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在日本儿科白血病/淋巴瘤研究组临床试验中,对成熟 B 细胞非霍奇金淋巴瘤的青少年患者给予儿科治疗的疗效和安全性。

Efficacy and safety of administering pediatric treatment to adolescent patients with mature B-cell non-Hodgkin lymphoma within the Japanese Pediatric Leukemia/Lymphoma Study Group clinical trial.

机构信息

Department of Pediatrics, National Hospital Organization Nagoya Medical Center, Aichi, Japan.

Clinical Research Center, National Hospital Organization Nagoya Medical Center, Aichi, Japan.

出版信息

Pediatr Blood Cancer. 2018 Aug;65(8):e27068. doi: 10.1002/pbc.27068. Epub 2018 Apr 10.

DOI:10.1002/pbc.27068
PMID:29637700
Abstract

BACKGROUND

Currently, there is no standardized treatment for adolescents, aged 15 years or older, with mature B-cell non-Hodgkin lymphoma (B-NHL), although this age group has been reported to have a poorer prognosis than younger patients.

PROCEDURE

The present study analyzed the data of 321 patients with B-NHL, enrolled in a pediatric clinical trial, comparing the treatment outcomes between adolescents (aged 15-18 years, n = 25) and children (≤15 years, n = 297), with a particular focus on the safety and tolerability of administering pediatric regimens to adolescents.

RESULTS

The probability of event-free survival (EFS) at 4 years was 79.3 ± 8.3% for the adolescents and 88.0 ± 1.9% for the children (P = 0.236). After adjusting for treatment group and lactate dehydrogenase value at the time of diagnosis, the probability of 4-year EFS of adolescents was lower than that of children, but only in the patients with central nervous system positive lymphoma or Burkitt leukemia. The frequency of treatment-related mortalities, severe adverse events (SAEs), and SAEs leading to treatment discontinuation or treatment completion rate was similar in adolescent and pediatric patients. There was no difference in treatment duration between adolescent and pediatric patients.

CONCLUSIONS

The treatment outcomes of adolescents with B-NHL were not statistically different from those of the pediatric patients and the safety of a pediatric regimen in adolescents was similar to that in the pediatric patients. A pediatric treatment foundation can be adopted for adolescents, although further prospective studies and biological investigations are required for treatment optimization.

摘要

背景

目前,对于 15 岁及以上的成熟 B 细胞非霍奇金淋巴瘤(B-NHL)患者,尚无标准化治疗方法,尽管据报道该年龄组的预后比年轻患者差。

方法

本研究分析了在一项儿科临床试验中入组的 321 例 B-NHL 患者的数据,比较了青少年(15-18 岁,n=25)和儿童(≤15 岁,n=297)的治疗结果,特别关注将儿科方案用于青少年的安全性和耐受性。

结果

青少年组的 4 年无事件生存(EFS)概率为 79.3±8.3%,儿童组为 88.0±1.9%(P=0.236)。在校正治疗组和诊断时乳酸脱氢酶值后,青少年组的 4 年 EFS 概率低于儿童组,但仅在中枢神经系统阳性淋巴瘤或伯基特白血病患者中。青少年和儿科患者的治疗相关死亡率、严重不良事件(SAE)和导致治疗中断的 SAE 或治疗完成率的频率相似。青少年和儿科患者的治疗持续时间无差异。

结论

青少年 B-NHL 患者的治疗结果与儿科患者无统计学差异,儿科方案在青少年中的安全性与儿科患者相似。尽管需要进一步的前瞻性研究和生物学研究来优化治疗,但可以为青少年采用儿科治疗基础。

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