Evidence map›Paper›PMID 29282078›Full record

Trial reportJournal of experimental & clinical cancer research : CR2017

Short course hypofractionated whole breast irradiation after conservative surgery: a single institution phase II study.

Paola Pinnarò, Carolina Giordano, Alessia Farneti, Adriana Faiella, Giuseppe Iaccarino, Valeria Landoni, Diana Giannarelli, Patrizia Vici, Lidia Strigari, Giuseppe Sanguineti

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of experimental & clinical cancer research : CR, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06224244 (A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 44% 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.

NCT06224244 phase2active not recruitingnot on this mapstarted 2022, after this paper: background citation

A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost (HF-SIB) in Early Breast Cancer Patients Undergoing Breast Conserving Surgery

TypeinterventionalSponsorRegina Elena Cancer InstituteRan2022 to 2027Enrolled180ConditionsBreast Neoplasms, Breast CancerArmsTen-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost, Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. 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 2 institutions in 2 countries.

Paola PinnaròDepartments of Radiation Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Carolina GiordanoDepartments of Radiation Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Alessia FarnetiDepartments of Radiation Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Adriana FaiellaDepartments of Radiation Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.
Giuseppe IaccarinoLaboratory of Medical Physics and Expert Systems, Regina Elena National Cancer Institute, Rome, Italy.
Valeria LandoniLaboratory of Medical Physics and Expert Systems, Regina Elena National Cancer Institute, Rome, Italy.
Diana GiannarelliDepartments of Statistics, Regina Elena National Cancer Institute, Rome, Italy.
Patrizia ViciDepartments of Clinical Oncology, Regina Elena National Cancer Institute, Rome, Italy.
Lidia StrigariLaboratory of Medical Physics and Expert Systems, Regina Elena National Cancer Institute, Rome, Italy.
Giuseppe SanguinetiDepartments of Radiation Oncology, Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy. giuseppe.sanguineti@ifo.gov.it.
National Cancer Institute · MYExpert System (Italy) · IT

Funding

NATO G4815/2014 - Programme SPS
6 · The paper itself

Abstract

backgroundTo assess the oncologic outcomes of hypofractionated whole breast irradiation (Hypo-WBI).

methodsEligible patients had undergone breast conservative surgery for early breast cancer (pTis-2) and none/limited nodal involvement. Hypo-WBI consisted of 34 Gy in 10 daily fractions over 2 weeks to the whole breast three-dimensional conformal radiotherapy (3DCRT), followed by a single fraction of 8 Gy to the tumor bed after 1 week (electrons). Primary endpoint is freedom from ipsilateral breast tumor recurrence (IBTR). Minimum follow up for living & event-free patients is 3 yrs.; median follow up time of the whole analyzed patient population is 5.4 yrs. (range: 1.8-11.4 yrs).

resultsTwo hundred fifty-one patients were accrued from 2004 to 2013. All patients underwent local excision of the primary tumor to negative margins. Four patients failed in the ipsilateral breast after a median time of 3.2 years (range: 1.7-5.7 yrs) for a 5-year IBTR-free survival of 98.7% (95%CI: 97.3%-100%). IBTR-free survival was significantly higher for patients with invasive cancer than for patients with intraductal carcinoma (p = 0.036). Within patients with invasive tumors, no clear trends or associations were detected between IBTR and age, grading, molecular subtype, pT or pN stage. At 5 years, the actuarial rates of GR2 fibrosis and GR2+ teleangectasia are 2.4% (95%CI: 0-6.5%) and 7.1% (95%CI: 0.4-13.7%), respectively. Cosmesis was scored as excellent/good by ≈95% of patients and ≈60% of clinicians.

conclusionsHypo-WBI in 3 weeks allows excellent oncologic outcomes for invasive breast cancer after conservative surgery. Patients with intraductal carcinoma should be treated with Hypo-WBI only within a controlled study.

trial registrationIRE-IFO Ethical and Scientific Committee (cod. RS61/04).

Indexed as

AdultAgedBreast NeoplasmsCarcinoma, Ductal, BreastCombined Modality TherapyDisease-Free SurvivalDose Fractionation, RadiationFemaleHumansKaplan-Meier EstimateMastectomy, SegmentalMiddle AgedNeoplasm Recurrence, LocalProportional Hazards ModelsRadiotherapy, AdjuvantRadiotherapy, ConformalBreast carcinoma in situBreast neoplasmsDose hypofractionationLocal neoplasm recurrenceRadiotherapy

Identifiers

PMID29282078
PMCPMC5744389
OpenAlexW2777223745

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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.