Breast Cancer Radiation Therapy Unit, Sheba Medical Center, Ramat Gan, Israel; Sackler School of Medicine, Tel-Aviv University, Israel; GROW-School for Oncology and Developmental Biology or GROW (Maastro), Maastricht University, The Netherlands.
The European Organisation for Research and Treatment of Cancer (EORTC) Headquarters, Brussels, Belgium.
Radiother Oncol. 2022 Jul;172:99-110. doi: 10.1016/j.radonc.2022.05.006. Epub 2022 May 12.
The multicentre EORTC 22922/10925 trial (ClinicalTrials.gov, NCT00002851) was conducted between 1996 and 2004. The trial evaluated the effect of irradiation of the internal mammary and medial supraclavicular lymph node chains (IM-MS) vs no further radiation therapy (RT) on survival and cause of death in breast cancer stage I-III patients. At 15.7 years of median follow-up, a significant reduction of breast cancer specific mortality (BCSM) and any recurrence, not translating in improved overall survival (OS), and low absolute rates of side effects were found. The aim of the current analysis was to evaluate the association of RT techniques of IM-MS lymph node irradiation with long-term outcomes.
Three RT techniques were used for IM-MS: a standard technique using a fixed set-up combining photon/electron beams to the IM and tangential fields to the breast or chest wall vs a standard-modified technique with minor adaptation for beam settings vs a more individualised technique based on individual localisation of the IM. Techniques used were fixed per institution over the duration of the trial. We performed an exploratory and descriptive analysis of the outcomes after 15 years follow-up for the three RT techniques.
Between July 1996 and January 2004, 46 radiation oncology departments from 13 countries accrued 4004 patients. Median follow-up was 15.7 years. The number of patients treated by each technique was 2440 (61%) by standard vs 635 (16%) by standard-modified vs 929 (23%) patients by individualised technique. The absolute improvements of oncological outcomes in terms of disease-free survival (DFS), OS and BCSM with IM-MS RT compared to no IM-MS RT were 6.8%, 4.9% and -5.8% for the individualised technique, vs 1.6%, 2.9% and -4.3% for modified standard and -1.4%, 1.1% and -3% for standard technique, respectively. The increase in 15-year rates of side effects due to IM-MS RT, both scored longitudinally and cross-sectionally, were similar among the techniques.
Even though a straightforward comparison by technique is not possible because of variations in baseline characteristics between institutions, our findings suggest that the use of more individualised RT techniques is associated with higher rates of oncological improvements without increased risks for late side effects.
EORTC 22922/10925 多中心试验（ClinicalTrials.gov，NCT00002851）于 1996 年至 2004 年进行。该试验评估了对 I 期至 III 期乳腺癌患者照射内乳和内侧锁骨上淋巴结链（IM-MS）与不进行进一步放射治疗（RT）对生存和死亡原因的影响。在中位随访 15.7 年后，发现乳腺癌特异性死亡率（BCSM）和任何复发均显著降低，但总生存（OS）无改善，且副作用的绝对发生率较低。本分析的目的是评估 IM-MS 淋巴结照射的 RT 技术与长期结果的相关性。
三种 RT 技术用于 IM-MS：一种标准技术，使用固定设置，将光子/电子束联合用于 IM 和乳房或胸壁切线野，或一种标准改良技术，对射束设置进行较小的调整，或一种更个体化的技术，基于 IM 的个体化定位。试验期间，各机构均采用固定技术。我们对三种 RT 技术 15 年随访后的结果进行了探索性和描述性分析。
1996 年 7 月至 2004 年 1 月，来自 13 个国家的 46 个放射肿瘤学部门共入组 4004 例患者。中位随访时间为 15.7 年。接受每种技术治疗的患者人数分别为：标准技术 2440 例（61%），标准改良技术 635 例（16%），个体化技术 929 例（23%）。与不进行 IM-MS RT 相比，IM-MS RT 的无病生存（DFS）、OS 和 BCSM 的肿瘤学结局绝对改善分别为个体化技术 6.8%、4.9%和-5.8%，改良标准技术 1.6%、2.9%和-4.3%，标准技术 1.4%、1.1%和-3%。由于 IM-MS RT，15 年时的不良反应发生率无论纵向还是横向评分，在各技术之间均相似。
尽管由于机构间基线特征的差异，无法直接比较技术，但我们的发现表明，使用更个体化的 RT 技术与更高的肿瘤学改善率相关，而不会增加晚期副作用的风险。
