NCT06780059

Effects of Radiotherapy in Borderline and Malignant Phyllodes Tumors After R0 Resection

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 480 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Radiotherapy, Adjuvant
• Phyllodes Breast Tumor
• Prognosis

Interventions

Type	Name	Description
RADIATION	Adjuvant Radiotherapy	Postoperative Radiotherapy with 3D-CRT and IMRT Techniques Following R0 Resection in BoPT and MPT Patients
PROCEDURE	R0 resection	Patients who received R0 resection (complete resection without tumor margin)

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-01-02
• Completion: 2025-01-02
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

3 sites across 1 country: China