Browsing by Author "Ellis, Matthew"

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    Cardiac Outcomes of Patients Receiving Adjuvant Weekly Paclitaxel and Trastuzumab for Node-Negative, ERBB2-Positive Breast Cancer
    (American Medical Association, 2016-01) Dang, Chau; Guo, Hao; Najita, Julie; Yardley, Denise; Marcom, Kelly; Albain, Kathy; Rugo, Hope; Miller, Kathy; Ellis, Matthew; Shapira, Iuliana; Wolff, Antonio C.; Carey, Lisa A.; Moy, Beverly; Groarke, John; Moslehi, Javid; Krop, Ian; Burstein, Harold J.; Hudis, Clifford; Winer, Eric P.; Tolaney, Sara M.; Department of Medicine, IU School of Medicine
    IMPORTANCE: Trastuzumab is a life-saving therapy but is associated with symptomatic and asymptomatic left ventricular ejection fraction (LVEF) decline. We report the cardiac toxic effects of a nonanthracycline and trastuzumab-based treatment for patients with early-stage human epidermal growth factor receptor 2 (ERBB2, formerly HER2 or HER2/neu)-positive breast cancer. OBJECTIVE: To determine the cardiac safety of paclitaxel with trastuzumab and the utility of LVEF monitoring in patients with node-negative, ERBB2-positive breast cancer. DESIGN, SETTING, AND PARTICIPANTS: In this secondary analysis of an uncontrolled, single group study across 14 medical centers, enrollment of 406 patients with node-negative, ERBB2-positive breast cancer 3 cm, or smaller, and baseline LVEF of greater than or equal to 50% occurred from October 9, 2007, to September 3, 2010. Patients with a micrometastasis in a lymph node were later allowed with a study amendment. Median patient age was 55 years, 118 (29%) had hypertension, and 30 (7%) had diabetes. Patients received adjuvant paclitaxel for 12 weeks with trastuzumab, and trastuzumab was continued for 1 year. Median follow-up was 4 years. INTERVENTIONS: Treatment consisted of weekly 80-mg/m2 doses of paclitaxel administered concurrently with trastuzumab intravenously for 12 weeks, followed by trastuzumab monotherapy for 39 weeks. During the monotherapy phase, trastuzumab could be administered weekly 2-mg/kg or every 3 weeks as 6-mg/kg. Radiation and hormone therapy were administered per standard guidelines after completion of the 12 weeks of chemotherapy. Patient LVEF was assessed at baseline, 12 weeks, 6 months, and 1 year. MAIN OUTCOMES AND MEASURES: Cardiac safety data, including grade 3 to 4 left ventricular systolic dysfunction (LVSD) and significant asymptomatic LVEF decline, as defined by our study, were reported. RESULTS: Overall, 2 patients (0.5%) (95% CI, 0.1%-1.8%) developed grade 3 LVSD and came off study, and 13 (3.2%) (95% CI, 1.9%-5.4%) had significant asymptomatic LVEF decline, 11 of whom completed study treatment. Median LVEF at baseline was 65%; 12 weeks, 64%; 6 months, 64%; and 1 year, 64%. CONCLUSIONS AND RELEVANCE: Cardiac toxic effects from paclitaxel with trastuzumab, manifesting as grade 3 or 4 LVSD or asymptomatic LVEF decline, were low. Patient LVEF was assessed at baseline, 12 weeks, 6 months, and 1 year, and our findings suggest that LVEF monitoring during trastuzumab therapy without anthracyclines could be simplified for many individuals.
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    The demographics and traumatic causes of spinal cord injury in Nepal: An observational study
    (Sage, 2021) Willott, Arran; Dhakal, Raju; Groves, Christine; Mytton, Julie; Ellis, Matthew; Physical Medicine and Rehabilitation, School of Medicine
    Introduction: There has been little systematic study of the epidemiology of traumatic spinal cord injury (TSCI) in Nepal, South-East Asia, and low- and middle-income countries (LMICs) in general. One third of the global morbidity and mortality due to injuries is concentrated in South-East Asia. We need to better understand the circumstances leading to TSCI if we are to make progress with prevention. Method: The Spinal Injury Rehabilitation Centre (SIRC) in Nepal systemically collected prospective data describing people with TSCI admitted between September 2015 and August 2016. Descriptive analyses of variables yielded demographic, aetiological and clinical descriptors of this cohort. Cross-tabulations were used to explore the associations between variables. Results: Of 184 admissions over one year, males were admitted to SIRC almost 2.3 times more often than females. Young adults (21–30 years) were the largest age group (34%). The majority of TSCI resulted in paraplegia (67%) and was complete in nearly half (49%). Falls caused the majority of TSCI (69%), and falls from trees were the most common. Road traffic injuries (RTIs) were the second leading cause (29%); the majority involved two- or three-wheeled motorised vehicles and patients were most commonly driving. Conclusion: Falls were the leading cause of TSCI across both genders and all age groups, followed by RTIs, which occurred most often in young adults and men. Injury surveillance and further research would provide a greater understanding of the pattern of TSCI and enable progress in TSCI prevention and rehabilitation.