Patient Reported Experience with Treatment Modalities and Safety of Adjuvant Breast Radiotherapy - First Results of the Randomized HYPOSIB – Study

Dunst, Juergen; Krug, David; Schreiber, Andreas; Boicev, Alexander D.; Zimmer, Joerg; Laubach, R.; Weidner, N.; Dinges, Stefan; Hipp, Matthias; Schneider, R.; Weinstrauch, E; Martin, Thomas J.; Hörner-Rieber, Juliane; Vonthein, Reinhard; Olbrich, Denise; Illen, A; Koenig, Inke R.; Dellas, Kathrin

doi:10.1016/j.ijrobp.2020.07.2091

Cited by 8 publications

(5 citation statements)

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“…The trial HYPOSIB also discuessed SIB of 48Gy/15fx in patients after BCS. The preliminary results were presented during the 2020 American Society of Clinical Oncology annual meeting, and initially proved the safety of HFRT with SIB technique (31). In our center, a phase II trial investigating SIB technique irradiated the whole breast with 45 Gy in breast cancer was 98.7%, and none of the patients had grade 3 skin toxicity (32).…”

Section: Discussionmentioning

confidence: 85%

Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial

Jin,

Luo,

et al. 2024

Preprint

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Background: The effectiveness and safety of moderately hypofractionated radiotherapy (HFRT) in patients undergoing breast-conserving surgery (BCS) has been demonstrated in several pivotal randomized trials. However, the feasibility of applying simultaneous integrated boost (SIB) to the tumor bed and regional node irradiation (RNI) using modern radiotherapy techniques with HFRT needs further evaluation. Methods: This prospective, multi-center, randomized controlled, non-inferiority phase III trial aims to determine the non-inferiority of HFRT combined with SIB (HFRTsib) compared with conventional fractionated radiotherapy with sequential boost (CFRTseq) in terms of five-year locoregional control rate in breast cancer patients undergoing upfront BCS. A total of 2904 participants will be recruited and randomized in a 1:1 ratio into the HFRTsib and CFRTseq groups. All patients will receive whole breast irradiation, and those with positive axillary nodes will receive additional RNI, including internal mammary irradiation. The prescribed dose for the HFRTsib group will be 40 Gy in 15 fractions, combined with a SIB of 48 Gy in 15 fractions to the tumor bed. The CFRTseq group will receive 50 Gy in 25 fractions, with a sequential boost of 10 Gy in 5 fractions to the tumor bed. Discussion: This trial intends to assess the effectiveness and safety of SIB combined with HFRT in early breast cancer patients following BCS. The primary endpoint is locoregional control, and the results of this trial are expected to offer crucial evidence for utilizing HFRT in breast cancer patients after BCS. Trial registration: This trial was registered at ClincalTrials.gov (NCT04025164) on July 18, 2019.

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Section: Discussionmentioning

confidence: 85%

Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial

Jin,

Luo,

et al. 2024

Preprint

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“…The late cosmetic effect of the whole breast combined with tumor bed concurrent IMRT-SIB has always been the focus of attention. The comprehensive publication of long-term cosmetic results and longer follow-up data for several large randomized controlled phase III trials investigating the application of SIB in adjuvant WBI is still pending [ 37 , 38 ]. Our findings had a high rate of excellent cosmetic outcomes (96.9% at 2 years) highlight the patient-centric benefits of IMRT-SIB, better than some studies [ 39 , 40 ].…”

Section: Discussionmentioning

confidence: 99%

Simultaneous integrated boost intensity-modulated radiotherapy post breast-conserving surgery: clinical efficacy, adverse effects, and cosmetic outcomes in breast cancer patients

Bao,

Yu,

Huang

et al. 2024

Breast Cancer

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Background Simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) is an innovative technique delivering a higher dose to the tumor bed while irradiating the entire breast. This study aims to assess the clinical outcomes, adverse effects, and cosmetic results of SIB-IMRT following breast-conserving surgery in breast cancer patients. Methods We conducted a retrospective analysis of 308 patients with stage 0–III breast cancer who underwent breast-conserving surgery and SIB-IMRT from January 2016 to December 2020. The prescribed doses included 1.85 Gy/27 fractions to the whole breast and 2.22 Gy/27 fractions or 2.20 Gy/27 fractions to the tumor bed. Primary endpoints included overall survival (OS), local–regional control (LRC), distant metastasis-free survival (DMFS), acute and late toxicities, and cosmetic outcomes. Results The median follow-up time was 36 months. The 3-year OS, LRC, and DMFS rates were 100%, 99.6%, and 99.2%, respectively. Five patients (1.8%) experienced local recurrence or distant metastasis, and one patient succumbed to distant metastasis. The most common acute toxicity was grade 1–2 skin reactions (91.6%). The most common late toxicity was grade 0–1 skin and subcutaneous tissue reactions (96.7%). Five patients (1.8%) developed grade 1–2 upper limb lymphedema, and three patients (1.1%) had grade 1 radiation pneumonitis. Among the 262 patients evaluated for cosmetic outcomes at least 2 years post-radiotherapy, 96.9% achieved excellent or good results, while 3.1% had fair or poor outcomes. Conclusions SIB-IMRT after breast-conserving surgery in breast cancer patients demonstrated excellent clinical efficacy, mild acute and late toxicities, and satisfactory cosmetic outcomes in our study. SIB-IMRT appears to be a feasible and effective option for breast cancer patients suitable for breast-conserving surgery.

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“…Patient characteristics and patterns of fractionation in the standard arm have been published [ 32 ]. Acute toxicity-data were presented at the ASTRO annual meeting and demonstrated a favorable safety profile for moderate HF with SIB [ 33 ]. Long-term results of HYPOSIB and RTOG 1005 (NCT01349322) trials will allow definitive conclusions on the efficacy and safety of HF with SIB.…”

Section: Discussionmentioning

confidence: 99%

Hypofractionation with simultaneous integrated boost after breast-conserving surgery: Long term results of two phase-II trials

Pfaffendorf¹,

Vonthein²,

Krockenberger-Ziegler³

et al. 2022

The Breast

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Patient Reported Experience with Treatment Modalities and Safety of Adjuvant Breast Radiotherapy - First Results of the Randomized HYPOSIB – Study

Cited by 8 publications

References 0 publications

Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial

Hypofractionated radiotherapy with simultaneous tumor bed boost (Hi-RISE) in breast cancer patients receiving upfront breast-conserving surgery: study protocol for a phase III randomized controlled trial

Simultaneous integrated boost intensity-modulated radiotherapy post breast-conserving surgery: clinical efficacy, adverse effects, and cosmetic outcomes in breast cancer patients

Hypofractionation with simultaneous integrated boost after breast-conserving surgery: Long term results of two phase-II trials

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