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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
Author(s) -
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
Publication year - 2014
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.12632
Subject(s) - medicine , cytarabine , asparaginase , randomized controlled trial , acute lymphocytic leukemia , pediatrics , lymphoblastic leukemia , oncology , chemotherapy , leukemia
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 < 0·001). In conclusion, experimental early intensification including high‐dose cytarabine followed by L‐asparaginase had no advantage over standard early intensification in paediatric IR ALL patients.