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临床试验/NCT06780059
NCT06780059已完成不适用

Effects of Radiotherapy on Recurrence and Survival in Borderline and Malignant Phyllodes Tumors After R0 Resection: a Propensity Score Analysis

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University3 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
480
试验地点
3
主要终点
5-year Local Recurrence-free Survival

研究概览

简要总结

Breast phyllodes tumors (PT) are rare fibroepithelial neoplasms originating from stromal tissue and account for less than 1% of all breast tumors. The World Health Organization (WHO) classifies PT into benign, borderline, and malignant subtypes based on pathological features such as mitotic activity, cellular atypia, tumor margin invasion, and stromal composition 1. The presence of malignant heterologous elements characterizes the tumor as malignant 2. Surgery is the primary treatment. However, even after R0 resection, borderline phyllodes tumors (BoPT) and malignant phyllodes tumors (MPT) patients remain face a high risk of local recurrence, with rates of 15%-20% and 25%-30%, respectively. Moreover, metastases occur almost merely in MPT, with a distant metastasis rate reaching 22%.

Adjuvant radiotherapy has attracted attention for its potential to improve local control and reduce recurrence, but the role after R0 resection in PT patients remains unclear. Radiotherapy significantly reduces local recurrence rates in BoPT and MPT but shows no substantial benefit in benign cases. However, a meta-analysis by Yu et al. found that this effect is limited to MPT. Additionally, the effect of radiotherapy on survival rates in PT remains controversial. Most existing studies are retrospective and face limitations such as small sample sizes. The rarity of PT and conflicting evidence of impact of radiotherapy necessitate further study. While prospective trials are difficult due to limited cases, well-designed retrospective studies can offer valuable insights. In this study, the investigators also analyzed prognostic factors and identified subgroups to provide a clinical reference for the application of postoperative radiotherapy in BoPT and MPT patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • patients who were initially diagnosed with BoPT or MPT and underwent R0 resection surgery

排除标准

  • patients who had their initial surgery at other hospitals without accurate baseline data
  • patients who received radiotherapy before surgery
  • those presenting with initial distant metastasis before treatment
  • patients lost to follow-up after treatment
  • patients with a history of or concurrent breast cancer or precancerous lesions in the ipsilateral breast or with breast cancer in the contralateral breast

结局指标

主要结局

5-year Local Recurrence-free Survival

时间窗: Five years

The time period from the initial R0 resection to either the detection of local recurrence or the final follow-up.

次要结局

  • 5-year Overall Survival(Five years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yan Nie

Principal Investigator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (3)

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