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Aim: To report treatment patterns and quality of life (QoL) in HER2-negative advanced breast cancer patients. Methods: Data were drawn from a cross-sectional survey in Europe and USA. Results: Hormone plus targeted therapy was the most frequent first-line (1L, 62%) and second-line (2L, 45%) treatment for HR+/HER2-patients. Chemotherapy was most frequent at third-line or greater (3L+, 39%) for HR+/HER2- patients, 2L (51%) and 3L+ (48%) for triple negative breast cancer (TNBC) patients. Time to progression was 13.8 (2L) and 11.0 (3L+) months for HR+/HER2- patients. No comparisons were observed for TNBC patients. EQ-5D-5L scores were highest in patients at 1L and lowest at 3L+. Conclusion: Reduced QoL and treatment response were reported in patients at later lines of therapy. Plain Language Summary Breast cancer is the most common cancer in women. Differences in survival are seen depending on how widespread or advanced the cancer is, how many different treatments the patient has been given, as well as whether certain receptors on the tumor are present or absent. Many new treatments are available which can target these receptors. These treatments have improved survival in patients with advanced breast cancer, but other benefits for the patient are not always clear. In addition, differences between countries are possible as official guidance can vary. This study aimed to understand these issues, by asking physicians and their patients across Europe and USA for their views on quality of life and satisfaction with their treatments. We found that, in general, physicians prescribed treatments as recommended in the treatment guidelines. As breast cancer progressed and treatment stopped working, patients were switched on to different treatments. Survival, quality of life and treatment satisfaction were all worse in patients who had switched treatments. It appears that the patients lose confidence that their new treatment will work to improve their quality of life. We also saw differences in some of these outcomes between Europe and USA, which were likely due to differences in the treatment guidelines between countries. Both quality of life and treatment satisfaction are important for the well-being of patients with advanced breast cancer as they now live longer with these new treatments. This should be considered by physicians and taken into account for future work. Given the rapidly evolving treatment landscape for patients with advanced breast cancer (ABC), the aim of this analysis was to describe treatment patterns, quality of life (QoL) outcomes, and treatment satisfaction at subsequent treatment lines (first- [1L], second- [2L]; third/later- [3L+] lines) among patients with hormone-receptor positive (HR+)/human epidermal growth factor-negative (HER2-) and triple negative breast cancer (TNBC) in Europe (France, Italy and Spain) and USA in a real-world setting. Data were drawn from the Advanced Breast Cancer (ABC) Disease Specific Programme™, a point-in-time survey of physicians and their consulting patients conducted in Europe and the USA 2019–2020. Median time to progression at 2L and 3L was 13.8 and 11.0 months for patients with HR+/HER2, and 8.0 and 4.6 months, respectively for TNBC patients; patient overall response rates at 1L, 2L and 3L+ were 54, 53 and 42%, respectively. The average EuroQol-5 dimensions-5 level (EQ-5D-5L) health utility score of HR+/HER2- and TNBC patients was 0.77 at 1L, 0.70 and 0.71 at 2L, and 0.65 and 0.79 at 3L+, respectively; EQ-5D-5L visual analog scale mean score was 70.9, 67.4, and 63.4 for HR+/HER2- patients, and 69.4, 65.2, and 65.8 for TNBC patients, at 1L, 2L and 3L+, respectively. The Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status mean score was 64.6, 60.0 and 57.7 for HR+/HER2- patients, and 64.0, 61.2 and 59.3 for TNBC patients, at 1L, 2L and 3L+, respectively; there was a small meaningful difference between scores at 1L and at 2L and 3L+. EORTC scores were generally higher at 1L and lower at 3L+ in HR+/HER2- patients' functioning and symptoms. This differed for TNBC patients where scores were higher in 3L+ patients compared with 2L patients for physical, role, emotional, cognitive and social functioning. Meaningful differences in the scores at 2L and/or 3L+ were seen for most functioning scales, particularly in cognitive functioning and social functioning, and over half of the symptom scales in HR+/HER2- patients. Physicians were 'satisfied' or 'very satisfied' with current treatment for 77%, HR+/HER2- and 68% TNBC patients on 1L, 73% HR+/HER2- and 57% TNBC patients on 2L, and 59% HR+/HER2- and 54% TNBC patients on 3L+; likewise, patients' treatment satisfaction was reduced for both patient populations. This analysis demonstrated that patients with HR+/HER2- and triple negative ABC treated with 3L+ therapy, compared with patients treated with 1L or 2L therapies, reported a reduction in QoL, while concurrently, time to progression was shorter and overall response rate was poorer; similarly, satisfaction with treatment was reduced for both physicians and patients. [ABSTRACT FROM AUTHOR]

The objective of this study was to define and characterize the unmet needs in the pharmacological management of insomnia. A systematic literature review was conducted to identify relevant literature reporting real-world evidence in insomnia, published from January 2009 to April 2020. Pharmacological treatments – both prescription (benzodiazepines, 'Z-drugs' and suvorexant) and off-label (antidepressants, antipsychotics, and antihistamines) – were considered. Overall, 108 publications describing the humanistic (n = 59) and economic burden (n = 20) of insomnia, off-label treatment patterns (n = 28) and factors influencing treatment adherence or persistence (n = 8) were identified. A high prevalence of comorbid conditions was reported in patients with insomnia resulting in significantly lower health-related QoL compared to those with insomnia or a comorbidity alone. Current treatment options were associated with adverse events, including reduced sleep quality and next-day somnolence. An increased risk of accidents/injuries was also associated with insomnia and its treatment. Furthermore, safety concerns and perceived lack of efficacy for approved treatments have led to frequent off-label prescribing, despite a lack of clinical evidence of risk/benefit ratios. Safety concerns associated with benzodiazepines include risk of dependence, leading to prolonged treatment persistence and exacerbated adverse events, making them unsuitable for use in patients with chronic insomnia. Finally, the substantial economic burden of insomnia was evident, with reduced work productivity demonstrated in patients with insomnia compared to the general population. This review highlights a clear unmet need for insomnia therapies that improve sleep quality without resulting in next-day impairment and/or dependence. [ABSTRACT FROM AUTHOR]

Background: Outpatients treated with oral anti-cancer drugs, including selective cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), may benefit from a pharmacy practice setting adapted to support proper oral anti-cancer drug monitoring. This real-world study aimed to characterize patient-centered pharmacy practice aligned with American Society of Clinical Oncology (ASCO)/National Community Oncology Dispensing Association (NCODA) standards and to describe its impact on CDK4/6i treatment use. Methods: This retrospective study included women with confirmed hormone receptor-positive/human epidermal growth factor 2 negative locally advanced or metastatic breast cancer treated with either palbociclib, abemaciclib or ribociclib combined with letrozole or fulvestrant. Pharmacists collected patient characteristics, clinical activities, and treatment patterns using data from the pharmacy chart. CDK4/6i treatment adherence rates were estimated based on medication claims data. Time-to-treatment discontinuation, a proxy for time-to-event, was assessed using the Kaplan-Meier estimate. Results: Of the 195 patients assessed for eligibility, 65 were included in this study. The median observation duration was 13.6 months. An average of seven pharmaceutical care activities (range 2.8–21.7) per patient was documented for each treatment cycle. The mean proportion of days covered was 89.6%. The median time-to-treatment discontinuation was estimated at 44.2 months in patients treated with CDK4/6i + letrozole and 17.0 months in patients treated with CDK4/6i + fulvestrant. The average relative dose intensity was 85%, and the benefits of treatment were maintained regardless of the relative dose intensity levels. Conclusion: A structured patient-centered pharmacy practice model integrating the ASCO/NCODA patient-centered standards and ongoing communication with patients and healthcare providers ensure timely refills, close monitoring, and allows patients to achieve high adherence and persistence rates comparable to those reported in clinical trials. [ABSTRACT FROM AUTHOR]