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放疗方案依从性和质量对腹膜后肉瘤治疗的关键影响:EORTC 62092-22092 STRASS 试验结果。

Critical impact of radiotherapy protocol compliance and quality in the treatment of retroperitoneal sarcomas: Results from the EORTC 62092-22092 STRASS trial.

机构信息

Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.

Department of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands.

出版信息

Cancer. 2022 Jul 15;128(14):2796-2805. doi: 10.1002/cncr.34239. Epub 2022 May 10.

DOI:10.1002/cncr.34239
PMID:35536104
Abstract

BACKGROUND

The European Organization for Research and Treatment of Cancer 22092-62092 STRASS trial failed to demonstrate the superiority of neoadjuvant radiotherapy (RT) over surgery alone in patients with retroperitoneal sarcoma. Therefore, an RT quality-assurance program was added to the study protocol to detect and correct RT deviations. The authors report results from the trial RT quality-assurance program and its potential effect on patient outcomes.

METHODS

To evaluate the effect of RT compliance on survival outcomes, a composite end point was created. It combined the information related to planning target volume coverage, target delineation, total dose received, and overall treatment time into 2 groups: non-RT-compliant (NRC) for patients who had unacceptable deviation(s) in any of the previous categories and RT-compliant (RC) otherwise. Abdominal recurrence-free survival (ARFS) and overall survival were compared between the 2 groups using a Cox proportional hazard model adjusted for known prognostic factors.

RESULTS

Thirty-six of 125 patients (28.8%) were classified as NRC, and the remaining 89 patients (71.2%) were classified as RC. The 3-year ARFS rate was 66.8% (95% confidence interval [CI], 55.8%-75.7%) and 49.8% (95% CI, 32.7%-64.8%) for the RC and NRC groups, respectively (adjusted hazard ratio, 2.32; 95% CI, 1.25-4.32; P = .008). Local recurrence after macroscopic complete resection occurred in 13 of 89 patients (14.6%) versus 2 of 36 patients (5.6%) in the RC and NRC groups, respectively.

CONCLUSIONS

The current analysis suggests a significant benefit in terms of ARFS in favor of the RC group. This association did not translate into less local relapses after complete resection in the RC group. Multidisciplinary collaboration and review of cases are critical to avoid geographic misses, especially for rare tumors like retroperitoneal sarcoma.

摘要

背景

欧洲癌症研究与治疗组织 22092-62092 STRASS 试验未能证明新辅助放疗(RT)在腹膜后肉瘤患者中优于单纯手术。因此,在研究方案中增加了 RT 质量保证计划,以检测和纠正 RT 偏差。作者报告了试验 RT 质量保证计划的结果及其对患者结局的潜在影响。

方法

为了评估 RT 依从性对生存结局的影响,创建了一个复合终点。它将与计划靶区覆盖、靶区勾画、总剂量和总治疗时间相关的信息组合成 2 组:非 RT 依从组(NRC)用于在上述任何类别中存在不可接受偏差的患者,以及 RT 依从组(RC)。采用 Cox 比例风险模型,根据已知的预后因素,比较两组之间的腹部无复发生存(ARFS)和总生存。

结果

125 例患者中有 36 例(28.8%)被归类为 NRC,其余 89 例(71.2%)被归类为 RC。RC 组和 NRC 组的 3 年 ARFS 率分别为 66.8%(95%置信区间[CI],55.8%-75.7%)和 49.8%(95% CI,32.7%-64.8%)(调整后的危险比,2.32;95%CI,1.25-4.32;P=0.008)。RC 组完全切除后局部复发 13 例(14.6%),NRC 组 2 例(5.6%)。

结论

目前的分析表明,RC 组在 ARFS 方面有显著获益。这种关联并没有转化为 RC 组完全切除后局部复发减少。多学科合作和病例审查对于避免地理漏诊至关重要,特别是对于腹膜后肉瘤等罕见肿瘤。

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