Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol: A phase II study by the Japan Adult Leukemia Study Group

F. Hayakawa, T. Sakura, T. Yujiri, E. Kondo, K. Fujimaki, O. Sasaki, J. Miyatake, H. Handa, Y. Ueda, Y. Aoyama, S. Takada, Y. Tanaka, N. Usui, S. Miyawaki, S. Suenobu, K. Horibe, H. Kiyoi, K. Ohnishi, Y. Miyazaki, S. OhtakeY. Kobayashi, K. Matsuo, T. Naoe

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Abstract

The superiority of the pediatric protocol for adolescents with acute lymphoblastic leukemia (ALL) has already been demonstrated, however, its efficacy in young adults remains unclear. The ALL202-U protocol was conducted to examine the efficacy and feasibility of a pediatric protocol in adolescents and young adults (AYAs) with BCR'ABL-negative ALL. Patients aged 15'24 years (n = 139) were treated with the same protocol used for pediatric B-ALL. The primary objective of this study was to assess the disease-free survival (DFS) rate and its secondary aims were to assess toxicity, the complete remission (CR) rate and the overall survival (OS) rate. The CR rate was 94%. The 5-year DFS and OS rates were 67% (95% confidence interval (CI) 58'75%) and 73% (95% CI 64'80%), respectively. Severe adverse events were observed at a frequency that was similar to or lower than that in children treated with the same protocol. Only insufficient maintenance therapy significantly worsened the DFS (hazard ratio 5.60, Po0.001).These results indicate that this protocol may be a feasible and highly effective treatment for AYA with BCR'ABL-negative ALL.

Original languageEnglish
Article numbere252
JournalBlood Cancer Journal
Volume4
Issue number10
DOIs
Publication statusPublished - Jan 1 2014

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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Young Adult
Japan
Leukemia
Pediatrics
Disease-Free Survival
Survival Rate
Confidence Intervals
Therapeutics

ASJC Scopus subject areas

  • Oncology
  • Hematology
  • Medicine(all)

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Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol : A phase II study by the Japan Adult Leukemia Study Group. / Hayakawa, F.; Sakura, T.; Yujiri, T.; Kondo, E.; Fujimaki, K.; Sasaki, O.; Miyatake, J.; Handa, H.; Ueda, Y.; Aoyama, Y.; Takada, S.; Tanaka, Y.; Usui, N.; Miyawaki, S.; Suenobu, S.; Horibe, K.; Kiyoi, H.; Ohnishi, K.; Miyazaki, Y.; Ohtake, S.; Kobayashi, Y.; Matsuo, K.; Naoe, T.

In: Blood Cancer Journal, Vol. 4, No. 10, e252, 01.01.2014.

Research output: Contribution to journalArticle

Hayakawa, F, Sakura, T, Yujiri, T, Kondo, E, Fujimaki, K, Sasaki, O, Miyatake, J, Handa, H, Ueda, Y, Aoyama, Y, Takada, S, Tanaka, Y, Usui, N, Miyawaki, S, Suenobu, S, Horibe, K, Kiyoi, H, Ohnishi, K, Miyazaki, Y, Ohtake, S, Kobayashi, Y, Matsuo, K & Naoe, T 2014, 'Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol: A phase II study by the Japan Adult Leukemia Study Group', Blood Cancer Journal, vol. 4, no. 10, e252. https://doi.org/10.1038/bcj.2014.72
Hayakawa, F. ; Sakura, T. ; Yujiri, T. ; Kondo, E. ; Fujimaki, K. ; Sasaki, O. ; Miyatake, J. ; Handa, H. ; Ueda, Y. ; Aoyama, Y. ; Takada, S. ; Tanaka, Y. ; Usui, N. ; Miyawaki, S. ; Suenobu, S. ; Horibe, K. ; Kiyoi, H. ; Ohnishi, K. ; Miyazaki, Y. ; Ohtake, S. ; Kobayashi, Y. ; Matsuo, K. ; Naoe, T. / Markedly improved outcomes and acceptable toxicity in adolescents and young adults with acute lymphoblastic leukemia following treatment with a pediatric protocol : A phase II study by the Japan Adult Leukemia Study Group. In: Blood Cancer Journal. 2014 ; Vol. 4, No. 10.
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abstract = "The superiority of the pediatric protocol for adolescents with acute lymphoblastic leukemia (ALL) has already been demonstrated, however, its efficacy in young adults remains unclear. The ALL202-U protocol was conducted to examine the efficacy and feasibility of a pediatric protocol in adolescents and young adults (AYAs) with BCR'ABL-negative ALL. Patients aged 15'24 years (n = 139) were treated with the same protocol used for pediatric B-ALL. The primary objective of this study was to assess the disease-free survival (DFS) rate and its secondary aims were to assess toxicity, the complete remission (CR) rate and the overall survival (OS) rate. The CR rate was 94{\%}. The 5-year DFS and OS rates were 67{\%} (95{\%} confidence interval (CI) 58'75{\%}) and 73{\%} (95{\%} CI 64'80{\%}), respectively. Severe adverse events were observed at a frequency that was similar to or lower than that in children treated with the same protocol. Only insufficient maintenance therapy significantly worsened the DFS (hazard ratio 5.60, Po0.001).These results indicate that this protocol may be a feasible and highly effective treatment for AYA with BCR'ABL-negative ALL.",
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T2 - A phase II study by the Japan Adult Leukemia Study Group

AU - Hayakawa, F.

AU - Sakura, T.

AU - Yujiri, T.

AU - Kondo, E.

AU - Fujimaki, K.

AU - Sasaki, O.

AU - Miyatake, J.

AU - Handa, H.

AU - Ueda, Y.

AU - Aoyama, Y.

AU - Takada, S.

AU - Tanaka, Y.

AU - Usui, N.

AU - Miyawaki, S.

AU - Suenobu, S.

AU - Horibe, K.

AU - Kiyoi, H.

AU - Ohnishi, K.

AU - Miyazaki, Y.

AU - Ohtake, S.

AU - Kobayashi, Y.

AU - Matsuo, K.

AU - Naoe, T.

PY - 2014/1/1

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N2 - The superiority of the pediatric protocol for adolescents with acute lymphoblastic leukemia (ALL) has already been demonstrated, however, its efficacy in young adults remains unclear. The ALL202-U protocol was conducted to examine the efficacy and feasibility of a pediatric protocol in adolescents and young adults (AYAs) with BCR'ABL-negative ALL. Patients aged 15'24 years (n = 139) were treated with the same protocol used for pediatric B-ALL. The primary objective of this study was to assess the disease-free survival (DFS) rate and its secondary aims were to assess toxicity, the complete remission (CR) rate and the overall survival (OS) rate. The CR rate was 94%. The 5-year DFS and OS rates were 67% (95% confidence interval (CI) 58'75%) and 73% (95% CI 64'80%), respectively. Severe adverse events were observed at a frequency that was similar to or lower than that in children treated with the same protocol. Only insufficient maintenance therapy significantly worsened the DFS (hazard ratio 5.60, Po0.001).These results indicate that this protocol may be a feasible and highly effective treatment for AYA with BCR'ABL-negative ALL.

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