俯卧位低分割加速乳腺及区域淋巴结调强放射治疗的1-2期研究
Phase 1-2 Study of Prone Hypofractionated Accelerated Breast and Nodal Intensity Modulated Radiation Therapy.
作者信息
Purswani Juhi M, Maisonet Olivier, Xiao Julie, Teruel Jose R, Hitchen Christine, Li Xiaochun, Goldberg Judith D, Perez Carmen A, Formenti Silvia C, Gerber Naamit K
机构信息
Department of Radiation Oncology, New York University Langone Health and Perlmutter Cancer Center, New York, New York.
Department of Radiation Oncology, New York University Langone Health and Perlmutter Cancer Center, New York, New York.
出版信息
Int J Radiat Oncol Biol Phys. 2025 Aug 1;122(5):1128-1139. doi: 10.1016/j.ijrobp.2024.12.027. Epub 2025 Jan 7.
PURPOSE
In patients with breast cancer, prone radiation therapy (RT) has been shown to reduce heart and lung dose. Though prone positioning is routinely used for whole breast RT, its use when treating the regional lymph nodes is not widespread.
METHODS AND MATERIALS
In this phase 1/2 trial for stage IB-IIA breast cancer treated with lumpectomy or mastectomy, patients received 40.5 Gy in 15 fractions to the breast or chest wall and regional lymph nodes with an integrated tumor bed boost for lumpectomy patients. Primary endpoints were grade >2 acute toxicity and dosimetric feasibility. Secondary endpoints were the incidence of resimulation to improve dosimetry and late toxicity. Exploratory endpoints were local recurrence, disease-free survival, distant recurrence-free survival, and overall survival.
RESULTS
From 2009 to 2016, 97 patients were enrolled (68% lumpectomy and 32% mastectomy), among which 92 were treated in the prone position. Five patients were resimulated and treated supine. Among the prone-treated patients, there were no acute toxicities greater than grade 2. A total of 92%, 98%, and 89% met a planning target volume tumor V48 Gy ≥98%, breast V40.5 Gy ≥95%, and nodal V38.5 Gy ≥95%, respectively. All met the heart V5 Gy <5%, contralateral lung V5 Gy <15%, spinal cord dose maximum (Dmax) ≤37.5 Gy, esophagus V30 Gy <50%, and Dmax ≤40.5 Gy. Ninety-eight percent met the ipsilateral lung V10 Gy. Brachial plexus Dmax <42 Gy was met in 74% with a mean increase of 1.61 Gy (SD, 1.96 Gy) over the target. At a median follow-up of 8 years, grade 2 to 3 late toxicity was 23% for prone patients. There were 2 local recurrences (2%) and no chest wall or nodal recurrences. The 8-year distant recurrence-free survival, disease-free survival, and overall survival were 88% (95% CI, 81%-95%), 86% (95% CI, 78%-95%), and 91% (95% CI, 84%-98%), respectively.
CONCLUSIONS
Toxicity was low, and outcomes were excellent in this prospective trial of prone hypofractionated nodal RT.
目的
在乳腺癌患者中，俯卧位放射治疗（RT）已被证明可降低心脏和肺部剂量。尽管俯卧位常用于全乳放疗，但在治疗区域淋巴结时其应用并不广泛。
方法和材料
在这项针对接受保乳手术或乳房切除术的IB-IIA期乳腺癌的1/2期试验中，患者接受40.5 Gy分15次照射乳房或胸壁及区域淋巴结，保乳手术患者对瘤床进行同步加量照射。主要终点为2级以上急性毒性和剂量学可行性。次要终点为为改善剂量学进行重新模拟的发生率和晚期毒性。探索性终点为局部复发、无病生存率、远处无复发生存率和总生存率。
结果
2009年至2016年，共入组97例患者（68%为保乳手术，32%为乳房切除术），其中92例采用俯卧位治疗。5例患者重新模拟后仰卧位治疗。在俯卧位治疗的患者中，没有大于2级的急性毒性反应。分别有92%、98%和89%的患者满足计划靶区肿瘤V48 Gy≥98%、乳房V40.5 Gy≥95%和淋巴结V38.5 Gy≥95%。所有患者均满足心脏V5 Gy<5%、对侧肺V5 Gy<15%、脊髓剂量最大值（Dmax）≤37.5 Gy、食管V30 Gy<50%且Dmax≤40.5 Gy。98%的患者满足同侧肺V10 Gy。74%的患者臂丛神经Dmax<42 Gy，比靶区平均增加了1.61 Gy（标准差，1.96 Gy）。中位随访8年时，俯卧位患者2至3级晚期毒性为23%。有2例局部复发（2%），无胸壁或淋巴结复发。8年远处无复发生存率、无病生存率和总生存率分别为88%（95%CI，81%-95%）、86%（95%CI，78%-95%）和91%（95%CI，84%-98%）。
结论
在这项俯卧位低分割淋巴结放疗的前瞻性试验中，毒性较低，结果良好。
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