Evidence map›Paper›PMID 21061074›Full record

Trial reportAnnals of surgical oncology2011

Local control following single-dose intraoperative radiotherapy prior to surgical excision of early-stage breast cancer.

Randall J Kimple, Nancy Klauber-DeMore, Cherie M Kuzmiak, Dag Pavic, Jun Lian, Chad A Livasy, WingKeung M Chiu, Dominic T Moore, Carolyn I Sartor, David W Ollila

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of surgical oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 20% 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.

NCT00182728 nacompletednot on this map

Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue

TypeinterventionalSponsorUNC Lineberger Comprehensive Cancer CenterRan2003 to 2019Enrolled89ConditionsBreast CancerArmssurgery, therapy, radiation therapy
NCT07188246 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Trial of Neoadjuvant, Hypofractionated Radiation, With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy, in Stage 3 or High-risk Stage 2 Breast Cancer

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2026 to 2029Enrolled40ConditionsBreast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer InvasiveArmsRadiation, Pembrolizumab (KEYTRUDA®)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Intraoperative Period and Breast Cancer: Review.The journal of breast health · 2014
    Review
  5. Review
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 1 institution in 1 country.

Randall J KimpleDepartment of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Nancy Klauber-DeMore
Cherie M Kuzmiak
Dag Pavic
Jun Lian
Chad A Livasy
WingKeung M Chiu
Dominic T Moore
Carolyn I Sartor
David W Ollila
University of North Carolina at Chapel Hill · US

Funding

Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Deborah F. Tate · 1985 to 2026
$201.5M
Tissue Procurement & PathologyP50CA058223 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI KATHERINE A. HOADLEY · 1992 to 2026
$59.3M
TRAINING PROGRAM FOR MEDICAL SCIENTISTST32GM008716 · NIGMS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI DEMORE, NANCY · 1999 to 2024
$9.3M
NCI NIH HHS P30 CA016086NCI NIH HHS P50 CA058223NIGMS NIH HHS T32 GM008716
6 · The paper itself

Abstract

backgroundMultiple partial breast radiotherapy techniques are available. We have previously presented the technical details of our procedure of delivering partial breast irradiation with a single fraction of intraoperative radiotherapy (IORT) targeting the tumor in situ prior to partial mastectomy. This study details our completed, single-institution trial. MATERIALS AND

methodsAn IRB-approved, DSMB-monitored phase II trial was performed with the following inclusion criteria: women age ≥48, ultrasound-visible invasive ductal cancers <3 cm, clinically negative axillary nodes. IORT was delivered using mobile electron irradiator, at least a 1.5-cm radial and 1-cm deep margin; patients received 15 Gy and immediately underwent partial mastectomy. Ipsilateral breast recurrence was classified as true/marginal, elsewhere in the breast or nodal basin. Kaplan-Meier methods were used to estimate survival functions and exact 95% confidence intervals are reported.

resultsBetween 2003 and 2007, 71 women underwent IORT (median follow-up: 3.5 years). For patients with tumor-involved or close margins, additional therapy was required: 7 patients, total mastectomy; 11, whole breast radiation. Four women experienced invasive ipsilateral breast failures (1 new primary, 3 margin recurrences) for a 3-year local control rate of 49 of 53 (94.8%; 95% confidence interval 92.4% [95% CI] 84.2–98.3%), actuarial three-year in breast recurrence was 8% (95% CI 2–18%), and breast cancer-specific survival was 100%.

conclusionsIntraoperative radiotherapy delivered to an in situ tumor is feasible, but our local control rate at 3.5 years is concerning. Possible changes to this technique to improve local control rates include better preoperative imaging (MRI), routine intraoperative ultrasound, and improved IORT delivery (larger cone, increased dose).

Indexed as

MastectomyAgedAged, 80 and overBreast NeoplasmsFemaleFollow-Up StudiesHumansIntraoperative CareMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingRadiotherapy, AdjuvantRadiotherapy DosageSurvival RateTreatment Outcome

Identifiers

PMID21061074
PMCPMC7243848
OpenAlexW2071781591

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.