Evidence map›Paper›PMID 33209058›Full record

ArticleBreast cancer (Dove Medical Press)2020

Intensity-Modulated Radiotherapy with Concomitant Boost After Breast Conserving Surgery: A Phase I-II Trial.

Gabriella Macchia, Savino Cilla, Milly Buwenge, Alice Zamagni, Ilario Ammendolia, Claudio Zamagni, Giovanni P Frezza, Vincenzo Valentini, Francesco Deodato, Alessio G Morganti

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Breast cancer (Dove Medical Press), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03471741 (Moderated Accelerated RAdiotherapy), 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
0.2field-weighted citation impact, top 52% 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.

NCT03471741 completednot on this map

Moderated Accelerated RAdiotherapy (MARA-2) in Moderate-high Risk Breast Cancer: a Phase I-II Study

TypeobservationalSponsorIRCCS Azienda Ospedaliero-Universitaria di BolognaRan2001 to 2017Enrolled451ConditionsBreast Cancer, Radiation ToxicityArmsIMRT with concomitant boost, 3D-RT with sequential boost
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
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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 3 institutions in 1 country.

Gabriella MacchiaRadiotherapy Unit, Gemelli Molise Hospital, Università Cattolica Del Sacro Cuore, Campobasso, Italy.ORCID 0000-0002-0529-201x
Savino CillaMedical Physics Unit, Gemelli Molise Hospital, Università Cattolica Del Sacro Cuore, Campobasso, Italy.
Milly BuwengeRadiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.ORCID 0000-0002-0779-1875
Alice ZamagniRadiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.ORCID 0000-0001-8942-793x
Ilario AmmendoliaRadiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.
Claudio ZamagniAddarii Medical Oncology Unit, S. Orsola-Malpighi Hospital, Bologna, Italy.
Giovanni P FrezzaRadiation Oncology Unit, Bellaria Hospital, Bologna, Italy.ORCID 0000-0002-2332-6770
Vincenzo ValentiniDipartimento di Scienze Radiologiche, Radioterapiche ed Ematologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC di Radioterapia, Rome, Italy.ORCID 0000-0003-4637-6487
Francesco Deodato *Radiotherapy Unit, Gemelli Molise Hospital, Università Cattolica Del Sacro Cuore, Campobasso, Italy.ORCID 0000-0003-1276-5070
Alessio G Morganti *Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine ‑ DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy.ORCID 0000-0001-9793-3410
IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola · ITOspedale Bellaria · ITUniversità Cattolica del Sacro Cuore · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeA concomitant boost (CB) in patients treated with postoperative radiotherapy after conservative surgery of invasive breast cancer (BC) has been suggested for treatment time reduction and therapy intensification. The aim of this analysis was to assess long-term tolerability of a CB in patients treated with postoperative intensity Modulated Accelerated RAdiotherapy (MARA). PATIENTS AND

methodsIn this phase I-II trial, 321 patients with intermediate-high risk BC (pT1-4 with at least one of the following characteristics: pre or perimenopausal status, pN2-3, positive or close margins) were enrolled. Patients were treated with forward-planned intensity modulated radiotherapy (IMRT) and CB. A total dose of 50 Gy (2 Gy/fraction) and 60 Gy (2.4 Gy/fraction) was prescribed to the whole breast and the tumor bed, respectively. The potential impact of hypertension, diabetes, smoking habit, alcohol consumption, chemotherapy, and hormone therapy on both skin and subcutaneous late toxicity-free survival (LTFS) was evaluated. Survival curves were calculated using the Kaplan-Meier method.

resultsMedian follow-up was 52 months (range: 3-115). Regional node irradiation, adjuvant chemotherapy and hormonal therapy were prescribed to 29.3%, 65.4% and 81.0% of patients, respectively. Five-year G2 and G3 skin LTFS were 95.6% and 100.0%, respectively. Five-year G2 and G3 subcutaneous LTFS were 80.0% and 98.6%, respectively. Only diabetes showed a significant correlation with worse G3 subcutaneous LTFS (p: 0.024). Five-year loco-regional control, metastasis-free survival, disease-free survival, and overall survival were 98.0%, 91.8%, 89.7% and 96.3%, respectively.

conclusionIMRT combined with CB was associated with a low risk of > G2 late toxicities (0.0% and 1.4% for skin and subcutaneous tissue, respectively). The cumulative actuarial incidence of local recurrences was 2.0% despite the exclusion of low-risk patients. Our results suggest that CB is safe and effective in patients with intermediate-high risk BC.

trial registrationClinicalTrials.gov: NCT03471741.

Indexed as

adjuvant radiotherapybreast cancerconcomitant boostIMRTtoxicity

Identifiers

PMID33209058
PMCPMC7670173
OpenAlexW3101309705

What OpenQuestion holds

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LicenceCC BY-NC
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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.