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CCG 5942 研究:儿童霍奇金淋巴瘤化疗联合或不联合放疗的随机比较——儿童肿瘤协作组的报告

Long-term results of CCG 5942: a randomized comparison of chemotherapy with and without radiotherapy for children with Hodgkin's lymphoma--a report from the Children's Oncology Group.

机构信息

Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, SM-17, New York, NY 10065, USA.

出版信息

J Clin Oncol. 2012 Sep 10;30(26):3174-80. doi: 10.1200/JCO.2011.41.1819. Epub 2012 May 29.

Abstract

PURPOSE

In 1995, the Children's Cancer Group (CCG) opened a trial for patients with Hodgkin's lymphoma evaluating whether low-dose involved-field radiation therapy (IFRT) improved event-free survival (EFS) for patients achieving a complete response after chemotherapy. We present the long-term study outcome using final data through March 2007.

PATIENTS AND METHODS

Between January 1995 and December 1998, 826 eligible patients were enrolled onto CCG 5942. Four hundred ninety-eight patients achieving an initial complete response to chemotherapy were randomly assigned to receive IFRT or no further therapy. EFS and overall survival (OS) were assessed from the date of study entry or random assignment, as appropriate.

RESULTS

Ten-year EFS and OS rates for the entire cohort were 83.5% and 92.5%, respectively. In an as-treated analysis for randomly assigned patients, the 10-year EFS and OS rates were 91.2% and 97.1%, respectively, for IFRT and 82.9% and 95.9%, respectively, for no further therapy. For EFS and OS comparisons, P = .004 and P = .50, respectively. Bulk disease, "B" symptoms, and nodular sclerosis histology were risk factors for inferior EFS.

CONCLUSION

With a median follow-up of 7.7 years, IFRT produced a statistically significant improvement in EFS but no improvement in OS. For individual patients, the relative risks of relapse versus late effects of IFRT must be considered. Patient and disease characteristics and early response assessment will aid in deciding which patients are most likely to benefit from IFRT.

摘要

目的

1995 年,儿童癌症组(CCG)开展了一项评估化疗后完全缓解患者接受低剂量累及野放疗(IFRT)是否能改善无事件生存(EFS)的霍奇金淋巴瘤临床试验。我们使用截至 2007 年 3 月的最终数据报告该长期研究结果。

患者和方法

1995 年 1 月至 1998 年 12 月,826 例符合条件的患者入组 CCG5942 试验。498 例化疗初始完全缓解的患者被随机分配接受 IFRT 或不进一步治疗。EFS 和总生存(OS)分别从研究入组或随机分组日期开始评估。

结果

整个队列的 10 年 EFS 和 OS 率分别为 83.5%和 92.5%。在按治疗分配的随机患者分析中,IFRT 和不进一步治疗的 10 年 EFS 和 OS 率分别为 91.2%和 97.1%,82.9%和 95.9%。EFS 和 OS 比较的 P 值分别为 0.004 和 0.50。大肿块疾病、“B”症状和结节性硬化组织学是 EFS 较差的危险因素。

结论

在中位随访 7.7 年时,IFRT 可显著改善 EFS,但对 OS 无改善。对于个别患者,必须考虑复发与 IFRT 晚期效应的相对风险。患者和疾病特征以及早期反应评估将有助于决定哪些患者最有可能从 IFRT 中获益。

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