IBRUTINIB IN CHRONIC LYMPHOCYTIC LEUKAEMIA: A SINGLE CENTRE EXPERIENCE
(Abstract release date: 05/21/15)
EHA Library. Russell J. 06/12/15; 103017; PB1727
Disclosure(s): Norfolk and Norwich University Hospital
Dr. James Russell
Contributions
Contributions
Abstract
Abstract: PB1727
Type: Publication Only
Background
Ibrutinib, a first-in-class Bruton’s Tyrosine Kinase inhibitor, was available to National Health Service patients with relapsed/refractory Chronic Lymphocytic Leukaemia (CLL) through a Named Patient Supply (NPS) program from April to September 2014, funded by Janssen Pharmaceuticals. Approximately 600 patients with CLL were enrolled in the United Kingdom (UK). The James Paget University Hospital treated 23 patients with CLL through the NPS (including 10 patients from the Norfolk and Norwich University Hospital).
Aims
To evaluate the therapeutic response to ibrutinib in the clinical setting compared to clinical trial data.
Methods
Therapeutic response was assessed in October 2014 using clinical and laboratory data. The patient group was 65.2% male, with a median age of 74 years (range 45–89) and a median of 3 prior lines of therapy (range 1-6). Cytogenetic analysis was available for 20 (87%) patients. Five (25%) patients had 17p deletion, four (20%) had 13q deletion, three (15%) had trisomy 12p, two (10%) had 11q deletion, and six (30%) had no detectable abnormalities. Five patients were excluded from the analysis, including four who had received less than eight weeks of treatment and one who had withdrawn from the NPS early.
Results
Out of 18 patients, comprising a total of 242 drug-weeks, there was one (5.6%) Clinical Complete Response (CR), four (22.2%) Partial Responses (PR), nine (50%) Partial Responses with Lymphocytosis (PR+L), two (11.1%) with Stable Disease (SD), one (5.6%) with Disease Progression (DP) and histological transformation, and one (5.6%) death from sepsis. The Overall Response Rate (including PR+L patients) was 78%. Notably, both the patient in Clinical CR and the patient with histological transformation had 17p deletion. Common side-effects included diarrhoea (16.7%), upper respiratory tract infections (11.1%), low platelet counts (<30x109/L in 5.6%), and lymphocytosis (>two-fold increase in 22.2%). None were treatment-limiting.
Summary
These encouraging early results must be interpreted cautiously, but they suggest that Ibrutinib has similar efficacy and side-effect profiles in the clinical setting as it does in clinical trials.
Keyword(s): Chronic lymphocytic leukemia, Clinical data
Session topic: Publication Only
Type: Publication Only
Background
Ibrutinib, a first-in-class Bruton’s Tyrosine Kinase inhibitor, was available to National Health Service patients with relapsed/refractory Chronic Lymphocytic Leukaemia (CLL) through a Named Patient Supply (NPS) program from April to September 2014, funded by Janssen Pharmaceuticals. Approximately 600 patients with CLL were enrolled in the United Kingdom (UK). The James Paget University Hospital treated 23 patients with CLL through the NPS (including 10 patients from the Norfolk and Norwich University Hospital).
Aims
To evaluate the therapeutic response to ibrutinib in the clinical setting compared to clinical trial data.
Methods
Therapeutic response was assessed in October 2014 using clinical and laboratory data. The patient group was 65.2% male, with a median age of 74 years (range 45–89) and a median of 3 prior lines of therapy (range 1-6). Cytogenetic analysis was available for 20 (87%) patients. Five (25%) patients had 17p deletion, four (20%) had 13q deletion, three (15%) had trisomy 12p, two (10%) had 11q deletion, and six (30%) had no detectable abnormalities. Five patients were excluded from the analysis, including four who had received less than eight weeks of treatment and one who had withdrawn from the NPS early.
Results
Out of 18 patients, comprising a total of 242 drug-weeks, there was one (5.6%) Clinical Complete Response (CR), four (22.2%) Partial Responses (PR), nine (50%) Partial Responses with Lymphocytosis (PR+L), two (11.1%) with Stable Disease (SD), one (5.6%) with Disease Progression (DP) and histological transformation, and one (5.6%) death from sepsis. The Overall Response Rate (including PR+L patients) was 78%. Notably, both the patient in Clinical CR and the patient with histological transformation had 17p deletion. Common side-effects included diarrhoea (16.7%), upper respiratory tract infections (11.1%), low platelet counts (<30x109/L in 5.6%), and lymphocytosis (>two-fold increase in 22.2%). None were treatment-limiting.
Summary
These encouraging early results must be interpreted cautiously, but they suggest that Ibrutinib has similar efficacy and side-effect profiles in the clinical setting as it does in clinical trials.
Keyword(s): Chronic lymphocytic leukemia, Clinical data
Session topic: Publication Only
Abstract: PB1727
Type: Publication Only
Background
Ibrutinib, a first-in-class Bruton’s Tyrosine Kinase inhibitor, was available to National Health Service patients with relapsed/refractory Chronic Lymphocytic Leukaemia (CLL) through a Named Patient Supply (NPS) program from April to September 2014, funded by Janssen Pharmaceuticals. Approximately 600 patients with CLL were enrolled in the United Kingdom (UK). The James Paget University Hospital treated 23 patients with CLL through the NPS (including 10 patients from the Norfolk and Norwich University Hospital).
Aims
To evaluate the therapeutic response to ibrutinib in the clinical setting compared to clinical trial data.
Methods
Therapeutic response was assessed in October 2014 using clinical and laboratory data. The patient group was 65.2% male, with a median age of 74 years (range 45–89) and a median of 3 prior lines of therapy (range 1-6). Cytogenetic analysis was available for 20 (87%) patients. Five (25%) patients had 17p deletion, four (20%) had 13q deletion, three (15%) had trisomy 12p, two (10%) had 11q deletion, and six (30%) had no detectable abnormalities. Five patients were excluded from the analysis, including four who had received less than eight weeks of treatment and one who had withdrawn from the NPS early.
Results
Out of 18 patients, comprising a total of 242 drug-weeks, there was one (5.6%) Clinical Complete Response (CR), four (22.2%) Partial Responses (PR), nine (50%) Partial Responses with Lymphocytosis (PR+L), two (11.1%) with Stable Disease (SD), one (5.6%) with Disease Progression (DP) and histological transformation, and one (5.6%) death from sepsis. The Overall Response Rate (including PR+L patients) was 78%. Notably, both the patient in Clinical CR and the patient with histological transformation had 17p deletion. Common side-effects included diarrhoea (16.7%), upper respiratory tract infections (11.1%), low platelet counts (<30x109/L in 5.6%), and lymphocytosis (>two-fold increase in 22.2%). None were treatment-limiting.
Summary
These encouraging early results must be interpreted cautiously, but they suggest that Ibrutinib has similar efficacy and side-effect profiles in the clinical setting as it does in clinical trials.
Keyword(s): Chronic lymphocytic leukemia, Clinical data
Session topic: Publication Only
Type: Publication Only
Background
Ibrutinib, a first-in-class Bruton’s Tyrosine Kinase inhibitor, was available to National Health Service patients with relapsed/refractory Chronic Lymphocytic Leukaemia (CLL) through a Named Patient Supply (NPS) program from April to September 2014, funded by Janssen Pharmaceuticals. Approximately 600 patients with CLL were enrolled in the United Kingdom (UK). The James Paget University Hospital treated 23 patients with CLL through the NPS (including 10 patients from the Norfolk and Norwich University Hospital).
Aims
To evaluate the therapeutic response to ibrutinib in the clinical setting compared to clinical trial data.
Methods
Therapeutic response was assessed in October 2014 using clinical and laboratory data. The patient group was 65.2% male, with a median age of 74 years (range 45–89) and a median of 3 prior lines of therapy (range 1-6). Cytogenetic analysis was available for 20 (87%) patients. Five (25%) patients had 17p deletion, four (20%) had 13q deletion, three (15%) had trisomy 12p, two (10%) had 11q deletion, and six (30%) had no detectable abnormalities. Five patients were excluded from the analysis, including four who had received less than eight weeks of treatment and one who had withdrawn from the NPS early.
Results
Out of 18 patients, comprising a total of 242 drug-weeks, there was one (5.6%) Clinical Complete Response (CR), four (22.2%) Partial Responses (PR), nine (50%) Partial Responses with Lymphocytosis (PR+L), two (11.1%) with Stable Disease (SD), one (5.6%) with Disease Progression (DP) and histological transformation, and one (5.6%) death from sepsis. The Overall Response Rate (including PR+L patients) was 78%. Notably, both the patient in Clinical CR and the patient with histological transformation had 17p deletion. Common side-effects included diarrhoea (16.7%), upper respiratory tract infections (11.1%), low platelet counts (<30x109/L in 5.6%), and lymphocytosis (>two-fold increase in 22.2%). None were treatment-limiting.
Summary
These encouraging early results must be interpreted cautiously, but they suggest that Ibrutinib has similar efficacy and side-effect profiles in the clinical setting as it does in clinical trials.
Keyword(s): Chronic lymphocytic leukemia, Clinical data
Session topic: Publication Only
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