Civil Yasmin A, Vasmel Jeanine E, Charaghvandi Ramona K, Houweling Anette C, Vreuls Celien P H, van Diest Paul J, Witkamp Arjen J, Doeksen Annemiek, van Dalen Thijs, Felderhof Joeke, van Dam Iris, Slotman Ben J, Kirby Anna M, Verkooijen Helena M, van der Velde Susanne, van der Leij Femke, van den Bongard H J G Desirée
Department of Radiation Oncology, Amsterdam UMC location Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; Cancer Center Amsterdam, Cancer Treatment and Quality of Life/Cancer Biology and Immunology, Amsterdam, The Netherlands.
Department of Radiation Oncology, UMC Utrecht, Utrecht, The Netherlands.
Int J Radiat Oncol Biol Phys. 2025 Mar 1;121(3):613-622. doi: 10.1016/j.ijrobp.2024.07.2326. Epub 2024 Aug 2.
Preoperative partial breast irradiation (PBI) can increase accuracy of target volume definition and decrease irradiated volumes compared with postoperative PBI. In the ABLATIVE trial (NCT02316561), 15 of 36 patients achieved pathologic complete response 6 to 8 months after preoperative PBI and breast-conserving surgery (BCS). We now present the 5-year results.
The ABLATIVE trial is a Dutch prospective cohort study conducted in 4 hospitals. Women aged ≥50 years with unifocal, nonlobular breast cancer, estrogen receptor-positive, HER2-negative, and a tumor negative sentinel node were treated between 2015 and 2018 with preoperative single-dose PBI followed by BCS after 6 or 8 months. The primary endpoint was pathologic complete response. Secondary endpoints were annually evaluated oncological outcomes, toxicity, cosmetic outcome (assessed by patients and physicians), and quality of life.
Thirty-six patients were treated with BCS 6 (n = 15) and 8 (n = 21) months following PBI. Median tumor size was 13 mm (IQR 9-16 mm). After a median follow-up of 5.5 years (IQR, 5.1-6.0), 2 (6%) patients had ipsilateral breast events and 2 (6%) distant metastases. The 5-year overall survival was 94% (95% CI, 87-100). The 5-year cumulative incidence of clinician-reported grade 1/2 breast fibrosis and breast discomfort/pain were 94%/6% and 75%/6%, respectively. The proportion of patients (very) satisfied with the cosmetic results was 89% at baseline and 78% at 5 years. Cosmetic results evaluated using the BCCT.core software were excellent or good in all patients. The 4-year median global quality of life score was 83 (IQR, 67-92), similar to baseline (83; IQR, 75-83; P = .42).
Preoperative single-dose PBI and BCS may be an oncologically safe treatment with mild late toxicity and no decline in cosmetic results and quality of life during 5 years of follow-up. This means that preoperative instead of standard postoperative irradiation has the potential to challenge the current clinical practice.
与术后部分乳腺照射（PBI）相比，术前PBI可提高靶体积定义的准确性并减少照射体积。在ABLATIVE试验（NCT02316561）中，36例患者中有15例在术前PBI和保乳手术（BCS）后6至8个月达到病理完全缓解。我们现在展示5年的结果。
ABLATIVE试验是一项在4家医院进行的荷兰前瞻性队列研究。年龄≥50岁、患有单灶性、非小叶性乳腺癌、雌激素受体阳性、人表皮生长因子受体2阴性且前哨淋巴结阴性的女性在2015年至2018年间接受术前单次剂量PBI治疗，并在6或8个月后接受BCS。主要终点是病理完全缓解。次要终点是每年评估的肿瘤学结局、毒性、美容效果（由患者和医生评估）以及生活质量。
36例患者在PBI后6个月（n = 15）和8个月（n = 21）接受了BCS。肿瘤大小中位数为13 mm（四分位间距9 - 16 mm）。中位随访5.5年（四分位间距，5.1 - 6.0）后，2例（6%）患者发生同侧乳腺事件，2例（6%）发生远处转移。5年总生存率为94%（95%置信区间，87 - 100）。临床医生报告的1/2级乳腺纤维化和乳腺不适/疼痛的5年累积发生率分别为94%/6%和75%/6%。对美容效果（非常）满意的患者比例在基线时为89%，在5年时为78%。使用BCCT.core软件评估的美容效果在所有患者中均为优秀或良好。4年中位总体生活质量评分为83（四分位间距，67 - 92），与基线（83；四分位间距，75 - 83；P = 0.42）相似。
术前单次剂量PBI和BCS可能是一种肿瘤学上安全的治疗方法，晚期毒性轻微，在5年随访期间美容效果和生活质量无下降。这意味着术前而非标准的术后照射有可能挑战当前的临床实践。
