Department of Radiation Oncology, Brown Cancer Center, University of Louisville School of Medicine, Louisville, KY, USA.
Biostatistics and Bioinformatics Facility, James Graham Brown Cancer Center, University of Louisville, Louisville, KY, USA.
Ann Surg Oncol. 2021 Oct;28(11):5880-5892. doi: 10.1245/s10434-021-09777-3. Epub 2021 Mar 18.
To report an interim analysis of a phase II trial of once weekly, hypofractionated breast irradiation (WH-WBI) following breast conserving surgery (BCS).
Patients had stage 0-II breast cancer treated with breast BCS with negative margins. WH-WBI was 28.5 or 30Gy delivered to the whole breast using tangential beams with no elective coverage of lymph nodes. The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Secondary endpoints were distant disease-free survival (DDFS), recurrence free survival (RFS), overall survival (OS), adverse events and cosmesis.
From 2011 to 2015, 158 patients received WH-WBI. Median follow up was 4.4 years (range 0.2-8.1). Stage distribution was DCIS 22%; invasive pN0 68%; invasive pN1 10%. 80 patients received 30 Gy and 78 received 28.5 Gy with median follow up times of 5.6 and 3.7 years, respectively. There were 5 IBTR events, all in the 30 Gy group. The 5- and 7- year risks of IBRT for all patients were 2.2% (95% CI 0.6-5.8) and 6.0% (95% CI 1.1-17.2), respectively. The 7-year rates of DDFS, RFS, and OS were 96.3%, 91.5% and 89.8%, respectively. Improvement in IBTR-free time was seen in DCIS, lobular histology, low grade tumors, Her2 negative tumors and 28.5 Gy dose (all p < 0.0001).
Disease-specific outcomes after WH-WBI are favorable and parallel those seen with conventional radiation techniques for stage 0-II breast cancer.
报告保乳手术后每周一次、低分割乳房照射（WH-WBI）的 II 期试验的中期分析结果。
患者患有 0 期-II 期乳腺癌，接受了保乳手术（BCS）且切缘阴性。WH-WBI 采用切线野照射 28.5 或 30Gy 全乳剂量，不选择性覆盖淋巴结。主要终点为同侧乳房肿瘤复发（IBTR）。次要终点为远处无病生存（DDFS）、无复发生存（RFS）、总生存（OS）、不良事件和美容效果。
2011 年至 2015 年，158 例患者接受了 WH-WBI。中位随访时间为 4.4 年（范围 0.2-8.1 年）。分期分布为 DCIS 22%；浸润性 pN0 68%；浸润性 pN1 10%。80 例患者接受 30 Gy，78 例患者接受 28.5 Gy，中位随访时间分别为 5.6 年和 3.7 年。30 Gy 组有 5 例 IBTR 事件。所有患者的 5 年和 7 年 IBTR 风险分别为 2.2%（95%CI 0.6-5.8）和 6.0%（95%CI 1.1-17.2）。7 年 DDFS、RFS 和 OS 率分别为 96.3%、91.5%和 89.8%。在 DCIS、小叶组织学、低级别肿瘤、Her2 阴性肿瘤和 28.5 Gy 剂量方面，IBTR 无复发生存时间均有所改善（均<0.0001）。
WH-WBI 后的疾病特异性结果是有利的，与 0 期-II 期乳腺癌的常规放疗技术结果相当。
