Background
Art therapy (AT) as supportive care may help patients cope with cancer treatments. This non‐blinded randomized trial assessed the impact of creative AT on severe fatigue and quality of ...life (QoL) in localized breast cancer patients undergoing irradiation.
Material and Methods
320 patients were randomized to an AT group (ATG; 8 weekly sessions starting during irradiation) or to a standard group (SG). The primary endpoint was severe global fatigue (Functional Assessment of Chronic Therapy Fatigue subscale score <37) at 1 month post‐irradiation. Quality of life (Fact‐B), anxiety/depression (Hospital Anxiety and Depression Scale (HADS)) and different dimensions of fatigue 20‐item Multidimensional Fatigue Inventory (MFI‐20) were assessed at 1, 6 and 12 months post‐irradiation. The secondary endpoints, fatigue among patients treated with chemotherapy, QoL (Fact‐B), anxiety/depression (HADS) and different dimensions of fatigue (MFI‐20) at 1, 6 and 12 months post‐irradiation (with post hoc analysis in patients with treated with chemotherapy) were also assessed.
Results
82% of patients completed ≥8 sessions. Severe initial global fatigue was observed in 43% of patients in each group, and among in 64% of patients whose treatment protocol contained chemotherapy. At 1 month post‐irradiation, 45% in the ATG and 57% of patients in the SG reported severe global fatigue (p = 0.37); among patients with initial severe mental fatigue (MFF), 79% and 44% had improved MFF (p = 0.007) respectively; similarly 79% and 44% with initial poor motivation had better mental motivation (p = 0.03). At 6 and 12 months, social well‐being scores in the ATG were higher (21.3 and 21.4 vs. 19.8 and 19.2, p = 0.05 and p < 0.01) with a significant improvement for patients who had chemotherapy (41% vs. 18%, p = 0.017). A positive association was observed between the number of AT sessions, fatigue and QoL (p < 0.01).
Conclusion
AT did not significantly improve global severe fatigue among all cancer participants 1 month after radiation therapy, however it had a positive impact on social well‐being and may improve MFF and motivation.
Highlights
Randomized controlled trial assessed the impact of creative Art therapy (AT) on severe fatigue and quality of life in patients with localized breast cancer undergoing irradiation
Art therapy did not significantly improve global severe fatigue among all cancer participants 1 month after radiation therapy
Art therapy had a positive impact on social well‐being and may improve mental fatigue and motivation
Introduction
Improvement in overall survival (OS) by locoregional treatment (LRT) of the primary tumor in de novo metastatic breast cancer (MBC) patients remains controversial.
Objective
The aim of ...our study was to evaluate the impact of LRT on OS in a large retrospective cohort of de novo MBC patients, with regard to immunohistochemical characteristics and pattern of metastatic dissemination.
Methods
We conducted a multicentric retrospective study of patients diagnosed with de novo MBC selected from the French Epidemiological Strategy and Medical Economics MBC database (NCT03275311) between 2008 and 2014. Overall, 4276 women were included in the study. LRT comprised either radiotherapy, surgery, or both.
Results
LRT was used in 40% of patients. Compared with no LRT, patients who received LRT were younger (
p
< 0.0001) and were more likely to have only one metastatic site (
p
< 0.0001) or bone-only metastases (
p
< 0.0001). LRT was associated with a significantly better OS based on landmark multivariate analysis at 1-year (hazard ratio 0.65, 95% confidence interval 0.55–0.76,
p
< 0.001). Similar results were observed in all sensitivity analyses, including propensity score matching. In subgroup analysis, LRT was associated with better OS in patients with hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative (61.6 vs. 45.9 months,
p
< 0.001) and HER2-positive tumors (77.2 vs. 52.6 months,
p
= 0.008), but not in triple-negative tumors (19 vs. 18.6 months,
p
= 0.54), and was also associated with a reduction in the risk of death in visceral metastatic patients (
p
< 0.001).
Conclusions
LRT was associated with a significantly better OS in de novo MBC patients, including patients with visceral involvement at diagnosis; however, LRT did not impact OS in triple-negative MBC.
•ERT was commonly performed in dnMBC patients despite the absence of guidelines.•This is the largest study evaluating the impact of ERT on OS in dnMBC patients.•ERT and BMT were associated with ...reductions in the hazard of death compared with no LRT.•ERT could be an appropriate locoregional treatment in selected dnMBC patients.
The impact of locoregional treatment (LRT) on overall survival (OS) in de novo metastatic breast cancer (dnMBC) is still under debate, with very few data available regarding exclusive radiotherapy (ERT) as a therapeutic modality.
We evaluated the impact of ERT, exclusive surgery, or a combination of surgery plus radiotherapy (bimodality therapy, BMT) on survival outcomes in a national real-life dnMBC cohort. The primary and secondary end points were OS and progression free survival (PFS) according to LRT (ERT, exclusive surgery, BMT) and no LRT. Sensitivity analyses were performed using propensity score matched analyses.
From 2008 to 2014, 4507 dnMBC patients were identified. Only patients alive and free from progression under systemic therapy at least 1 year after diagnosis were included (n = 1965). Forty-five percent of patients (891/1965) underwent LRT: 41.1% (n = 366) ERT, 13.7% (n = 122) exclusive surgery, and 45.2% (n = 403) BMT. OS adjusted for major prognostic factors was significantly longer in the ERT and BMT group compared with no-LRT group, but not exclusive surgery (hazard ratio (HR) = 0.63, 95% confidence interval (CI) 0.49, 0.80, p < 0.001, HR = 0.61, 95%CI 0.47, 0.78, p < 0.001 and HR = 0.87, 95%CI 0.61, 1.26, p = 0.466 respectively). Results were similar after matching on a propensity score. ERT, surgery and BMT were all associated with a significantly better PFS in multivariable analysis.
ERT was significantly associated with better OS in dnMBC, in the same magnitude as BMT, compared with no-LRT. However, even with statistical models adjusted for known prognostic factors and propensity score analysis, selection biases cannot be eliminated from observational studies.
•The role of an additional boost to the tumor bed in DCIS is still unknown.•Severity of acute skin toxicities is significantly increased by tumor bed boost.•Smoking history and large breast CTV are ...predictive factors of acute toxicities.•Dummy run before patients’ inclusion reduced the risk of major TP deviations.
To describe the quality assurance (QA) program and early toxicities in the phase III randomized trial BONBIS (NCT00907868) on the role of a localized radiation boost in ductal carcinoma in situ (DCIS).
From November 2008 to July 2014, 2004 patients were randomized in arm A (only whole breast radiotherapy, WBRT) and arm B (WBRT + boost). The QA program involved 44 participant centers that performed the dummy run (DR). Compliance and uniformity of clinical target volume (CTV) delineations, and dose prescription and delivery according to the BONBIS trial radiotherapy guidelines were analyzed. Acute toxicities (during and up to 3 months after radiotherapy completion, NCI-CTCAE v3.0 classification) were evaluated in 1929 patients.
The differences in whole breast CTV (CTV1) and planning target volume (PTV1) were ≤10%, and the differences in boost CTV (CTV2) and PTV (PTV2) were ≥20% compared with the reference DR values; 95% of the prescribed dose encompassed 98.7% and 100% of the median CTV1 and CTV2. Grade ≥2 breast erythema (38.3% vs. 22.4% of grade 2 and 5.4% vs. 2.1% of grade 3, p < 0.001), grade ≥2 dermatitis (2.8% vs. 0.7%, p < 0.001), and grade 2 hyperpigmentation (6.9% vs. 3.6%, p = 0.005) were more frequent in arm B than arm A. No acute lung or cardiac toxicity was observed. Smoking history, large breast size, and large breast CTV were strong predictive factors of grade ≥2 acute skin toxicities.
The QA program showed deviations in breast and tumor bed delineation. The boost significantly increased acute skin toxicities.
Skin damage is the most common and most important toxicity during and after radiotherapy. Its assessment and understanding of the factors influencing its occurrence, is a major issue in the ...management of patients irradiated for an early breast cancer CANTO is a prospective clinical cohort study of 10 150 patients with stage I-III BC treated from 2012-2017 in 26 cancer centers. In this study, we used CANTO-RT, a sub-cohort of CANTO, including 3480 patients who received RT. We are focus on specifical skin toxicities: Erythema, fibrosis, telangiectasia, and cutaneous pigmentation The prevalence of toxicities of interest varied over time, so at M3-6, 41.1% of patients had erythema while 24.8% of patients had fibrosis. At M12 and M36, the prevalence of erythema decreased respectively while fibrosis remains stable. The prevalence of telangiectasia increases from 1% to 7.1% from M3-6 to M36. After adjustments, we showed an association between the occurrence of skin erythema and obesity; the type of surgery; the presence of axillary dissection; the use of taxane-based CT and the 3DvsIMRT irradiation technique. Regarding fibrosis, an association is found, at M3-6, with age at diagnosis, obesity, tobacco, and the use of boost. Only obesity and the type of surgery received by the patient remained statistically significant at M12 and M36. In this study we identified several risk factors for acute and late skin. The use of a boost was mainly related to the occurrence of fibrosis while the use of IMRT-type technique decreased the occurrence of skin erythema.
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