Evidence map›Paper›PMID 37870228›Full record

Trial reportJournal of the American College of Surgeons2024

Novel Form of Breast Intraoperative Radiation Therapy with CT-Guided High-Dose-Rate Brachytherapy: Interim Results of a Prospective Phase-II Clinical Trial.

Lena M Turkheimer, Gina R Petroni, Adam C Berger, Anneke T Schroen, David R Brenin, Melissa Lazar, Bruce Libby, Einsley M Janowski, Timothy N Showalter, Shayna L Showalter

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American College of Surgeons, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02400658 (A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02400658 naactive not recruitingnot on this map

A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer

TypeinterventionalSponsorShayna Showalter, MDRan2015 to 2027Enrolled358ConditionsBreast CancerArmsIORT with CT-Guided HDR Brachytherapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 1 country.

Lena M TurkheimerFrom the Departments of Surgery (Turkheimer, Schroen, Brenin, SL Showalter), University of Virginia School of Medicine, Charlottesville, VA.
Gina R PetroniDivision of Translational Research and Applied Statistics, Department of Public Health Sciences, University of Virginia Health System, Charlottesville, VA (Petroni).
Adam C BergerDepartment of Surgery, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ (Berger).
Anneke T SchroenFrom the Departments of Surgery (Turkheimer, Schroen, Brenin, SL Showalter), University of Virginia School of Medicine, Charlottesville, VA.
David R BreninFrom the Departments of Surgery (Turkheimer, Schroen, Brenin, SL Showalter), University of Virginia School of Medicine, Charlottesville, VA.
Melissa LazarDepartment of Surgery, Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA (Lazar).
Bruce LibbyRadiation Oncology, Moffitt Cancer Center, Tampa, FL (Libby).
Einsley M JanowskiRadiation Oncology (Janowski, TN Showalter), University of Virginia School of Medicine, Charlottesville, VA.
Timothy N ShowalterRadiation Oncology (Janowski, TN Showalter), University of Virginia School of Medicine, Charlottesville, VA.
Shayna L ShowalterFrom the Departments of Surgery (Turkheimer, Schroen, Brenin, SL Showalter), University of Virginia School of Medicine, Charlottesville, VA.
University of Virginia · USMoffitt Cancer Center · USRutgers Cancer Institute of New JerseySidney Kimmel Cancer Center · USUniversity of Virginia Health System · US

Funding

Women's Oncology Program - WONP30CA044579 · NCI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Jay William FOX · 1987 to 2026
$72.1M
Postdoctoral Training Grant for MDs in Surgical Oncology ResearchT32CA163177 · NCI · UNIVERSITY OF VIRGINIA · PI Craig Lee Slingluff, Allan Tsung · 2011 to 2026
$4.6M
Evaluation of image-guided, conformal, high-dose intraoperative radiation therapy (Precision Breast IORT) for early stage breast cancerR01CA214594 · NCI · UNIVERSITY OF VIRGINIA · PI SHOWALTER, SHAYNA LEFRAK, SHOWALTER, TIMOTHY NORMAN · 2018 to 2022
$1.9M
NCI NIH HHS P30 CA044579NCI NIH HHS R01 CA214594NCI NIH HHS T32 CA163177
6 · The paper itself

Abstract

backgroundPrecision breast intraoperative radiation therapy (PB-IORT) is a novel method of IORT that uses customized CT-based treatment plans and high-dose-rate (HDR) brachytherapy. We conducted a phase-II multi-institution trial to evaluate the efficacy of PB-IORT. STUDY

designBetween 2015 and 2022, 3 centers enrolled women aged 45 years and older with invasive or in situ carcinoma measuring 3 cm or smaller and N0 status (n = 358). Breast-conserving surgery was performed, and a multilumen balloon catheter was placed in the lumpectomy bed. CT images were used to create customized HDR brachytherapy plans that delivered 12.5 Gy to the tumor bed. The primary outcome assessed was the 5-year rate of index quadrant tumor recurrence. An interim analysis was conducted after one-third of eligible participants completed 5 years of follow-up. This trial is registered with clinicaltrials.gov (NCT02400658).

resultsThe cohort comprised 153 participants with a median age of 64 years and median follow-up time of 5.9 years. The estimated 5-year index quadrant tumor recurrence rate and overall survival were 5.08% (95% CI 2.23 to 9.68) and 95.1%, respectively. Locoregional (ipsilateral breast and axilla) and distant recurrence rates were each 1.96%. Seven deaths occurred during the first 5 years of follow-up, with only 1 attributable to breast cancer. Overall, 68.6% of patients experienced any adverse effects, and 4 cases of breast-related severe toxicities were observed.

conclusionsThis study presents the results of a planned interim analysis of a phase-II trial investigating PB-IORT and demonstrates the efficacy and safety of single-fraction, CT-based, HDR brachytherapy after breast-conserving surgery. These findings provide valuable insights into the use of PB-IORT as a treatment modality.

Indexed as

BrachytherapyBreast NeoplasmsFemaleHumansMastectomy, SegmentalMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRadiotherapy DosageTomography, X-Ray Computed

Identifiers

PMID37870228
PMCPMC12032993
OpenAlexW4387866282

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.