A comparison of acute patient-reported outcomes in breast cancer patients with and without regional nodal irradiation using the ESAS and PRFS tool.

BACKGROUND AND PURPOSE: Regional nodal irradiation (RNI) is commonly administered in patients with breast cancer with node-positive disease to prevent cancer recurrence. The purpose of this study is to identify whether RNI is associated with greater acute symptom burden from baseline to 1 to 3 months post completion of radiotherapy (RT) when compared to localized RT. MATERIALS AND METHODS: Patient and treatment characteristics were collected prospectively for breast cancer patients with and without RNI from February 2018 to September 2020. The Edmonton Symptom Assessment System (ESAS) and Patient-Reported Functional Status (PRFS) tool were completed by patients at baseline, weekly during RT, and at a 1- to 3-month follow-up visit. The Wilcoxon rank-sum or Fisher exact tests were used to compare variables between patients with or without RNI. RESULTS: A total of 781 patients were included in the analysis. Baseline symptom reporting was similar between cohorts, with the exception of PRFS scores (p = 0.0023), which were worse in patients receiving RNI. Across all time points, differences in outcomes between cohorts were minimal, except for lack of appetite (p = 0.03) and PRFS scores (p = 0.049), which were significantly aggravated in patients treated with RNI. CONCLUSION: There is insufficient evidence to suggest that RNI is associated with greater symptom burden as assessed with the ESAS. Further research should be conducted over a longer time period to determine the impact of late effects of RNI on patient-reported symptoms.

Comparison of neoadjuvant versus adjuvant chemotherapy for breast cancer patients prior to receiving radiation therapy using Edmonton Symptom assessment system (ESAS) scores.

BACKGROUND AND PURPOSE: Patients undergoing radiotherapy (RT) for breast cancer may receive adjuvant or neoadjuvant chemotherapy prior to the initiation of RT treatment. In the present study, baseline Edmonton Symptom Assessment System (ESAS) scores of patients who received neoadjuvant and adjuvant chemotherapy were collected prior to RT and compared to assess the association of each chemotherapy intent with pre-RT symptom burden. MATERIAL AND METHODS: The ESAS and Patient-Reported Functional Status (PRFS) tools were used to collect patient-reported symptoms at baseline. Patient and treatment-related factors were collected prospectively from February 2018 to September 2020. Univariate general linear regression analysis was applied to compare baseline scores between adjuvant and neoadjuvant chemotherapy patients. RESULTS: A total of 338 patients were included for analysis. Comparison of baseline ESAS scores revealed that patients who received adjuvant chemotherapy were more likely to report higher scores, reflecting higher symptom burden, compared to patients receiving neoadjuvant chemotherapy, including tiredness (p = 0.005), lack of appetite (p = 0.0005), shortness of breath (p < 0.0001), and PRFS (p = 0.012). CONCLUSION: This study suggests an association between patients who have received adjuvant chemotherapy for breast cancer and higher RT baseline ESAS scores when compared to patients who received neoadjuvant chemotherapy. Due to these findings, considerations should be made by healthcare providers of the symptom burden during RT for patients who receive adjuvant chemotherapy.

Impact of adjuvant radiotherapy on patient-reported shortness of breath in patients with breast cancer using the ESAS.

BACKGROUND AND PURPOSE: As breast cancer radiotherapy (RT) has been shown to give rise to adverse pulmonary outcomes, such as radiation pneumonitis, trends in patient-reported shortness of breath (SOB) associated with RT were investigated. Adjuvant RT is commonly administered for local and/or regional control of breast cancer and was therefore included. METHODS: The Edmonton Symptom Assessment System (ESAS) was used to observe changes in SOB during RT, up to 6 weeks after RT completion, and one to three months post-RT. Patients with at least one completed ESAS were included in the analysis. Generalized linear regression analysis was performed to identify associations between demographic factors and SOB. RESULTS: A total of 781 patients were included in the analysis. There was a significant association between ESAS SOB scores and adjuvant chemotherapy when compared to neoadjuvant chemotherapy (p=0.0012). Meanwhile, loco-regional RT had no significant impact on ESAS SOB scores in comparison to local RT. SOB scores were stable over time (p>0.05) from baseline to follow-up appointments. CONCLUSION: The findings of this study suggest that RT was not associated with changes in SOB from baseline to 3 months post-RT. However, patients who underwent adjuvant chemotherapy reported significant higher SOB scores over time. Additional research is recommended to analyze the lasting effects of adjuvant breast cancer RT on SOB during physical activity.

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.

The Real-World Experience of the Biosimilar (Grastofil®) to the Reference Biologic (Neupogen®) in Breast Cancer and Lymphoma: A Canadian Single-Centre Retrospective Study.

Febrile neutropenia (FN) is a common side effect of cytotoxic chemotherapy that may result in poor treatment outcomes. The short acting granulocyte colony stimulating factors (G-CSF) act to stimulate granulocytes to increase production of white blood cells. The filgrastim biosimilar is useful, as it may provide a cheaper and equally effective treatment to FN. This study explored the usage of the filgrastim biosimilar (Grastofil®) and the reference biologic (Neupogen®) in breast cancer and lymphoma patients. A retrospective chart review of patients receiving Grastofil® from January 2017 to June 2019 or Neupogen® for primary prophylaxis of FN from January 2013 to December 2017 was conducted. The endpoints included the incidence of FN and the occurrence of dose reduction (DR) and dose delay (DD). One hundred and fifty-three Grastofil® patients were matched to 153 Neupogen® patients. This cohort was further split into breast cancer (n = 275) and non-Hodgkin's lymphoma (n = 31) cohorts. After adjusting for chemotherapy cycles, the biosimilar filgrastim was non-inferior to the reference biologic based on FN incidence in addition to related outcomes including DR and DD.

Impact of adjuvant breast radiotherapy on patient-reported fatigue.

PURPOSE: Breast cancer patients receiving adjuvant radiotherapy (RT) benefit from local control. However, RT can give rise to increased fatigue, lowering quality of life. The aim of this study was to prospectively identify trends and risk factors in patient-reported fatigue associated with breast RT. MATERIAL AND METHODS: Patients were assessed using the Edmonton Symptom Assessment Scale (ESAS) before, once per week during RT, up to 6 weeks after RT completion, and 1-3 months post RT. Patients were included in the analysis if the ESAS was completed before, at least once during, and at least once after RT. RESULTS: A total of 651 patients were included. Fatigue scores increased significantly during weeks 1-3 (p < 0.001) and weeks 5-6 (p < 0.0001) during RT compared to baseline. After RT completion, fatigue scores did not change significantly compared to baseline. Mastectomy patients who received previous chemotherapy experienced significantly more fatigue compared to mastectomy patients without previous chemotherapy (p = 0.0002). Patients less than 50 (p = 0.002), 50-59 (p = 0.007), or 60-69 (p = 0.048) years of age at RT start were more likely to have higher proportions of moderate or severe fatigue compared to patients ≥ 70 years of age. CONCLUSIONS: Fatigue associated with breast irradiation increased up to 6 weeks during RT and returned to near baseline scores at 1-3 months post treatment. Given that fatigue was significant in mastectomy patients, further research is needed to reduce fatigue among this cohort, especially those who have received previous chemotherapy and younger patients who are receiving breast RT.

Symptom Burden Associated With Radiation Dermatitis in Breast Cancer Patients Undergoing Radiotherapy.

PURPOSE: Radiation dermatitis (RD) is a side effect experienced by many patients undergoing radiotherapy (RT) for breast cancer. In the present study, the Edmonton Symptom Assessment System (ESAS), a validated patient-reported symptom screening tool, was used to determine the impacts of RT-induced skin outcomes on ESAS items. Patient- and treatment-related factors and skin treatments to manage RD symptoms, were assessed for association with ESAS scores. METHODS: Patient and treatment characteristics were collected retrospectively for breast cancer patients treated with adjuvant RT between December 2013 and November 2015. Prospective data was collected through clinician-reported surveys. Linear regression analyses were performed to detect the relationship between patient-reported ESAS scores and clinician-reported RD symptoms. RESULTS: A total of 857 patients were included in the analysis. Moderate to severe scores were commonly reported for fatigue (n = 412, 48%), wellbeing (n = 386, 45%) and anxiety (n = 266, 31%). Oral analgesic use was associated with ESAS fatigue, drowsiness, pain, nausea, lack of appetite, shortness of breath, and wellbeing (P < .05), while dressings were only associated with anxiety (P = .02). No RD symptoms were found to be significantly associated with any ESAS items. CONCLUSIONS: The ESAS accurately reflects symptoms of fatigue, anxiety, and wellbeing for breast cancer patients undergoing RT. Our study, however, found no association between ESAS scores and RD severity, which may reflect the shortcomings of the ESAS in assessing symptom burden. Further research is necessary to warrant the development of a new site-specific symptom screening tool for use in RT for breast cancer.

Predictive factors associated with radiation dermatitis in breast cancer.

PURPOSE: Radiation dermatitis (RD) is a side effect that frequently arises during radiotherapy (RT) in breast cancer patients. The present study investigates possible predictive factors of RD, as well as the use of skin treatments to manage symptoms. METHODS: Demographic and treatment characteristics were collected retrospectively, while skin symptoms and treatments were collected prospectively for patients who received adjuvant RT between December 2013 and November 2015. Patients were seen weekly by clinicians throughout treatment, during which a clinician-reported survey was completed on RD symptoms and skin treatments. Possible predictive factors were correlated with skin outcomes through a univariate ordinal logistic regression analysis. RESULTS: A total of 1093 patients were included in this analysis. Predictive factors for erythema included dose fractionation (p<0.0001), tissue volume irradiated by tangential fields (p = 0.01), and administration of a boost (p = 0.005). High BMI (≥30 kg/m2) (p = 0.0004) and boost (p = 0.02) were predictive of edema. A dose of 50 Gy/25 (p<0.0001) and a high irradiated tissue volume (p = 0.0001) were predictive of desquamation. A dose of 50 Gy/25 (p = 0.0005) and high BMI (p = 0.02) were predictors of pain. Bolus use was the only factor associated with bleeding (p = 0.02). Patients who developed desquamation were likely to receive corticosteroids/antihistamines (p<0.0001), topical antibiotics/antifungals (p<0.001), and dressings (p<0.0001). CONCLUSION: The findings of this study provide evidence of potential predictors of RD and methods of symptom management based on symptom severity. Prevention of RD is needed among high-risk groups, such as patients with a high BMI or receiving a standard fractionation, boost, or bolus.

How do patient-reported outcomes compare with clinician assessments? A prospective study of radiation dermatitis in breast cancer.

BACKGROUND AND PURPOSE: Breast cancer patients frequently develop radiation dermatitis (RD) when undergoing post-operative radiation therapy (RT). Traditional RD assessment methods measure clinician-reported outcomes (CROs), but patient-reported outcomes (PROs) have gained recent popularity. The purpose of this prospective analysis was to compare PROs with CROs of breast RD. MATERIALS AND METHODS: Demographic and treatment characteristics were prospectively collected for patients receiving post-operative RT between February 2018 to September 2020. Patients and clinicians completed a skin symptom assessment at baseline, weekly during RT, and at a one- to three-month follow-up visit. Skin treatments used by patients were collected. Concordance between each PRO and CRO was determined using percent concordance and concordance index (C-statistic) by logistic regression analysis. RESULTS: A total of 777 patients were included in the present study. All skin symptom assessment items were significantly underreported by clinicians in comparison to patients (p < 0.0001), with a low to moderate level of concordance (C-statistic range: 0.58-0.70; percent concordance range: 29-50%). The majority of patients used moisturizing creams as a prophylactic measure (65.1%), as per institutional guidelines. CONCLUSION: There were significant discrepancies between PROs and CROs when assessing breast RD. CROs alone are insufficient in measuring RD as they fail to capture the impact on patient quality of life. The study findings highlight the need for improved RD symptom assessment and support the development of a new tool with both patient and clinician components.

Pediatric osteoblastoma of the sternum: a new surgical technique for reconstruction after removal: case report and review of the literature.

Benign osteoblastoma is a rare tumor of bone that has been reported in a variety of skeletal locations. A case of an isolated benign osteoblastoma in the sternum of an 11-year-old boy is described. In the chest wall, osteoblastoma has been reported in the ribs, and rarely in the sternum. To the authors' knowledge, this is the first report of an isolated sternal osteoblastoma in a child presented in the literature. The clinical and radiologic presentation of osteoblastoma is discussed, as well as an approach for reconstruction of the sternal defect following removal of the tumor. Experience with sternal reconstruction in the pediatric population is limited. This case demonstrates that osteoblastoma of the sternum can be successfully treated with wide resection and that sternal defect reconstruction can be accomplished successfully in a child.

The use of postoperative subcutaneous closed suction drainage after posterior spinal fusion in adolescents with idiopathic scoliosis.

BACKGROUND The purpose of this prospective study was to assess the impact of closed suction drainage on transfusion requirements, frequency of dressing changes, and wound healing following posterior spinal fusion in adolescents with idiopathic scoliosis. METHODS Thirty patients were randomly assigned to one of two groups: drain or no drain. Although the group with drains received more postoperative autologous blood transfusions than the group with no drains (0.88 vs 0.5 unit), the difference was not statistically significant (P = 0.2131). In the undrained group, 58% of the patients had moderate to completely saturated dressings on the second postoperative day compared with only 17% of patients in the drained group. Three of 12 patients in the undrained group demonstrated a wound complication rate compared with no complications in the drained group. CONCLUSION In conclusion, subcutaneous closed suction drainage can improve immediate postoperative wound care without significantly increasing blood loss and transfusion requirements for patients undergoing surgery for idiopathic scoliosis.