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Clinical Trial
. 2014 Oct 17;4(10):e252.
doi: 10.1038/bcj.2014.72.

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  1 , T Sakura  2 , T Yujiri  3 , E Kondo  4 , K Fujimaki  5 , O Sasaki  6 , J Miyatake  7 , H Handa  8 , Y Ueda  9 , Y Aoyama  10 , S Takada  2 , Y Tanaka  3 , N Usui  11 , S Miyawaki  12 , S Suenobu  13 , K Horibe  14 , H Kiyoi  1 , K Ohnishi  15 , Y Miyazaki  16 , S Ohtake  17 , Y Kobayashi  18 , K Matsuo  19 , T Naoe  20 ; Japan Adult Leukemia Study Group (JALSG)
Affiliations
Clinical Trial

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 et al. Blood Cancer J. .

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, P<0.001). 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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Figures

Figure 1
Figure 1
Comparison of DFS and OS rates. (a) Patient flow chart. (b) Comparison of DFS rates between ALL202-U (red line) and ALL97-U (blue line). The median follow-up times were 5.1 and 5.2 years, respectively. (c) Comparison of OS rates between ALL202-U (red line) and ALL97-U (blue line). The median follow-up times were 5.1 and 5.8 years, respectively.
Figure 2
Figure 2
Forest plot of subgroup analysis for DFS rates. 5-year DFS rate of each subgroup was calculated and compared by the log-rank test. Patients undergoing transplantation were not censored. The 5-year DFS rate with 95% CIs are plotted and P-values of the log-rank test are shown. Numbers following subgroup names indicate the number of cases in the groups.
Figure 3
Figure 3
Comparison of the DFS rate in each risk group. (a) Comparison between ALL202-U standard-risk (SR) patients (red line) and ALL97-U SR patients (blue line). (b) Comparison between ALL202-U high-risk (HR) patients (red line) and ALL97-U HR patients (blue line).
Figure 4
Figure 4
Analysis of protocol therapy termination. (a) The reasons for and frequencies of protocol therapy termination. (b) The periods of and reasons for protocol therapy termination. (c) The effect of therapy insufficiency on the DFS rate. DFS rates were compared among groups of patients who received planned post-remission therapy (blue line), those who received SCT in first CR (green line), those who received insufficient consolidation therapy (yellow line) and those who received insufficient maintenance therapy (red line).
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