Fastner Gerd, Reitsamer Roland, Gaisberger Christoph, Hitzl Wolfgang, Urbański Bartosz, Murawa Dawid, Matuschek Christiane, Budach Wilfried, Ciabattoni Antonella, Reiland Juliann, Molnar Marie, Vidali Cristiana, Schumacher Claudia, Sedlmayer Felix
Department of Radiotherapy and Radio-Oncology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, 5020 Salzburg, Austria.
Department of Gynecology, Paracelsus Medical University, University Hospital Salzburg, Landeskrankenhaus, 5020 Salzburg, Austria.
Cancers (Basel). 2022 Mar 9;14(6):1396. doi: 10.3390/cancers14061396.
Background and purpose: To investigate intraoperative electron radiation therapy (IOERT) as a tumor bed boost during breast conserving surgery (BCS) followed by hypofractionated whole breast irradiation (HWBI) on age-correlated in-breast recurrence (IBR) rates in patients with low- to high-risk invasive breast cancer. Material and methods: BCS and IOERT (11.1 Gy) preceded a HWBI (40.5 Gy) in 15 fractions. Five-year IBR-rates were compared by a sequential ratio test (SQRT) with best evidences in three age groups (35−40 y and 41−50 y: 3.6%, >50 y: 2%) in a prospective single arm design. Null hypothesis (H0) was defined to undershoot these benchmarks for proof of superiority. Results: Of 1445 enrolled patients, 326 met exclusion criteria, leaving 1119 as eligible for analysis. After a median follow-up of 50 months (range 0.7−104), we detected two local recurrences, both in the age group >50 y. With no observed IBR, superiority was demonstrated for the patient groups 41−50 and >50 y, respectively. For the youngest group (35−40 y), no appropriate statistical evaluation was yet possible due to insufficient recruitment. Conclusions: In terms of five-year IBR-rates, Boost-IOERT followed by HWBI has been demonstrated to be superior in patients older than 50 and in the age group 41−50 when compared to best published evidence until 2010.
探讨术中电子放射治疗（IOERT）作为保乳手术（BCS）后瘤床加量放疗，随后进行大分割全乳照射（HWBI）对低至高危浸润性乳腺癌患者年龄相关的乳腺内复发（IBR）率的影响。材料与方法：15次分割的HWBI（40.5 Gy）之前先进行BCS和IOERT（11.1 Gy）。在前瞻性单臂设计中，通过序贯比检验（SQRT）比较三个年龄组（35 - 40岁和41 - 50岁：3.6%，>50岁：2%）的五年IBR率，并以最佳证据为参照。定义零假设（H0）低于这些基准以证明优越性。结果：在1445名入组患者中，326名符合排除标准，剩余1119名符合分析条件。中位随访50个月（范围0.7 - 104个月）后，我们检测到两例局部复发，均在>50岁年龄组。未观察到IBR，分别证明了41 - 50岁和>50岁患者组的优越性。对于最年轻的组（35 - 40岁），由于入组不足，尚无合适的统计学评估。结论：就五年IBR率而言，与2010年之前发表的最佳证据相比，IOERT加量放疗后进行HWBI已证明在50岁以上患者和41 - 50岁年龄组中具有优越性。
