Evidence map›Paper›PMID 38893184›Full record

ArticleCancers2024

Acute and Long-Term Toxicity after Planned Intraoperative Boost and Whole Breast Irradiation in High-Risk Patients with Breast Cancer-Results from the Targeted Intraoperative Radiotherapy Boost Quality Registry (TARGIT BQR).

Lukas Goerdt, Robert Schnaubelt, Uta Kraus-Tiefenbacher, Viktoria Brück, Lelia Bauer, Stefan Dinges, Albert von der Assen, Heidrun Meye, Christina Kaiser, Christel Weiss and 9 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancers, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01440010 (TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany), which is 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
–field-weighted citation impact
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.

NCT01440010 completednot on this map

TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany (TARGIT BQR)

TypeobservationalSponsorUniversitätsmedizin MannheimRan2011 to 2020Enrolled1,133ConditionsBreast CancerArmsIORT with 20 Gy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. 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

19 authors.

Lukas GoerdtDepartment of Gynecology and Obstetrics, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Robert SchnaubeltRadiation Oncology, MVZ Rheinland Klinikum Neuss, 41462 Neuss, Germany.
Uta Kraus-TiefenbacherDepartment of Radiation Oncology, Krankenhaus Nordwest, 60488 Frankfurt am Main, Germany.
Viktoria BrückBreast Center, Asklepios Klinik Barmbek, 22307 Hamburg, Germany.
Lelia BauerBreast Center, GRN Klinik Weinheim, 69469 Weinheim, Germany.
Stefan DingesDepartment of Radiation Oncology, Städtisches Klinikum Lüneburg, 21339 Lüneburg, Germany.
Albert von der AssenBreast Center, Department of Senology, Franziskus Hospital Harderberg-Niels Stensen Kliniken, 49124 Georgsmarienhütte, Germany.
Heidrun MeyeDepartment of Radiation Oncology, MVZ Gesundheit Nordhessen, 34125 Kassel, Germany.
Christina KaiserUniversity Medical Center Bonn, Medical Faculty Bonn, Bonn University, 53113 Bonn, Germany.
Christel WeissDepartment of Medical Biometry, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Sven ClausenDepartment of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Frank SchneiderDepartment of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Yasser Abo-MadyanDepartment of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Katharina FleckensteinDepartment of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Sebastian BerlitDepartment of Gynecology and Obstetrics, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Benjamin TuschyDepartment of Gynecology and Obstetrics, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Marc SütterlinDepartment of Gynecology and Obstetrics, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.
Frederik WenzUniversity Hospital Freiburg, 79106 Freiburg, Germany.
Elena SperkDepartment of Radiation Oncology, University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University, 68167 Mannheim, Germany.ORCID 0000-0002-8771-8124

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the context of breast cancer treatment optimization, this study prospectively examines the feasibility and outcomes of utilizing intraoperative radiotherapy (IORT) as a boost in combination with standard external beam radiotherapy (EBRT) for high-risk patients. Different guidelines recommend such a tumor bed boost in addition to whole breast irradiation with EBRT for patients with risk factors for local breast cancer recurrence. The TARGIT BQR (NCT01440010) is a prospective, multicenter registry study aimed at ensuring the quality of clinical outcomes. It provides, for the first time, data from a large cohort with a detailed assessment of acute and long-term toxicity following an IORT boost using low-energy X-rays. Inclusion criteria encompassed tumors up to 3.5 cm in size and preoperative indications for a boost. The IORT boost, administered immediately after tumor resection, delivered a single dose of 20 Gy. EBRT and systemic therapy adhered to local tumor board recommendations. Follow-up for toxicity assessment (LENT SOMA criteria: fibrosis, teleangiectasia, retraction, pain, breast edema, lymphedema, hyperpigmentation, ulceration) took place before surgery, 6 weeks to 90 days after EBRT, 6 months after IORT, and then annually using standardized case report forms (CRFs). Between 2011 and 2020, 1133 patients from 10 centers were preoperatively enrolled. The planned IORT boost was conducted in 90%, and EBRT in 97% of cases. Median follow-up was 32 months (range 1-120, 20.4% dropped out), with a median age of 61 years (range 30-90). No acute grade 3 or 4 toxicities were observed. Acute side effects included erythema grade 1 or 2 in 4.4%, palpable seroma in 9.1%, punctured seroma in 0.3%, and wound healing disorders in 2.1%. Overall, chronic teleangiectasia of any grade occurred in 16.2%, fibrosis grade ≥ 2 in 14.3%, pain grade ≥ 2 in 3.4%, and hyperpigmentation in 1.1%. In conclusion, a tumor bed boost through IORT using low-energy X-rays is a swift and feasible method that demonstrates low rates in terms of acute or long-term toxicity profiles in combination with whole breast irradiation.

Indexed as

boostbreast cancerfibrosishigh riskintraoperative radiotherapyIORTtoxicitywhole breast irradiation

Identifiers

PMID38893184
PMCPMC11171237

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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.