Breast Cancer Radiation Therapy Unit, Sheba Medical Center, Ramat Gan, Israel; The School of Medicine, Tel-Aviv University, Tel-Aviv, Israel; Dept. Radiation Oncology (Maastro), GROW-Research Institute for Oncology and Reproduction, Maastricht University Medical Centre+, Maastricht, the Netherlands.
Dept. Radiation Oncology (Maastro), GROW-Research Institute for Oncology and Reproduction, Maastricht University Medical Centre+, Maastricht, the Netherlands.
Radiother Oncol. 2024 Dec;201:110563. doi: 10.1016/j.radonc.2024.110563. Epub 2024 Sep 26.
The EORTC 22922/10925 trial aimed to investigate the impact on overall survival (OS) of elective internal mammary and medial supraclavicular (IM-MS) radiation therapy (RT) in breast cancer stage I-III. Surgery for the primary tumour and axillary lymph nodes, chest wall RT, boost RT after whole breast RT in breast conserving therapy (BCT), RT to operated axilla, and systemic therapy were per physician's preference. The aim of the current analysis is to assess breast cancer outcomes according to different locoregional and systemic therapy used in the trial.
MATERIAL/METHODS: Data with a median follow-up of 15.7 years were extracted from the trial's case report forms. Kaplan-Meier curves of disease-free and OS and cumulative incidence curves of breast cancer events were produced. An exploratory analysis of the effect of the type of locoregional and systemic therapy on breast cancer outcomes was conducted using the Cox model or the Fine & Gray model accounting for competing risks, both models being adjusted for baseline patient and disease characteristics and treatment. The significance level was set at 5 %, 2-sided.
Of the 4,004 patients included, 625 (16%) did not receive any postoperative systemic therapy, 1,185 (30%) received endocrine therapy only, 994 (25%) chemotherapy only, and 1,200 (30%) both chemotherapy and endocrine therapy, without differences between the randomisation arms. Administration and type of therapy was associated with age, menopausal status, clinical T- and N-stage and ER status (p < 0.0001). Local control was better with mastectomy (with/without postmastectomy RT) as compared to BCT, but mastectomy was associated with more distant metastasis (DM) as first event. Similarly, DM as first event occurred more in the BCT group that received a boost as compared to no boost and in those who received RT to the lower axillary level. IM-MS RT reduced significantly regional recurrences and improved disease-free survival in a sensitivity stratified analysis. OS was worse with mastectomy as compared to BCT and with irradiation of the axilla but better with sentinel node dissection and adjuvant combined chemo and hormonal therapy.
Different components of therapy influenced the site of first event. IM-MS RT improved outcomes in different breast cancer outcomes were most probably related that the group were balanced due to the trial arms and stratification methods.
EORTC22922/10925 试验旨在研究选择性内乳和内侧锁骨上（IM-MS）放射治疗（RT）对乳腺癌 I-III 期患者总生存（OS）的影响。主要肿瘤和腋窝淋巴结手术、胸壁 RT、保乳治疗（BCT）后全乳 RT 的局部加量 RT、腋窝手术 RT 以及全身治疗均根据医生的偏好进行。本分析的目的是评估试验中使用的不同局部和全身治疗对乳腺癌结局的影响。
材料/方法：从试验病例报告表中提取中位随访 15.7 年的数据。绘制无病生存（DFS）和 OS 的 Kaplan-Meier 曲线和乳腺癌事件的累积发生率曲线。使用 Cox 模型或 Fine-Gray 模型（考虑竞争风险）对局部和全身治疗类型对乳腺癌结局的影响进行探索性分析，两个模型均根据基线患者和疾病特征以及治疗进行调整。显著性水平设定为 5%，双侧。
在纳入的 4004 例患者中，625 例（16%）未接受任何术后全身治疗，1185 例（30%）仅接受内分泌治疗，994 例（25%）仅接受化疗，1200 例（30%）同时接受化疗和内分泌治疗，各随机分组间无差异。治疗的实施和类型与年龄、绝经状态、临床 T 和 N 分期以及 ER 状态相关（p<0.0001）。与 BCT 相比，乳房切除术（伴或不伴乳房切除术 RT）局部控制更好，但乳房切除术与更多远处转移（DM）作为首发事件相关。同样，在接受局部加量 RT 的 BCT 组中，DM 作为首发事件的发生率高于未接受局部加量 RT 组，在接受下腋窝水平 RT 的 BCT 组中，DM 作为首发事件的发生率更高。IM-MS RT 分层分析显示，可显著减少区域复发，改善无病生存。与 BCT 相比，乳房切除术 OS 较差，与腋窝照射相比 OS 较好，与前哨淋巴结清扫术和辅助联合化疗和激素治疗相比 OS 较好。
不同的治疗成分影响首发事件的部位。IM-MS RT 改善了不同乳腺癌结局，这可能与由于试验臂和分层方法，各组之间平衡有关。
