PRECISE: Preoperative Radiation Therapy to Elicit Critical Immune Stimulating Effects-A Phase 2 Clinical Trial.

IF 6.4 1区 医学 Q1 ONCOLOGY International Journal of Radiation Oncology Biology Physics Pub Date : 2025-01-01 Epub Date: 2024-08-13 DOI:10.1016/j.ijrobp.2024.08.008
Simona F Shaitelman, Huong Le-Petross, Maria G Raso, David M Swanson, Aislyn P Schalck, Alejandro Contreras, Fei Yang, Manickam Muruganandham, George Z Zhao, Gabriel O Sawakuchi, Leonard H Kim, Harsh Batra, Benjamin D Smith, Michael C Stauder, Wendy A Woodward, Jay P Reddy, Jennifer K Litton, Alastair Thompson, Isabelle Bedrosian, Elizabeth A Mittendorf
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Abstract

Purpose: Radiation therapy is an underinvestigated tool for priming the immune system in intact human breast cancers. We sought here to investigate if a preoperative radiation therapy boost delivered was associated with a significant change in tumor-infiltrating lymphocytes (TILs) in the tumor in estrogen receptor positive, HER2Neu nonamplified breast cancers.

Methods and materials: A total of 20 patients were enrolled in a phase 2 clinical trial and received either 7.5 Gy × 1 fraction or 2 Gy × 5 fractions, completed 6 to 8 days before surgery. Percent stromal TILs were evaluated on hematoxylin and eosin-stained samples. Short-term safety was assessed based on time to surgery, toxicities, and cosmesis up to 6 months after boost.

Results: Stromal TIL increased 6 to 8 days after completion of boost radiation therapy (median 3.0 [IQR, 1.0-6.5]) before radiation therapy versus median 5.0 (IQR, 1.5-8.0) after radiation therapy, P = .0037. Zero grade ≥3 toxicities up to 6 months after boost were experienced. In all, 94% (16/17) patients with 6-month follow-up cosmetic assessment after breast conservation had good-excellent cosmesis by physician assessment.

Conclusion: In this phase 2 trial, preoperative radiation therapy boost resulted in a short-term increase in stromal TIL with minimal toxicities. Preoperative breast radiation therapy appears to be safe and may be a feasible means for priming the tumor microenvironment.

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PRECISE:激发关键免疫刺激效应的术前放疗 - II 期临床试验。
目的:在完整的人类乳腺癌中,放疗是一种启动免疫系统的工具,但对其研究不足。方法和材料:20 名患者参加了一项 II 期临床试验,接受了 7.5Gy x 1 次分次或 2Gy x 5 次分次放疗,在手术前 6-8 天完成。根据苏木精和伊红染色样本评估基质肿瘤浸润淋巴细胞(TIL)的百分比。根据手术时间、毒性和促进后 6 个月内的外观评估短期安全性:结果:基质TIL在放疗后6-8天有所增加(放疗前中位3.0(IQR 1.0-6.5),放疗后中位5.0(IQR 1.5-8.0),P=0.0037)。放疗后6个月内无≥3级毒性反应。经医生评估,94%(16/17)的患者在保乳后6个月的随访美容评估结果为良好-极佳:在这项 II 期试验中,术前放疗增强可在短期内增加基质 TIL,且毒性极低。术前乳腺放疗似乎是安全的,而且可能是启动肿瘤微环境的可行方法。
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来源期刊
CiteScore
11.00
自引率
7.10%
发文量
2538
审稿时长
6.6 weeks
期刊介绍: International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.
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