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放疗对于乳腺癌治疗具有重要作用，尤其保乳术后放疗可减少复发可能并提高总生存率。不过，传统的术后全乳放疗需要每天进行1次，连续5～6周。2013年，英国《柳叶刀》肿瘤学分册发表的ELIOT研究中位随访5.8年结果表明，对于早期乳腺癌患者，术中快速局部乳房放疗与术后同侧全乳放疗相比，虽然5年同侧乳腺肿瘤复发率较高，但是5年总生存率相似。 ELIOT (NCT01849133): ELectron IntraOperative radioTherapy (Randomized Clinical Trial: Comparison Between Quadrantectomy Followed by External Fractionated Radiotherapy and Quadrantectomy Associated With Intraoperative Radiotherapy in Women >= 48 Years of Age Affected by Early-stage Breast Carcinoma) 2021年4月9日，英国《柳叶刀》肿瘤学分册在线发表意大利米兰大学、欧洲肿瘤研究院的ELIOT研究中位随访12.4年结果，对术中快速部分乳房放疗与术后同侧全乳放疗的长期复发率和总生存率进行了比较。欧洲肿瘤研究院是位于意大利米兰的综合癌症中心，集肿瘤医疗、肿瘤教育、肿瘤研究于一体。 该单中心非盲随机对照三期等效临床研究于2000年11月20日～2007年12月27日从欧洲肿瘤研究院入组年龄48～75岁、临床诊断为单灶乳腺癌、超声直径不超过25毫米、腋窝淋巴结临床阴性、适合保乳手术的1305例女性，通过网络系统采用随机排列区组设计（区组大小为16）按1∶1的比例随机分为两组并按临床肿瘤大小进行分层：
该研究主要终点为同侧乳腺肿瘤复发。假设术后全乳放疗组的5年同侧乳腺肿瘤复发率为3%，若术中局部放疗组的5年同侧乳腺肿瘤复发率未超过3倍（7.5%），则认为二者等效。该研究次要终点为总生存。按意向治疗进行主要分析。随访5、10、15年时评定同侧乳腺肿瘤复发事件累计发生率和总生存率。 结果，中位随访12.4年（四分位9.7～14.7）时，同侧乳腺肿瘤复发86例（7%），术中局部放疗组与术后全乳放疗组相比，同侧乳腺肿瘤复发率为11%比2%（70例比16例，相差54例；风险比：4.62，95%置信区间：2.68～7.95，P<0.0001）。 术中局部放疗组与术后全乳放疗组相比，同侧乳腺肿瘤复发率：
2019年3月11日最终随访时，由于任何原因死亡193例（15%），术中局部放疗组与术后全乳放疗组相似，分别为98例与95例（风险比：1.03，95%置信区间：0.77～1.36，P=0.85）。 术中局部放疗组与术后全乳放疗组相比，总生存率：
该研究未收集不良事件的长期数据。 因此，该研究长期结果证实，术中局部放疗与术后全乳放疗相比，虽然同侧乳腺肿瘤复发率较高，但是总生存相似，故术中局部放疗应提供给经过筛选的同侧乳腺肿瘤复发风险较低患者。 对此，美国德克萨斯大学MD安德森癌症中心发表同期评论：不断提高放疗对于乳腺癌的价值。 Lancet Oncol. 2021 Apr 9. Online ahead of print. Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial. Roberto Orecchia, Umberto Veronesi, Patrick Maisonneuve, Viviana Enrica Galimberti, Roberta Lazzari, Paolo Veronesi, Barbara Alicja Jereczek-Fossa, Federica Cattani, Claudia Sangalli, Alberto Luini, Pietro Caldarella, Marco Venturino, Daniele Sances, Stefano Zurrida, Giuseppe Viale, Maria Cristina Leonardi, Mattia Intra. European Institute of Oncology IRCCS, Milan, Italy; University of Milan, Milan, Italy. BACKGROUND: In the randomised, phase 3 equivalence trial on electron intraoperative radiotherapy (ELIOT), accelerated partial breast irradiation (APBI) with the use of intraoperative radiotherapy was associated with a higher rate of ipsilateral breast tumour recurrence (IBTR) than whole-breast irradiation (WBI) in patients with early-stage breast cancer. Here, we aimed to examine the planned long-term recurrence and survival outcomes from the ELIOT trial. METHODS: This single-centre, randomised, phase 3 equivalence trial was done at the European Institute of Oncology (Milan, Italy). Eligible women, aged 48-75 years with a clinical diagnosis of a unicentric breast carcinoma with an ultrasound diameter not exceeding 25 mm, clinically negative axillary lymph nodes, and who were suitable for breast-conserving surgery, were randomly assigned (1:1) via a web-based system, with a random permuted block design (block size of 16) and stratified by clinical tumour size, to receive post-operative WBI with conventional fractionation (50 Gy given as 25 fractions of 2 Gy, plus a 10 Gy boost), or 21 Gy intraoperative radiotherapy with electrons (ELIOT) in a single dose to the tumour bed during surgery. The trial was open label and no-one was masked to treatment group assignment. The primary endpoint was the occurrence of IBTR. The trial was designed assuming a 5-year IBTR rate of 3% in the WBI group and equivalence of the two groups, if the 5-year IBTR rate in the ELIOT group did not exceed a 2.5 times excess, corresponding to 7.5%. Overall survival was the secondary endpoint. The main analysis was done by intention to treat. The cumulative incidence of IBTR events and overall survival were assessed at 5, 10, and 15 years of follow-up. This trial is registered with ClinicalTrials.gov, NCT01849133. FINDINGS: Between Nov 20, 2000, and Dec 27, 2007, 1305 women were enrolled and randomly assigned: 654 to the WBI group and 651 to the ELIOT group. After a median follow-up of 12.4 years (IQR 9.7-14.7), 86 (7%) patients developed IBTR, with 70 (11%) cases in the ELIOT group and 16 (2%) in the WBI group, corresponding to an absolute excess of 54 IBTRs in the ELIOT group (HR 4.62, 95% CI 2.68-7.95, p<0.0001). In the ELIOT group, the 5-year IBTR rate was 4.2% (95% CI 2.8-5.9), the 10-year rate was 8.1% (6.1-10.3), and the 15-year rate was 12.6% (9.8-15.9). In the WBI group, the 5-year IBTR rate was 0.5% (95% CI 0.1-1.3), the 10-year rate was 1.1% (0.5-2.2), and the 15-year rate was 2.4% (1.4-4.0). At final follow-up on March 11, 2019, 193 (15%) women had died from any cause, with no difference between the two groups (98 deaths in the ELIOT group vs 95 in the WBI group; HR 1.03, 95% CI 0.77-1.36, p=0.85). In the ELIOT group, the overall survival rate was 96.8% (95% CI 95.1-97.9) at 5 years, 90.7% (88.2-92.7) at 10 years, and 83.4% (79.7-86.4) at 15 years; and in the WBI group, the overall survival rate was 96.8% (95.1-97.9) at 5 years, 92.7% (90.4-94.4) at 10 years, and 82.4% (78.5-85.6) at 15 years. We did not collect long-term data on adverse events. INTERPRETATION: The long-term results of this trial confirmed the higher rate of IBTR in the ELIOT group than in the WBI group, without any differences in overall survival. ELIOT should be offered to selected patients at low-risk of IBTR. FUNDING: Italian Association for Cancer Research, Jacqueline Seroussi Memorial Foundation for Cancer Research, Umberto Veronesi Foundation, American Italian Cancer Foundation, The Lombardy Region, and Italian Ministry of Health. DOI: 10.1016/S1470-2045(21)00080-2 Lancet Oncol. 2021 Apr 9. Online ahead of print. Increasing the value of radiotherapy in breast cancer. Thomas A Buchholz. Scripps MD Anderson Cancer Center, San Diego, CA, USA; The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Radiotherapy plays an important role in breast cancer management. After breast-conserving surgery, radiotherapy reduces the probability of recurrence and improves overall survival. Adjuvant whole-breast irradiation (WBI) was previously delivered in daily treatments, given over 5-6 weeks. These treatments, coupled with other multidisciplinary advances such as increasing the use of systemic therapy, yielded outstanding outcomes. DOI: 10.1016/S1470-2045(21)00120-0
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