Department of Radiation Oncology, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.
Department of Radiation Oncology, Seoul National University College of Medicine, Seoul, Republic of Korea.
BMC Cancer. 2022 Nov 16;22(1):1179. doi: 10.1186/s12885-022-10285-0.
Postoperative radiotherapy (PORT) could be useful for pN1 breast cancer patients who have undergone breast-conserving surgery (BCS) or mastectomy. However, the value of regional nodal irradiation (RNI) for BCS patients, and the indications for post-mastectomy radiotherapy (PMRT) for pN1 breast cancer mastectomy patients, have recently been challenged due to the absence of relevant trials in the era of modern systemic therapy. "PORT de-escalation" should be assessed in patients with pN1 breast cancer.
The PORT-N1 trial is a multicenter, randomized, phase 3 clinical trial for patients with pN1 breast cancer that compares the outcomes of control [whole-breast irradiation (WBI) and RNI/PMRT] and experimental (WBI alone/no PMRT) groups. PORT-N1 aims to demonstrate non-inferiority of the experimental group by comparing 7-year disease-free survival rates with the control group. Female breast cancer patients with pT1-3 N1 status after BCS or mastectomy are eligible. Participants will be randomly assigned to the two groups in a 1:1 ratio. Randomization will be stratified by surgery type (BCS vs. mastectomy) and histologic subtype (triple-negative vs. non-triple-negative). In patients who receive mastectomy, dissection of ≥5 nodes is required when there is one positive node, and axillary lymph node dissection when there are two or three positive nodes. Patients receiving neoadjuvant chemotherapy are not eligible. RNI includes a "high-tangent" or wider irradiation field. This study will aim to recruit 1106 patients.
The PORT-N1 trial aims to verify that PORT de-escalation after BCS or mastectomy is safe for pN1 breast cancer patients in terms of oncologic outcomes and capable of reducing toxicity rates. This trial will provide information crucial for designing PORT de-escalation strategies for patients with pN1 breast cancer.
This trial was registered at ClinicalTrials.gov (NCT05440149) on June 30, 2022.
对于接受保乳手术（BCS）或乳房切除术的 pN1 乳腺癌患者，术后放疗（PORT）可能有用。然而，由于在现代系统治疗时代缺乏相关试验，BCS 患者的区域淋巴结照射（RNI）和 pN1 乳腺癌乳房切除术患者的术后放疗（PMRT）的适应证最近受到了挑战。应该对 pN1 乳腺癌患者进行“PORT 降级”评估。
PORT-N1 试验是一项针对 pN1 乳腺癌患者的多中心、随机、III 期临床试验，比较了对照组[全乳照射（WBI）和 RNI/PMRT]和实验组（WBI 单药/无 PMRT）的结果。PORT-N1 旨在通过比较 7 年无病生存率来证明实验组的非劣效性。BCS 或乳房切除术后 pT1-3N1 状态的女性乳腺癌患者符合条件。参与者将按 1:1 的比例随机分配到两组。随机分组将按手术类型（BCS 与乳房切除术）和组织学亚型（三阴性与非三阴性）分层。在接受乳房切除术的患者中，当有一个阳性淋巴结时需要至少 5 个淋巴结的解剖，当有两个或三个阳性淋巴结时需要进行腋窝淋巴结清扫。接受新辅助化疗的患者不符合条件。RNI 包括“高切线”或更广泛的照射野。该研究计划招募 1106 名患者。
PORT-N1 试验旨在验证对于 pN1 乳腺癌患者，BCS 或乳房切除术后 PORT 降级在肿瘤学结果方面是安全的，并且能够降低毒性发生率。该试验将为设计 pN1 乳腺癌患者的 PORT 降级策略提供关键信息。
该试验于 2022 年 6 月 30 日在 ClinicalTrials.gov（NCT05440149）注册。
