Robijns Jolien, Lodewijckx Joy, Claes Marithé, Lenaerts Melissa, Van Bever Leen, Claes Stefan, Pannekoeke Luc, Verboven Katleen, Noé Leen, Maes Annelies, Bulens Paul, Mebis Jeroen
Faculty of Medicine & Life Sciences, Hasselt University, Limburg Clinical Research Center, Hasselt, Belgium.
Limburg Oncology Center, Jessa Hospital-Campus Virga Jesse, Hasselt, Belgium.
Lasers Surg Med. 2022 Dec;54(10):1261-1268. doi: 10.1002/lsm.23608. Epub 2022 Oct 2.
The evidence demonstrating the efficacy of photobiomodulation (PBM) therapy for preventing and managing acute radiation dermatitis (ARD) is growing steadily. The question that arises from many clinicians is, if PBM is safe for oncologic patients. This study aimed to evaluate the disease-free survival (DFS), cancer-free survival (CFS), and overall survival (OS) of breast cancer patients treated with PBM for ARD.
Clinical data of 120 breast cancer patients treated with prophylactic PBM (n = 60, 2x/week, 808-905 nm, 4 J/cm ) or placebo (n = 60) during conventional fractionation (CF) radiotherapy (RT) between April 2015 and June 2017 were retrospectively analyzed (TRANSDERMIS trial). During follow-up (April 2015 to May 2022), patients underwent a complete clinical evaluation every 6 months and blood analysis and mammography yearly in the first 5 years after the end of RT. The DFS, CFS, and OS were estimated.
At a median follow-up time of 66 months (range 4-81), there was no significant difference in DFS (73.7% vs. 98.3%, resp., p = 0.54), CFS (68.4% vs. 77.8%, resp., p = 0.79), and OS (87.9% vs. 98.3%, resp., p = 0.30) between the placebo and PBM group.
This paper is the first to describe the results of a long-term follow-up in early-stage breast cancer patients who underwent PBM for ARD. Results suggest that using PBM in breast cancer patients undergoing CF RT does not influence the locoregional recurrence, the development of new primary tumors, or OS.
证明光生物调节（PBM）疗法预防和治疗急性放射性皮炎（ARD）有效性的证据正在稳步增加。许多临床医生提出的问题是，PBM对肿瘤患者是否安全。本研究旨在评估接受PBM治疗ARD的乳腺癌患者的无病生存期（DFS）、无癌生存期（CFS）和总生存期（OS）。
回顾性分析2015年4月至2017年6月期间120例在常规分割（CF）放疗（RT）期间接受预防性PBM（n = 60，每周2次，808 - 905 nm，4 J/cm²）或安慰剂（n = 60）治疗的乳腺癌患者的临床数据（TRANSDERMIS试验）。在随访期间（2015年4月至2022年5月），患者在放疗结束后的前5年每6个月进行一次全面的临床评估，每年进行血液分析和乳房X线摄影。评估DFS、CFS和OS。
在中位随访时间66个月（范围4 - 81个月）时，安慰剂组和PBM组在DFS（分别为73.7%对98.3%，p = 0.54）、CFS（分别为68.4%对77.8%，p = 0.79）和OS（分别为87.9%对98.3%，p = 0.30）方面没有显著差异。
本文首次描述了接受PBM治疗ARD的早期乳腺癌患者的长期随访结果。结果表明，在接受CF RT的乳腺癌患者中使用PBM不会影响局部区域复发、新原发性肿瘤的发生或OS。
