Health Technologies Assessment Center, Department of Gynecology, Federal University of São Paulo (UNIFESP), Rua Napoleão de Barros, 632, Vila clementino, ZIP Code, 04024-000, São Paulo, Brazil.
Health Technologies Assessment Center, Department of Gynecology, Federal University of São Paulo (UNIFESP), Rua Napoleão de Barros, 632, Vila clementino, ZIP Code, 04024-000, São Paulo, Brazil.
Breast. 2019 Dec;48:24-31. doi: 10.1016/j.breast.2019.08.001. Epub 2019 Aug 16.
To evaluate the efficacy and safety of hypofractionated radiotherapy in women with early stage breast cancer after breast conservative surgery.
We performed a search for randomized controlled trials (RCTs) that compare conventional fractioning and hypofractioned radiotherapy. The studied outcomes were local and loco-regional recurrence, disease-free survival, mortality, cardiac ischemia, rib fracture and pulmonary fibrosis up to 5 years and 5 years after treatment. Shrinkage of the breast, breast tightening, telangiectasia, breast edema, shoulder stiffness and arm edema were evaluated within 10 years. Cosmesis and acute skin radiation toxicity were evaluated.
Ten publications of six RCTs were included. No statistical difference in local and loco-regional recurrence, disease-free survival, mortality, cardiac ischemia, ribs fracture and pulmonary fibrosis, shrinkage of the breast, breast tightening, shoulder stiffness, arm edema and cosmesis was found. However, there was a significant difference in favor of hypofractionated for breast edema (RR 0.68, 95% CI 0.53 to 0.88, p = 0.003, 4675 patients), telangiectasia (RR 0.41, 95% CI 0.19 a 0.87, p = 0.02, 5167 patients), and acute skin radiation toxicity (RR 0.34, 95% CI 0.19 to 0.61, p = 0.0003, 347 patients).
There is no difference between conventional fractionation and hypofractionated in terms of efficacy when we evaluate local recurrence, loco-regional recurrence, distance recurrence, disease-free survival and mortality. There is also no difference concerning safety when we assess the occurrence of fibrosis, ischemia and ribs fractures. Hypofractionated showed better results in relation to breast edema, telangiectasia, and acute skin radiation toxicity.
评估早期乳腺癌保乳术后接受低分割放疗的疗效和安全性。
我们检索了比较常规分割与低分割放疗的随机对照试验(RCT)。研究结局包括局部和局部区域复发、无病生存率、死亡率、心脏缺血、肋骨骨折和肺纤维化(治疗后 5 年及 5 年以上)。在 10 年内评估乳房缩小、乳房紧绷、毛细血管扩张、乳房水肿、肩部僵硬和手臂肿胀。评估美容效果和急性皮肤放射性毒性。
纳入了 6 项 RCT 的 10 项研究。局部和局部区域复发、无病生存率、死亡率、心脏缺血、肋骨骨折和肺纤维化、乳房缩小、乳房紧绷、肩部僵硬、手臂肿胀和美容效果无统计学差异。然而,低分割在乳房水肿(RR 0.68,95%CI 0.53 至 0.88,p=0.003,4675 例患者)、毛细血管扩张(RR 0.41,95%CI 0.19 至 0.87,p=0.02,5167 例患者)和急性皮肤放射性毒性(RR 0.34,95%CI 0.19 至 0.61,p=0.0003,347 例患者)方面具有显著优势。
在评估局部复发、局部区域复发、远处复发、无病生存率和死亡率时,常规分割与低分割在疗效方面无差异。在评估纤维化、缺血和肋骨骨折的发生时,安全性方面也无差异。低分割在乳房水肿、毛细血管扩张和急性皮肤放射性毒性方面具有更好的结果。