Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2026
Definitive, stereotactic ablative radiotherapy and endocrine therapy without surgery for select low-risk breast cancers: A prospective, phase II trial.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Shaitelman Simona F, Krishnamurthy Savitri, Rauch Gaiane M, Lin Heather, Shen Yu, Valero Vicente, Johnson Helen M, Muruganandham Manickam, Smith Benjamin D, Hoffman Karen E, Lee Belinda M, Shinn Eileen, Symmans W Fraser, Woodward Wendy A, Mitchell Melissa P, Goodman Chelain R, Buzdar Aman, Singh Puneet, Tamirisa Nina, Kuerer Henry, Division of Radiation Oncology Biomarker Strategic Initiative Laboratory Group, Exceptional Responders Study Group
Аннотация
BACKGROUND: Early-stage, hormone receptor positive (HR+) breast cancer has excellent outcomes with lumpectomy, radiotherapy, and endocrine therapy (ET), prompting interest in treatment de-escalation. Advances in stereotactic ablative radiotherapy (SABR) raise the possibility of definitive local therapy without surgery in select patients. We conducted a prospective, phase II trial (NCT02945579) evaluating SABR with ET as a non-operative strategy.
MATERIALS AND METHODS: Patients aged ≥ 40 years with cT1N0M0, unicentric, HR+, HER2-negative breast cancer received 3 months of ET followed by SABR in 5 fractions. Vacuum-assisted image-guided core biopsy of the tumor bed was performed 6-12 months after SABR. Patients with pathologic complete response (pCR) omitted surgery. Co-primary endpoints were pCR and 3-year progression-free survival (PFS) rates. Patient-reported outcomes were collected as a secondary endpoint. A Bayesian framework evaluated futility using posterior probabilities to assess a clinically meaningful pCR rate.
RESULTS: Twenty patients were enrolled (median age 70.5 years). Nineteen underwent biopsy after SABR. pCR was observed in 10/19 patients (53%, 95% CI 30-73%), and 7 (37%) had near complete response. Among the 12 patients managed without surgery, median follow-up was 44.9 months. Three-year PFS was 92% (95% CI 54-99%), with one non-breast cancer-related death and no breast cancer recurrences. Longitudinal patient-reported outcomes of decisional regret and breast-specific outcomes remained stable.
CONCLUSION: Definitive SABR combined with ET achieved substantial pCR rates and encouraging tumor control. These findings support further evaluation of radiotherapy-based definitive treatment and potential surgery omission in carefully selected patients with favorable, HR + breast cancer.
MATERIALS AND METHODS: Patients aged ≥ 40 years with cT1N0M0, unicentric, HR+, HER2-negative breast cancer received 3 months of ET followed by SABR in 5 fractions. Vacuum-assisted image-guided core biopsy of the tumor bed was performed 6-12 months after SABR. Patients with pathologic complete response (pCR) omitted surgery. Co-primary endpoints were pCR and 3-year progression-free survival (PFS) rates. Patient-reported outcomes were collected as a secondary endpoint. A Bayesian framework evaluated futility using posterior probabilities to assess a clinically meaningful pCR rate.
RESULTS: Twenty patients were enrolled (median age 70.5 years). Nineteen underwent biopsy after SABR. pCR was observed in 10/19 patients (53%, 95% CI 30-73%), and 7 (37%) had near complete response. Among the 12 patients managed without surgery, median follow-up was 44.9 months. Three-year PFS was 92% (95% CI 54-99%), with one non-breast cancer-related death and no breast cancer recurrences. Longitudinal patient-reported outcomes of decisional regret and breast-specific outcomes remained stable.
CONCLUSION: Definitive SABR combined with ET achieved substantial pCR rates and encouraging tumor control. These findings support further evaluation of radiotherapy-based definitive treatment and potential surgery omission in carefully selected patients with favorable, HR + breast cancer.