Contributions
Abstract: PB1374
Type: Publication Only
Session title: Acute lymphoblastic leukemia - Clinical
Background
L-asparaginase (LASPA)is an important anti-tumoral drug in the treatment of acute lymphoblastic leukemia in children, however, its toxicity, mainly due to severe allergic reactions, limits its use and even leads to its permanent discontinuation.
Aims
Describe the allergic reactions associated with the use of LASPA and their impact on overall survival (OS) and relapse-free survival (RFS).
Methods
Retrospective study conducted over 10 years (from January 2006 to December 2015) involving 316 patients treated in the clinical hematology department of Aziza Othmana Hospital according to the EORTC 58951 protocol and who received E.coli asparaginase.Allergic reactions were graded according to the Common Terminology Criteria for Adverse Events (CTAE) score
Results
All patients received intravenous LASPA.
Out of 316 patients,74 had an allergic reaction to L-asparaginase.
The median age was 6 years (18 months - 26 years) with a sex ratio of 2.36 (52 males and 22 females).
According to the CTAE score, they were grade 1 or 2 in 66% of cases, grade 3 in 24% of cases and grade 4 in 10% of cases. No deaths were noted. The occurrence of allergic reactions were noted essentially, (in 84% of cases), in post induction at the time of reintroduction of LASPA, and after having received an average of 5 doses(1-7).
The severity of the reaction was independent of age (p=0.45) and the total dose of LASPA.
Forty three patients were switched to Erwiniase. An allergic reaction was noted in 25.6% of these patients.
Of the 31 patients (42%) who were not switched to Erwiniase, 17 patients (55%) were permanently discontinued, and 14 patients (45%) were premedicated for E.coli asparaginase and have continued
their treatment with LASPA.
The 5-years OS was significantly different between patients in whom LASPA was permanently discontinued due to a severe allergic reaction and patients who continued LASPA therapy (94% versus 64% with p=0.005).
Similarly, The 5 –years RFS was 85% versus 65% with p=0.034.
Patients who received a total dose of LASPA ≥100 000 IU/m2 had better OS and RFS than those who received a lower dose with p=0.004 and p=0.01, respectively.
However, the switch to Erwiniase had no impact on OS and RFS with p=0.07 and p=0.11, respectively.
Conclusion
Discontinuation of LASPA treatment due to allergic reactions is quite frequent with important prognostic implication, which encourages to better study these allergic reactions to better manage them and to discuss new therapeutic alternatives more effective and less allergenic than LASPA to optimize the survival rates of LAL.
Keyword(s): Acute lymphoblastic leukemia, Asparaginase
Abstract: PB1374
Type: Publication Only
Session title: Acute lymphoblastic leukemia - Clinical
Background
L-asparaginase (LASPA)is an important anti-tumoral drug in the treatment of acute lymphoblastic leukemia in children, however, its toxicity, mainly due to severe allergic reactions, limits its use and even leads to its permanent discontinuation.
Aims
Describe the allergic reactions associated with the use of LASPA and their impact on overall survival (OS) and relapse-free survival (RFS).
Methods
Retrospective study conducted over 10 years (from January 2006 to December 2015) involving 316 patients treated in the clinical hematology department of Aziza Othmana Hospital according to the EORTC 58951 protocol and who received E.coli asparaginase.Allergic reactions were graded according to the Common Terminology Criteria for Adverse Events (CTAE) score
Results
All patients received intravenous LASPA.
Out of 316 patients,74 had an allergic reaction to L-asparaginase.
The median age was 6 years (18 months - 26 years) with a sex ratio of 2.36 (52 males and 22 females).
According to the CTAE score, they were grade 1 or 2 in 66% of cases, grade 3 in 24% of cases and grade 4 in 10% of cases. No deaths were noted. The occurrence of allergic reactions were noted essentially, (in 84% of cases), in post induction at the time of reintroduction of LASPA, and after having received an average of 5 doses(1-7).
The severity of the reaction was independent of age (p=0.45) and the total dose of LASPA.
Forty three patients were switched to Erwiniase. An allergic reaction was noted in 25.6% of these patients.
Of the 31 patients (42%) who were not switched to Erwiniase, 17 patients (55%) were permanently discontinued, and 14 patients (45%) were premedicated for E.coli asparaginase and have continued
their treatment with LASPA.
The 5-years OS was significantly different between patients in whom LASPA was permanently discontinued due to a severe allergic reaction and patients who continued LASPA therapy (94% versus 64% with p=0.005).
Similarly, The 5 –years RFS was 85% versus 65% with p=0.034.
Patients who received a total dose of LASPA ≥100 000 IU/m2 had better OS and RFS than those who received a lower dose with p=0.004 and p=0.01, respectively.
However, the switch to Erwiniase had no impact on OS and RFS with p=0.07 and p=0.11, respectively.
Conclusion
Discontinuation of LASPA treatment due to allergic reactions is quite frequent with important prognostic implication, which encourages to better study these allergic reactions to better manage them and to discuss new therapeutic alternatives more effective and less allergenic than LASPA to optimize the survival rates of LAL.
Keyword(s): Acute lymphoblastic leukemia, Asparaginase