IMMUNOGLOBULIN SUPPLEMENTATION IN ACUTE LYMPHOBLASTIC LEUKEMIA TREATMENT IN A SINGLE PEDIATRIC INSTITUTION: COMPARISON BETWEEN TWO CONSECUTIVE AIEOP CLINICAL TRIALS.
(Abstract release date: 05/19/16)
EHA Library. Parasole R. 06/09/16; 134791; PB1891
Dr. Rosanna Parasole
Contributions
Contributions
Abstract
Abstract: PB1891
Type: Publication Only
Background
The intensification of chemotherapy in childhood acute lymphoblastic leukemia (ALL) has dramatically improved the 5-years overall survival but, at the same time, has increased the site effects therapy related. The most common complication remains the immunosuppression that causes increased risk of infections. The recent introduction of a pegylated formulation of L-Asparaginase (Peg-L-Asp), with more prolonged half-life and immunosuppressive effect than native E. Coli L-Asp, could result in a greater injury on ALL patients’ humoral immunity.
Aims
We compared the rate of supportive Immunoglobulin (Ig) infusion during two consecutive therapeutic protocol of the Italian Association of Hematology and Pediatric Oncology (AIEOP) in a single pediatric center. The first trial, ALL 2009, contained Peg-L-Asp and the second, ALL 2006, native L-Asp; the remaining chemotherapy was similar.
Methods
Seventy-three patients, stratified in high-risk (HR; n=19), medium-risk (MR; n=32) and standard risk (SR; n=22), enrolled in ALL 2009 protocol, were compared with 68 patients (15 HR, 30 MR and 23 SR), of ALL 2006 trial. Patients submitted to a bone marrow transplantation or early relapsed were excluded by the analysis. Number of Immunoglobulin infusions, type and number of L-Asp administrations, risk stratification, IgG levels at diagnosis and episode of infections were collected by clinical records of both protocols. Possible correlations between Ig supplementation rate and the other parameters were analyzed using t-Student test and linear regression. Immunoglobulins were supplemented for Ig levels beyond 5.0 g/L at the standard dose of 0.5 g/kg.
Results
In ALL 2009 protocol, mean of Ig infusions were 6.2 ± 2.9 SD (range 1-12) in HR, 2.8 ± 2.0 SD in MR (range 0-8), and 2.2 ± 2.1 SD in SR (range 0-4), while in ALL 2006, mean of Ig administrations were 2.9 ± 1.7 in HR (range 0-6), 1.2 ± 1.3 in MR (range 0-6) and 1.5 ± 1.6 in SR (range 0-7), respectively. A higher rate of Ig infusions was observed in ALL2009 trial but this cumulative rate is not statistically significant. However, the difference between HR and MR risk stratification for the average of Ig infusions was significant (p <0.05) comparing ALL2009 and ALL 2006 trials. No correlation was found between Ig supplementations and risk of infections, number of L-Asp administrations, and IgG level at diagnosis.
Conclusion
In our experience, an higher Ig supplementation was observed in the very intensive protocol (HR and MR), mostly in ALL2009 trial. Further studies, with more extensive series of patients, need to understand the reason to the increased demand of immunoglobulin support in HR and MR patients treated with Peg-L-Asp.
Session topic: E-poster
Keyword(s): Acute lymphoblastic leukemia, Childhood, Immunoglobulin
Type: Publication Only
Background
The intensification of chemotherapy in childhood acute lymphoblastic leukemia (ALL) has dramatically improved the 5-years overall survival but, at the same time, has increased the site effects therapy related. The most common complication remains the immunosuppression that causes increased risk of infections. The recent introduction of a pegylated formulation of L-Asparaginase (Peg-L-Asp), with more prolonged half-life and immunosuppressive effect than native E. Coli L-Asp, could result in a greater injury on ALL patients’ humoral immunity.
Aims
We compared the rate of supportive Immunoglobulin (Ig) infusion during two consecutive therapeutic protocol of the Italian Association of Hematology and Pediatric Oncology (AIEOP) in a single pediatric center. The first trial, ALL 2009, contained Peg-L-Asp and the second, ALL 2006, native L-Asp; the remaining chemotherapy was similar.
Methods
Seventy-three patients, stratified in high-risk (HR; n=19), medium-risk (MR; n=32) and standard risk (SR; n=22), enrolled in ALL 2009 protocol, were compared with 68 patients (15 HR, 30 MR and 23 SR), of ALL 2006 trial. Patients submitted to a bone marrow transplantation or early relapsed were excluded by the analysis. Number of Immunoglobulin infusions, type and number of L-Asp administrations, risk stratification, IgG levels at diagnosis and episode of infections were collected by clinical records of both protocols. Possible correlations between Ig supplementation rate and the other parameters were analyzed using t-Student test and linear regression. Immunoglobulins were supplemented for Ig levels beyond 5.0 g/L at the standard dose of 0.5 g/kg.
Results
In ALL 2009 protocol, mean of Ig infusions were 6.2 ± 2.9 SD (range 1-12) in HR, 2.8 ± 2.0 SD in MR (range 0-8), and 2.2 ± 2.1 SD in SR (range 0-4), while in ALL 2006, mean of Ig administrations were 2.9 ± 1.7 in HR (range 0-6), 1.2 ± 1.3 in MR (range 0-6) and 1.5 ± 1.6 in SR (range 0-7), respectively. A higher rate of Ig infusions was observed in ALL2009 trial but this cumulative rate is not statistically significant. However, the difference between HR and MR risk stratification for the average of Ig infusions was significant (p <0.05) comparing ALL2009 and ALL 2006 trials. No correlation was found between Ig supplementations and risk of infections, number of L-Asp administrations, and IgG level at diagnosis.
Conclusion
In our experience, an higher Ig supplementation was observed in the very intensive protocol (HR and MR), mostly in ALL2009 trial. Further studies, with more extensive series of patients, need to understand the reason to the increased demand of immunoglobulin support in HR and MR patients treated with Peg-L-Asp.
Session topic: E-poster
Keyword(s): Acute lymphoblastic leukemia, Childhood, Immunoglobulin
Abstract: PB1891
Type: Publication Only
Background
The intensification of chemotherapy in childhood acute lymphoblastic leukemia (ALL) has dramatically improved the 5-years overall survival but, at the same time, has increased the site effects therapy related. The most common complication remains the immunosuppression that causes increased risk of infections. The recent introduction of a pegylated formulation of L-Asparaginase (Peg-L-Asp), with more prolonged half-life and immunosuppressive effect than native E. Coli L-Asp, could result in a greater injury on ALL patients’ humoral immunity.
Aims
We compared the rate of supportive Immunoglobulin (Ig) infusion during two consecutive therapeutic protocol of the Italian Association of Hematology and Pediatric Oncology (AIEOP) in a single pediatric center. The first trial, ALL 2009, contained Peg-L-Asp and the second, ALL 2006, native L-Asp; the remaining chemotherapy was similar.
Methods
Seventy-three patients, stratified in high-risk (HR; n=19), medium-risk (MR; n=32) and standard risk (SR; n=22), enrolled in ALL 2009 protocol, were compared with 68 patients (15 HR, 30 MR and 23 SR), of ALL 2006 trial. Patients submitted to a bone marrow transplantation or early relapsed were excluded by the analysis. Number of Immunoglobulin infusions, type and number of L-Asp administrations, risk stratification, IgG levels at diagnosis and episode of infections were collected by clinical records of both protocols. Possible correlations between Ig supplementation rate and the other parameters were analyzed using t-Student test and linear regression. Immunoglobulins were supplemented for Ig levels beyond 5.0 g/L at the standard dose of 0.5 g/kg.
Results
In ALL 2009 protocol, mean of Ig infusions were 6.2 ± 2.9 SD (range 1-12) in HR, 2.8 ± 2.0 SD in MR (range 0-8), and 2.2 ± 2.1 SD in SR (range 0-4), while in ALL 2006, mean of Ig administrations were 2.9 ± 1.7 in HR (range 0-6), 1.2 ± 1.3 in MR (range 0-6) and 1.5 ± 1.6 in SR (range 0-7), respectively. A higher rate of Ig infusions was observed in ALL2009 trial but this cumulative rate is not statistically significant. However, the difference between HR and MR risk stratification for the average of Ig infusions was significant (p <0.05) comparing ALL2009 and ALL 2006 trials. No correlation was found between Ig supplementations and risk of infections, number of L-Asp administrations, and IgG level at diagnosis.
Conclusion
In our experience, an higher Ig supplementation was observed in the very intensive protocol (HR and MR), mostly in ALL2009 trial. Further studies, with more extensive series of patients, need to understand the reason to the increased demand of immunoglobulin support in HR and MR patients treated with Peg-L-Asp.
Session topic: E-poster
Keyword(s): Acute lymphoblastic leukemia, Childhood, Immunoglobulin
Type: Publication Only
Background
The intensification of chemotherapy in childhood acute lymphoblastic leukemia (ALL) has dramatically improved the 5-years overall survival but, at the same time, has increased the site effects therapy related. The most common complication remains the immunosuppression that causes increased risk of infections. The recent introduction of a pegylated formulation of L-Asparaginase (Peg-L-Asp), with more prolonged half-life and immunosuppressive effect than native E. Coli L-Asp, could result in a greater injury on ALL patients’ humoral immunity.
Aims
We compared the rate of supportive Immunoglobulin (Ig) infusion during two consecutive therapeutic protocol of the Italian Association of Hematology and Pediatric Oncology (AIEOP) in a single pediatric center. The first trial, ALL 2009, contained Peg-L-Asp and the second, ALL 2006, native L-Asp; the remaining chemotherapy was similar.
Methods
Seventy-three patients, stratified in high-risk (HR; n=19), medium-risk (MR; n=32) and standard risk (SR; n=22), enrolled in ALL 2009 protocol, were compared with 68 patients (15 HR, 30 MR and 23 SR), of ALL 2006 trial. Patients submitted to a bone marrow transplantation or early relapsed were excluded by the analysis. Number of Immunoglobulin infusions, type and number of L-Asp administrations, risk stratification, IgG levels at diagnosis and episode of infections were collected by clinical records of both protocols. Possible correlations between Ig supplementation rate and the other parameters were analyzed using t-Student test and linear regression. Immunoglobulins were supplemented for Ig levels beyond 5.0 g/L at the standard dose of 0.5 g/kg.
Results
In ALL 2009 protocol, mean of Ig infusions were 6.2 ± 2.9 SD (range 1-12) in HR, 2.8 ± 2.0 SD in MR (range 0-8), and 2.2 ± 2.1 SD in SR (range 0-4), while in ALL 2006, mean of Ig administrations were 2.9 ± 1.7 in HR (range 0-6), 1.2 ± 1.3 in MR (range 0-6) and 1.5 ± 1.6 in SR (range 0-7), respectively. A higher rate of Ig infusions was observed in ALL2009 trial but this cumulative rate is not statistically significant. However, the difference between HR and MR risk stratification for the average of Ig infusions was significant (p <0.05) comparing ALL2009 and ALL 2006 trials. No correlation was found between Ig supplementations and risk of infections, number of L-Asp administrations, and IgG level at diagnosis.
Conclusion
In our experience, an higher Ig supplementation was observed in the very intensive protocol (HR and MR), mostly in ALL2009 trial. Further studies, with more extensive series of patients, need to understand the reason to the increased demand of immunoglobulin support in HR and MR patients treated with Peg-L-Asp.
Session topic: E-poster
Keyword(s): Acute lymphoblastic leukemia, Childhood, Immunoglobulin
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