Evidence map›Paper›PMID 27639373›Full record

Trial reportRadiation oncology (London, England)2016

Phase II trial of hypofractionated VMAT-based treatment for early stage breast cancer: 2-year toxicity and clinical results.

Fiorenza De Rose, Antonella Fogliata, Davide Franceschini, Piera Navarria, Elisa Villa, Cristina Iftode, Giuseppe D'Agostino, Luca Cozzi, Francesca Lobefalo, Pietro Mancosu and 2 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Radiation oncology (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 51 citations in OpenAlex.

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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

12 authors at 2 institutions in 1 country.

Fiorenza De RoseRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Antonella FogliataRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy. antonella.fogliata@humanitas.it.
Davide FranceschiniRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Piera NavarriaRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Elisa VillaRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Cristina IftodeRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Giuseppe D'AgostinoRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Luca CozziRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Francesca LobefaloRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Pietro MancosuRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Stefano TomatisRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
Marta ScorsettiRadiotherapy and Radiosurgery Department, Humanitas Research Hospital and Cancer Center, Milan-Rozzano, Italy.
IRCCS Humanitas Research Hospital · ITHumanitas University · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo report toxicity and early clinical outcomes of hypofractionated simultaneous integrated boost (SIB) approach with Volumetric Modulated Arc Therapy (VMAT) as adjuvant treatment after breast-conserving surgery.

methodsPatients presenting early-stage breast cancer were enrolled in a phase II trial. ELIGIBILITY CRITERIA: age > 18 years old, invasive cancer or ductal carcinoma in situ (DCIS), Stage I-II (T < 3 cm and N ≤ 3), breast-conserving surgery without oncoplastic reconstruction. Any systemic therapy was allowed in neoadjuvant or adjuvant setting. All patients underwent VMAT-SIB technique to irradiate the whole breast and the tumor bed. Doses to whole breast and surgical bed were 40.5 Gy and 48 Gy, respectively, delivered in 15 fractions over 3 weeks. Acute and late skin toxicities were recorded. Cosmetic outcome was assessed as excellent/good or fair/poor.

resultsThe present study focused on results of a cohort of 144 patients with a minimum follow-up of 24 months (median 37, range 24-55 months). Median age was 62 years old (range 30-88). All patients had an invasive carcinoma (no patients with DCIS were present in this subset). At one year, the highest reported skin toxicity was G1, in 14 % of the patients; this data dropped to 4 % at the last follow-up, after more than 2 years. Breast pain was recorded in 21.6 % of the patients 6 months after treatment, while it was present in 3.5 % of the patients at the last follow-up, showing a significant improvement with time. Correlation between liponecrosis and boost target volume was found not significant. Breast pain was correlated with breast volume. No pulmonary or cardiological toxicities were recorded. After an early evaluation of clinical outcomes, only one case presented disease relapse, as liver metastases.

conclusionsThe 3-week VMAT-SIB course as adjuvant treatment after breast-conserving surgery showed to be well tolerated and was associated with optimal local control. Long-term follow-up data are needed to assess late toxicity and clinical outcomes.

Indexed as

Dose Fractionation, RadiationAdultAgedAged, 80 and overBreast NeoplasmsCohort StudiesFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessRadiotherapyRadiotherapy, AdjuvantRadiotherapy, Intensity-ModulatedTreatment OutcomeBreast cancerHypofractionationSimultaneous integrated boostVolumetric modulated arc therapy

Identifiers

PMID27639373
PMCPMC5027088
OpenAlexW2519293369

What OpenQuestion holds

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Registered trials

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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.