
Background
Chronic Lymphocytic Leukemia (CLL) is one of the most common chronic lymphoproliferative disorder (CLPD) in India and the most common CLPD in the west. Treatment of CLL has changed over 2 decades from single agent alkylating compound to combination chemo like Fludarabine, Cyclophosphamide, and Rituximab (FCR) or , Bendamustine and Rituximab based treatment depending on comorbidities and diseases cytogenetic risk. BR chemotherapy has shown impressive results in CLL patient in many phase 2 studies. FCR regimen has many side effects including severe immunosuppression and profound cytopenias. BR has been proven to be better than FCR in CLL10 trial especially in elderly patients with comorbidities. We analysed our “real world” response data of B+R chemotherapy in Indian patients with CLL outside a clinical trial.
Aims
The aim of this study was to analyse safety and efficacy of Bendamustine and Rituximab (B+R) chemotherapy in patients with previously untreated CLL
Methods
We retrospectively analysed the departmental data of all CLL patients who received B+R as the first line treatment. Thirty six patients receiving at least IV cycles of B+R chemo between December 2012 to September 2017 were included in the study. Bendamustine was administered at a dose of 90 mg/m2 on days 1 and 2 combined with 375mg/m2 Rituximab on day 1 in a 28 days cycle. Baseline IGHV mutational status and FISH analysis was not done and MRD was not assessed. Responses were analysed at end of IV - VI cycles of chemo by clinical examination and haematological parameters. Response rates were defined based on IWGCLL response criteria for CR, PR and stable disease. Progression free survival and Overall survival was analysed using Kaplan Meier survival analysis.
Results
Thirty six patients were included in the study with the median age of 55 years (34-75 years). Only 3 patients (8.3%) were above 70 years of age. Most patients belonged to Rai stage III /IV (80%) and Binet C (80%) stage. Mean Hb was 104g/L (26-154), mean total WBC count 144X109/L (66-390) and platelet count 50x 109/L (30-200).Median number of chemotherapy cycles administered were 6 (range 4-12). Overall response rate was 100% with CR and PR rates of 41 % & 59% at the end of 4-6 cycles of chemotherapy. Major side effects were cytopenias of any grade in 56% (grade 3 in 25%), febrile neutropenia in 16% and skin toxicities 36% (11% having grade 3 skin toxicity). At the median observation period of 24 month median PFS was 40 months and 70% of patients were surviving. Most common cause of death was progressive disease in 10 patients (27%) and febrile neutropenia in 2 patients (5.5%).
Conclusion
B+R chemotherapy is well tolerated by previously untreated Indian patients of CLL with impressive response rates, long progression free survival, and manageable side effects in a real world scenario outside a clinical trial.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Chronic Lymphocytic Leukemia
Abstract: PB1885
Type: Publication Only
Background
Chronic Lymphocytic Leukemia (CLL) is one of the most common chronic lymphoproliferative disorder (CLPD) in India and the most common CLPD in the west. Treatment of CLL has changed over 2 decades from single agent alkylating compound to combination chemo like Fludarabine, Cyclophosphamide, and Rituximab (FCR) or , Bendamustine and Rituximab based treatment depending on comorbidities and diseases cytogenetic risk. BR chemotherapy has shown impressive results in CLL patient in many phase 2 studies. FCR regimen has many side effects including severe immunosuppression and profound cytopenias. BR has been proven to be better than FCR in CLL10 trial especially in elderly patients with comorbidities. We analysed our “real world” response data of B+R chemotherapy in Indian patients with CLL outside a clinical trial.
Aims
The aim of this study was to analyse safety and efficacy of Bendamustine and Rituximab (B+R) chemotherapy in patients with previously untreated CLL
Methods
We retrospectively analysed the departmental data of all CLL patients who received B+R as the first line treatment. Thirty six patients receiving at least IV cycles of B+R chemo between December 2012 to September 2017 were included in the study. Bendamustine was administered at a dose of 90 mg/m2 on days 1 and 2 combined with 375mg/m2 Rituximab on day 1 in a 28 days cycle. Baseline IGHV mutational status and FISH analysis was not done and MRD was not assessed. Responses were analysed at end of IV - VI cycles of chemo by clinical examination and haematological parameters. Response rates were defined based on IWGCLL response criteria for CR, PR and stable disease. Progression free survival and Overall survival was analysed using Kaplan Meier survival analysis.
Results
Thirty six patients were included in the study with the median age of 55 years (34-75 years). Only 3 patients (8.3%) were above 70 years of age. Most patients belonged to Rai stage III /IV (80%) and Binet C (80%) stage. Mean Hb was 104g/L (26-154), mean total WBC count 144X109/L (66-390) and platelet count 50x 109/L (30-200).Median number of chemotherapy cycles administered were 6 (range 4-12). Overall response rate was 100% with CR and PR rates of 41 % & 59% at the end of 4-6 cycles of chemotherapy. Major side effects were cytopenias of any grade in 56% (grade 3 in 25%), febrile neutropenia in 16% and skin toxicities 36% (11% having grade 3 skin toxicity). At the median observation period of 24 month median PFS was 40 months and 70% of patients were surviving. Most common cause of death was progressive disease in 10 patients (27%) and febrile neutropenia in 2 patients (5.5%).
Conclusion
B+R chemotherapy is well tolerated by previously untreated Indian patients of CLL with impressive response rates, long progression free survival, and manageable side effects in a real world scenario outside a clinical trial.
Session topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical
Keyword(s): Chronic Lymphocytic Leukemia