A prospective phase 3 clinical trial of postmastectomy hypofractionation radiotherapy in high risk breast cancer | ||
| Bulletin of Pharmaceutical Sciences Assiut University | ||
| Articles in Press, Accepted Manuscript, Available Online from 15 September 2025 | ||
| Document Type: Original Article | ||
| DOI: 10.21608/bfsa.2025.381209.2551 | ||
| Authors | ||
| Nihal Kamel Ghaffier* ; Hoda Hassan Essa; Amal Rayan Ibrahiem | ||
| Clinical Oncology and Nuclear Medicine Department, Faculty of Medicine, Assuit University | ||
| Abstract | ||
| A prospective phase III Clinical Trial of Post mastectomy Hypo fractionation Radiotherapy in High – risk Breast Cancer Background: The role of hypo-fractionated radiotherapy (HFRT) in high-risk breast cancer (BC) is controversial. Objective: to compare the toxicity & disease-free survival (DFS) of HFRT vs. conventional fractionated radiotherapy CFRT after mastectomy. Methods: A prospective study was conducted in the period between 2017 & 2023 and enrolled 60 BC patients who randomized to receive either adjuvant CFRT (50 Gy / 25 fractions/5 weeks) or HFRT (42, 5 Gy / 16 fractions /3.2 weeks). Clinical Trials registry number NCT03319069. Results: Grade 3 wet desquamation & darkness were significantly higher in CFRT (P = 0.01). Grade 3 lymphedema was more frequent in CFRT (10% vs. 0%, p= 0.17). No significant differences in DFS (89.7 vs. 93.2%), or metastasis free survival (89.74 vs. 93.21%) for CFRT & HFRT respectively. The 5-year overall survival was 93% for both arms. Conclusion: HFRT is equivalent to CFRT in terms of recurrence, survival but lower arm lymphedema. Keywords: Breast cancer, adjuvant hypo fractionated radiotherapy, node positive, survival | ||
| Keywords | ||
| Effectiveness; oncologic outcomes; cost benefits; toxicity | ||
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