Successful toxicity reduction during delayed intensification in the non-high-risk arm of Malaysia-Singapore Acute Lymphoblastic Leukaemia 2010 study

In non–high-risk (non-HR) patients, the Malaysia-Singapore Acute Lymphoblastic Leukaemia 2003 (MS2003) study achieved good outcomes. However, its delayed-intensification (DI) phase, comprising repeated blocks of protocol III (2003-PIII), was toxic and caused significant treatment delays. The success...

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Published in:European journal of cancer (1990) 2021-01, Vol.142, p.92-101
Main Authors: Oh, Bernice L.Z., Lee, Shawn H.R., Foo, Koon M., Chiew, Kean H., Seeto, Zelia Z.L., Chen, Zhi W., Neoh, Cheryl C.C., Liew, Germaine S.M., Eng, Jing J., Lam, Joyce C.M., Chan, Yiong H., Quah, Thuan C., Tan, Ah M., Yeoh, Allen E.J.
Format: Article
Language:English
Subjects:
Acute lymphoblastic leukaemia
Acute lymphoblastic leukemia
Amplification
Asparaginase
Bacteremia
Child
Child, Preschool
Childhood
Cytarabine
Delayed intensification
Doxorubicin
Female
Fever
History, 21st Century
Humans
Infant
Infective complications
Leukemia
Malaysia
Male
Precursor Cell Lymphoblastic Leukemia-Lymphoma - complications
Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy
Risk
Singapore
Survival
Toxicity
Treatment toxicity
Vincristine
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container_title European journal of cancer (1990)
container_volume 142
creator Oh, Bernice L.Z.
Lee, Shawn H.R.
Foo, Koon M.
Chiew, Kean H.
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Chen, Zhi W.
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Liew, Germaine S.M.
Eng, Jing J.
Lam, Joyce C.M.
Chan, Yiong H.
Quah, Thuan C.
Tan, Ah M.
Yeoh, Allen E.J.
description In non–high-risk (non-HR) patients, the Malaysia-Singapore Acute Lymphoblastic Leukaemia 2003 (MS2003) study achieved good outcomes. However, its delayed-intensification (DI) phase, comprising repeated blocks of protocol III (2003-PIII), was toxic and caused significant treatment delays. The successor MS2010 study attempted to lower DI toxicity by replacing myelosuppressive drugs (doxorubicin, cytarabine) with vincristine and asparaginase. We analysed 1748 admissions for fever in 315 Singapore children with non-HR acute lymphoblastic leukaemia (ALL) (MS2003, n = 183; MS2010, n = 132), comprising 76% of the total cohort (n = 413), to study the impact of these changes. The new 2010-PVa which has no doxorubicin, was associated with significantly fewer hospitalisations due to fever (0.08 versus 0.30 admissions per block [A/blk], p 
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However, its delayed-intensification (DI) phase, comprising repeated blocks of protocol III (2003-PIII), was toxic and caused significant treatment delays. The successor MS2010 study attempted to lower DI toxicity by replacing myelosuppressive drugs (doxorubicin, cytarabine) with vincristine and asparaginase. We analysed 1748 admissions for fever in 315 Singapore children with non-HR acute lymphoblastic leukaemia (ALL) (MS2003, n = 183; MS2010, n = 132), comprising 76% of the total cohort (n = 413), to study the impact of these changes. The new 2010-PVa which has no doxorubicin, was associated with significantly fewer hospitalisations due to fever (0.08 versus 0.30 admissions per block [A/blk], p &lt; 0.001), as than 2003-PIIIa. Similarly in 2010-PIIIb and PVb, where one block of cytarabine was replaced by two doses of vincristine, admissions for fever were also fewer (0.47 versus 0.74 A/blk, p &lt; 0.001) than in 2003-PIIIb. However, the addition of single doses of vincristine and asparaginase in 2010-PIIIa, even with a mandatory seven-day rest, led to more hospitalisations (0.45 A/blk, p &lt; 0.001), increased risk of bacteraemia (relative-risk (RR) = 7.66, p = 0.005) and critical-care admissions (RR = 4.31, p = 0.13). Despite this, overall treatment-related mortality decreased from 2.7% to 0.8%. Taken together, the reduced phase delays allowed earlier completion of the intensive phase of treatment (standard risk: 38.1 versus 49.4 weeks, p &lt; 0.001; intermediate risk: 50.9 versus 58.8 weeks, p &lt; 0.001), while maintaining excellent 10-year event-free survival of 95.4% and overall survival of 96.2%. In non-HR ALL, replacing doxorubicin/cytarabine with vincristine/asparaginase during some DI blocks is effective in reducing toxicity without compromising outcomes. NCT0289464. [Display omitted] •Reducing doxorubicin and cytarabine in MS2010 significantly reduced toxicity.•Treatment intensity was maintained with additional vincristine and asparaginase.•With these strategies, treatment outcomes were not compromised and with less toxicity.•However, intensification of Berlin-Frankfurt-Münster (BFM)-inspired protocol III increased infectious toxicities.</description><identifier>ISSN: 0959-8049</identifier><identifier>EISSN: 1879-0852</identifier><identifier>DOI: 10.1016/j.ejca.2020.10.010</identifier><identifier>PMID: 33246161</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Acute lymphoblastic leukaemia ; Acute lymphoblastic leukemia ; Amplification ; Asparaginase ; Bacteremia ; Child ; Child, Preschool ; Childhood ; Cytarabine ; Delayed intensification ; Doxorubicin ; Female ; Fever ; History, 21st Century ; Humans ; Infant ; Infective complications ; Leukemia ; Malaysia ; Male ; Precursor Cell Lymphoblastic Leukemia-Lymphoma - complications ; Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy ; Risk ; Singapore ; Survival ; Toxicity ; Treatment toxicity ; Vincristine</subject><ispartof>European journal of cancer (1990), 2021-01, Vol.142, p.92-101</ispartof><rights>2020 Elsevier Ltd</rights><rights>Copyright © 2020 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Science Ltd. 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However, its delayed-intensification (DI) phase, comprising repeated blocks of protocol III (2003-PIII), was toxic and caused significant treatment delays. The successor MS2010 study attempted to lower DI toxicity by replacing myelosuppressive drugs (doxorubicin, cytarabine) with vincristine and asparaginase. We analysed 1748 admissions for fever in 315 Singapore children with non-HR acute lymphoblastic leukaemia (ALL) (MS2003, n = 183; MS2010, n = 132), comprising 76% of the total cohort (n = 413), to study the impact of these changes. The new 2010-PVa which has no doxorubicin, was associated with significantly fewer hospitalisations due to fever (0.08 versus 0.30 admissions per block [A/blk], p &lt; 0.001), as than 2003-PIIIa. Similarly in 2010-PIIIb and PVb, where one block of cytarabine was replaced by two doses of vincristine, admissions for fever were also fewer (0.47 versus 0.74 A/blk, p &lt; 0.001) than in 2003-PIIIb. However, the addition of single doses of vincristine and asparaginase in 2010-PIIIa, even with a mandatory seven-day rest, led to more hospitalisations (0.45 A/blk, p &lt; 0.001), increased risk of bacteraemia (relative-risk (RR) = 7.66, p = 0.005) and critical-care admissions (RR = 4.31, p = 0.13). Despite this, overall treatment-related mortality decreased from 2.7% to 0.8%. Taken together, the reduced phase delays allowed earlier completion of the intensive phase of treatment (standard risk: 38.1 versus 49.4 weeks, p &lt; 0.001; intermediate risk: 50.9 versus 58.8 weeks, p &lt; 0.001), while maintaining excellent 10-year event-free survival of 95.4% and overall survival of 96.2%. In non-HR ALL, replacing doxorubicin/cytarabine with vincristine/asparaginase during some DI blocks is effective in reducing toxicity without compromising outcomes. NCT0289464. 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However, its delayed-intensification (DI) phase, comprising repeated blocks of protocol III (2003-PIII), was toxic and caused significant treatment delays. The successor MS2010 study attempted to lower DI toxicity by replacing myelosuppressive drugs (doxorubicin, cytarabine) with vincristine and asparaginase. We analysed 1748 admissions for fever in 315 Singapore children with non-HR acute lymphoblastic leukaemia (ALL) (MS2003, n = 183; MS2010, n = 132), comprising 76% of the total cohort (n = 413), to study the impact of these changes. The new 2010-PVa which has no doxorubicin, was associated with significantly fewer hospitalisations due to fever (0.08 versus 0.30 admissions per block [A/blk], p &lt; 0.001), as than 2003-PIIIa. Similarly in 2010-PIIIb and PVb, where one block of cytarabine was replaced by two doses of vincristine, admissions for fever were also fewer (0.47 versus 0.74 A/blk, p &lt; 0.001) than in 2003-PIIIb. However, the addition of single doses of vincristine and asparaginase in 2010-PIIIa, even with a mandatory seven-day rest, led to more hospitalisations (0.45 A/blk, p &lt; 0.001), increased risk of bacteraemia (relative-risk (RR) = 7.66, p = 0.005) and critical-care admissions (RR = 4.31, p = 0.13). Despite this, overall treatment-related mortality decreased from 2.7% to 0.8%. Taken together, the reduced phase delays allowed earlier completion of the intensive phase of treatment (standard risk: 38.1 versus 49.4 weeks, p &lt; 0.001; intermediate risk: 50.9 versus 58.8 weeks, p &lt; 0.001), while maintaining excellent 10-year event-free survival of 95.4% and overall survival of 96.2%. In non-HR ALL, replacing doxorubicin/cytarabine with vincristine/asparaginase during some DI blocks is effective in reducing toxicity without compromising outcomes. NCT0289464. [Display omitted] •Reducing doxorubicin and cytarabine in MS2010 significantly reduced toxicity.•Treatment intensity was maintained with additional vincristine and asparaginase.•With these strategies, treatment outcomes were not compromised and with less toxicity.•However, intensification of Berlin-Frankfurt-Münster (BFM)-inspired protocol III increased infectious toxicities.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>33246161</pmid><doi>10.1016/j.ejca.2020.10.010</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-4504-8257</orcidid><orcidid>https://orcid.org/0000-0001-6184-8935</orcidid><orcidid>https://orcid.org/0000-0002-0359-0208</orcidid><orcidid>https://orcid.org/0000-0002-6454-976X</orcidid></addata></record>
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subjects Acute lymphoblastic leukaemia
Acute lymphoblastic leukemia
Amplification
Asparaginase
Bacteremia
Child
Child, Preschool
Childhood
Cytarabine
Delayed intensification
Doxorubicin
Female
Fever
History, 21st Century
Humans
Infant
Infective complications
Leukemia
Malaysia
Male
Precursor Cell Lymphoblastic Leukemia-Lymphoma - complications
Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy
Risk
Singapore
Survival
Toxicity
Treatment toxicity
Vincristine
title Successful toxicity reduction during delayed intensification in the non-high-risk arm of Malaysia-Singapore Acute Lymphoblastic Leukaemia 2010 study
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