The Preventive Effects of Boron-Based Gel on Radiation Dermatitis in Patients Being Treated for Breast Cancer: A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial

<b><i>Introduction:</i></b> Radiation dermatitis (RD) is a side effect of radiation therapy (RT) which is experienced by over 90% of patients being treated for breast cancer. The current clinical trial was conducted to measure the preventative effects of a boron-based gel on several different clinical outcomes (dermatitis, erythema, dry desquamation, and moist desquamation) after 25 radiotherapy sessions. <b><i>Methods:</i></b> This research used a double-blind parallel-group design with a placebo control (<i>n</i> = 76) and randomized group (<i>n</i> = 181), with all participants being between 18 and 75 years old. Fifteen minutes before each radiotherapy, participants in the intervention group were given a gel containing 3% sodium pentaborate pentahydrate, while those in the placebo group received a gel with no chemical substance. Dermatitis, erythema, dry desquamation, and moist desquamation were compared between the 2 groups. <b><i>Results:</i></b> At baseline, there were no significant differences between the groups (<i>p</i> &#x3e; 0.05), except for body mass index. After 14 days of treatment, dermatitis (98.7% vs. 9.9%; <i>p</i> &#x3c; 0.001), erythema (96.1% vs. 12.2%; <i>p</i> &#x3c; 0.001), dry desquamation (50% vs. 3.9%; <i>p</i> &#x3c; 0.001), and moist desquamation (18.4% vs. 0.6%; <i>p</i> &#x3c; 0.001) were much more common in the placebo group than the intervention group. To prevent dermatitis, erythema, dry desquamation, and moist desquamation in 1 patient, on average, 1.1 (95% confidence interval [CI]: 1.1–1.2), 1.2 (95% CI: 1.1–1.3), 2.2 (95% CI: 1.7–2.9), and 5.6 (95% CI: 3.8–11.0) patients need to be treated, respectively. <b><i>Conclusion:</i></b> The boron-based gel has a significant preventive effect on several categories of RD which might be used by clinicians in breast cancer.

Carbon ion radiotherapy with complete tumor regression for primary malignant melanoma of female urethra orifice: a case report

Primary malignant melanoma of the female urethra (PMMFU) is extremely rare, accounting for 0.2% of all melanomas, and fewer than 200 cases have been reported worldwide. Because of the small number of clinical cases and unclear biological characteristics, there is no uniform and standard treatment protocol. We herein describe the treatment of PMMFU using carbon ion radiotherapy. The radiotherapy was delivered at 60.8 Gy (RBE) in 16 fractions, once daily, five times per week. The patient achieved complete tumor disappearance within 1 year after carbon ion radiotherapy and remained disease-free thereafter. She developed acute grade 1 radiation dermatitis and urethritis, which resolved quickly; no other toxic effects were observed. At the time of this writing, her survival duration was 33 months. This case demonstrates that carbon ion radiotherapy may be a good option for primary genitourinary mucosal malignancies.

Quantitative Radiomics Approach to Assess Acute Radiation Dermatitis in Breast Cancer Patients

We applied a radiomics approach to skin surface images to objectively assess radiodermatitis in patients undergoing radiotherapy for breast cancer. A prospective cohort study of 20 patients was conducted. Skin surface images in normal, polarised, and UV modes were acquired using a skin analysis device before starting radiotherapy (‘before RT’), 7 days after the first treatment ('RT_D7'), on ‘RT_D14’, and 10 days after radiotherapy ended (‘after RT_D10’). Eighteen types of radiomic feature ratios were calculated. We measured skin doses in ipsilateral breasts using OSLDs on the first day of radiotherapy. Clinical evaluation of acute radiodermatitis was performed using the RTOG scoring criteria on ‘RT_D14’ and ‘after RT_D10’. Several statistical analysis methods were used to test the performance of radiomic features as indicators of radiodermatitis evaluation. As the skin was damaged by radiation, the energy for normal mode and sum variance for polarised and UV modes decreased significantly for ipsilateral breasts. The radiomic feature ratios at ‘RT_D7’ had strong correlations to skin doses and those at ‘RT_D14’ and ‘after RT_D10’ with statistical significance. The energy for normal mode and sum variance for polarised and UV modes demonstrated the potential to evaluate and predict acute radiation, which assists in its appropriate management.

Individual Radiosensitivity as a Risk Factor for the Radiation-Induced Acute Radiodermatitis

Background: Up to 95% of irradiated patients suffer from ionizing radiation (IR) induced early skin reaction, acute radiation dermatitis (ARD). Some experts think that additional skin hydration can reduce acute skin reactions. Individual radiosensitivity (IRS) determined from lymphocytes may help to predict acute radiation toxicity. The purpose of this study is to evaluate the clinical manifestation of ARD in different skincare groups during whole breast radiotherapy depending on IRS and other risk factors. Methods: A total of 108 early-stage breast cancer patients were randomized into best supportive care (BSC) and additional skincare (ASC) groups. IRS was evaluated using a G2 assay modified with caffeine-induced G2 checkpoint arrest. All patients received a 50 Gy dose to the breast planning target volume (PTV). Clinical assessment of ARD symptoms according to the CTCAE grading scale was performed once a week. Results: IRS was successfully determined for 91 out of 108 patients. A total of 10 patients (11%) had normal IRS, 47 patients (52%) were categorized as radiosensitive, and 34 (37%) as highly radiosensitive. There was no significant difference in the manifestation of ARD between patient groups by skincare or IRS. According to logistic regression, patients with bigger breasts were prone to more severe ARD (p = 0.002). Conclusions: The additional skincare did not improve skin condition during RT. A total of 89% of patients had increased radiosensitivity. IRS determined before RT did not show the predictive value for the manifestation of ARD. Logistic regression revealed that breast volume was the most significant risk factor for the manifestation of ARD.

Prevention and correction of radiation dermatitis with basic skin care: doctor and patient consensus

External beam radiation therapy is widely used by doctors around the world as one of the most common form of cancer treatment. The radiotherapy can help reduce the treatment aggression as compared with the surgical intervention in a large number of clinical situations, which ensures that the patient's quality of life will be decreased to a lesser extent in the after-treatment period. However, like the vast majority of anticancer treatments, the radiation therapy has a number of side effects, which are classified into acute radiation reactions and post-radiation injuries. Among them is radiation dermatitis, which is one of the most common adverse reactions to the radiotherapy. This complication manifests as erythema, as well as hyperpigmentation, dry and itchy skin, hair loss. In addition to the obvious negative impact on the patient's quality of life, some of the above factors can result in the development of a secondary skin infection. As one of the most frequent post-radiation complications, radiation dermatitis places radiotherapists before a challenge to reduce the incidence rates of this side effect, as well as to decrease the intensity of its clinical manifestations if it occurs. This challenge suggests the search for targeted drugs aimed to prevent and treat clinical symptoms. To date, dermatocosmetic products that are used to relieve skin manifestations of radiation treatment complications is an alternate option of the effective solution to the problem of radiation dermatitis. In the described clinical case, we assess the experience of using some of the dermatocosmetic products in a patient with a florid form of radiation dermatitis.

What Is the Appropriate Skin Cleaning Method for Nasopharyngeal Cancer Radiotherapy Patients? a Randomized Controlled Trial

Purpose To determine the effect of various cleaning methods for skin with acute radiation dermatitis (RD) in patients treated for nasopharyngeal carcinoma (NPC). Methods A total of 168 NPC inpatients were randomized, while 152 patients completed the whole trial and the data were analyzed. Patients were randomly divided into non-washing group, washing with water alone group, and washing with water and soap group. All three groups received intensity modulated radiation therapy (IMRT) among other treatments. Follow-up from recruitment or the initial radiotherapy dose to 1 month after the final radiotherapy dose. CONSORT checklist was applied as the reporting guidelines for this study. Study evaluated a range of endpoints including incidence, timing, severity of acute RD and quality of life (QOL).Results There were no allergic reactions or aggravating in both washing groups during the whole treatment. The incidence of acute RD was 100% in all three groups, while the degree of severity differed among groups. Washing moderately reduced severity compared with patients without washing; washing also delayed the onset time of acute RD, reduced the incidence of moist desquamation and pruritus. There were no significant difference among groups with respect to pain or burning sensation. Washing improved QOL on physical, emotional, and social functional dimensions. Washing with water and soap was the most effective on reducing itching and improving QOL among three groups. Conclusion Washing irradiated skin reduces the occurrence and severity of acute radiation dermatitis.Clinical trial information ChiCTR2000038231, date of registration 09.18.2020

Risk Factors Related to Acute Radiation Dermatitis in Breast Cancer Patients After Radiotherapy: A Systematic Review and Meta-Analysis

BackgroundAcute radiation dermatitis (ARD) is the most common acute response after adjuvant radiotherapy in breast cancer patients and negatively affects patients’ quality of life. Some studies have reported several risk factors that can predict breast cancer patients who are at a high risk of ARD. This study aimed to identify patient- and treatment-related risk factors associated with ARD.MethodsPubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, and WanFang literature databases were searched for studies exploring the risk factors in breast cancer patients. The pooled effect sizes, relative risks (RRs), and 95% CIs were calculated using the random-effects model. Potential heterogeneity and sensitivity analyses by study design, ARD evaluation scale, and regions were also performed.ResultsA total of 38 studies composed of 15,623 breast cancer patients were included in the analysis. Of the seven available patient-related risk factors, four factors were significantly associated with ARD: body mass index (BMI) ≥25 kg/m2 (RR = 1.11, 95% CI = 1.06–1.16, I2 = 57.1%), large breast volume (RR = 1.02, 95% CI = 1.01–1.03, I2 = 93.2%), smoking habits (RR = 1.70, 95% CI = 1.24–2.34, I2 = 50.7%), and diabetes (RR = 2.24, 95% CI = 1.53–3.27, I2 = 0%). Of the seven treatment-related risk factors, we found that hypofractionated radiotherapy reduced the risk of ARD in patients with breast cancer compared with that in conventional fractionated radiotherapy (RR = 0.28, 95% CI = 0.19–0.43, I2 = 84.5%). Sequential boost and bolus use was significantly associated with ARD (boost, RR = 1.91, 95% CI = 1.34–2.72, I2 = 92.5%; bolus, RR = 1.94, 95% CI = 1.82–4.76, I2 = 23.8%). However, chemotherapy regimen (RR = 1.17, 95% CI = 0.95–1.45, I2 = 57.2%), hormone therapy (RR = 1.35, 95% CI = 0.94–1.93, I2 = 77.1%), trastuzumab therapy (RR = 1.56, 95% CI = 0.18–1.76, I2 = 91.9%), and nodal irradiation (RR = 1.57, 95% CI = 0.98–2.53, I2 = 72.5%) were not correlated with ARD. Sensitivity analysis results showed that BMI was consistently associated with ARD, while smoking, breast volume, and boost administration were associated with ARD depending on study design, country of study, and toxicity evaluation scale used. Hypofractionation was consistently shown as protective. The differences between study design, toxicity evaluation scale, and regions might explain a little of the sources of heterogeneity.ConclusionThe results of this systematic review and meta-analysis indicated that BMI ≥ 25 kg/m2 was a significant predictor of ARD and that hypofractionation was consistently protective. Depending on country of study, study design, and toxicity scale used, breast volume, smoking habit, diabetes, and sequential boost and bolus use were also predictive of ARD.

Radiation-Induced Toxicity Risks in Photon Versus Proton Therapy for Synchronous Bilateral Breast Cancer

Purpose This study compares photon and proton therapy plans for patients with synchronous bilateral early breast cancer and estimates risks of early and late radiation-induced toxicities. Materials and Methods Twenty-four patients with synchronous bilateral early breast cancer receiving adjuvant radiation therapy using photons, 3-dimensional conformal radiation therapy or volumetric modulated arc therapy, were included and competing pencil beam scanning proton therapy plans were created. Risks of dermatitis, pneumonitis, acute esophageal toxicity, lung and breast fibrosis, hypothyroidism, secondary lung and esophageal cancer and coronary artery events were estimated using published dose-response relationships and normal tissue complication probability (NTCP) models. Results The primary clinical target volume V95% and/or nodal clinical target volume V90% were less than 95% in 17 photon therapy plans and none of the proton plans. Median NTCP of radiation dermatitis ≥ grade 2 was 18.3% (range, 5.4-41.7) with photon therapy and 58.4% (range, 31.4-69.7) with proton therapy. Median excess absolute risk (EAR) of secondary lung cancer at age 80 for current and former smokers was 4.8% (range, 0.0-17.0) using photons and 2.7% (range, 0.0-13.6) using protons. Median EAR of coronary event at age 80, assuming all patients have preexisting cardiac risk factors, was 1.0% (range, 0.0-5.6) with photons and 0.2% (range, 0.0-1.3) with protons. Conclusion Proton therapy plans improved target coverage and reduced risk of coronary artery event and secondary lung cancer while increasing the risk of radiation dermatitis.

A Systematic Review on the Role of Topical Corticosteroids for the Management of Radiation Dermatitis

Background: Radiation dermatitis (RD) is a widespread complication of radiation therapy; however, there is still no agreement on the best treatment. The goal of this review is to go over how corticosteroids work throughout the treatment of radiation dermatitis. Methodology: A comprehensive evaluation of randomized controlled trials, retrospective and prospective studies involving topical corticosteroid (TC) for the treatment of radiation dermatitis. A thorough search was carried out in Medline, Embase, the Cochrane library, Clinical trials.gov, and Google scholar. The original search took place in August and was updated on September 2021. There were no restrictions on terminology or dates. Two reviewers independently examined each of the listed papers. A search of the relevant studies of all of the mentioned publications yielded additional papers. Results: We identified 19 studies on the role of corticosteroids for the prevention of radiation therapy. All the papers were published between 2001 and 2021. The total sample size of the included studies was 1974 with a mean sample size of 103.89. Among the included studies, four studies (21.05 %) represented head and neck cancer, 14 studies (73.68 %) were regarding breast cancer and 1 (5.26 %) hospital-based cross-sectional study represented multiple malignancies such as head and neck, breast and cervix carcinoma, respectively. Among all the participants, 1696 (85.91 %) were females while 278 (14.08 %) were males. Conclusion: Prophylactic treatment with TC was found to minimize the rate of RD and wet desquamation. Participants who used topical steroids reported improved symptoms and a higher quality of life, whereas the use of topical steroids during radiation had few side effects. ARD can be prevented using topical corticosteroids, based on these findings. As a result, further research must be done on the most effective TC to utilize during radiation.

Case Report: Carcinoma en Cuirasse in a Middle-Aged Woman Mimicking Postirradiation Morphea

Breast carcinoma en cuirasse (CeC) is an extremely rare form of cutaneous metastases of breast cancer, characterized by diffuse sclerodermoid induration of the skin. It may be difficult to distinguish CeC from some skin diseases, including postirradiation morphea, inflammatory breast cancer, radiation dermatitis, and other cutaneous metastases, but it can be easily discerned by histology. Because of the small number of documented cases, the treatment consensus has not been clearly defined. Here, we show a 45-year-old woman with grade III infiltrating ductal carcinoma manifesting as CeC to the chest wall. Early diagnosis and treatment are essential to prevent the catastrophic natural progression of this rare malignancy.