乳がん手術後の放射線治療が不要なケースを特定(Study Finds Radiotherapy Can Be Avoided After a Mastectomy)

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2025-11-05 エディンバラ大学

エディンバラ大学主導の国際共同臨床試験「SUPREMO試験」は、乳房切除術(マステクトミー)を受けた早期〜中期乳がん患者1,607人を対象に、術後放射線治療(RT)の有無が生存率に及ぼす影響を10年間追跡した。結果、RT群(808人)と非RT群(799人)の10年全生存率はそれぞれ81.4%と81.9%で有意差がなく、再発率や転移発生率も同等だった。これにより、化学療法やホルモン療法を併用する現代医療環境では、従来“中リスク”とされた一部の患者においてRTを省略しても治療成績を損なわないことが示された。放射線治療を省くことで副作用や再建手術への影響を回避でき、QOL改善に寄与する可能性がある。一方で、多数リンパ節転移など高リスク症例では適応除外とされ、今後も慎重な臨床判断が求められる。成果はThe Lancet Oncology誌に掲載。

乳がん手術後の放射線治療が不要なケースを特定(Study Finds Radiotherapy Can Be Avoided After a Mastectomy)

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乳がんにおける乳房切除後胸壁照射後の10年生存率 Ten-Year Survival after Postmastectomy Chest-Wall Irradiation in Breast Cancer

Ian H. Kunkler, F.R.C.R., Nicola S. Russell, M.D., Ph.D., Niall Anderson, Ph.D., Richard Sainsbury, M.D., J. Michael Dixon, M.D., David Cameron, M.D., Juliette Loncaster, F.R.C.R., +37 , for the SUPREMO Trial Investigators
New England Journal of Medicine  Published November 5, 2025
DOI: 10.1056/NEJMoa2412225

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. (Funded by the Medical Research Council and others; SUPREMO ISRCTN Clinical Study Registry number, 61145589.)

医療・健康
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