Institutional Priority-Setting for Novel Drugs and Therapeutics: A Qualitative Systematic Review.

BACKGROUND: There is a lack of guidance on approaches to formulary management and funding for high-cost drugs and therapeutics by individual healthcare institutions. The objective of this review was to assess institutional approaches to resource allocation for such therapeutics, with a particular focus on paediatric and rare disease populations. METHODS: A search of Embase and MEDLINE was conducted for studies relevant to decision-making for off-formulary, high-cost drugs and therapeutics. Abstracts were evaluated for inclusion based on the Simple Multiple-Attribute Rating Techniques (SMART) criteria. A framework of 30 topics across 4 categories was used to guide data extraction and was based on findings from the initial abstract review and previous health technology assessment (HTA) publications. Reflexive thematic analysis was conducted using QSR NVivo 12 software. RESULTS: A total of 168 studies were included for analysis. Only 4 (2%) focused on paediatrics, while 21 (12%) centred on adults and the remainder (85%) did not specify. Thirty-two (19%) studies discussed the importance of high-cost therapeutics and 34 (23%) focused on rare/orphan drugs. Five themes were identified as being relevant to institutional decision-making for high-cost therapeutics: institutional strategy, substantive criteria, procedural considerations, guiding principles and frameworks, and operational activities. Each of these themes encompassed several sub-themes and was complemented by a sixth category specific to paediatrics and rare diseases. CONCLUSION: The rising cost of novel drugs and therapeutics underscores the need for robust, evidence-based, and ethically defensible decision-making processes for health technology funding, particularly at the hospital level. Our study highlights practices and themes to aid decision-makers in thinking critically about institutional, substantive, procedural, and operational considerations in support of legitimate decisions about institutional funding of high-cost drugs and therapeutics, as well as opportunities and challenges that exist for paediatric and rare disease populations.

Priority-setting for hospital funding of high-cost innovative drugs and therapeutics: A qualitative institutional case study.

OBJECTIVES: Rising costs of innovative drugs and therapeutics (D&Ts) have led to resource allocation challenges for healthcare institutions. There is limited evidence to guide priority-setting for institutional funding of high-cost D&Ts. This study sought to identify and elaborate on the substantive principles and procedures that should inform institutional funding decisions for high-cost off-formulary D&Ts through a case study of a quaternary care paediatric hospital. METHODS: Semi-structured, qualitative interviews, both virtual and in-person, were conducted with institutional stakeholders (i.e. staff clinicians, senior leadership, and pharmacists) (n = 23) and two focus groups at The Hospital for Sick Children in Toronto, Canada. Participants involved in, and impacted by, high-cost off-formulary drug funding decisions were recruited through stratified, purposive sampling. Participants were approached for study involvement between July 27, 2020 and June 7, 2022. Data was analysed through reflexive thematic analysis. RESULTS: Institutional resource allocation for high-cost D&Ts was identified as ethically challenging but critical to sustainable access to novel therapies. Important substantive principles included: 1) clinical evidence of safety and efficacy, 2) economic considerations (direct costs, opportunity costs, value for money), 3) ethical principles (social justice, professional/organizational responsibility), and 4) disease-specific considerations. Multidisciplinary deliberation was identified as an essential procedural component of decision-making. Participants identified tension between innovation and the need for evidence-based decision-making; clinician and institutional responsibilities; and value for money and social justice. Participants emphasized the role of health system-level funding allocation in alleviating the financial and moral burden of decision-making by institutions. CONCLUSIONS: This study identifies values and processes to aid in the development and implementation of institutional resource allocation frameworks for high-cost innovative D&Ts.

Age and sex-related comparison of referral-based telemedicine service utilization during the COVID-19 pandemic in Ontario: a retrospective analysis.

BACKGROUND: The COVID-19 pandemic has led to increased utilization of telemedicine services. METHODS: A retrospective analysis of all referral-based ambulatory telemedicine services in Ontario from November 2019 to June 2021 was collected from the Ontario Health Insurance Plan (OHIP) billing database. Only fee-for-service billings were included in the present analysis. Coincident COVID-19 cases were obtained from Public Health Ontario. Comparisons were made based on age bracket, sex, telemedicine and in-person care. RESULTS: Billings for telemedicine services in Ontario increased from $1.7 million CAD in November 2019 to $64 million CAD in April 2020 and the proportions reached a mean peak of 72% in April 2020 and declined to 46% in June 2021. A positive correlation was found between the use of telemedicine and COVID-19 cases (p = 0.05). The age group with the highest proportion of telemedicine use was the 10-20-year-olds, followed by the 20-50-year-olds (61 ± 9.0%, 55 ± 7.3%, p = 0.01). Both age groups remained above 50% telemedicine services at the end of the study period. There seemed to be higher utilization by females (females 54.2 ± 8.0%, males 47.9 ± 7.7%, ANCOVA p = 0.05) for all specialties, however, after adjusting for male to female ratio m:f of 0.952:1.0 according to the 2016 census, this was no longer significant. CONCLUSIONS: The use of telemedicine services remained at a high level across groups, particularly the 10-50-year-olds. There were clear age preferences for using telemedicine. Studying these differences may provide insights into how the delivery of non-hospital-based medicine has changed during the COVID-19 pandemic.

A qualitative study of what motivates and enables climate-engaged physicians in Canada to engage in health-care sustainability, advocacy, and action.

Increasing numbers of health-care professionals are aware of the need to deliver low-carbon sustainable health systems. We aimed to explore how physicians can be motivated and supported to pursue this ambition by conducting an exploratory qualitative descriptive study that involved individual in-depth interviews with climate-engaged Canadian physicians participating in health-care sustainability advocacy and action. Interview transcripts were analysed to identify themes related to the actions that physicians can take to promote sustainable health care, and the motivators and enablers of physician engagement in sustainable health care. Participants (n=19) engaged in a spectrum of health-care sustainability initiatives ranging from reducing health-care waste to lobbying and political action. They were motivated to advance health-care sustainability by their concern about the health implications of climate change, frustration with health-care waste, and recognition of their locus of influence as physicians. Participants articulated that policy and system, organisational and team, and knowledge generation and translation supports are required to strengthen their capacity to advance health-care sustainability. These findings can provide inspiration for engagement opportunities in health-care sustainability, guide service delivery and educational innovations to promote health-care professionals' interest in becoming sustainability champions, and extend the capacity of health-care professionals to reduce the climate impact of health care.

A retrospective review of the real-world experience of the Pegfilgrastim biosimilar (Lapelga®) to the reference biologic (Neulasta®).

INTRODUCTION: Cancer patients receiving myelosuppressive chemotherapy are vulnerable to febrile neutropenia (FN) which contributes to poor treatment outcomes. The use of granulocyte colony-stimulating factors is administered to prevent chemotherapy-induced neutropenia. The introduction of biosimilars has allowed for greater cost-savings while maintaining safety and efficacy. This retrospective study assessed the incidence of FN and related treatment outcomes and the cost minimization of a pegfilgrastim biosimilar and its reference. METHODS: A retrospective chart review of breast cancer patients receiving (neo) adjuvant chemotherapy from February 2017 to May 2020 was conducted. The endpoints included the incidence of FN, the occurrence of dose reduction (DR), dose delay (DD) and pain. A cost minimization analysis was performed from a third-party payer perspective. RESULTS: One hundred Neulasta® and 74 Lapelga® patients were included in the first-cycle analysis. The rate of FN in cycle 1 for Neulasta® and Lapelga® was 2/100 and 4/74, respectively; risk difference (RD) = 3.4%; 95% CI: -2.4 to 9.2%. Eighty-three Neulasta® and 59 Lapelga® patients were included in the all-cycle analyses, where DR was reported in 76 (15%) Neulasta® cycles vs 33 (10%) Lapelga® cycles (RD = -3.6, 95% CI: -10.2 to 2.9). DD was reported in 20 (4%) Neulasta® cycles vs. 11 (3.5%) Lapelga® cycles (RD = -0.3; 95% CI: -2.7 to 2.0). Adverse events were similar between groups. Cost minimization using a cohort of 20,000 patients translated into an incremental savings of $21,606,800 CAD for each cycle. CONCLUSION: The biosimilar pegfilgrastim 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.

Case series of radiation pneumonitis in breast cancer.

BACKGROUND: Radiation pneumonitis (RP) is a potentially severe inflammatory reaction that occurs in approximately 1-16% of breast cancer patients treated with radiation (RT). METHODS: Case histories and patient demographics were collected from 4 patients who received either hypofractionated (42.56 Gy in 16 fractions) or conventionally fractionated (50 Gy in 25 fractions) RT for breast cancer at a cancer centre from 2018-2020 and experienced clinically symptomatic RP. Lung dose parameters including mean lung dose, V5, and V20 were collected from institutional planning software and compared to institutional guidelines. RESULTS: The 4 cases were all female, aged 42-73 years old and received 2- or 4-field RT with wide or high tangent techniques. The most common symptoms in patients who developed RP were exertional dyspnea and dry cough. Corticosteroid doses in the daily range of 40-60 mg were the primary treatment followed by a highly variable tapering schedule. Two patients experienced a recurrence of symptoms after initial treatment and were restarted on corticosteroids. Patients had several predisposing risk factors including administration of wide tangents, chemotherapy with cyclophosphamide and/or taxanes, age>65 years, and comorbidities such as diabetes. DISCUSSION: Identification of RP is difficult as evidenced by the large gap in time between the appearance of RP symptoms to treatment with corticosteroids in several patients. Irregular tapering schedules may contribute to symptom recurrence. Three of the four patients treated with 4-field wide tangents exceeded the 35% dose constraint for ipsilateral lung V20 or V17.5. CONCLUSION: Careful radiation planning and review of lung dose constraints is essential to reduce risk of RP. Greater standardization of steroid tapering practices is recommended.

Dosimetry and outcomes in patients receiving radiotherapy for synchronous bilateral breast cancers.

BACKGROUND: Synchronous bilateral breast cancer (SBBC) is rare and there is little evidence describing organs at risk (OAR) and limits to the heart and lungs caused by radiotherapy (RT). Quantifying mean heart dose (MHD) and mean lung dose (MLD) from RT in this patient cohort may lead to better understanding of doses to OAR and resultant effects on clinical outcomes. The primary objective was to assess median MHD and MLD in SBBC, while secondary aims included analyses of 1) factors associated with MHD and MLD, 2) V5 and V20 values and 3) factors associated with clinical outcomes. METHODS: Patients planned for adjuvant bilateral whole breast/chest wall (WB) RT from a single institution treated in 2011-2018 were included. Median MHD and MLD (Gy) were stratified by hypofractionated (42.56 Gy/16 fractions, HFRT) and conventional fractionation (50 Gy/ 25 fractions, CFRT) and summarized separately based on the following treatments: 1) locoregional RT, WB tangential RT either 2) no boost 3) sequential boost or 4) simultaneous integrated boost. MHD, MLD, lung V5 and V20 values, and demographics were collected. Linear regression analyses identified factors associated with MHD and MLD and factors associated with clinical outcomes. RESULTS: A total of 88 patients were included. The median MHD for HFRT and CFRT was 1.99 Gy and 2.94 Gy, respectively. The median MLD for HFRT and CFRT was 6.00 Gy and 10.08 Gy, respectively. MHD and MLD were significantly associated with the occurrence of a cardiac or pulmonary event post-radiation. Patients who had a mastectomy or tumoral muscle involvement were more likely to develop a local recurrence, metastasis or new primary while patients who had a lumpectomy or tumor with a positive estrogen receptor status were less likely to experience these events. CONCLUSIONS: Further investigation should be conducted to identify SBBC RT techniques that mitigate dose to OARs to improve clinical outcomes in bilateral breast patients.

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.

Prediction of breast cancer-related outcomes with the Edmonton Symptom Assessment Scale: A literature review.

PURPOSE: The Edmonton Symptom Assessment Scale (ESAS) is a validated tool used in patients with varied cancer diagnoses to measure patient symptoms. The present manuscript will review the literature assessing the ability of the ESAS to predict patient-related outcomes in breast cancer patients. METHODS: A literature search was conducted of Cochrane Central Register of Controlled Trials databases, Ovid MEDLINE, and Embase for English articles that investigated the use of predictive modelling with the ESAS in the breast cancer population. Study type, publication year, sample size, patient demographics, predicted outcomes, and strongest predictive factors/symptoms were summarized for each study. RESULTS: A total of nine articles were included in this review. Five articles used the ESAS in predictive models to determine patient time to death. ESAS was also used to predict emergency department visits, determine symptoms associated with decreased quality of life, and generate a Health Utility Score. Lack of appetite was the most common ESAS symptom, as it was reported in five studies to be associated with decreased survival. In four of the nine articles, an additional survey investigating physical functioning was used in combination with ESAS to strengthen the predictive models. CONCLUSIONS: Included studies support the use of ESAS in predictive models, particularly for predicting survival. Using the ESAS as a predictive tool allows for more accurate time to death predictions, potentially improving symptom management and preventing overtreatment of palliative patients near the end of life.

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.

Radiation dermatitis assessment tools used in breast cancer: A systematic review of measurement properties.

PURPOSE: This review aimed to assess the quality and efficacy of tools currently used in breast cancer patients to score radiation dermatitis (RD), a common debilitating side effect of radiotherapy (RT). METHODS: A search was conducted through Ovid Medline, Embase, and Cochrane Central Register of Controlled Trials databases on 14 February 2020. English articles that evaluated an instrument's use in assessing RD among breast cancer patients receiving external beam RT were included. Studies that reported on the reliability, validity, or concordance of items between assessment tools were included in accordance with the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. RESULTS: Twelve studies were included in this review, with a total of 13 skin toxicity assessment tools discussed. Tools that assessed clinician-reported outcomes (CROs) mostly reported moderate correlation with biophysical parameter (BP) measurements and low correlation with patient-reported outcomes (PROs). Traditionally used CRO scoring tools demonstrated moderate inter-rater reliability between clinicians, likely due to the subjective nature of items on the grading scales. Most commonly used tools were found to be either insufficient or indeterminate in their measurement properties. CONCLUSIONS: Current standardized tools that measure CROs are subject to clinician interpretation and fail to represent the patient experience. Tools designed to assess PROs are promising in their assessments of the impact of RT on patient quality of life; however, most PRO tools are generic to all skin conditions and require further validation for use in breast cancer. Among tools that measure CROs, PROs, and BPs, there is insufficient evidence on their measurement properties to establish a "gold standard" for the assessment of RD in breast cancer patients.

Factors Affecting Mean Heart Dose in Patients Receiving Breast Radiotherapy from 2011 to 2018 in a Single Institution.

INTRODUCTION: Breast cancer radiotherapy (RT) can increase the risk of cardiac disease with increasing dose; as such, reducing excessive dosage to the heart is a concern for clinicians. The purpose of the present study was to assess mean heart dose (MHD) in patients with breast cancer receiving RT, where it was hypothesized that MHD decreased over time. METHODS: Patients planned for adjuvant unilateral whole breast/chest wall RT from 2011 to 2018 were included for a retrospective chart-review at a single-institution, academic center. MHD (Gy) was summarized by laterality, fractionation, and heart-sparing techniques. RESULTS: A total of 4,687 patients were included. The median MHD for left-sided conventional RT (50 Gy in 25 fractions) was 2.16 Gy across all years, decreasing until 2015 and increasing after. Median MHD for left-sided hypofractionated RT (42.6 Gy in 16 fractions) was 1.47 Gy, also decreasing until 2015 and increasing after. The increase in MHD after 2015 was attributed to a significant increase in the use of wide tangents (including internal mammary chain) after 2015 (P < .0001). Several treatment factors were associated with higher MHD in both right- and left-sided cancers, including locoregional RT, high tangents, wide tangents, bolus, heart shielding, treatment to the chest wall, higher volume of tissue irradiated by tangential fields, higher baseline breast separation values, and smaller heart volume. After adjusting for laterality and fractionation in the multivariate analysis, locoregional RT, wide tangents, heart shielding, boost, treatment to the chest wall, higher volume of tissue irradiated by tangential fields, higher baseline breast separation, and lower heart volume were significantly associated with higher MHD (P < .0001). DISCUSSION/CONCLUSIONS: MHD should be considered when determining the most appropriate RT techniques for both right- and left-sided cancers as higher MHD was significantly associated with various treatment techniques and patient factors.

Use of Adjuvant Breast Hypofractionation Radiation Treatment at a Cancer Center in Ontario From 2011 to 2018.

BACKGROUND: The adoption of hypofractionated radiotherapy (HFRT) into clinical practice varies widely despite randomized trials and guidelines supporting its equivalence to conventional fractionated radiotherapy (CFRT) for certain patient populations. We assessed the use of HFRT at a single institution from 2011 to 2018, as well as time-savings calculations. PATIENTS AND METHODS: A retrospective cohort study was conducted for patients with breast cancer receiving adjuvant radiotherapy by HFRT or CFRT. Trends in HFRT use (≤ 16 fractions) were stratified according to 4 subgroups: tangential breast RT, locoregional breast RT, tangential chest wall RT, and locoregional chest wall RT. Treatment time savings were approximated using the institutional median treatment time. RESULTS: A total of 5190 patients were included. HFRT use in all subgroups increased from 2011 to 2018. Tangential breast HFRT alone increased from 62.2% in 2011 to 96.9% in 2018. Locoregional breast HFRT and tangential chest wall HFRT use increased from less than 10% in 2011 to 76.2% and 76.9% in 2018. In locoregional chest wall RT, HFRT use of 44.9% was observed in 2018. Increased use of locoregional HFRT was mainly due to institutional policy changes. Time-savings calculations showed that 4002 hours of treatment or an additional 1402 HFRT courses could have been administered if all patients received HFRT. CONCLUSION: The use of HFRT at our center increased in all patient subgroups. More evidence and guidelines for patients receiving chest wall or locoregional HFRT are required because the use of HFRT remains low in these patient cohorts.

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.

Symptom correlates of dyspnea in advanced cancer patients using the Edmonton Symptom Assessment System.

PURPOSE: Dyspnea is frequently experienced in advanced cancer patients and is associated with poor prognosis and functional decline. This study used the Edmonton Symptom Assessment System (ESAS) to characterize the relationship between dyspnea and concurrent symptoms experienced by advanced cancer patients. METHODS: A prospective database was collected and analyzed to extract patient demographics and ESAS scores. Logistic regression analysis and generalized estimating equations (GEE) identified correlations of other ESAS symptoms in three categories: severity of dyspnea (none, mild, moderate, severe), moderate/severe dyspnea (ESAS ≥ 4), and presence of dyspnea (ESAS ≥ 1), at patients' first visit and over time, respectively. RESULTS: Multivariable analysis revealed drowsiness (p = 0.001), and anxiety (p = 0.01) and appetite loss (p = 0.02) were associated with increased severity of dyspnea at first visit. Over time, tiredness (p = 0.02), drowsiness (p = 0.04), nausea (p = 0.02), and anxiety (p = 0.0006) were more likely to experience increased dyspnea severity. Tiredness (p = 0.0003), depression (p = 0.03), and appetite loss (p = 0.003) were significant for moderate/severe dyspnea at first visit. Over multiple visits, tiredness (p < 0.0001), anxiety (p = 0.0008), and appetite loss (p = 0.0008) had higher probabilities of moderate/severe dyspnea. For the presence of dyspnea at the first visit, anxiety (p = 0.03) and drowsiness (p = 0.002) were significantly correlated with an increased frequency of dyspnea. Over time, anxiety (p < 0.0001) and drowsiness (p < 0.0001) remained significant with the addition of nausea (p = 0.0007). CONCLUSIONS: The highly interactive relationship between dyspnea and other common cancer symptoms necessitates the development of comprehensive symptom assessments and utilization of multimodal management approaches that consider concurrent symptoms for improved identification and treatment of dyspnea.

Evolution of antiemetic studies for radiation-induced nausea and vomiting within an outpatient palliative radiotherapy clinic.

PURPOSE: Radiation-induced nausea and vomiting (RINV) is a common side effect of radiotherapy and can affect up to 50-80% of patients, potentially causing detrimental effects to physical health, clinical efficacy, and patient quality of life. Antiemetic drugs act on receptors involved in the emesis pathway to block the uptake of neurotransmitters and inhibit stimulation of vomiting centers in the brain to prevent and treat RINV. The most commonly prescribed antiemetics for RINV are 5-hydroxytryptamine receptor antagonists (5-HT3 RA). Guidelines describing the optimal management of RINV are produced by the Multinational Association for Supportive Care in Cancer, the European Society of Medical Oncology, the American Society of Clinical Oncology, and the National Comprehensive Cancer Network. This review will present findings from research on antiemetic management for RINV conducted at our center. METHODS: A selective review of research conducted in a palliative outpatient radiotherapy clinic relating to antiemetic management for RINV was performed. RESULTS: Several studies investigating the efficacy of different routes of administration, new antiemetic drug types, and novel combinations of antiemetics have been tested at our clinic to elucidate which approach provides the best response. These include studies on the use of ondansetron rapidly dissolving film, palonosetron, and the addition of a neurokinin-1 receptor antagonist to traditional 5-HT3 RA regimens. CONCLUSIONS: These studies provide a framework for future research and could potentially inform changes to future guidelines to include the use of these novel regimens and techniques.

Radiation-induced nausea and vomiting: a comparison between MASCC/ESMO, ASCO, and NCCN antiemetic guidelines.

PURPOSE: Radiation-induced nausea and vomiting (RINV) can affect 50-80% of patients undergoing radiotherapy and negatively impacts quality of life. This review aimed to compare the most recent RINV antiemetic guidelines produced by the Multinational Association for Supportive Care in Cancer (MASCC), the European Society of Clinical Oncology (ESMO), the American Society of Clinical Oncology (ASCO), and the National Comprehensive Cancer Network (NCCN). Future improvements to the guidelines and the need for further research in RINV were also discussed. METHODS: Antiemetic guidelines produced by MASCC/ESMO, ASCO, and NCCN were examined to identify similarities, differences, and inadequacies within the guidelines. RESULTS: Areas of dissension within the guidelines include the addition of dexamethasone to moderate-risk antiemetic regimens, the prophylactic treatment of RINV in the low-risk categories, and the appropriate treatment for breakthrough emesis. The guidelines are in accordance that high-risk radiotherapy regimens should be treated prophylactically with a serotonin receptor antagonist and for those undergoing concurrent chemotherapy and radiotherapy, antiemetic treatment should be prescribed according to the emetic risk associated with their respective chemotherapy regimen. Low- and minimal-risk recommendations are based on low-level evidence and informal consensus. CONCLUSION: RINV is a frequent and distressing side effect of radiotherapy and requires further research to establish effective antiemetic guidelines and ensure optimal treatment outcomes.

ASCO, NCCN, MASCC/ESMO: a comparison of antiemetic guidelines for the treatment of chemotherapy-induced nausea and vomiting in adult patients.

Chemotherapy-induced nausea and vomiting (CINV) is a common toxicity that may impair the quality of life of patients with a variety of early- and end-stage malignancies. In light of recent changes in the optimal management of CINV, we undertook this narrative review to compare the latest guidelines published by ASCO (2017), NCCN (2018), and MASCC/ESMO (2016). The processes undertaken by each organization to evaluate existing literature were also described. Although ASCO, NCCN, and MASCC/ESMO guidelines for the treatment and prevention of CINV share many fundamental similarities, literature surrounding low and minimal emetic risk regimens is lacking. Data regarding the use of complementary alternative medicine for CINV is particularly scarce and in need of further investigation.