USE OF IBRUTINIB IN PATIENTS WITH B CELL LYMPHOID MALIGNANCIES: ADVERSE EVENTS AND MANAGEMENT IN COMMUNITY SETTING
(Abstract release date: 05/19/16)
EHA Library. Ramakrishna R. 06/09/16; 134700; PB1800
Mr. Rajeev Ramakrishna
Contributions
Contributions
Abstract
Abstract: PB1800
Type: Publication Only
Background
Bruton’s tyrosine kinase (BTK) is expressed in B-cell malignancies, playing an important role in B-cell receptor (BCR) signaling and offering a promising new strategy for the development of targeted drugs. Malignant B cells in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) rely on BCR signaling pathways for cell survival, proliferation, adhesion, and migration. Ibrutinib is a BTK inhibitor which has been found to be an effective therapy option in patients with relapsed/refractory mantle cell lymphoma, relapsed/refractory chronic lymphocytic leukemia/small cell lymphoma (SLL) or newly diagnosed patients with CLL and a chromosome 17 deletion (del 17p)1. Most responses tend to be partial, but nearly two thirds of MCL and CLL patients treated have had a durable response, despite many being refractory, having high risk cytogenetic abnormality and/or heavily pre-treated2. The medication is tolerable with <10% of trial patients discontinuing use due to side effects3. Published trial data highlight side effects including nausea, diarrhoea, fatigue, bleeding, decrease in blood cell counts, renal impairment2. Our analysis of data on side effects from this drug in our cohort differs from those side effects highlighted in drug trials.
Aims
To better understand the side effect profile of ibrutinib and management of these patients in real life.
Methods
A cohort of 36 patients all refractory to at least two lines of therapy or with del 17p were entered into this study; with a mix of 25 patients with CLL, 7 with SLL, 4 with MCL. All were treated with ibrutinib at either 560mg/day (MCL) or 420mg/day (all others) until disease progression or death with a median treatment time of 9 months.Response and adverse event data has been recorded for these patients and subsequently analysed.
Results
In our cohort the most common side effects were dermatologic complications, affecting nearly one third of patients to some degree. As well, one sixth of patients in our cohort experienced symptomatic gastro-oesophageal reflux requiring treatment with proton pump inhibitors. We had one patient who experienced transaminitis related to ibrutinib requiring cessation of therapy. No patient in our cohort experienced cytopenias or renal impairment or significant diarrhoea or nausea related to therapy. Bruising and platelet dysfunction was noted in 20% of patients, especially if already on antiplatelet therapy (APA) or anticoagulants (OAC). None of these patients required cessation of either therapies, but dose or frequency reduction of APA or OAC.Most of the patients in our cohort have achieved at least very good partial response, with only six patients with progressive disease (all with CLL or SLL).
Conclusion
Our real life experience of using ibrutinib in patients with refractory CLL or MCL has shown very good response with most patients tolerating the therapy very well. In our cohort the side effects were different from those recorded in clinical trials. Cutaneous reactions and acne like lesions as well as staphylococcal infections appear to be more common than appreciated and GIT side effects were less common in our experience. We have found topical treatment of acne lesions with antibiotics to be mostly effective and oral or intravenous antibiotics required for extreme cases. Ibrutinib therapy is a well tolerated and effective therapy option for patients with high-risk CLL or MCL. Therapy can be managed in the community without requiring hospitalisation.
Session topic: E-poster
Keyword(s): Chronic lymphocytic leukemia, Mantle cell lymphoma, Side effects, Treatment
Type: Publication Only
Background
Bruton’s tyrosine kinase (BTK) is expressed in B-cell malignancies, playing an important role in B-cell receptor (BCR) signaling and offering a promising new strategy for the development of targeted drugs. Malignant B cells in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) rely on BCR signaling pathways for cell survival, proliferation, adhesion, and migration. Ibrutinib is a BTK inhibitor which has been found to be an effective therapy option in patients with relapsed/refractory mantle cell lymphoma, relapsed/refractory chronic lymphocytic leukemia/small cell lymphoma (SLL) or newly diagnosed patients with CLL and a chromosome 17 deletion (del 17p)1. Most responses tend to be partial, but nearly two thirds of MCL and CLL patients treated have had a durable response, despite many being refractory, having high risk cytogenetic abnormality and/or heavily pre-treated2. The medication is tolerable with <10% of trial patients discontinuing use due to side effects3. Published trial data highlight side effects including nausea, diarrhoea, fatigue, bleeding, decrease in blood cell counts, renal impairment2. Our analysis of data on side effects from this drug in our cohort differs from those side effects highlighted in drug trials.
Aims
To better understand the side effect profile of ibrutinib and management of these patients in real life.
Methods
A cohort of 36 patients all refractory to at least two lines of therapy or with del 17p were entered into this study; with a mix of 25 patients with CLL, 7 with SLL, 4 with MCL. All were treated with ibrutinib at either 560mg/day (MCL) or 420mg/day (all others) until disease progression or death with a median treatment time of 9 months.Response and adverse event data has been recorded for these patients and subsequently analysed.
Results
In our cohort the most common side effects were dermatologic complications, affecting nearly one third of patients to some degree. As well, one sixth of patients in our cohort experienced symptomatic gastro-oesophageal reflux requiring treatment with proton pump inhibitors. We had one patient who experienced transaminitis related to ibrutinib requiring cessation of therapy. No patient in our cohort experienced cytopenias or renal impairment or significant diarrhoea or nausea related to therapy. Bruising and platelet dysfunction was noted in 20% of patients, especially if already on antiplatelet therapy (APA) or anticoagulants (OAC). None of these patients required cessation of either therapies, but dose or frequency reduction of APA or OAC.Most of the patients in our cohort have achieved at least very good partial response, with only six patients with progressive disease (all with CLL or SLL).
Conclusion
Our real life experience of using ibrutinib in patients with refractory CLL or MCL has shown very good response with most patients tolerating the therapy very well. In our cohort the side effects were different from those recorded in clinical trials. Cutaneous reactions and acne like lesions as well as staphylococcal infections appear to be more common than appreciated and GIT side effects were less common in our experience. We have found topical treatment of acne lesions with antibiotics to be mostly effective and oral or intravenous antibiotics required for extreme cases. Ibrutinib therapy is a well tolerated and effective therapy option for patients with high-risk CLL or MCL. Therapy can be managed in the community without requiring hospitalisation.
Session topic: E-poster
Keyword(s): Chronic lymphocytic leukemia, Mantle cell lymphoma, Side effects, Treatment
Abstract: PB1800
Type: Publication Only
Background
Bruton’s tyrosine kinase (BTK) is expressed in B-cell malignancies, playing an important role in B-cell receptor (BCR) signaling and offering a promising new strategy for the development of targeted drugs. Malignant B cells in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) rely on BCR signaling pathways for cell survival, proliferation, adhesion, and migration. Ibrutinib is a BTK inhibitor which has been found to be an effective therapy option in patients with relapsed/refractory mantle cell lymphoma, relapsed/refractory chronic lymphocytic leukemia/small cell lymphoma (SLL) or newly diagnosed patients with CLL and a chromosome 17 deletion (del 17p)1. Most responses tend to be partial, but nearly two thirds of MCL and CLL patients treated have had a durable response, despite many being refractory, having high risk cytogenetic abnormality and/or heavily pre-treated2. The medication is tolerable with <10% of trial patients discontinuing use due to side effects3. Published trial data highlight side effects including nausea, diarrhoea, fatigue, bleeding, decrease in blood cell counts, renal impairment2. Our analysis of data on side effects from this drug in our cohort differs from those side effects highlighted in drug trials.
Aims
To better understand the side effect profile of ibrutinib and management of these patients in real life.
Methods
A cohort of 36 patients all refractory to at least two lines of therapy or with del 17p were entered into this study; with a mix of 25 patients with CLL, 7 with SLL, 4 with MCL. All were treated with ibrutinib at either 560mg/day (MCL) or 420mg/day (all others) until disease progression or death with a median treatment time of 9 months.Response and adverse event data has been recorded for these patients and subsequently analysed.
Results
In our cohort the most common side effects were dermatologic complications, affecting nearly one third of patients to some degree. As well, one sixth of patients in our cohort experienced symptomatic gastro-oesophageal reflux requiring treatment with proton pump inhibitors. We had one patient who experienced transaminitis related to ibrutinib requiring cessation of therapy. No patient in our cohort experienced cytopenias or renal impairment or significant diarrhoea or nausea related to therapy. Bruising and platelet dysfunction was noted in 20% of patients, especially if already on antiplatelet therapy (APA) or anticoagulants (OAC). None of these patients required cessation of either therapies, but dose or frequency reduction of APA or OAC.Most of the patients in our cohort have achieved at least very good partial response, with only six patients with progressive disease (all with CLL or SLL).
Conclusion
Our real life experience of using ibrutinib in patients with refractory CLL or MCL has shown very good response with most patients tolerating the therapy very well. In our cohort the side effects were different from those recorded in clinical trials. Cutaneous reactions and acne like lesions as well as staphylococcal infections appear to be more common than appreciated and GIT side effects were less common in our experience. We have found topical treatment of acne lesions with antibiotics to be mostly effective and oral or intravenous antibiotics required for extreme cases. Ibrutinib therapy is a well tolerated and effective therapy option for patients with high-risk CLL or MCL. Therapy can be managed in the community without requiring hospitalisation.
Session topic: E-poster
Keyword(s): Chronic lymphocytic leukemia, Mantle cell lymphoma, Side effects, Treatment
Type: Publication Only
Background
Bruton’s tyrosine kinase (BTK) is expressed in B-cell malignancies, playing an important role in B-cell receptor (BCR) signaling and offering a promising new strategy for the development of targeted drugs. Malignant B cells in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) rely on BCR signaling pathways for cell survival, proliferation, adhesion, and migration. Ibrutinib is a BTK inhibitor which has been found to be an effective therapy option in patients with relapsed/refractory mantle cell lymphoma, relapsed/refractory chronic lymphocytic leukemia/small cell lymphoma (SLL) or newly diagnosed patients with CLL and a chromosome 17 deletion (del 17p)1. Most responses tend to be partial, but nearly two thirds of MCL and CLL patients treated have had a durable response, despite many being refractory, having high risk cytogenetic abnormality and/or heavily pre-treated2. The medication is tolerable with <10% of trial patients discontinuing use due to side effects3. Published trial data highlight side effects including nausea, diarrhoea, fatigue, bleeding, decrease in blood cell counts, renal impairment2. Our analysis of data on side effects from this drug in our cohort differs from those side effects highlighted in drug trials.
Aims
To better understand the side effect profile of ibrutinib and management of these patients in real life.
Methods
A cohort of 36 patients all refractory to at least two lines of therapy or with del 17p were entered into this study; with a mix of 25 patients with CLL, 7 with SLL, 4 with MCL. All were treated with ibrutinib at either 560mg/day (MCL) or 420mg/day (all others) until disease progression or death with a median treatment time of 9 months.Response and adverse event data has been recorded for these patients and subsequently analysed.
Results
In our cohort the most common side effects were dermatologic complications, affecting nearly one third of patients to some degree. As well, one sixth of patients in our cohort experienced symptomatic gastro-oesophageal reflux requiring treatment with proton pump inhibitors. We had one patient who experienced transaminitis related to ibrutinib requiring cessation of therapy. No patient in our cohort experienced cytopenias or renal impairment or significant diarrhoea or nausea related to therapy. Bruising and platelet dysfunction was noted in 20% of patients, especially if already on antiplatelet therapy (APA) or anticoagulants (OAC). None of these patients required cessation of either therapies, but dose or frequency reduction of APA or OAC.Most of the patients in our cohort have achieved at least very good partial response, with only six patients with progressive disease (all with CLL or SLL).
Conclusion
Our real life experience of using ibrutinib in patients with refractory CLL or MCL has shown very good response with most patients tolerating the therapy very well. In our cohort the side effects were different from those recorded in clinical trials. Cutaneous reactions and acne like lesions as well as staphylococcal infections appear to be more common than appreciated and GIT side effects were less common in our experience. We have found topical treatment of acne lesions with antibiotics to be mostly effective and oral or intravenous antibiotics required for extreme cases. Ibrutinib therapy is a well tolerated and effective therapy option for patients with high-risk CLL or MCL. Therapy can be managed in the community without requiring hospitalisation.
Session topic: E-poster
Keyword(s): Chronic lymphocytic leukemia, Mantle cell lymphoma, Side effects, Treatment
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