Cabozantinib and Axitinib After Vascular Endothelial Growth Factor Therapy in Patients with Advanced Renal Cell Carcinoma: A Retrospective Cohort Study from England.

BACKGROUND AND OBJECTIVE: The tyrosine kinase inhibitors cabozantinib and axitinib have been widely used in England to treat advanced renal cell carcinoma following prior vascular endothelial growth factor-targeted therapy, but data on real-world usage remain limited. Our objective was to describe the real-world treatment patterns and outcomes of patients with advanced renal cell carcinoma who received second-line or later-line (≥ 2L) cabozantinib or axitinib after vascular endothelial growth factor-targeted therapy in clinical practice in England. METHODS: This retrospective cohort study used clinical practice data (collected 2011-20) from the English Cancer Analysis System database. Patient characteristics, treatment sequence and duration, and overall survival (time from initiation of cabozantinib/axitinib treatment to death) were evaluated. RESULTS: Data from 1485 eligible adults with advanced renal cell carcinoma were analyzed: 440 received ≥  2L cabozantinib (2L for 88.6% of them); 1045 received ≥  2L axitinib (2L for 89.5%). The most common first-line treatments were sunitinib (2L cabozantinib subcohort, 48%; 2L axitinib subcohort, 46%) and pazopanib (46% and 54%, respectively); nivolumab was the most common third-line treatment (18% and 19%, respectively). Median (interquartile range) 2L therapy duration was 5.52 (2.73-11.74) months for cabozantinib and 4.60 (1.45-12.36) months for axitinib. Following adjustment for potential confounders using inverse probability weighting, overall survival (median [interquartile range]) was longer for ≥ 2L cabozantinib (11.2 [5.7-28.0] months) than for ≥  2L axitinib (10.4 [4.7-22.0] months; log-rank p = 0.0034). CONCLUSIONS: The Cancer Analysis System database is a valuable research resource providing extensive real-world clinical data. Real-world overall survival was longer with ≥  2L cabozantinib than with axitinib. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04637204; registered November 2020.

Cabozantinib and axitinib are anticancer drugs called tyrosine kinase inhibitors. They work by blocking the activity of proteins that cancer cells use to help them divide and grow. Cabozantinib and axitinib are treatment options for a common type of kidney cancer called renal cell carcinoma (RCC). There is evidence about how well cabozantinib and axitinib work in clinical trials, but it is less clear how well they work in standard practice outside of clinical trials. We investigated how cabozantinib and axitinib are used and how well they work as part of 'real-world' RCC care. We did this by analyzing patient data from an English cancer database. All patients in the study had advanced RCC and had been treated with at least one previous anticancer drug. This includes a type of drug that blocks new blood vessels forming, which tumors need for rapid growth. Most of the 1485 patients received cabozantinib or axitinib after receiving only one previous anticancer drug. These patients were treated for a median of 5.5 months with cabozantinib and 4.6 months with axitinib. Patients lived for a median of 11.2 months after starting cabozantinib treatment and a median of 10.4 months after starting axitinib treatment. This study provides new evidence showing how well cabozantinib and axitinib work in everyday RCC care. The results add to those from clinical trials and show the value of the English cancer registry for conducting studies of routine cancer care.

Psychosocial and productivity impact of caring for a child with peanut allergy.

BACKGROUND: Limited previous research has assessed the psychosocial burden and productivity impact of caring for a child with peanut allergy and factors associated with burden. The objective of this research was to explore caregiver burden in terms of psychosocial and productivity impact of caring for a child with peanut allergy, the influence of caregiver and child gender on caregiver burden, and factors predicting caregiver burden in peanut allergy. METHODS: A cross-sectional survey of caregivers of children with peanut allergy was conducted in the United Kingdom, and included sociodemographic and clinical questions, EQ-5D, Hospital Anxiety and Depression Scale, Food Allergy Quality of Life-Parental Burden, Food Allergy Independent Measure, and productivity questions. RESULTS: One hundred caregivers (55% female) of children with peanut allergy (aged 4-15 years) completed the survey. Male and female caregivers reported mean levels of anxiety significantly higher than United Kingdom population norms. Caregivers of children with severe peanut allergy reported significant impacts on their careers and health-related quality of life. Neither caregiver nor child gender impacted burden, indicating that male and female caregivers are equally anxious and suffer the same level of negative career, productivity, and health-related quality-of-life impact due to their child's peanut allergy. Caregivers' perceived risk of outcomes related to their child's peanut allergy (e.g., death or severe reaction) as measured by the Food Allergy Independent Measure independently predicted burden. CONCLUSIONS: Caregivers of children with peanut allergy in the United Kingdom experience health-related quality-of-life, psychosocial, and productivity burden; this study demonstrates the high levels of anxiety reported by both male and female caregivers.

Economic burden of moderate to severe irritable bowel syndrome with constipation in six European countries.

BACKGROUND: Irritable bowel syndrome with predominant constipation (IBS-C) is a complex disorder with gastrointestinal and nervous system components. The study aim was to assess the economic burden of moderate to severe IBS-C in six European countries (France, Germany, Italy, Spain, Sweden and the UK). METHODS: An observational, one year retrospective-prospective (6 months each) study of patients diagnosed in the last five years with IBS-C (Rome III criteria) and moderate to severe disease at inclusion (IBS Symptom Severity Scale score ≥ 175). The primary objective was to assess the direct cost to European healthcare systems. RESULTS: Five hundred twenty-five patients were included, 60% (range: 43.1-78.8%) suffered from severe IBS-C. During follow-up 11.1-24.0% of patients had a hospitalisation/emergency room (ER) visit, median stay range: 1.5-12.0 days and 41.1-90.4% took prescription drugs for IBS-C. 21.4-50.8% of employed patients took sick leave (mean: 11.6-64.1 days). The mean annual direct cost to the healthcare systems was €937.1- €2108.0. The total direct cost (combined costs to healthcare systems and patient) for IBS-C was €1421.7-€2487.1. CONCLUSIONS: IBS-C is not a life-threatening condition; however, it has large impact on healthcare systems and society. Direct and indirect costs for moderate to severe IBS-C were high with the largest direct cost driver being hospitalisations/ER visits.

Economic costs of chemotherapy-induced febrile neutropenia among patients with non-Hodgkin's lymphoma in European and Australian clinical practice.

BACKGROUND: Economic implications of chemotherapy-induced febrile neutropenia (FN) in European and Australian clinical practice are largely unknown. METHODS: Data were obtained from a European (97%) and Australian (3%) observational study of patients with non-Hodgkin's lymphoma (NHL) receiving CHOP (±rituximab) chemotherapy. For each patient, each cycle of chemotherapy within the course, and each occurrence of FN within cycles, was identified. Patients developing FN in a given cycle ("FN patients"), starting with the first, were matched to those who did not develop FN in that cycle ("comparison patients"), irrespective of subsequent FN events. FN-related healthcare costs (£2010) were tallied for the initial FN event as well as follow-on care and FN events in subsequent cycles. RESULTS: Mean total cost was £5776 (95%CI £4928-£6713) higher for FN patients (n = 295) versus comparison patients, comprising £4051 (£3633-£4485) for the initial event and a difference of £1725 (£978-£2498) in subsequent cycles. Among FN patients requiring inpatient care (76% of all FN patients), mean total cost was higher by £7259 (£6327-£8205), comprising £5281 (£4810-£5774) for the initial hospitalization and a difference of £1978 (£1262-£2801) in subsequent cycles. CONCLUSIONS: Cost of chemotherapy-induced FN among NHL patients in European and Australian clinical practice is substantial; a sizable percentage is attributable to follow-on care and subsequent FN events.

Baseline observations from the POSSIBLE EU® study: characteristics of postmenopausal women receiving bone loss medications.

SUMMARY: Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU®) is an ongoing longitudinal cohort study that utilises physician- and patient-reported measures to describe the characteristics and management of postmenopausal women on bone loss therapies. We report the study design and baseline characteristics of 3,402 women recruited from general practice across five European countries. PURPOSE: The POSSIBLE EU® is a study describing the characteristics and management of postmenopausal women receiving bone loss medications. METHODS: Between 2005 and 2008, general practitioners enrolled postmenopausal women initiating, switching or continuing treatment with bone loss treatment in France, Germany, Italy, Spain and the UK. Patients and physicians completed questionnaires at study entry and at 3-month intervals, for 1 year. RESULTS: Of 3,402 women enrolled (mean age 68.2 years [SD] 9.83), 96% were diagnosed with low bone mass; 55% of these using dual energy X-ray absorptiometry. Most women (92%) had comorbidities. Mean minimum T score (hip or spine) at diagnosis was -2.7 (SD 0.89; median -2.7 [interquartile range, -3.2, -2.2]) indicating low bone mineral density. Almost 40% of the women had prior fractures in adulthood, mostly non-vertebral, non-hip in nature, 30% of whom had at least two fractures and more than half experienced moderate/severe pain or fatigue. Bisphosphonates were the most common type of bone loss treatment prescribed in the 12 months preceding the study. CONCLUSIONS: POSSIBLE EU® characterises postmenopausal women with low bone mass, exhibiting a high rate of prevalent fracture, substantial bone fragility and overall comorbidity burden. Clinical strategies for managing osteoporosis in this population varied across the five participating European countries, reflecting their different guidelines, regulations and standards of care.

A multi-centre comparison of nursing staff time required for the preparation and administration of liposomal amphotericin B and amphotericin B deoxycholate vs. voriconazole.

AIMS AND OBJECTIVES: To compare the nursing time and cost required for preparation and administration of liposomal amphotericin B, amphotericin B deoxycholate and voriconazole. DESIGN: Cost comparison study. METHODS: Nurse activities associated with the preparation and administration of the three study drugs were divided into 11 tasks and timed by observers at five hospitals. Target tasks were defined as those likely to be affected by the differences between drugs and excluded those tasks likely to differ owing to site-specific factors. Mean times for administration of a single day of therapy for each study drug were compared. Costs of preparation and administration of a 14-day regimen were estimated. RESULTS: Sixty-nine patients were observed receiving a total of 256 doses of study medications. Labour times were 20, 16, 14 and 3 minutes per day for liposomal amphotericin B, amphotericin B deoxycholate, intravenous voriconazole and oral voriconazole, respectively. Administration time was significantly lower for intravenous voriconazole compared with liposomal amphotericin B (p < 0.05), and for oral voriconazole compared with all intravenous regimens (p < 0.05). Preparation of medications took the longest time for intravenous formulations and was longer for liposomal amphotericin B than for the other drugs by 3-5 minutes. Average non-drug costs associated with preparation and administration of a 14-day regimen were greatest in the amphotericin B deoxycholate arm at US$ 335, followed by liposomal amphotericin B (US$ 310) and voriconazole (US$ 180). CONCLUSION: Intravenous voriconazole required less time to prepare and administer on a daily basis than liposomal amphotericin B, and was similar to amphotericin B deoxycholate. Measurements of intravenous vs. oral voriconazole administration suggest the opportunity to save 10-17 minutes per day with the oral formulation. RELEVANCE TO CLINICAL PRACTICE: Oral voriconazole may provide significant savings in terms of nursing time compared with intravenous antifungal drugs.

An economic evaluation of voriconazole versus amphotericin B for the treatment of invasive aspergillosis in Canada.

BACKGROUND: Invasive aspergillosis (IA) is a serious fungal infection that affects immunocompromised patients. The Global Comparative Aspergillosis study demonstrated that voriconazole, a new broad-spectrum triazole, had better responses and improved survival compared with conventional amphotericin B deoxycholate (CAB) and other licensed antifungal therapy (OLAT) for the treatment of definite or probable aspergillosis. OBJECTIVES: To compare costs and outcomes of voriconazole and CAB for the treatment of definite or probable aspergillosis in Canada. METHODS: A cost-consequence decision tree model was designed to reflect the treatment pathways used in clinical practice when using voriconazole or CAB as primary therapy for IA. Therapy included initial treatment with either voriconazole or CAB and then switched to an OLAT in the event of an inadequate response, severe toxicity or intolerance. The principal data source used was the Global Comparative Aspergillosis study. RESULTS: The total cost of voriconazole when compared with CAB as initial therapy for IA was $38,319 versus $42,495 per patient, respectively, representing a 9.8% cost reduction for each patient treated with voriconazole. The higher mean cost in the CAB arm was primarily due to the high proportion of patients (73.7%) who were switched to an OLAT due to severe side effects or an inadequate response. Treating with voriconazole was a dominant strategy. The number of patients that had to be treated with voriconazole instead of CAB to save one additional life was eight. CONCLUSIONS: Voriconazole as primary treatment for IA increased the chances of successful treatment, improved survival and may represent a potential cost saving strategy in Canada.