ArticleClinical and translational radiation oncology2026
A prospective phase II trial of 10-fraction whole-breast radiotherapy following breast-conserving surgery.
Article in Clinical and translational radiation oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Moderate hypofractionation is established as the standard of care for adjuvant whole-breast radiotherapy after breast-conserving surgery. Ultra-hypofractionated regimens further shorten treatment but have raised concerns about toxicity and cosmetic outcomes. In younger Asian patients frequently requiring a boost, we evaluated a 10-fraction whole-breast radiotherapy schedule as a practical and tolerable choice. Methods: This single-arm, prospective phase II trial enrolled 64 patients with early-stage breast cancer at Peking University Cancer Hospital between November 2023 and March 2025. All patients received intensity-modulated radiotherapy (IMRT) with a prescribed dose of 37 Gy in 10 fractions, followed by a sequential tumor-bed boost of 7.4 Gy in 2 fractions according to clinical indications. The primary endpoint was the incidence of grade ≥2 acute radiation dermatitis; secondary endpoints included patient-reported outcomes, cosmetic assessment, oncologic outcomes and exploratory immune profiling. Clinical Trial registration: ChiCTR2300075391. Results: All patients completed radiotherapy without interruption. Tumor-bed boost was delivered to 58 patients (90.6%). Grade 2 acute dermatitis was observed in 17.2% of patients, with no grade ≥3 events, and all reactions resolved to grade 0-1 within three months. Among the 11 cases with grade 2 dermatitis, the most frequently affected site was the nipple-areola complex (6 cases, 54.5%). Patient-reported cosmetic and breast symptom scores transiently worsened at two weeks after radiotherapy but recovered thereafter. No significant decline occurred in functional or global quality-of-life domains. Exploratory analyses suggested that prior chemotherapy and lower baseline CD4 Conclusion: This 10-fraction whole-breast radiotherapy regimen was acceptable. These findings support this regimen as a practical alternative for adjuvant breast radiotherapy.
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