Randomized prospective trial comparing two schedules of hypofractionated adjuvant radiotherapy 3 weeks against 1 week fractionation regimen in females with breast cancer

Radwa A. Yassin, Ehab Mostafa, Khaled Naguib, Hany Ammar, Diaa El Din Moussa
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Abstract

Acceleration of radiotherapy in five fractions for breast cancer can improve treatment accessibility, especially in low, middle-income countries and during pandemics. We report on acute toxicity after whole breast irradiation/chest wall irradiation±nodal irradiation, radiotherapy interruption and reported acute pneumonitis with an ultra-hypofractionation schedule compared to modest hypofractionation protocol during the coronavirus disease pandemic. Acute toxicity assessment using the RTOG acute toxicity scoring system. One of two specified doses was administered to the breast: 15 × 2.67 Gy (40.05 Gy) or 5 × 5.2 Gy (26 Gy), tumor boost when indicated prescribed dose 5 × 200 Gy with three-dimensional conformal radiotherapy technique. Inclusion criteria were: T1–T3 invasive breast cancer, N0–N1 and N2 after breast conserving or modified radical surgery. A total of 101 patients were included in the study. Median age was 53 ± 10.29 years, with median follow-up time 14 months (12–20 months). A significant difference was observed for acute skin toxicity after radiotherapy in favor of better tolerability for the ultrafractionation schedule (P<0.0001). None of the cases in ultra-hypofractionation had interrupted radiotherapy course for more than 2 days, on the other hand, 45.8% of the cases in modest hypofractionation had interrupted course with chest infection as the second most common cause. Regarding acute radiation pneumonitis none of the cases in both arms reported grades 3–4 acute radiation pneumonitis within the first 90 days postradiotherapy. Regarding initial toxicity and patient adherence to the radiation course, this single institute study suggests that hypofractionated breast irradiation in 15 fractions compares favorably to accelerated breast radiotherapy in five fractions over 5 days. However, a longer time for follow-up and larger enrolled numbers are needed to confirm noninferiority of this approach.
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随机前瞻性试验:比较乳腺癌女性患者接受 3 周低分次辅助放疗和 1 周分次辅助放疗的两种方案
加快乳腺癌的五次分割放疗可以提高治疗的可及性,尤其是在中低收入国家和大流行病期间。我们报告了在冠状病毒疾病大流行期间,全乳照射/胸壁照射±结节照射、放疗中断后的急性毒性,并报告了超低分次计划与适度低分次方案相比的急性肺炎。 使用 RTOG 急性毒性评分系统进行急性毒性评估。对乳腺进行两种指定剂量中的一种:15 × 2.67 Gy(40.05 Gy)或 5 × 5.2 Gy(26 Gy),有指征时进行肿瘤增强,规定剂量为 5 × 200 Gy,采用三维适形放疗技术。纳入标准为T1-T3浸润性乳腺癌,保乳手术或改良根治术后N0-N1和N2。 研究共纳入了 101 名患者。中位年龄为 53 ± 10.29 岁,中位随访时间为 14 个月(12-20 个月)。在放疗后的急性皮肤毒性方面,超分割放疗方案的耐受性更好,两者之间存在明显差异(P<0.0001)。在超低分量放疗中,没有一个病例中断放疗疗程超过两天,而在适度低分量放疗中,45.8%的病例中断了放疗疗程,胸部感染是第二大常见原因。在急性放射性肺炎方面,两组患者在放疗后90天内均未出现3-4级急性放射性肺炎。 关于初始毒性和患者对放疗疗程的依从性,这项单一机构的研究表明,15次分次的低分次乳腺照射与5天5次分次的加速乳腺放疗相比效果更好。不过,还需要更长的随访时间和更多的入组人数来证实这种方法的非劣效性。
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