背景:锁骨上淋巴结(SCL)照射通常用于乳腺癌术后高危乳腺癌患者。放射治疗肿瘤组(RTOG)和欧洲放射治疗和肿瘤学会(ESTRO)乳房轮廓图谱描绘了SCL区域的内侧部分,而不包括后外侧部分。然而,最近的研究发现,很大一部分SCL失败位于后外侧SCL区域,在RTOG/ESTRO定义的SCL目标卷之外。因此,许多放射肿瘤学家主张扩大SCL照射目标体积,使其同时包括内侧和后外侧SCL区域.然而,对于高危乳腺癌患者,增加后外侧SCL照射是否能改善生存结局仍不确定.
方法:SUCLANODE试验是一个开放标签,多中心,随机化,3期试验比较内侧SCL照射(M-SCLI组)和内侧加后外侧SCL照射(整个SCL照射,E-SCLI组)在接受保乳手术或乳房切除术的高危乳腺癌患者中。初次手术后患有病理性N2-3b疾病的患者,或临床III期或病理性N1-3b,如果接受新辅助系统治疗,符合条件并随机分配(1:1)到M-SCLI组和E-SCLI组。按化疗顺序分层(新辅助与佐剂),T级(T3-4vs.T1-2),N级(N1-2vs.N3),和ER状态(阳性vs.负)。两个臂中的其他辐射量相同,包括乳房/胸壁,未解剖的腋窝淋巴结,和乳腺内结节.先进的调强放射治疗(IMRT),体积调制电弧治疗(VMAT),或断层治疗技术的建议。允许低分馏和常规分馏时间表。主要终点是侵袭性无病生存率,次要终点包括总生存期,SCL复发,局部区域复发,距离复发,安全结果,和患者报告的结果。目标样本量为1650名参与者。
结论:SUCLANODE试验的结果将提供高水平的证据,证明在内侧SCL目标体积中增加后外侧SCL照射是否能在高危乳腺癌患者中提供生存益处。
背景:ClinicalTrials.gov标识符:NCT05059379。2021年9月28日注册,https://www.
结果:gov/ct2/show/NCT05059379。
BACKGROUND: Supraclavicular nodal (SCL) irradiation is commonly used for patients with high-risk breast cancer after breast surgery. The Radiation Therapy Oncology Group (RTOG) and European Society for Radiotherapy and Oncology (ESTRO) breast contouring atlases delineate the medial part of the SCL region, while excluding the posterolateral part. However, recent studies have found that a substantial proportion of SCL failures are located in the posterolateral SCL region, outside of the RTOG/ESTRO-defined SCL target volumes. Consequently, many radiation oncologists advocate for enlarging the SCL irradiation target volume to include both the medial and posterolateral SCL regions. Nevertheless, it remains uncertain whether adding the posterolateral SCL irradiation improves survival outcomes for high-risk breast cancer patients.
METHODS: The SUCLANODE trial is an open-label, multicenter, randomized, phase 3 trial comparing the efficacy and adverse events of medial SCL irradiation (M-SCLI group) and medial plus posterolateral SCL irradiation (entire SCL irradiation, E-SCLI group) in high-risk breast cancer patients who underwent breast conserving-surgery or mastectomy. Patients with pathological N2-3b disease following initial surgery, or clinical stage III or pathological N1-3b if receiving neoadjuvant systemic therapy, are eligible and randomly assigned (1:1) to M-SCLI group and E-SCLI group. Stratification is by chemotherapy sequence (neoadjuvant vs. adjuvant), T stage (T3-4 vs. T1-2), N stage (N1-2 vs. N3), and ER status (positive vs. negative). Other radiation volumes are identical in the two arms, including breast/chest wall, undissected axillary lymph node, and internal mammary node. Advanced intensity modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), or tomotherapy techniques are recommended. Both hypofractionated and conventional fractionation schedules are permitted. The primary end point is invasive disease-free survival, and secondary end points included overall survival, SCL recurrence, local-regional recurrence, distance recurrence, safety outcome, and patient-reported outcomes. The target sample size is 1650 participants.
CONCLUSIONS: The results of the SUCLANODE trial will provide high-level evidence regarding whether adding posterolateral SCL irradiation to medial SCL target volume provides survival benefit in patients with high-risk breast cancer.
BACKGROUND: ClinicalTrials.gov Identifier: NCT05059379. Registered 28 September 2021, https://www.
RESULTS: gov/ct2/show/NCT05059379 .