Favorable safety profile of moderate hypofractionated over normofractionated radiotherapy in breast cancer patients: a multicentric prospective real-life data farming analysis

Abstract

Background Moderately hypofractionated whole-breast radiotherapy (HFRT) has proven to be as safe and efficient as normofractionated radiotherapy (NFRT) in randomized trials resulting in major changes in clinical practice. Toxicity rates observed in selected clinical trial patients may differ from those observed in unselected patients with possible comorbidities and frailty in real-life. This study aimed to examine the influence of HFRT versus NFRT on acute toxicity and identify risks factors of dermatitis in real-life patients. Materials and methods Prospective data from breast cancer patients, treated with locoregional radiotherapy were collected between November 2015 and February 2020 in 3 comprehensive cancer centers. Through a systematic data-farming strategy, acute toxicity evaluation forms (CTCAEv4.0) were prospectively completed and extracted electronically. The results from each center were then anonymously merged into a single database for analysis. A Chi-2 test was used to compare HFRT and NFRT. Furthermore, risk factors of dermatitis were identified in a sub-study (622 patients) by multivariate logistic regression analysis. Results In total, 3518 T0-4 N0-3 mostly M0 (85.8%) breast cancer patients with a median age of 60.7 (24–96 years old) were analyzed. Acute grade 2–3 dermatitis, grade 1–3 breast oedema, and grade 1–2 hyperpigmentation were less frequent with HFRT versus NFRT: respectively 8.9% versus 35.1% (Chi-2 = 373.7; p < 0.001), 29.0% versus 37.0% (Chi-2 = 23.1; p < 0.001) and 27.0% versus 55.8% (Chi-2 = 279.2; p < 0.001). Fewer patients experienced pain with HFRT versus NFRT: 33.4% versus 53.7% respectively (Chi-2 = 137.1; p < 0.001). Factors such as high BMI (OR = 2.30 [95% CI, 1.28–4.26], p < 0.01), large breast size (OR = 1.88 [95% CI, 1.07–3.28], p < 0.01) and lumpectomy over mastectomy (OR = 0.52 [95% CI, 0.27–0.97], p < 0.05) were associated with greater risk factors of grade 2–3 dermatitis in multivariate analysis regardless of NFRT or HFRT. Conclusion The results of this study suggests that breast HFRT may be a better option even for patients with a high BMI or large breast size. Acute toxicity was low to mild, and lower with HFRT compared to NFRT. Results from real-life data were robust, and support the use of HFRT beyond randomized study populations. Long-term real-life data awaits further investigation.

Prediction of radiation-induced acute skin toxicity in breast cancer patients using data encapsulation screening and dose-gradient-based multi-region radiomics technique: A multicenter study

“…In this study, all patients were divided into three groups: (1) lumpectomy (i.e., partial breast resection surgery or breast conserving surgery) group, (2) mastectomy group, (3) breast reconstruction group. Previous studies found that lumpectomy was associated with a higher rate of moderate or severe dermatitis than mastectomy (63% vs. 24%, P = 0.003) ( 21 – 23 ), which might be due to the local dose escalation after breast conserving surgery. However, our data did not show the same situation.…”

Efficiency of moderately hypofractionated radiotherapy in NSCLC cell model

“…Hypofractionation is suggested to be a safe and feasible therapeutic option for glioblastoma ( 29 , 30 ), large brain metastases ( 31 ) or soft tissue sarcomas ( 32 ). Safety and efficacy of hypofractionated RT for breast cancer treatment was reported in a number of studies ( 33 – 36 ). However, to our best knowledge, there are very little preclinical experimental data on in vitro radiobiology of hypofractionation for any type of tumor, including our recent research on triple-negative breast cancer cell-line model ( 16 ).…”

Enhancing Patient Care in Radiotherapy: Proof-of-Concept of a Monitoring Tool

“…Future developments of ODM will enable linking data treatment with planning data. Furthermore, a French national project led by the Unitrad group aims to generate structured clinical data directly in OIS [19,20]. Three crucial categories of information for radiotherapy will be stored in the OIS: treatment planning data, patient clinical data (including initial consultation, follow-up during treatment, and post-treatment follow-up), and data related to the course of radiotherapy.…”