TREATMENT-EMERGENT ADVERSE EVENTS IN LENALIDOMIDE-TREATED LOW/INT-1-RISK MYELODYSPLASTIC SYNDROMES PATIENTS WITHOUT DEL(5Q) INELIGIBLE FOR OR REFRACTORY TO ERYTHROPOIESIS-STIMULATING AGENTS
(Abstract release date: 05/19/16)
EHA Library. De Almeida A. 06/09/16; 132766; E1217
Prof. Antonio De Almeida
Contributions
Contributions
Abstract
Abstract: E1217
Type: Eposter Presentation
Background
In the phase 3 MDS-005 study of lenalidomide (LEN) in RBC transfusion-dependent lower-risk non-del(5q) myelodysplastic syndromes (MDS) patients (pts) ineligible for or refractory to erythropoiesis-stimulating agents (ESAs), a significantly higher proportion of LEN-treated pts achieved RBC transfusion independence ≥ 8 weeks vs placebo (P < 0.001).
Aims
To describe the frequency, timing, and management of treatment-emergent adverse events (TEAEs) in pts from MDS-005.
Methods
AEs of all 160 pts randomized to LEN who received ≥ 1 dose were reported per NCI-CTCAE v3.0.
Results
Median duration of LEN treatment was 164 days (range 7–1,158). Grade (G)1/2 and G3/4 TEAEs were reported in 96.9% and 86.3% of pts, respectively. The most common G3/4 TEAEs were neutropenia (61.9%), thrombocytopenia (35.6%), anemia (5.6%), pneumonia (5.6%); G3/4 deep vein thrombosis (DVT) occurred in 1.9%. G3/4 neutropenia and thrombocytopenia generally occurred in cycles 1–4. The most common G1/2 TEAEs were diarrhea (42.5%), constipation (22.5%), asthenia (21.9%), rash (21.3%), fatigue (20.6%), peripheral edema (20.6%). TEAEs led to 54.4% dose interruptions, 6.3% dose reductions, and 42.5% dose interruptions with subsequent reduction. Median time to first dose interruption or reduction was 57 days (range 6–504). The most common reasons for dose reduction following interruption were neutropenia (25.0%) and thrombocytopenia (16.3%); 1.9% of pts due to rash. TEAEs led to LEN discontinuation in 31.9% of pts; the most common reasons were thrombocytopenia (8.8%), neutropenia (4.4%), DVT (1.9%). In this short follow-up period, no increased incidence of AML or secondary primary malignancies was seen.
Conclusion
LEN has a predictable and manageable TEAE profile in this pt population. Diarrhea was the most common G1/2 TEAE; G1/2 TEAEs generally did not require dose reduction or discontinuation. The most common G3/4 TEAEs were neutropenia and thrombocytopenia; these occurred early and, in the majority of pts, reverted with dose reductions or interruptions, avoiding the need for discontinuation. The timing and characterization of TEAEs highlights the importance of frequent monitoring at the start of therapy.
Session topic: E-poster
Keyword(s): MDS
Type: Eposter Presentation
Background
In the phase 3 MDS-005 study of lenalidomide (LEN) in RBC transfusion-dependent lower-risk non-del(5q) myelodysplastic syndromes (MDS) patients (pts) ineligible for or refractory to erythropoiesis-stimulating agents (ESAs), a significantly higher proportion of LEN-treated pts achieved RBC transfusion independence ≥ 8 weeks vs placebo (P < 0.001).
Aims
To describe the frequency, timing, and management of treatment-emergent adverse events (TEAEs) in pts from MDS-005.
Methods
AEs of all 160 pts randomized to LEN who received ≥ 1 dose were reported per NCI-CTCAE v3.0.
Results
Median duration of LEN treatment was 164 days (range 7–1,158). Grade (G)1/2 and G3/4 TEAEs were reported in 96.9% and 86.3% of pts, respectively. The most common G3/4 TEAEs were neutropenia (61.9%), thrombocytopenia (35.6%), anemia (5.6%), pneumonia (5.6%); G3/4 deep vein thrombosis (DVT) occurred in 1.9%. G3/4 neutropenia and thrombocytopenia generally occurred in cycles 1–4. The most common G1/2 TEAEs were diarrhea (42.5%), constipation (22.5%), asthenia (21.9%), rash (21.3%), fatigue (20.6%), peripheral edema (20.6%). TEAEs led to 54.4% dose interruptions, 6.3% dose reductions, and 42.5% dose interruptions with subsequent reduction. Median time to first dose interruption or reduction was 57 days (range 6–504). The most common reasons for dose reduction following interruption were neutropenia (25.0%) and thrombocytopenia (16.3%); 1.9% of pts due to rash. TEAEs led to LEN discontinuation in 31.9% of pts; the most common reasons were thrombocytopenia (8.8%), neutropenia (4.4%), DVT (1.9%). In this short follow-up period, no increased incidence of AML or secondary primary malignancies was seen.
Conclusion
LEN has a predictable and manageable TEAE profile in this pt population. Diarrhea was the most common G1/2 TEAE; G1/2 TEAEs generally did not require dose reduction or discontinuation. The most common G3/4 TEAEs were neutropenia and thrombocytopenia; these occurred early and, in the majority of pts, reverted with dose reductions or interruptions, avoiding the need for discontinuation. The timing and characterization of TEAEs highlights the importance of frequent monitoring at the start of therapy.
Session topic: E-poster
Keyword(s): MDS
Abstract: E1217
Type: Eposter Presentation
Background
In the phase 3 MDS-005 study of lenalidomide (LEN) in RBC transfusion-dependent lower-risk non-del(5q) myelodysplastic syndromes (MDS) patients (pts) ineligible for or refractory to erythropoiesis-stimulating agents (ESAs), a significantly higher proportion of LEN-treated pts achieved RBC transfusion independence ≥ 8 weeks vs placebo (P < 0.001).
Aims
To describe the frequency, timing, and management of treatment-emergent adverse events (TEAEs) in pts from MDS-005.
Methods
AEs of all 160 pts randomized to LEN who received ≥ 1 dose were reported per NCI-CTCAE v3.0.
Results
Median duration of LEN treatment was 164 days (range 7–1,158). Grade (G)1/2 and G3/4 TEAEs were reported in 96.9% and 86.3% of pts, respectively. The most common G3/4 TEAEs were neutropenia (61.9%), thrombocytopenia (35.6%), anemia (5.6%), pneumonia (5.6%); G3/4 deep vein thrombosis (DVT) occurred in 1.9%. G3/4 neutropenia and thrombocytopenia generally occurred in cycles 1–4. The most common G1/2 TEAEs were diarrhea (42.5%), constipation (22.5%), asthenia (21.9%), rash (21.3%), fatigue (20.6%), peripheral edema (20.6%). TEAEs led to 54.4% dose interruptions, 6.3% dose reductions, and 42.5% dose interruptions with subsequent reduction. Median time to first dose interruption or reduction was 57 days (range 6–504). The most common reasons for dose reduction following interruption were neutropenia (25.0%) and thrombocytopenia (16.3%); 1.9% of pts due to rash. TEAEs led to LEN discontinuation in 31.9% of pts; the most common reasons were thrombocytopenia (8.8%), neutropenia (4.4%), DVT (1.9%). In this short follow-up period, no increased incidence of AML or secondary primary malignancies was seen.
Conclusion
LEN has a predictable and manageable TEAE profile in this pt population. Diarrhea was the most common G1/2 TEAE; G1/2 TEAEs generally did not require dose reduction or discontinuation. The most common G3/4 TEAEs were neutropenia and thrombocytopenia; these occurred early and, in the majority of pts, reverted with dose reductions or interruptions, avoiding the need for discontinuation. The timing and characterization of TEAEs highlights the importance of frequent monitoring at the start of therapy.
Session topic: E-poster
Keyword(s): MDS
Type: Eposter Presentation
Background
In the phase 3 MDS-005 study of lenalidomide (LEN) in RBC transfusion-dependent lower-risk non-del(5q) myelodysplastic syndromes (MDS) patients (pts) ineligible for or refractory to erythropoiesis-stimulating agents (ESAs), a significantly higher proportion of LEN-treated pts achieved RBC transfusion independence ≥ 8 weeks vs placebo (P < 0.001).
Aims
To describe the frequency, timing, and management of treatment-emergent adverse events (TEAEs) in pts from MDS-005.
Methods
AEs of all 160 pts randomized to LEN who received ≥ 1 dose were reported per NCI-CTCAE v3.0.
Results
Median duration of LEN treatment was 164 days (range 7–1,158). Grade (G)1/2 and G3/4 TEAEs were reported in 96.9% and 86.3% of pts, respectively. The most common G3/4 TEAEs were neutropenia (61.9%), thrombocytopenia (35.6%), anemia (5.6%), pneumonia (5.6%); G3/4 deep vein thrombosis (DVT) occurred in 1.9%. G3/4 neutropenia and thrombocytopenia generally occurred in cycles 1–4. The most common G1/2 TEAEs were diarrhea (42.5%), constipation (22.5%), asthenia (21.9%), rash (21.3%), fatigue (20.6%), peripheral edema (20.6%). TEAEs led to 54.4% dose interruptions, 6.3% dose reductions, and 42.5% dose interruptions with subsequent reduction. Median time to first dose interruption or reduction was 57 days (range 6–504). The most common reasons for dose reduction following interruption were neutropenia (25.0%) and thrombocytopenia (16.3%); 1.9% of pts due to rash. TEAEs led to LEN discontinuation in 31.9% of pts; the most common reasons were thrombocytopenia (8.8%), neutropenia (4.4%), DVT (1.9%). In this short follow-up period, no increased incidence of AML or secondary primary malignancies was seen.
Conclusion
LEN has a predictable and manageable TEAE profile in this pt population. Diarrhea was the most common G1/2 TEAE; G1/2 TEAEs generally did not require dose reduction or discontinuation. The most common G3/4 TEAEs were neutropenia and thrombocytopenia; these occurred early and, in the majority of pts, reverted with dose reductions or interruptions, avoiding the need for discontinuation. The timing and characterization of TEAEs highlights the importance of frequent monitoring at the start of therapy.
Session topic: E-poster
Keyword(s): MDS
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