全乳放疗＋瘤床追加放疗可以显著减少早期乳腺癌术后局部复发风险。对于早期乳腺癌保乳术后女性，常规分割放疗将50戈瑞分割为25次，每周5次，通常需要5周；瘤床追加放疗将10戈瑞分割为5次，又需1周。由于长时间住院或频繁就诊对患者造成很大的心理与经济压力，故迫切需要减少就诊次数、缩短治疗时间，以提高生活质量、减少治疗费用。大分割放疗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。不少欧美随机对照研究已经证实，大分割放疗与常规分割放疗等效。不过，目前尚无亚洲随机对照研究对保乳术后大分割放疗与常规分割放疗进行比较。
2020年8月11日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表中国医学科学院（北京协和医学院）肿瘤医院王淑莲、房辉、宋永文、王维虎、金晶、刘跃平、任骅、唐玉、景灏、马玉超、黄州、陈波、唐源、李宁、卢宁宁、亓姝楠、杨勇、孙广毅、刘新帆、李晔雄、复旦大学附属中山医院刘娟、北李高峰、中国科学院大学附属（浙江省）肿瘤医院杜向慧、美国霍普金斯大学悉德尼·金梅尔综合癌症中心胡晨等学者的研究报告，对中国早期乳腺癌保乳术后3.5周大分割放疗方案与标准6周常规分割放疗方案的有效性和安全性进行了比较。
NCT01413269: Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery
该中国多中心非盲随机对照三期临床研究于2010年8月～2015年11月从中国中国4家医院入组早期（T1-2 N0-3）乳腺浸润癌保乳手术患者734例，利用计算机生成的集中随机化方案（未分层）按1∶1的比例将患者随机分入两组：
常规分割放疗组366例：5周将50戈瑞分割为25次进行全乳放疗，随后1周将10戈瑞分割为5次进行瘤床追加放疗
大分割放疗组368例：3周将43.5戈瑞分割为15次进行全乳放疗，随后3天将8.7戈瑞分割为3次进行瘤床追加放疗
主要终点为5年局部复发比例，预设相差5%为非劣效临界值。次要终点包括局部区域复发比例、无病生存、总生存、毒性反应。
结果，经过中位随访73.5个月（四分位：60.5～91.4个月），大分割放疗组与常规分割放疗组相比：
5年局部复发比例：1.2%比2.0%（风险比，0.62，95%置信区间：0.20～1.88，非劣效P=0.017）
5年局部区域复发比例：3.1%比3.8%（风险比：0.87，95%置信区间：0.46～1.66，对数秩P=0.758；正文风险比：1.15，95%置信区间：0.53～2.48，P=0.725）
5年无病生存比例：93.0%比94.1%（风险比：1.24，95%置信区间：0.74～2.08，P=0.422）
5年总生存比例：97.5%比98.0%（风险比：1.20，95%置信区间：0.50～2.91，P=0.680）
2～3级急性皮肤毒性反应比例：3.0%比7.5%（P=0.019）
其他急性、慢性毒性反应比例：相似
因此，该研究结果表明，对于中国早期乳腺癌保乳术后患者，大分割放疗与常规分割放疗＋瘤床追加放疗相比，局部复发和毒性反应相似。
相关链接
J Clin Oncol. 2020 Aug 11. Online ahead of print.
Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China.
Shu-Lian Wang, Hui Fang, Chen Hu, Yong-Wen Song, Wei-Hu Wang, Jing Jin, Yue-Ping Liu, Hua Ren, Juan Liu, Gao-Feng Li, Xiang-Hui Du, Yu Tang, Hao Jing, Yu-Chao Ma, Zhou Huang, Bo Chen, Yuan Tang, Ning Li, Ning-Ning Lu, Shu-Nan Qi, Yong Yang, Guang-Yi Sun, Xin-Fan Liu, 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; Zhongshan Hospital, Fudan University, Shanghai, China; Beijing Hospital, Beijing, China; Zhejiang Cancer Hospital, Hangzhou, China.
PURPOSE: No randomized trials have compared hypofractionated radiotherapy (HFRT) with conventional fractionated radiotherapy (CFRT) after breast-conserving surgery in the Asian population. This study aimed to determine whether a 3.5-week schedule of HFRT is noninferior to a standard 6-week schedule of CFRT in China.
PATIENTS AND METHODS: Patients from 4 Chinese institutions who had undergone breast-conserving surgery and had T1-2N0-3 invasive breast cancers participated this study. Patients were randomly assigned (1:1) using a computer-generated central randomization schedule, without stratification, to receive whole-breast irradiation with or without nodal irradiation, followed by tumor-bed boost, either at a dose of 50 Gy in 25 fractions over 5 weeks with a boost of 10 Gy in five fractions over 1 week (CFRT) or 43.5 Gy in 15 fractions over 3 weeks with a boost of 8.7 Gy in three daily fractions (HFRT). The primary endpoint was 5-year local recurrence (LR), and a 5% margin of 5-year LR was used to establish noninferiority.
RESULTS: Between August 2010 and November 2015, 734 patients were assigned to the HFRT (n = 368) or CFRT (n = 366) group. At a median follow-up of 73.5 months (interquartile range, 60.5-91.4 months), the 5-year cumulative incidence of LR was 1.2% in the HFRT group and 2.0% in the CFRT group (hazard ratio, 0.62; 95% CI, 0.20 to 1.88; P = .017 for noninferiority). There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group (P = .019).
CONCLUSION: CFRT and HFRT with a tumor-bed boost may have similar low LR and toxicity.
PMID: 32780661
DOI: 10.1200/JCO.20.01024
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