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Publications

Journal Article Ahead of print

PubMed: 42001960 DOI: 10.1016/j.radonc.2026.111538

Feasibility and safety of repeat breast-conserving surgery with intraoperative irradiation for local breast carcinoma recurrences: A phase 2 trial.

Radiother Oncol

Authors: Claire Lemanski, Gilles Houvenaeghel, Sophie Gourgou, Marian Gutowski, Marion Fournier, Severine Racadot, Magali Le Blanc-Onfroy, Etienne Martin, Olivier Pradier, Christophe Hennequin, Agnes Tallet, Aurélie Morel, David Azria, Celine Bourgier

Affiliations

  • Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut régional du Cancer Montpellier (ICM), Montpellier, France.
  • Aix-Marseille Univ, CNRS, INSERM, Institut Paoli-Calmettes, Department of Surgical Oncology, CRCM, Marseille, France.
  • Unité de Biométrie, Institut régional du Cancer Montpellier (ICM), Montpellier, France.
  • Département de chirurgie, Institut régional du Cancer Montpellier (ICM), Montpellier, France.
  • Département de Chirurgie, Centre Bergonié - Bordeaux, France.
  • Service de Radiothérapie, Centre Léon Bérard, Lyon, France.
  • Service de Radiothérapie, ICO René Gauducheau, Saint-Herblain, France.
  • Département d'Oncologie Radiothérapie Centre Georges-François LECLERC, Dijon, France.
  • Department of Radiation Oncology, University Hospital of Brest, Brest, France.
  • Department of Radiation Oncology, Hospital Saint Louis, Paris, France.
  • Département de radiothérapie, Institut Paoli-Calmettes, Marseille, France.
  • Unité de Physique Médicale, Institut régional du Cancer Montpellier (ICM), Montpellier, France.
  • Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut régional du Cancer Montpellier (ICM), Montpellier, France; Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier, France; Montpellier University, Montpellier, France.
  • Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, Institut régional du Cancer Montpellier (ICM), Montpellier, France; Institut de Recherche en Cancérologie de Montpellier (IRCM), INSERM U1194, Montpellier, France; Montpellier University, Montpellier, France.

Abstract

BACKGROUND AND PURPOSE

The RE-IORT prospective, multicenter, single-arm phase II trial (NCT02386371) evaluated the feasibility and safety of repeat breast-conserving surgery (BCS) combined with focal reirradiation using intraoperative radiotherapy (IOReIrr) in patients with locally recurrent breast carcinoma.

PATIENTS AND METHODS

Eligible patients had in-breast recurrence ≥ 5 years after whole-breast radiotherapy, with low-risk features (unifocal T1N0, non-lobular histology, grade 1-2, estrogen receptor-positive, HER2-negative). The primary endpoint was the absence of grade ≥ 2 breast fibrosis at month 12 post-BCS + IOReIrr, reported using the Common Terminology Criteria for Adverse Events, version 4.0. Secondary endpoints were cumulative incidence of local relapse, local relapse-free/distant metastasis-free/disease-free/overall/mastectomy-free survival, quality of life, definitive cosmetic results and satisfaction.

RESULTS

Fifty-three of the sixty-six patients enrolled from January 2015 to April 2018 were retained for the analysis (median follow-up of 59 months). At month 12 post-IOReIrr, 48 patients had not developed breast fibrosis (90.6% [95% CI: 79.3-96.9]). During the follow-up, three patients presented a new local relapse after the second BCS + IOReIrr. The 36-month and 60-month local recurrence-free survival rates were 96.8% [95% CI: 85.2-99.0] and 81.2% [95% CI: 65.2-90.3], respectively. The 36-month and 60-month mastectomy-free rates were 94.2% [95% CI: 83.1-98.1] and 92.3% [95% CI: 80.7-97.0], respectively.

CONCLUSIONS

Intraoperative reirradiation as part of a second BCS (one-day treatment) is feasible, safe, and well-tolerated in selected patients with late local breast cancer recurrence (i.e. < 2 cm. estrogen receptor-positive and node-negative). These findings suggests that shared decision-making between 'one-day treatment' and salvage mastectomy is a safe and viable option.

TRIAL REGISTRATION

NCT02386371 (https://clinicaltrials.gov/study/ NCT02386371).

MeSH

Radiotherapy, Mastectomy, Estrogens, Safety, Breast Neoplasms, Fibrosis, Receptors, Estrogen, Re-Irradiation, Breast, Therapeutics