近日，英国爱丁堡大学Ian H. Kunkler团队研究了乳腺癌症术后胸壁放疗后10年生存率。相关论文于2025年11月6日发表在《新英格兰医学杂志》上。

乳腺切除术后胸壁照射在pN1（累及1 - 3个腋窝淋巴结）或pN0（病理淋巴结阴性）伴有其他危险因素的乳腺癌患者中的作用尚不确定。

在这项国际iii期随机试验中，研究组评估了“中危”乳腺癌患者胸壁照射的遗漏，该乳腺癌定义为pT1N1期、pT2N1期、pT3N0期或pT2N0期，组织学分级为3级，淋巴血管浸润，或两者兼而有之（肿瘤大小：T1，≤2cm; T2, 2cm ~ 5cm; T3, 5cm），并接受乳房切除术、腋下手术和全身治疗。患者被分配接受胸壁照射（40 ~ 50 Gy；照射组）或不接受胸壁照射（无照射组）。主要终点是总生存期，随访10年。胸壁复发、局部复发、无病生存、无远处转移生存、死亡原因和辐射相关不良事件也进行了评估。

意向治疗人群中放疗组808例，非放疗组799例。中位随访时间为9.6年。根据10年Kaplan-Meier估计，胸壁照射的总生存率为81.4%，未胸壁照射的总生存率为81.9%（死亡风险比为1.04；95%可信区间为0.82 ~ 1.30；P=0.80）。共有29例患者出现胸壁复发，其中放疗组9例（1.1%），未放疗组20例（2.5%）（组间差异2个百分点；风险比0.45;95% CI 0.20 ~ 0.99）。放疗组和非放疗组的无病生存率分别为76.2%和75.5%（复发或死亡的危险比为0.97；95% CI为0.79至1.18），无远处转移生存率分别为78.2%和79.2%（远处转移或死亡的危险比为1.06；95% CI为0.86至1.31）。

研究结果表明，在这项试验中，在接受乳房切除术和当代辅助全身治疗的中危早期乳腺癌患者中，胸壁照射并没有导致比不进行胸壁照射更高的总生存率。

附：英文原文

Title: Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer

Author: Ian H. Kunkler, Nicola S. Russell, Niall Anderson, Richard Sainsbury, J. Michael Dixon, David Cameron, Juliette Loncaster, Matthew Hatton, Helen Westenberg, Jackie Clarke, Heather McCarty, Rhun Evans, Konstantinos Geropantas, Virginia Wolstenholme, Abdulla Alhasso, Pamela Woodings, Lisa Barraclough, Neil Bayman, Richard Welch, Fidelis Muturi, Tracy McEleney, Jacqueline Burns, Kathleen Riddle, Eve Macdonald, Joanna Dunlop, Nicole Sergenson, Geertjan van Tienhoven, Karen J. Taylor, John M.S. Bartlett, Tammy Piper, Galina Velikova, Edwin Aird, Boon Chua, Coen Hurkmans, Karen Venables, Linda J. Williams, Jeremy S. Thomas, Andrew M. Hanby, Marjory Maclennan, Susan Cleator, Eldo T. Verghese, Yexiong Li, Shulian Wang, Peter Canney

Issue&Volume: 2025-11-06

Abstract:

BACKGROUND

The role of postmastectomy chest-wall irradiation in patients with breast cancer classified as pN1 (with involvement of one to three axillary nodes) or pN0 (pathologically node negative) with additional risk factors is uncertain.

METHODS

In this international, phase 3, randomized trial, we evaluated the omission of chest-wall irradiation in women with “intermediate-risk” breast cancer — defined as cancer that was stage pT1N1, pT2N1, or pT3N0 or stage pT2N0 with a histologic grade of 3, lymphovascular invasion, or both (tumor size: T1, ≤2 cm; T2, >2 cm to 5 cm; or T3, >5 cm) — that was treated with mastectomy, an axillary procedure, and systemic therapy. Patients were assigned to undergo chest-wall irradiation (40 to 50 Gy; the irradiation group) or not to undergo chest-wall irradiation (the no-irradiation group). The primary end point was overall survival, with 10 years of follow-up. Chest-wall recurrence, regional recurrence, disease-free survival, distant metastasis–free survival, causes of death, and radiation-related adverse events were also assessed.

RESULTS

The intention-to-treat population included 808 patients in the irradiation group and 799 in the no-irradiation group. The median follow up was 9.6 years. Overall survival was 81.4% with chest-wall irradiation and 81.9% with no chest-wall irradiation according to 10-year Kaplan–Meier estimates (hazard ratio for death, 1.04; 95% confidence interval [CI], 0.82 to 1.30; P=0.80). A total of 29 patients had a chest-wall recurrence — 9 (1.1%) in the irradiation group and 20 (2.5%) in the no-irradiation group (between-group difference, <2 percentage points; hazard ratio, 0.45; 95% CI, 0.20 to 0.99). Disease-free survival was 76.2% in the irradiation group and 75.5% in the no-irradiation group (hazard ratio for recurrence or death, 0.97; 95% CI, 0.79 to 1.18), and distant metastasis–free survival was 78.2% and 79.2%, respectively (hazard ratio for distant metastasis or death, 1.06; 95% CI, 0.86 to 1.31).

CONCLUSIONS

In this trial, chest-wall irradiation did not result in higher overall survival than no chest-wall irradiation among patients with intermediate-risk, early breast cancer treated with mastectomy and contemporary adjuvant systemic therapy.

DOI: NJ202511063931807

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2412225