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中国高危乳腺癌患者乳房切除术后 大分割放疗的随机非劣效非盲研究 众所周知，乳腺癌术后放疗可以显著减少复发率和死亡率。常规放疗将50戈分割为25次，通常需要5周。由于长时间住院或频繁就诊，对患者造成了很大的心理及经济压力，故迫切需要减少治疗次数、缩短治疗时间，以提高生活质量、减少治疗费用。大分割是单次剂量大于常规剂量、总剂量和次数低于常规分割的放疗分割方式。英国大样本随机对照研究（START）已经证实，对于乳腺癌保乳术后，大分割放疗与常规分割放疗相比，有效性和安全性相似。不过，尚无随机对照研究比较乳腺癌乳房切除术后的大分割放疗与常规分割放疗。 2019年1月30日，英国《柳叶刀》肿瘤学分册在线发表美国霍普金斯大学医学院西德尼综合癌症中心胡晨、中国医学科学院北京协和医学院肿瘤医院国家癌症中心国家肿瘤临床医学研究中心王淑莲、房辉、宋永文、王维虎、刘跃平、金晶、刘新帆、余子豪、任骅、李宁、唐玉、唐源、李帅、陈波、李晔雄等学者的大样本随机对照研究报告，比较了乳房切除术后3周大分割放疗与5周常规分割放疗的有效性和安全性。 该单中心、随机对照、非劣效、非盲、3期研究（NCT00793962）于2008年6月12日～2016年6月16日从中国医学科学院肿瘤医院入组年龄18～75岁乳房切除术后至少4个腋窝淋巴结阳性或原发肿瘤最大径超过5厘米或已经侵犯胸壁或皮肤（或术前化疗后腋窝淋巴结病理阳性或临床III期）单侧乳腺浸润癌患者820例，根据计算机生成的中心随机化时间表按1∶1随机分组接受胸壁和淋巴结放疗：
对调整后的意向治疗人群（包括所有符合条件随机入组患者，不包括不符合条件或随机分组后退出研究的患者：常规分割放疗组409例、大分割放疗组401例）进行主要终点分析和安全性分析。主要终点为5年局部区域复发，预设非劣效临界值为5%（相当于风险比<1.883）。 结果，随访时间中位58.5个月（四分位：39.2～81.8），出现局部复发60例，占7%。 大分割放疗组与常规分割放疗组相比：
因此，该研究结果表明，对于高风险乳腺癌患者，乳房切除术后大分割放疗与传统分割放疗相比，有效性和安全性相似，三级急性皮肤毒性反应较少。大分割放疗可以提供更方便的治疗，并且可以节省时间，为更多患者提供服务。 对此，美国密歇根大学肿瘤放疗专家雷斯玛·贾吉教授发表同期评论：乳房切除术后——大分割放疗的新领域。 相关阅读 Lancet Oncol. 2019 Jan 30. [Epub ahead of print] Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Shu-Lian Wang, Hui Fang, Yong-Wen Song, Wei-Hu Wang, Chen Hu, Yue-Ping Liu, Jing Jin, Xin-Fan Liu, Zi-Hao Yu, Hua Ren, Ning Li, Ning-Ning Lu, Yu Tang, Yuan Tang, Shu-Nan Qi, Guang-Yi Sun, Ran Peng, Shuai Li, Bo Chen, Yong Yang, Ye-Xiong Li. National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, USA. BACKGROUND: To our knowledge, no randomised study has compared postmastectomy hypofractionated radiotherapy with conventional fractionated radiotherapy in patients with breast cancer. This study aimed to determine whether a 3-week schedule of postmastectomy hypofractionated radiotherapy is as efficacious and safe as a 5-week schedule of conventional fractionated radiotherapy. METHODS: This randomised, non-inferiority, open-label, phase 3 study was done in a single academic hospital in China. Patients aged 18-75 years who had undergone mastectomy and had at least four positive axillary lymph nodes or primary tumour stage T3-4 disease were eligible to participate. Patients were randomly assigned (1:1) according to a computer-generated central randomisation schedule, without stratification, to receive chest wall and nodal irradiation at a dose of 50 Gy in 25 fractions over 5 weeks (conventional fractionated radiotherapy) or 43.5 Gy in 15 fractions over 3 weeks (hypofractionated radiotherapy). The modified intention-to-treat population (including all eligible patients who underwent randomisation but excluding those who were considered ineligible or withdrew consent after randomisation) was used in primary and safety analyses. The primary endpoint was 5-year locoregional recurrence, and a 5% margin was used to establish non-inferiority (equivalent to a hazard ratio <1.883). This trial is registered at ClinicalTrials.gov, number NCT00793962. FINDINGS: Between June 12, 2008, and June 16, 2016, 820 patients were enrolled and randomly assigned to the conventional fractionated radiotherapy group (n=414) or hypofractionated radiotherapy group (n=406). 409 participants in the conventional fractionated radiotherapy group and 401 participants in the hypofractionated radiotherapy group were included in the modified intention-to-treat analyses. At a median follow-up of 58.5 months (IQR 39.2-81.8), 60 (7%) patients had developed locoregional recurrence (31 patients in the hypofractionated radiotherapy group and 29 in the conventional fractionated radiotherapy group); the 5-year cumulative incidence of locoregional recurrence was 8.3% (90% CI 5.8-10.7) in the hypofractionated radiotherapy group and 8.1% (90% CI 5.4-10.6) in the conventional fractionated radiotherapy group (absolute difference 0.2%, 90% CI -3.0 to 2.6; hazard ratio 1.10, 90% CI 0.72 to 1.69; p<0.0001 for non-inferiority). There were no significant differences between the groups in acute and late toxicities, except that fewer patients in the hypofractionated radiotherapy group had grade 3 acute skin toxicity than in the conventional fractionated radiotherapy group (14 [3%] of 401 patients vs 32 [8%] of 409 patients; p<0.0001). INTERPRETATION: Postmastectomy hypofractionated radiotherapy was non-inferior to and had similar toxicities to conventional fractionated radiotherapy in patients with high-risk breast cancer. Hypofractionated radiotherapy could provide more convenient treatment and allow providers to treat more patients. FUNDING: National Key Projects of Research and Development of China; the Chinese Academy of Medical Science Innovation Fund for Medical Sciences; and Beijing Marathon of Hope, Cancer Foundation of China. DOI: 10.1016/S1470-2045(18)30813-1 Lancet Oncol. 2019 Jan 30. [Epub ahead of print] Hypofractionated radiotherapy after mastectomy: a new frontier. Reshma Jagsi. Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA. DOI: 10.1016/S1470-2045(19)30062-2
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