Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Department of Obstetrics and Gynecology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Strahlenther Onkol. 2019 Jul;195(7):640-647. doi: 10.1007/s00066-019-01438-5. Epub 2019 Feb 22.
Partial breast irradiation using intraoperative radiotherapy (IORT) after breast-conserving surgery could be sufficient for a selected group of breast cancer patients. We report the results of a cohort of patients from a single center treated as part of the randomized phase-3 TARGIT-A trial.
Patients (≥50 years) with cT1 cN0 cM0 and invasive ductal histology on biopsy were randomized between IORT with 20 Gy (arm-A) or postoperative whole-breast RT (WBRT) up to 56 Gy in 2 Gy fractions (arm-B). Postoperatively, patients in arm-A with multifocality, lymphovascular invasion, nodal invasion, extensive intraductal component, invasive lobular carcinoma, or resection margins <1 cm received additional postoperative WBRT.
Between 2002 and 2012, 184 patients were randomized, of whom 90 in arm-A and 90 in arm-B were evaluated. Median follow-up was 8.5 years. The 5‑year overall survival was 94.4% in arm-A and 93.3% in arm-B (p = 0.73). Two local recurrences were observed: one at 70.3 months in an arm-A patient who received IORT + WBRT and another at 4.5 months in an arm-B patient who refused all forms of adjuvant treatment, thus resulting in a 5-year local recurrence of 0% in arm-A and 1.1% in arm-B. The 5‑year in-breast recurrence (outside of the index quadrant) was 0% in arm-A and 1.2% in arm-B. Salvage mastectomy was performed successfully in all patients with relapse.
Long-term follow-up of this single-center cohort consolidates the earlier reports of low local recurrence rates after single-dose IORT. Our results are in line with non-inferiority of risk-adapted IORT for selected patients with early breast cancer.
保乳手术后采用术中放疗（IORT）进行部分乳房照射，可能足以满足一部分乳腺癌患者的需求。我们报告了一项来自单一中心的患者队列的结果，这些患者是作为随机 3 期 TARGIT-A 试验的一部分进行治疗的。
≥50 岁、cT1cN0cM0、活检为浸润性导管组织学的患者，在 IORT 20Gy（A 组）与术后全乳放疗（WBRT）至 56Gy/2Gy 分次（B 组）之间进行随机分组。术后，A 组中多发病灶、脉管侵犯、淋巴结侵犯、广泛导管内成分、浸润性小叶癌或切缘<1cm 的患者，接受额外的术后 WBRT。
在 2002 年至 2012 年间，共有 184 名患者进行了随机分组，其中 A 组 90 名，B 组 90 名。中位随访时间为 8.5 年。A 组 5 年总生存率为 94.4%，B 组为 93.3%（p=0.73）。观察到 2 例局部复发：1 例发生在 A 组患者中，于 70.3 个月时出现，该患者接受了 IORT+WBRT；另 1 例发生在 B 组患者中，于 4.5 个月时出现，该患者拒绝接受任何辅助治疗，导致 A 组 5 年局部复发率为 0%，B 组为 1.1%。A 组的 5 年乳房内复发（指数象限外）为 0%，B 组为 1.2%。所有复发患者均成功进行了挽救性乳房切除术。
该单中心队列的长期随访结果巩固了早期单剂量 IORT 后局部复发率较低的报告。我们的结果与风险适应性 IORT 对早期乳腺癌患者的非劣效性一致。
