Mepitel Film for the Prevention of Acute Radiation Dermatitis in Breast Cancer: A Randomized Multicenter Open-Label Phase III Trial.

PURPOSE: Radiation dermatitis (RD) is common in patients undergoing breast radiotherapy. Mepitel film (MF) can reduce RD, but the results from two randomized controlled trials are conflicting. We aimed to conduct a confirmatory randomized controlled trial in patients at risk of RD. METHODS: Patients were randomly assigned to receive MF or standard care (2:1 ratio). Patients with large breasts after lumpectomy (bra size ≥ 36 inches or cup size ≥ C) or after mastectomy were eligible. Stratification factors included surgery type, dose fractionation, and administration of boost/bolus. The primary end point was grade (G) 2 or 3 RD using the Common Terminology Criteria for Adverse Events v5.0. Secondary end points included patient- and clinician-reported outcomes. RESULTS: Between January 2020 and May 2022, 376 patients were included in the modified intention-to-treat analysis. The incidence of G2 or 3 RD was significantly lower in MF patients compared with standard care (n = 39/251, 15.5%; 95% CI, 11.3 to 20.6% v n = 57/125, 45.6%; 95% CI, 36.7 to 54.8% respectively, odds ratio (OR): 0.20, P < .0001). Benefits of MF remained significant in patients who developed G 3 RD (n = 7, 2.8%; 95% CI, 1.1 to 5.7% v n = 17, 13.6%; 95% CI, 8.1 to 20.9%, OR: 0.19) and moist desquamation (n = 20, 8.0%; 95% CI, 4.9 to 12.0% v n = 24, 19.2%; 95% CI, 12.7 to 27.1%, OR: 0.36). When evaluating the combined patient and health care provider score using Radiation-Induced Skin Reaction Assessment Scale, the MF arm had significantly lower scores (P < .0001). Individual items on the Radiation-Induced Skin Reaction Assessment Scale also favored the MF for both patient- and clinician-reported outcomes. Blistering/peeling, erythema, pigmentation, and edema were significantly reduced in the MF arm. Three patients removed the film prematurely because of rash (n = 2) and excessive pruritus (n = 1). CONCLUSION: MF significantly reduces RD in patients undergoing breast radiotherapy.

Narrative review of neurocognitive and quality of life tools used in brain metastases trials.

Development of brain metastases are common in patients with advanced malignancies leading to significant morbidity and mortality. Although overall survival is an important endpoint in these patients, neurocognition and health related quality of life (HRQoL) more accurately highlights the impact of the disease and its treatment on patients. Whole brain radiotherapy (WBRT) has historically played a key role in the management of these patients, especially those with multiple brain metastases. Clinical trials have supported the use of stereotactic radiosurgery (SRS) alone in patients with limited brain metastases sparing neurocognitive function and HRQoL as compared to the combination of SRS plus WBRT. Furthermore, new systemic agents are increasingly being used in clinical practice and have shown promise in patients with brain metastases. The upcoming clinical trials are tasked with defining treatment guidelines that are more specific to patient and tumour factors incorporating radiation, surgery, and systemic therapy. The validity of findings in these trials rest on the rigor of the study methodology and the utilisation of validated assessment tools for neurocognition and HRQoL. This review aims to appraise and summarise the neurocognitive and HRQoL tools used in modern brain metastases trials.

Self-reported pain in breast cancer patients receiving adjuvant radiotherapy.

PURPOSE: Breast cancer patients receiving radiotherapy (RT) commonly report pain, contributing to physical and emotional distress, and potentially resulting in poor quality of life. This study prospectively identified trends and risk factors in patient-reported pain associated with breast irradiation using the Edmonton Symptom Assessment Scale (ESAS) and a study-specific Skin Symptom Assessment (SSA). METHODS: Before RT and once per week during RT, patients completed the ESAS and SSA. Upon RT completion, patients were contacted via telephone to complete both assessments weekly for 6 weeks, and a final assessment was conducted 1-3 months post-RT. Only data from patients who had completed both assessments before, at least once during, and at least once after RT were included in our analysis. RESULTS: A total of 426 patients provided data for the analysis. Overall acute pain increased significantly at week 1-2 (p < 0.0001), week 5 (p = 0.0011), and at 1-3 months (p < 0.0001) post-RT compared with baseline, and acute breast pain increased significantly at week 1 (p < 0.001) and week 2 (p = 0.0002) post-RT compared with baseline. Previous chemotherapy (adjuvant or neoadjuvant) in mastectomy patients was associated with increased overall pain compared with mastectomy patients without previous chemotherapy (p = 0.017). Younger patients (40-49 or 50-59 years of age) reported more overall pain (p = 0.0001, p = 0.038) and breast pain (p = 0.0003, p = 0.0038) compared with patients ≥ 60 years of age. CONCLUSIONS: Patient-reported pain associated with breast irradiation peaked 1 week after RT completion. Our findings provide support for closer monitoring of acute pain associated with breast RT in younger patients.

Quantitative Effect of Bolus on Skin Dose in Postmastectomy Radiation Therapy.

BACKGROUND: In postmastectomy radiation therapy (PMRT), some centres prescribe the use of a tissue-equivalent bolus to the skin to reduce the risk of chest wall recurrence. The addition of bolus causes an increase in the skin dose, which may lead to increased risk of radiodermatitis. Radiodermatitis can decrease patients' overall quality of life, bringing into question the benefit of using the bolus. The purpose of this retrospective chart review was to quantify the increase in skin dose associated with the use of bolus in the PMRT setting. MATERIALS AND METHODS: We evaluated 70 patients who underwent PMRT at our institution during 2012-2018. Two similar treatment plans were generated for each patient: one with bolus and one without. Skin dose-volume histogram values were evaluated, and statistical analysis was performed using MATLAB R2015b. RESULTS: There was no significant difference in the maximum skin dose within a depth of 5 mm for bolus versus nonbolus plans (P = 0.4). However, within a depth of 3 mm, bolus plans had a maximum skin dose 7% ± 2.5% higher than the nonbolus plans (P < .00001). Mean skin dose within depths of 3 and 5 mm were both significantly higher (P < .00001) for bolus plans. The photon beam energy and chest wall separation showed minimal or no effect on skin dose. CONCLUSION: Given the differing opinions in the literature regarding the role for bolus in PMRT, there is still uncertainty of the optimal treatment method. This retrospective study demonstrates a 20%-30% reduction in mean skin dose when bolus is not used.

Do patients enrolled in observational studies have better outcomes than non-participants? A retrospective analysis.

PURPOSE: Patients are commonly enrolled into clinical trials. It has been reported that these patients may have better outcomes than those not enrolled into the study. The reasoning from these improvements could be attributable to closer follow-up, better patient adherence, more health aware patients have, or reaction to observation such as the Hawthorne effect. METHODS: Three hundred forty-six patients were approached for a prospective skin toxicity study in adjuvant breast cancer radiotherapy (RT) but declined participation between January 2018 and July 2019 (non-trial group). They were retrospectively reviewed and patient, treatment and RT-related characteristics, as well as the occurrence of skin reactions, and the usage of topical treatments were collected. This was compared with a comparison cohort of 349 patients who were enrolled into a previously conducted prospective study (trial group). RESULTS: More patients in the trial group had conventional RT (CFRT) versus hypofractionated RT (HFRT). Data was further stratified and there was no significant difference in moist desquamation, topical antibiotic usage, dressing application, home care use, topical corticoid steroid use, and oral analgesic use. There was a significantly lower pain score in the group compared with the non-trial group in both HFRT and CFRT (OR = 0.091 and OR = 0.348, p < 0.0001). CONCLUSION: Our results demonstrated no differences other than pain between the trial group and non-trial group. Therefore, in this cohort, patients enrolled into an observational trial while undergoing adjuvant breast RT demonstrated similar experiences of skin reactions. There are challenges to assessing differences between these groups, as confounding is likely. Therefore, it is recommended for future studies to additionally assess the impact of study participation on outcomes such as quality of life, quality of care received, and/or anxiety levels.

Prevalence of pain in patients with breast cancer post-treatment: A systematic review.

PURPOSE: To evaluate the prevalence and severity of persistent pain after breast cancer treatment (PPBCT) in patients who received surgery, radiotherapy or a combination of treatments and to explore how different treatments and techniques impact pain. METHODS: Medline, Embase and Cochrane Central databases were searched for articles which evaluated the prevalence of PPBCT. Search results were limited to studies addressing chronic post-surgical pain (CPSP), persistent post-surgical pain (PPSP), post-mastectomy pain syndrome (PMPS) or radiotherapy (RT) related pain in breast cancer patients and published in the English language. The primary outcome was the incidence or severity of PPBCT. Descriptive analyses were performed. RESULTS: A total of 177 studies were included in this review. Overall, pain prevalence was 29.8% amongst 3746 patients (Group 1: 30 studies) post-surgery, 27.3% post-RT (Group 2: 41 studies, n = 15 019), and 21.8% amongst BC survivors who reported on the general prevalence of after receiving various combinations of BC treatment (Group 3: 106 studies, n = 135 437). CONCLUSION: PPBCT remains to be a prevalent and complex clinical issue, despite a variety of different techniques and treatments. Various factors such as varying definitions of pain, inconsistent use of assessment tools and differences in methodology between studies may contribute to discrepancies in reports of PPBCT. A greater understanding of BC treatments and their impact on PPBCT may help identify potential risk factors, prevention and pain management strategies.

Sexual healthcare for cancer patients receiving palliative care: a narrative review.

Palliative care aims to improve quality of life (QoL) for patients and families and does so by addressing issues not limited to pathology, but other symptoms that may be debilitating to patient experience and QoL. Despite sexual health being an important aspect of life for many patients, it is often omitted in clinical practice. This review summarizes published primary studies to explore the prevalence and importance of incorporating sexual health in the symptom screening and assessments of palliative patients, to identify current interventions that are implemented to address sexual health issues, and identify the barriers that health care professionals (HCPs) and patients may encounter which may prevent sexual health discussions. A literature review was conducted on Medline and Embase databases using keywords including "cancer", "sexual health", "intimacy", and "palliative care". Eleven papers focusing on the sexual health and intimacy of terminally ill patients in hospice, palliative or terminal care settings were identified for inclusion. Discussions about sexual health, functioning, and intimacy were not common in patient care, despite being a service that both patients and their partners desired. Referrals to sexologists, or discussions with patients and partners about intimacy and sexuality over the course of the disease trajectory were shown to improve QoL as well as alleviate some of the stress of receiving palliative care services. HCPs cited a lack of training, their own life experiences, or discomfort with the topic as barriers to initiating conversations with patients. In conclusion, sexuality and intimacy remain important parts of many people's lives regardless of their health, and should be incorporated into the care of all patients including those in palliative care. There is a need for further research to evaluate different methods or procedures for educating and counselling patients and their partners on sexual health issues. HCPs should have specific training and education in sexual health care to enable them to initiate and direct these discussions.