Does an integrated boost increase acute toxicity in prone hypofractionated breast irradiation? A randomized controlled trial

Paelinck, Leen; Gulybán, Ákos; Lakosi, Ferenc; Vercauteren, Tom; Gersem, Werner De; Speleers, Bruno; Monten, Christel; Mulliez, Thomas; Berkovic, P.; Greveling, Annick Van; Decoster, Frederik; Coucke, Philippe; Neve, Wilfried De; Veldeman, Liv

doi:10.1016/j.radonc.2016.12.023

Cited by 27 publications

(21 citation statements)

References 45 publications

(34 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Many published clinical experiences with H‐SIB have been reported, 12,19‐23 but these usually have short follow‐up and few have been compared with C‐SIB. Acute toxicity of H‐SIB was mild 24‐27 and slightly lower than in HF with sequential boost (H‐SEQ), 28 C‐SIB 27,29,30 or CF with sequential boost (C‐SEQ) 26,30 . Two prospective randomized trials comparing H‐SIB vs C‐SEQ or H‐SEQ remain unpublished 31,32 .…”

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

View full text Add to dashboard Cite

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.

show abstract

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

View full text Add to dashboard Cite

show abstract

“…Local control, disease-free survival and overall survival at 3 years were similar between the two groups. There are two small randomized controlled trials studying hypofractionated whole-breast radiotherapy (HF) and comparing SIB to seqB [27,28]. Both trials showed a reduction of acute skin toxicity by the incorporation of SIB.…”

Section: Discussionmentioning

confidence: 99%

“…Both trials showed a reduction of acute skin toxicity by the incorporation of SIB. However, the overall incidence of radiation dermatitis is significantly lower with hypofractionated radiotherapy [29] and one trial used prone radiotherapy [27], which might impair the cross-trial comparison. Two retrospective studies of HF-SIB and NF-SIB have been published recently.…”

Section: Discussionmentioning

confidence: 99%

Acute toxicity of normofractionated intensity modulated radiotherapy with simultaneous integrated boost compared to three-dimensional conformal radiotherapy with sequential boost in the adjuvant treatment of breast cancer

et al. 2020

View full text Add to dashboard Cite

Background Intensity-modulated radiotherapy (IMRT) improves dose homogeneity and late toxicity compared to simple tangential techniques in adjuvant whole-breast radiotherapy for patients with breast cancer. Simultaneous-integrated boost (SIB) radiotherapy shortens the overall treatment time and improves dose homogeneity. However, prospective randomized trials regarding IMRT with SIB for adjuvant radiotherapy in breast cancer are lacking. Methods The IMRT-MC2 (MINT) trial is a phase III prospective randomized controlled trial comparing IMRT with SIB (Arm A: whole breast 28 × 1.8 Gy, Boost 28 × 2.3 Gy) to 3D-conformal radiotherapy with a sequential boost (Arm B: whole breast 28 × 1.8 Gy, boost 8 × 2 Gy) in patients with breast cancer after BCS. Indication for boost radiotherapy was defined as age < 70 years or age > 70 years with presence of additional risk factors. This is a retrospective analysis of acute toxicity at one of two trial sites. Results Five hundred two patients were randomized, of which 446 patients were eligible for this analysis. There was no statistically significant difference in terms of any grade radiation dermatitis between the two treatment arms at the end of treatment (p = 0.26). However, radiation dermatitis grade 2/3 (29.1% vs. 20.1 and 3.5% vs. 2.3%) occurred significantly more often in Arm A (p = 0.02). Breast/chest wall pain at the first follow-up visit was significantly more common in patients treated on Arm B (p = 0.02). Conclusions Treatment on both arms was well tolerated, however there were some differences regarding radiodermatitis and breast pain. Further analyses are ongoing. Trial registration clinicaltrials.gov, NCT01322854, registered 24th March 2011.

show abstract

“…In addition, other studies have reported on the acute toxicities and patient-reported outcome. One randomized controlled trial reported by Paelink et al demonstrated no increase in moist desquamation after SIB in a randomized trial of 167 patients [20]. Another randomized controlled trial compared hypofractionated radiotherapy with SIB to conventionally fractionated radiotherapy with sequential boost.…”

Section: Simultaneous Integrated Boost (Sib)mentioning

confidence: 99%

Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)—study protocol for a multicentre, randomized phase III trial

Chatterjee

Chakraborty

2020

Trials

View full text Add to dashboard Cite

Background Hypofractionated radiotherapy is the current standard for adjuvant radiotherapy across many centres. Further hypofractionation may be possible but remains to be investigated in non-Caucasian populations with more advanced disease, with a higher proportion of patients requiring mastectomy as well as tumour bed boost. We are reporting the design of randomized controlled trial testing the hypothesis that a 1-week (5 fractions) regimen of radiotherapy will be non-inferior to a standard 3-week (15 fractions) schedule. Methods We describe a multicentre, randomized controlled trial recruiting patients at large academic centres across India. Patients without distant metastases who merit adjuvant radiotherapy will be eligible for inclusion in the study. Patients in the control arm will receive adjuvant radiotherapy to the breast or chest wall (with/without regional nodes) to a dose of 40 Gy/15 fractions/3 weeks, while those in the experimental arm will receive a dose of 26 Gy/5 fractions/1 week (to the same volume). The use of a simultaneous integrated boost (dose of 8 Gy and 6 Gy, respectively) is allowed in patients who have undergone breast conservation. A sample size of 2100 patients provides an 80% power to detect a non-inferiority of 3% in the 5-year locoregional recurrence rate with a one-sided type I error of 2.5%, assuming that the locoregional recurrence rate in the control arm is 5% at 5 years (corresponding to a hazard ratio of 1.63). Patients will be recruited over a period of 5 years and followed up for a further 5 years thereafter. Discussion If a five-fraction regimen of breast cancer is proven to be non-inferior, this will result in a significant improvement in the access to radiotherapy, as well as reduced costs of treatment. The trial gives an opportunity to standardize and quality-assure radiotherapy practices across the nation at the same time. Along with the results of the FAST-Forward trial, the safety of this intervention in advanced node-positive disease requiring regional nodal radiation will be established. Trial registration The trial has been registered at the Clinical Trial Registry of India (CTRI) vide registration number: CTRI/2018/12/016816 (December 31, 2018) as well as the ClinicalTrial.gov website at NCT03788213 (December 28, 2018).

show abstract

Does an integrated boost increase acute toxicity in prone hypofractionated breast irradiation? A randomized controlled trial

Cited by 27 publications

References 45 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

Acute toxicity of normofractionated intensity modulated radiotherapy with simultaneous integrated boost compared to three-dimensional conformal radiotherapy with sequential boost in the adjuvant treatment of breast cancer

Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)—study protocol for a multicentre, randomized phase III trial

Contact Info

Product

Resources

About