No impact of high‐dose cytarabine and asparaginase as early intensification with intermediate‐risk paediatric acute lymphoblastic leukaemia: results of randomized trial TCCSG study L99‐15

Summary The Tokyo Children's Cancer Study Group conducted a randomized controlled study to evaluate the effect of experimental early intensification using high‐dose cytarabine and L‐asparaginase in paediatric intermediate‐risk (IR) acute lymphoblastic leukaemia (ALL). A total of 310 IR ALL pati...

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Bibliographic Details
Published in:British journal of haematology 2014-02, Vol.164 (3), p.376-383
Main Authors: Kato, Motohiro, Koh, Katsuyoshi, Manabe, Atsushi, Saito, Tomohiro, Hasegawa, Daisuke, Isoyama, Keiichi, Kinoshita, Akitoshi, Maeda, Miho, Okimoto, Yuri, Kajiwara, Michiko, Kaneko, Takashi, Sugita, Kanji, Kikuchi, Akira, Tsuchida, Masahiro, Ohara, Akira
Format: Article
Language:English
Subjects:
Acute Disease
acute lymphoblastic leukaemia
Adolescent
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Asparaginase - administration & dosage
Biological and medical sciences
Child
Child, Preschool
Cytarabine - administration & dosage
Dose-Response Relationship, Drug
early intensification
Female
Hematologic and hematopoietic diseases
high‐dose cytarabine
Humans
Infant
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Male
Medical sciences
Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy
randomized trial
Remission Induction
Risk Factors
Survival Rate
Treatment Outcome
Tumors
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Summary:Summary The Tokyo Children's Cancer Study Group conducted a randomized controlled study to evaluate the effect of experimental early intensification using high‐dose cytarabine and L‐asparaginase in paediatric intermediate‐risk (IR) acute lymphoblastic leukaemia (ALL). A total of 310 IR ALL patients were randomized to receive either experimental early intensification (n = 156) or standard early intensification including standard‐dose cytarabine arm (n = 154) after induction therapy. The experimental arm consisted of high‐dose cytarabine and L‐asparaginase, while the standard arm consisted of standard‐dose cytarabine, oral 6‐mercaptopurine and cyclophosphamide. The probabilities of event‐free survival at 8 years in the experimental and standard arms were 72·3 ± 3·7% and 77·5 ± 3·5%, respectively (P = 0·32). The 8‐year overall survival rates for these two arms were 85·0 ± 3·0% and 86·9 ± 2·8%, respectively (P = 0·72). The frequency of infectious events was significantly higher in the experimental arm (66·4%) than in the standard arm (24·6%) (P 
ISSN:0007-1048
1365-2141
DOI:10.1111/bjh.12632