Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026.
Randomised trials testing 15- or 16-fraction regimens of adjuvant radiotherapy in women with early breast cancer have reported favourable outcomes compared with standard fractionation. To evaluate hypofractionation further, two 5-fraction schedules delivering 1 fraction per week have been tested against a 25-fraction regimen.
Women aged ⩾50years with node negative early breast cancer were randomly assigned after microscopic complete tumour resection to 50Gy in 25 fractions versus 28.5 or 30Gy in 5 once-weekly fractions of 5.7 or 6.0Gy, respectively, to the whole breast. The primary endpoint was 2-year change in photographic breast appearance.
Nine hundred and fifteen women were recruited from 2004 to 2007. Seven hundred and twenty-nine patients had 2-year photographic assessments. Risk ratios for mild/marked change were 1.70 (95% CI 1.26-2.29, p<0.001) for 30Gy and 1.15 (0.82-1.60, p=0.489) for 28.5Gy versus 50Gy. Three-year rates of physician-assessed moderate/marked adverse effects in the breast were 17.3% (13.3-22.3%, p<0.001) for 30Gy and 11.1% (7.9-15.6%, p=0.18) for 28.5Gy compared with 9.5% (6.5-13.7%) after 50Gy. With a median follow-up in survivors of 37.3months, 2 local tumour relapses and 23 deaths have occurred.
At 3years median follow-up, 28.5Gy in 5 fractions is comparable to 50Gy in 25 fractions, and significantly milder than 30Gy in 5 fractions, in terms of adverse effects in the breast.
与标准分割相比，在早期乳腺癌患者中进行的 15 或 16 个疗程辅助放疗的随机试验报告了有利的结果。为了进一步评估分割放疗，已经测试了两种每周 1 次共 5 次的 5 个疗程方案，与 25 个疗程方案进行了比较。
2004 年至 2007 年间，年龄 ⩾50 岁的淋巴结阴性早期乳腺癌患者在显微镜下完全切除肿瘤后，随机分配至 50Gy 25 次分割与 28.5Gy 或 30Gy 5 次分割，每周 1 次，每次 5.7Gy 或 6.0Gy，用于全乳房。主要终点为 2 年时乳房外观的摄影变化。
2004 年至 2007 年间，共招募了 915 名患者。729 名患者有 2 年的摄影评估。30Gy 和 28.5Gy 与 50Gy 相比，轻度/重度变化的风险比为 1.70（95%CI 1.26-2.29，p<0.001）和 1.15（0.82-1.60，p=0.489）。3 年时，医生评估的乳房中度/重度不良反应发生率分别为 30Gy 组 17.3%（13.3-22.3%，p<0.001）和 28.5Gy 组 11.1%（7.9-15.6%，p=0.18），而 50Gy 组为 9.5%（6.5-13.7%）。在幸存者的中位随访 37.3 个月时，发生了 2 例局部肿瘤复发和 23 例死亡。
在中位随访 3 年时，与 25 次分割 50Gy 相比，5 次分割 28.5Gy 与 5 次分割 30Gy 相比，在乳房不良反应方面更为相似，且明显更轻。
