Treatment with nephrectomy only for small, stage I/favorable histology Wilms' tumor: A report from the National Wilms' Tumor Study Group
Treatment with nephrectomy only for small, stage I/favorable histology Wilms' tumor: A report from the National Wilms' Tumor Study Group
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DOI：
10.1200/jco.2001.19.17.3719
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发表时间：
2001-09-01
影响因子：
45.3
通讯作者：
Weeks, D
中科院分区：
文献类型：
--
作者：
Green, DM;Breslow, NE;Weeks, D
目的：小于24个月的儿童与小（< 550克），良好的组织学（FH）肾母细胞瘤（WT）在一项试点研究中显示，有一个良好的预后时，肾切除术治疗只有Patients and Methods：一项研究肾切除术治疗选定的儿童FH WT进行。严格的停止规则的设计，以确保关闭的研究，如果真正的2年无复发生存率为90%或lower.Results：75个以前未经治疗的儿童年龄小于24个月的阶段I/FH WT的手术标本重量小于550克进行治疗肾切除术。3例患者在肾切除术后1.1、1.4和2.3年发生异时性、对侧WT，8例患者在诊断后0.3至1.05年复发（中位数0.4年，平均0.51年）。复发部位为肺部5例，手术床3例。2年无病（复发和异时对侧WT）生存率为86.5%。2年生存率100%，中位随访时间2.84年。2年无病生存率（不包括异时性对侧WT）为89.2%，异时性对侧WT的2年累积风险为3.1%。年龄小于24个月的儿童仅因体重小于550 g的I期/FH WT接受肾切除术治疗，有复发风险，包括发生异时性对侧WT，诊断后2年为13.5%。在本试验中经历复发的所有患者此时均存活。将在临床试验中使用不太保守的停止规则重新评价该方法。(C)2001年，美国临床肿瘤学会。
Purpose: Children younger than 24 months with small (< 550 g), favorable histology (FH) Wilms tumors (WTs) were shown in a pilot study to have an excellent prognosis when treated with nephrectomy only.Patients and Methods: A study of nephrectomy only for the tratment of selected children with FH WT was undertaken. Stringent stopping rules were designed to insure closure of the study if the true 2-year relapse-free survival rate was 90% or lower.Results: Seventy-five previously untreated children younger than 24 months with stage I/FH WTs for which the surgical specimen weighed less than 550 g were treated with nephrectomy only. Three patients developed metachronous, contralateral WT 1.1, 1.4, and 2.3 years after nephrectomy, and eight patients relapsed 0.3 to 1.05 years after diagnosis (median, 0.4 years; mean, 0.51 years). The sites of relapse were lung (n = 5) and operative bed (n = 3). The 2-year disease-free (relapse and metachronous contralateral WT) survival rate was 86.5%. The 2-year survival rate is 100% with a median follow-up of 2.84 years. The 2-year disease-free survival rate (excluding metachronous contralateral WT) was 89.2%, and the 2-year cumulative risk of metachronous contralateral WT was 3.1%.Conclusion: Children younger than 24 months treated with nephrectomy only for a stage I/FH WT that weighed less than 550 g had a risk of relapse, including the development of metachronous contralateral WT, of 13.5% 2 years after diagnosis. All patients who experienced relapse on this trial are alive at this time. This approach will be re-evaluated in a clinical trial using a less conservative stopping rule. (C) 2001 by American Society of Clinical Oncology.