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Effect of Elective Internal Mammary Node Irradiation on Disease-Free Survival in Women With Node-Positive Breast Cancer: A Randomized Phase 3 Clinical Trial

 Yong Bae Kim  ;  Hwa Kyung Byun  ;  Dae Yong Kim  ;  Sung-Ja Ahn  ;  Hyung-Sik Lee  ;  Won Park  ;  Su Ssan Kim  ;  Jin Hee Kim  ;  Kyu Chan Lee  ;  Ik Jae Lee  ;  Won Taek Kim  ;  Hyun Soo Shin  ;  Kyubo Kim  ;  Kyung Hwan Shin  ;  Chung Mo Nam  ;  Chang-Ok Suh 
 JAMA ONCOLOGY, Vol.8(1) : 96-105, 2022-01 
Journal Title
Issue Date
Breast Neoplasms* / pathology ; Disease-Free Survival ; Female ; Humans ; Lymph Nodes / pathology ; Mastectomy ; Middle Aged ; Progression-Free Survival
Importance: The benefit of internal mammary node irradiation (IMNI) for treatment outcomes in node-positive breast cancer is unknown.

Objective: To investigate whether the inclusion of IMNI in regional nodal irradiation improves disease-free survival (DFS) in women with node-positive breast cancer.

Design, setting, and participants: This multicenter, phase 3 randomized clinical trial was conducted from June 1, 2008, to February 29, 2020, at 13 hospitals in South Korea. Women with pathologically confirmed, node-positive breast cancer after breast-conservation surgery or mastectomy with axillary lymph node dissection were eligible and enrolled between November 19, 2008, and January 14, 2013. Patients with distant metastasis and those who had received neoadjuvant treatment were excluded. Data analyses were performed according to the intention-to-treat principle.

Interventions: All patients underwent regional nodal irradiation along with breast or chest wall irradiation. They were randomized 1:1 to receive radiotherapy either with IMNI or without IMNI.

Main outcomes and measures: The primary end point was the 7-year DFS. Secondary end points included the rates of overall survival, breast cancer-specific survival, and toxic effects.

Results: A total of 735 women (mean [SD] age, 49.0 [9.1] years) were included in the analyses, of whom 373 received regional nodal irradiation without IMNI and 362 received regional nodal irradiation with IMNI. Nearly all patients underwent taxane-based adjuvant systemic treatment. The median (IQR) follow-up was 100.4 (89.7-112.1) months. The 7-year DFS rates did not significantly differ between the groups treated without IMNI and with IMNI (81.9% vs 85.3%; hazard ratio [HR], 0.80; 95% CI, 0.57-1.14; log-rank P = .22). However, an ad hoc subgroup analysis showed significantly higher DFS rates with IMNI among patients with mediocentrally located tumors. In this subgroup, the 7-year DFS rates were 81.6% without IMNI vs 91.8% with IMNI (HR, 0.42; 95% CI, 0.22-0.82; log-rank P = .008), and the 7-year breast cancer mortality rates were 10.2% without IMNI vs 4.9% with IMNI (HR, 0.41; 95% CI, 0.17-0.99; log-rank P = .04). No differences were found between the 2 groups in the incidence of adverse effects, including cardiac toxic effects and radiation pneumonitis.

Conclusions and relevance: This randomized clinical trial found that including IMNI in regional nodal irradiation did not significantly improve the DFS in patients with node-positive breast cancer. However, patients with medially or centrally located tumors may benefit from the use of IMNI.

Trial registration: ClinicalTrials.gov Identifier: NCT04803266.
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Preventive Medicine (예방의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiation Oncology (방사선종양학교실) > 1. Journal Papers
Yonsei Authors
Kim, Yong Bae(김용배) ORCID logo https://orcid.org/0000-0001-7573-6862
Nam, Chung Mo(남정모) ORCID logo https://orcid.org/0000-0003-0985-0928
Byun, Hwa Kyung(변화경) ORCID logo https://orcid.org/0000-0002-8964-6275
Suh, Chang Ok(서창옥)
Lee, Ik Jae(이익재) ORCID logo https://orcid.org/0000-0001-7165-3373
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