Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial

Orecchia, Roberto; Veronesi, Umberto; Maisonneuve, Patrick; Galimberti, Viviana; Lazzari, Roberta; Veronesi, Paolo; Jereczek‐Fossa, Barbara Alicja; Cattani, Federica; Sangalli, Claudia; Luini, Alberto; Caldarella, Pietro; Venturino, Marco; Sances, Daniele; Zurrida, Stefano; Viale, Giuseppe; Leonardi, Maria Cristina; Intra, Mattia

doi:10.1016/s1470-2045(21)00080-2

Cited by 120 publications

(80 citation statements)

References 32 publications

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“…( 27 ) was excluded from this analysis because it only reported the information of pulmonary fibrosis which had been described by Veronesi et al. ( 12 ) and updated in 2021 ( 28 ). Six RCTs ( 24 , 29 – 33 ) derived from different centers of the TARGIT-A trial were included in this analysis, which evaluated radiotherapy-related AEs different with the TARGIT-A trial.…”

Section: Resultsmentioning

confidence: 99%

“…Six RCTs ( 24 , 29 – 33 ) derived from different centers of the TARGIT-A trial were included in this analysis, which evaluated radiotherapy-related AEs different with the TARGIT-A trial. Finally, 13 studies including 10 RCTs ( 2 , 12 , 14 , 23 – 26 , 28 – 33 ) involving 5,698 patients were eligible for this meta-analysis. The median follow-up time ranged from 0.67 to 18.9 years.…”

Section: Resultsmentioning

confidence: 99%

“…Data on OS were available in 5 RCTs involving 5,016 patients ( 2 , 12 , 14 , 23 , 25 , 26 , 28 , 34 ). Pooled analysis showed there was no statistical difference in OS between IORT and WBRT groups (RR = 0.966, 95% CI, 0.827–1.129, p = 0.6649).…”

Section: Resultsmentioning

confidence: 99%

“…Fifthly, the study of Veronesi et al. enrolled BC patients who were not completely suitable for IORT ( 8 , 12 , 28 ). Therefore, the results must be interpreted with caution.…”

Section: Discussionmentioning

confidence: 99%

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Intraoperative Radiotherapy Is Not a Better Alternative to Whole Breast Radiotherapy as a Therapeutic Option for Early-Stage Breast Cancer

et al. 2021

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ObjectiveIntraoperative radiotherapy (IORT) in early-stage breast cancer has been studied over the years. However, it has not been demonstrated whether IORT is more suitable as a therapeutic option for early-stage breast cancer than whole breast radiotherapy (WBRT). Therefore, we performed a meta-analysis to compare the efficacy and safety of IORT to those of WBRT as therapeutic options for early-stage breast cancer patients receiving breast-conserving surgery (INPLASY2020120008).MethodsPubMed, Embase, and Cochrane Library databases were searched from inception to October 2021. Computerized and manual searches were adopted to identify eligible randomized control trials from online databases. Risk ratio (RR) and 95% confidence intervals (CI) were calculated by random-effect models to assess the relative risk. Potential publication bias was quantified by Begg’s and Egger’s tests.ResultsBased on our inclusion criteria, 10 randomized control trials involving 5,698 patients were included in this meta-analysis. This meta-analysis showed that the IORT group was associated with a higher local recurrence risk (RR = 2.111, 95% CI, 1.130–3.943, p = 0.0191), especially in the long-term follow-up subgroup or published after 2020 subgroup or Caucasian subgroup (RR = 2.404, 95% CI, 1.183–4.885, p = 0.0154). Subgroup analysis showed that the IORT group had a higher recurrence risk than the WBRT group in the polycentric randomized controlled trial subgroup (RR = 1.213, 95% CI, 1.030–1.428, p = 0.0204). Pooled analysis showed that there was no statistically significant difference in overall survival, recurrence-free survival, distant metastasis-free survival, and cancer-specific survival between IORT and WBRT groups. Additionally, the risk of skin toxicity was reduced, but the incidences of fat toxicity, edema, and scar calcification were significantly increased in the patients who underwent IORT in comparison to those who underwent WBRT.ConclusionThis meta-analysis revealed that IORT was not a better alternative to WBRT. More large-scale and well-designed clinical trials with longer follow-up periods are encouraged to further investigate the value of IORT.Systematic Review Registrationhttps://inplasy.com/inplasy-2020-12-0008/.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

“…Fifthly, the study of Veronesi et al. enrolled BC patients who were not completely suitable for IORT ( 8 , 12 , 28 ). Therefore, the results must be interpreted with caution.…”

Section: Discussionmentioning

confidence: 99%

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Intraoperative Radiotherapy Is Not a Better Alternative to Whole Breast Radiotherapy as a Therapeutic Option for Early-Stage Breast Cancer

et al. 2021

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“…The RR reported among patients treated with IOERT was higher than that among patients with EBRT [6]. Long-term results from this trial are published in 2021 with a median follow-up of 12.4 years and confirm the higher RR in the IOERT group, without any difference in OS [51].…”

Section: Discussionmentioning

confidence: 50%

Intraoperative Radiotherapy with Balloon-Based Electronic Brachytherapy System—A Systematic Review and First Bulgarian Experience in Breast Cancer Patients

et al. 2021

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(1) Background: We aimed to analyze currently available studies with intraoperative radiotherapy (IORT) as a choice of treatment where the Xoft Axxent® electronic brachytherapy (eBx) system was used as a single-dose irradiation and an exclusive radiotherapy approach at the time of surgery in patients with early breast cancer (EBC). We also compared the results of the systematic review to the Bulgarian experience. (2) Methods and Materials: We performed a systematic review of the studies published before February 2021, which investigate the application of a single-fraction 20 Gy radiation treatment, delivered at the time of lumpectomy in EBC patients with the Xoft Axxent® eBx System. A systematic search in PubMed, Scopus, and ScienceDirect was performed. The results are reported following the PRISMA guidelines. The criteria on patients’ selection for IORT (the additional need for EBRT), cosmetic outcomes, and recurrence rate from the eligible studies are compared to the treatment results in Bulgarian patients. (3) Results: We searched through 1032 results to find 17 eligible studies. There are no published outcomes from randomized trials. When reported, the cosmetic outcomes in most of the studies are defined as excellent. The observed recurrence rate is low (1–5.8%). Still, the number of patients additionally referred to postoperative external breast radiotherapy (EBRT) is up to 31%. Amongst the 20 patients treated in Bulgaria, the cosmetic outcomes are also evaluated as excellent, five of which (25%) are referred for EBRT. Within median follow-up of 39 months, there was one local and one distal recurrence. (4) Conclusions: Current evidence demonstrates the Xoft Axxent® eBx system as a safe and feasible technique for IORT delivery in EBC patients. There are no randomized controlled trials conducted at this time point to prove its long-term effectiveness. Better patient selection and a reimbursement strategy have to be proposed to extend the application of this technique in Bulgaria.

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Eradication of Potential In-Transit Metastasis in Breast-Conserving Surgery

2022

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Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial

Cited by 120 publications

References 32 publications

Intraoperative Radiotherapy Is Not a Better Alternative to Whole Breast Radiotherapy as a Therapeutic Option for Early-Stage Breast Cancer

Intraoperative Radiotherapy Is Not a Better Alternative to Whole Breast Radiotherapy as a Therapeutic Option for Early-Stage Breast Cancer

Intraoperative Radiotherapy with Balloon-Based Electronic Brachytherapy System—A Systematic Review and First Bulgarian Experience in Breast Cancer Patients

Eradication of Potential In-Transit Metastasis in Breast-Conserving Surgery

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