Toxicity and cosmetic outcome after hypofractionated whole breast irradiation and boost-IOERT in early stage breast cancer (HIOB): First results of a prospective multicenter trial (NCT01343459)

Fastner, Gerd; Reitsamer, Roland; Urbański, Bartosz; Kopp, Peter; Murawa, Dawid; Adamczyk, Beata; Karzcewska, A.; Milecki, Piotr; Hager, Eva; Reiland, Juliann; Ciabattoni, Antonella; Matuschek, Christiane; Budach, Wilfried; Nowell, Kerri A.; Schumacher, Claudia; Ricke, A.; Fusco, Vincenzo; Vidali, Cristiana; Alessandro, M.; Ivaldi, Giovanni Battista; Ziegler, Ingrid; Fussl, Christoph; Zehentmayr, Franz; Grambozov, Brane; Sir, Andreas; Hitzl, Wolfgang; Ricardi, Umberto; Sedlmayer, Felix

doi:10.1016/j.radonc.2020.02.001

Cited by 32 publications

(42 citation statements)

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“…A high tumor‐to‐breast ratio is the most important factor affecting cosmesis 3,15,24,32 . Small tumor size and large breast volume were associated with better cosmesis when used HF with intraoperative RT 37 . However, Shaitelman et al found that cosmesis did not compromised when applied HF compared to CF among patient with bra cup D 30 …”

Section: Discussionmentioning

confidence: 99%

“…First, this study had a relatively small sample size. Second, the cross‐sectional study design may not allow temporal evaluation; however, published long‐term studies revealed the stability of cosmesis outcome over time 15,37,38 . Third, the cosmetic assessment was subjectively scored without photographic record or pre‐RT comparison; thus, the global cosmesis was the combined effects from surgery and RT.…”

Section: Discussionmentioning

confidence: 99%

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Long‐term patient‐rated cosmetic and satisfactory outcomes of early breast cancer treated with conventional versus hypofractionated breast irradiation with simultaneous integrated boost technique

et al. 2020

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To compare patient‐rated cosmetic and satisfactory outcomes between conventional fractionation with simultaneously integrated boost (C‐SIB) vs hypofractionation with SIB (H‐SIB) in early breast cancer. Patients with stage I and II breast cancer who received breast‐conserving surgery followed by radiation with SIB to tumor bed and completed questionnaire were included in this study. Radiotherapy was as follows: C‐SIB arm = 50 Gy and 65 Gy in 25 fractions and H‐SIB arm = 43.2 Gy and 52.8 Gy in 16 fractions to the whole breast and tumor bed, respectively. Single cross‐sectional assessment of the breast cosmesis was done by patients and radiation oncologist at a follow‐up visit. Breast cosmetic and satisfaction scores were collected using a four‐point Harvard/NSABP/RTOG cosmesis criteria scale and a four‐point Likert‐type scale, respectively. Of a total of 114 patients (C‐SIB = 57) and (H‐SIB = 57) arms, a median time from radiotherapy completion to questionnaire response was 7.2 years. Patient‐rated cosmetic outcome in C‐SIB vs H‐SIB was “excellent” in 40.3% vs 45.6%, “good” in 33.3% vs 42.1%, “fair” in 21.1% vs 10.5%, and “poor” in 5.3% vs 1.8% (P = .288). Corresponding satisfaction was “very satisfied” in 52.6% vs 57.9%, “satisfied” in 40.4% vs 35.1%, “neutral” in 7.0% vs 5.2%, and “unsatisfied” in 0% vs 1.8% (P = .683). Stage I and older age at radiotherapy were predictors for favorable (good or excellent) cosmesis and satisfaction, respectively. In early‐stage breast cancer, H‐SIB provided a trend for better cosmesis than C‐SIB while maintaining satisfaction. The reduction in treatment duration and cost as well as favorable cosmesis outcomes encourages the use of H‐SIB.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Long‐term patient‐rated cosmetic and satisfactory outcomes of early breast cancer treated with conventional versus hypofractionated breast irradiation with simultaneous integrated boost technique

et al. 2020

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“…However, few trials studied the combination of hypofractionated whole-breast radiotherapy and intraoperative boost irradiation. First results from the prospective single-arm HIOB trial studying intraoperative boost irradiation with electrons followed by hypofractionated whole-breast radiotherapy have been published recently [19]. With a median follow-up of 45 months and 583 patients, toxicity rates and cosmetic outcome were favorable [19].…”

Section: Introductionmentioning

confidence: 99%

“…First results from the prospective single-arm HIOB trial studying intraoperative boost irradiation with electrons followed by hypofractionated whole-breast radiotherapy have been published recently [19]. With a median follow-up of 45 months and 583 patients, toxicity rates and cosmetic outcome were favorable [19]. Regarding intraoperative boost irradiation with kV-photons, a prospective report of acute toxicity in 26 patients treated with hypofractionated whole-breast radiotherapy and intraoperative boost irradiation was published recently.…”

Section: Introductionmentioning

confidence: 99%

Moderate hypofractionation remains the standard of care for whole-breast radiotherapy in breast cancer: Considerations regarding FAST and FAST-Forward

et al. 2021

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Moderate hypofractionation is the standard of care for adjuvant whole-breast radiotherapy after breast-conserving surgery for breast cancer. Recently, 10-year results from the FAST and 5‑year results from the FAST-Forward trial evaluating adjuvant whole-breast radiotherapy in 5 fractions over 5 weeks or 1 week have been published. This article summarizes recent data for moderate hypofractionation and results from the FAST and FAST-Forward trial on ultra-hypofractionation. While the FAST trial was not powered for comparison of local recurrence rates, FAST-Forward demonstrated non-inferiority for two ultra-hypofractionated regimens in terms of local control. In both trials, the higher-dose experimental arms resulted in elevated rates of late toxicity. For the lower dose experimental arms of 28.5 Gy over 5 weeks and 26 Gy over 1 week, moderate or marked late effects were similar in the majority of documented items compared to the respective standard arms, but significantly worse in some subdomains. The difference between the standard arm and the 26 Gy of the FAST-Forward trial concerning moderate or marked late effects increased with longer follow-up in disadvantage of the experimental arm for most items. For now, moderate hypofractionation with 40–42.5 Gy over 15–16 fractions remains the standard of care for the majority of patients with breast cancer who undergo whole-breast radiotherapy without regional nodal irradiation after breast-conserving surgery.

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“…13 First clinical results on treatment tolerance (toxicity and cosmetic outcome) were published in 2020. 14 In the whole series before starting IOERT (either as a boost or as the unique radiation treatment), a shielding disk was positioned beneath the tumor bed on the pectoralis muscle (Figure 2A). A disk provided by IntraOp ® Company was employed, made by stacking a 5 mm polymethyl methacrylate (PMMA) layer, a 3 mm copper layer and 2 mm PMMA layer (Figure 2B).…”

Section: Methodsmentioning

confidence: 99%

State of the art in breast intraoperative electron radiation therapy after intraoperative ultrasound introduction

Vidali

Severgnini

Giudici

et al. 2021

Radiology and Oncology

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Background Breast intraoperative electron radiation therapy (B-IOERT) can be used in clinical practice both as elective irradiation (partial breast irradiation – APBI) in low risk breast cancer patients, and as an anticipated boost. The procedure generally includes the use of a shielding disk between the residual breast and the pectoralis fascia for the protection of the tissues underneath the target volume. The aim of the study was to evaluate the role of intraoperative ultrasound (IOUS) in improving the quality of B-IOERT. Patients and methods B-IOERT was introduced in Trieste in 2012 and its technique was improved in 2014 with IOUS. Both, needle and IOUS were used to measure target thickness and the latter was used even to check the correct position of the shielding disk. The primary endpoint of the study was the evaluation of the effectiveness of IOUS in reducing the risk of a disk misalignment related to B-IOERT and the secondary endpoint was the analysis of acute and late toxicity, by comparing two groups of patients treated with IOERT as a boost, either measured with IOUS and needle (Group 1) or with needle alone (Group 2). Acute and late toxicity were evaluated by validated scoring systems. Results From the institutional patients who were treated between June 2012 and October 2019, 109 were eligible for this study (corresponding to 110 cases, as one patients underwent bilateral conservative surgery and bilateral B-IOERT). Of these, 38 were allocated to group 1 and 72 to group 2. The target thickness measured with the IOUS probe and with the needle were similar (mean difference of 0.1 mm, p = 0.38). The percentage of patients in which the shield was perfectly aligned after IOUS introduction increased from 23% to more than 70%. Moreover, patients treated after IOUS guidance had less acute toxicity (36.8% vs. 48.6%, p = 0.33) from radiation therapy, which reached no statistical significance. Late toxicity turned out to be similar regardless of the use of IOUS guidance: 39.5% vs. 37.5% (p = 0.99). Conclusions IOUS showed to be accurate in measuring the target depth and decrease the misalignment between collimator and disk. Furthermore there was an absolute decrease in acute toxicity, even though not statistically significant, in the group of women who underwent B-IOERT with IOUS guidance.

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Toxicity and cosmetic outcome after hypofractionated whole breast irradiation and boost-IOERT in early stage breast cancer (HIOB): First results of a prospective multicenter trial (NCT01343459)

Cited by 32 publications

References 43 publications

Long‐term patient‐rated cosmetic and satisfactory outcomes of early breast cancer treated with conventional versus hypofractionated breast irradiation with simultaneous integrated boost technique

Long‐term patient‐rated cosmetic and satisfactory outcomes of early breast cancer treated with conventional versus hypofractionated breast irradiation with simultaneous integrated boost technique

Moderate hypofractionation remains the standard of care for whole-breast radiotherapy in breast cancer: Considerations regarding FAST and FAST-Forward

State of the art in breast intraoperative electron radiation therapy after intraoperative ultrasound introduction

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