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

Int J Radiat Oncol Biol Phys. 2025 Jan 1;121(1):90-96. doi: 10.1016/j.ijrobp.2024.08.008. Epub 2024 Aug 13.

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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Breast Neoplasms* / immunology
  • Breast Neoplasms* / pathology
  • Breast Neoplasms* / radiotherapy
  • Breast Neoplasms* / surgery
  • Dose Fractionation, Radiation
  • Female
  • Humans
  • Lymphocytes, Tumor-Infiltrating* / immunology
  • Middle Aged
  • Preoperative Care / methods
  • Receptors, Estrogen / analysis
  • Receptors, Estrogen / metabolism

Substances

  • Receptors, Estrogen