對(duì)于大多數(shù)早期乳腺癌女性,，治療首選保乳手術(shù)，術(shù)后進(jìn)行輔助放療可以降低局部復(fù)發(fā)風(fēng)險(xiǎn),，從而避免乳房切除術(shù),。不過(guò),，放療通常需要每周5天連續(xù)3至6周，而且費(fèi)用較高,，并且伴有短期和長(zhǎng)期副作用,。單純根據(jù)臨床病理因素，對(duì)于判斷哪些局部復(fù)發(fā)風(fēng)險(xiǎn)較低女性可以免放療的作用有限,。結(jié)合乳腺癌分子亞型,，可以提供額外的預(yù)后信息。其中,，管腔A型乳腺癌（雌激素受體陽(yáng)性≥1%,、孕激素受體陽(yáng)性>20%、HER2陰性,、Ki67指數(shù)≤13.25%）預(yù)后較好,，局部復(fù)發(fā)風(fēng)險(xiǎn)較低，回顧研究表明此類(lèi)乳腺癌保乳手術(shù)后可以免化療,，故有必要開(kāi)展前瞻研究進(jìn)行驗(yàn)證,。雖然隨機(jī)對(duì)照試驗(yàn)可以確定放療對(duì)此類(lèi)患者的有效性，但是需要較大樣本量才能檢出非常小的差異,，這沒(méi)有臨床意義,。前瞻隊(duì)列研究被認(rèn)為是最合適、最有效的設(shè)計(jì),，可以確定哪些患者的同側(cè)乳腺癌復(fù)發(fā)風(fēng)險(xiǎn)較低,。 2023年8月17日，創(chuàng)刊于1812年的國(guó)際四大醫(yī)學(xué)期刊之一,、美國(guó)麻省醫(yī)學(xué)會(huì)《新英格蘭醫(yī)學(xué)雜志》正式發(fā)表加拿大麥克馬斯特大學(xué),、朱拉文斯基癌癥中心、不列顛哥倫比亞大學(xué),、不列顛哥倫比亞癌癥中心,、多倫多大學(xué)、瑪格麗特公主癌癥中心,、森尼布魯克奧黛特癌癥中心,、皇家維多利亞地區(qū)醫(yī)療中心、渥太華大學(xué),、渥太華地區(qū)癌癥中心,、勞倫森大學(xué)、東北癌癥中心,、舍布魯克大學(xué)中心醫(yī)院,、拉瓦爾大學(xué)魁北克中心醫(yī)院、曼尼托巴大學(xué),、曼尼托巴癌癥治療中心,、麥吉爾大學(xué)的LUMINA研究報(bào)告,，首次前瞻調(diào)查了低風(fēng)險(xiǎn)管腔A型乳腺癌保乳手術(shù)和內(nèi)分泌治療后的局部復(fù)發(fā)風(fēng)險(xiǎn)。該研究由加拿大癌癥學(xué)會(huì)和加拿大乳腺癌基金會(huì)提供資助,。LUMINA (NCT01791829): A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer 該多中心前瞻隊(duì)列研究于2013年8月至2017年7月從加拿大全國(guó)26個(gè)中心招募年齡≥55歲,、腫瘤小于2厘米、淋巴結(jié)陰性,、分級(jí)為1或2的管腔A型乳腺癌保乳手術(shù)后已接受輔助內(nèi)分泌治療女性患者共計(jì)740例,，并集中進(jìn)行Ki67免疫組織化學(xué)分析，Ki67指數(shù)≤13.25%且未接受放療的500例患者入組,。主要結(jié)局為同側(cè)乳房局部復(fù)發(fā),。與腫瘤放療醫(yī)師和乳腺癌患者協(xié)商后，研究者預(yù)設(shè)：如果5年累積發(fā)生率的雙側(cè)90%置信區(qū)間上限低于5%,，那么代表5年局部復(fù)發(fā)風(fēng)險(xiǎn)可接受,。- 局部乳腺癌復(fù)發(fā)率：2.3%（90%置信區(qū)間：1.3～3.8,，95%置信區(qū)間：1.2～4.1）低于預(yù)設(shè)上限
- 對(duì)側(cè)乳腺癌發(fā)生率：1.9%（90%置信區(qū)間：1.1～3.2）低于預(yù)設(shè)上限
- 任何乳腺癌發(fā)生率：2.7%（90%置信區(qū)間：1.6～4.1）低于預(yù)設(shè)上限
因此,，該研究結(jié)果表明，對(duì)于年齡≥55歲,、腫瘤小于2厘米,、淋巴結(jié)陰性、分級(jí)為1或2的管腔A型乳腺癌女性患者,，僅接受保乳手術(shù)和內(nèi)分泌治療且未接受放療,，5年局部復(fù)發(fā)率較低。N Engl J Med. 2023 Aug 17;389(7):612-619. IF: 158.5 Omitting Radiotherapy after Breast-Conserving Surgery in Luminal A Breast Cancer. Whelan TJ, Smith S, Parpia S, Fyles AW, Bane A, Liu FF, Rakovitch E, Chang L, Stevens C, Bowen J, Provencher S, Théberge V, Mulligan AM, Kos Z, Akra MA, Voduc KD, Hijal T, Dayes IS, Pond G, Wright JR, Nielsen TO, Levine MN; LUMINA Study Investigators. McMaster University, Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON; University of British Columbia, Vancouver; BC Cancer Agency, Victoria; BC Cancer Agency, Vancouver; University of Toronto, Princess Margaret Cancer Centre, Sunnybrook Odette Cancer Centre, Toronto; Royal Victoria Regional Health Centre, Barrie, ON; University of Ottawa and Ottawa Regional Cancer Centre, Ottawa; Laurentian University, Northeast Cancer Centre, Health Sciences North, Sudbury, ON; Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC; Centre Hospitalier Universitaire de Québec-Université Laval, Quebec, QC; University of Manitoba and Cancer Care Manitoba, Winnipeg; McGill University, Montreal, Canada. BACKGROUND: Adjuvant radiotherapy is prescribed after breast-conserving surgery to reduce the risk of local recurrence. However, radiotherapy is inconvenient, costly, and associated with both short-term and long-term side effects. Clinicopathologic factors alone are of limited use in the identification of women at low risk for local recurrence in whom radiotherapy can be omitted. Molecularly defined intrinsic subtypes of breast cancer can provide additional prognostic information. METHODS: We performed a prospective cohort study involving women who were at least 55 years of age, had undergone breast-conserving surgery for T1N0 (tumor size <2 cm and node negative), grade 1 or 2, luminal A-subtype breast cancer (defined as estrogen receptor positivity of ≥1%, progesterone receptor positivity of >20%, negative human epidermal growth factor receptor 2, and Ki67 index of ≤13.25%), and had received adjuvant endocrine therapy. Patients who met the clinical eligibility criteria were registered, and Ki67 immunohistochemical analysis was performed centrally. Patients with a Ki67 index of 13.25% or less were enrolled and did not receive radiotherapy. The primary outcome was local recurrence in the ipsilateral breast. In consultation with radiation oncologists and patients with breast cancer, we determined that if the upper boundary of the two-sided 90% confidence interval for the cumulative incidence at 5 years was less than 5%, this would represent an acceptable risk of local recurrence at 5 years. RESULTS: Of 740 registered patients, 500 eligible patients were enrolled. At 5 years after enrollment, recurrence was reported in 2.3% of the patients (90% confidence interval [CI], 1.3 to 3.8; 95% CI, 1.2 to 4.1), a result that met the prespecified boundary. Breast cancer occurred in the contralateral breast in 1.9% of the patients (90% CI, 1.1 to 3.2), and recurrence of any type was observed in 2.7% (90% CI, 1.6 to 4.1). CONCLUSIONS: Among women who were at least 55 years of age and had T1N0, grade 1 or 2, luminal A breast cancer that were treated with breast-conserving surgery and endocrine therapy alone, the incidence of local recurrence at 5 years was low with the omission of radiotherapy. Funded by the Canadian Cancer Society and the Canadian Breast Cancer Foundation LUMINA ClinicalTrials.gov number: NCT01791829 PMID: 37585627 DOI: 10.1056/NEJMoa2302344
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