PMID- 38185607
OWN - NLM
STAT- MEDLINE
DCOM- 20240326
LR  - 20240409
IS  - 1938-0666 (Electronic)
IS  - 1526-8209 (Linking)
VI  - 24
IP  - 3
DP  - 2024 Apr
TI  - Intraoperative Radiation Therapy Delivered by Brachytherapy in Breast Cancer: An 
      Interim Analysis of a Phase 2 Trial.
PG  - 243-252
LID - S1526-8209(23)00310-5 [pii]
LID - 10.1016/j.clbc.2023.12.006 [doi]
AB  - PURPOSE: Intraoperative breast cancer radiotherapy (IORT) offers an alternative 
      to external beam radiotherapy (EBRT) after breast-conserving surgery (BCS). The 
      Intraoperative brachytherapy (IOBT) trial applies high dose rate (HDR) 
      brachytherapy with a new applicator prototype as IORT after BCS. In this interim 
      analysis of the IOBT trial, we present the oncological safety and toxicity of the 
      method METHODS: Eligible patients were women, >/= 50 years old with an unifocal 
      nonlobular, estrogen-receptor-positive, HER2-negative breast cancer, cN0, </= 3 cm, 
      treated with BCS and sentinel node biopsy (SNB). Toxicity was registered 
      according to the LENT-SOMA scale. Cumulative incidence of local (LR) and regional 
      recurrence (RR) were calculated through cumulative incidence function whereas 
      overall survival (OS) was illustrated through Kaplan-Meier curve. RESULTS: Until 
      February 2023, 155 women (median age 68 years) were included in the trial. 
      Twenty-nine women (18.7%) received supplemental EBRT, mostly due to positive SNB. 
      Three-year cumulative incidence of LR and RR were 1.0% (CI 95 % 0.1%-2.3%) and 
      2.1% (CI 95% 0.8%-4.2%) respectively. Five- year cumulative incidence of LR and 
      RR were 3.9% (CI 95% 1.8%-6.4%) and 2.1% (CI 95% 0.8%-4.2%) respectively. 
      Five-year OS was 96.3% (CI 95% 93.6%-98.4%). Side effects were limited, low 
      grade, and transient. CONCLUSION: Acknowledging the short median follow-up time 
      at interim analysis, our initial results indicate that delivering IORT through 
      HDR brachytherapy in carefully selected breast cancer patients is feasible and 
      oncological safe so far. A long-term follow-up is essential to confirm the 
      initial results.
CI  - Copyright (c) 2023 Elsevier Inc. All rights reserved.
FAU - Wickberg, Asa
AU  - Wickberg A
AD  - Department of Surgery, Faculty of Medicine and Health, Orebro University, Orebro, 
      Orebro, Sweden. Electronic address: asa.wickberg@regionorebrolan.se.
FAU - Prag, Clara
AU  - Prag C
AD  - Department of Surgery, Faculty of Medicine and Health, Orebro University, Orebro, 
      Orebro, Sweden.
FAU - Valachis, Antonis
AU  - Valachis A
AD  - Department of Oncology, Faculty of Medicine and Health, Orebro University, 
      Orebro, Orebro, Sweden.
FAU - Karlsson, Leif
AU  - Karlsson L
AD  - Department of medical Physics, Orebro University Hospital, Orebro, Sweden.
FAU - Johansson, Bengt
AU  - Johansson B
AD  - Department of Oncology, Faculty of Medicine and Health, Orebro University, 
      Orebro, Orebro, Sweden.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20231226
PL  - United States
TA  - Clin Breast Cancer
JT  - Clinical breast cancer
JID - 100898731
SB  - IM
MH  - Aged
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - *Brachytherapy/adverse effects/methods
MH  - Breast/pathology
MH  - *Breast Neoplasms/radiotherapy/surgery
MH  - Mastectomy, Segmental/methods
MH  - Neoplasm Recurrence, Local/pathology
MH  - Radiotherapy Dosage
OTO - NOTNLM
OT  - Breast-conserving surgery
OT  - Endocrine therapy
OT  - Intraoperative brachytherapy
OT  - Local recurrence
OT  - Partial breast irradiation
COIS- Disclosure No one of the authors declared any potential conflicts of interest 
      with respect to the research, authorship, and/or publication of this article.
EDAT- 2024/01/08 00:42
MHDA- 2024/03/26 06:45
CRDT- 2024/01/07 21:56
PHST- 2023/08/27 00:00 [received]
PHST- 2023/12/12 00:00 [revised]
PHST- 2023/12/17 00:00 [accepted]
PHST- 2024/03/26 06:45 [medline]
PHST- 2024/01/08 00:42 [pubmed]
PHST- 2024/01/07 21:56 [entrez]
AID - S1526-8209(23)00310-5 [pii]
AID - 10.1016/j.clbc.2023.12.006 [doi]
PST - ppublish
SO  - Clin Breast Cancer. 2024 Apr;24(3):243-252. doi: 10.1016/j.clbc.2023.12.006. Epub 
      2023 Dec 26.