MedicalResearch.com Interview with:
Josefa Briceno, MD
Medical Head, DDR/ADC Franchise
AstraZenca
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In January 2018, the US FDA expanded the approved use of LYNPARZA to treat patients with HER2- negative metastatic breast cancer with germline
BRCA mutations based on positive results from the Phase III OlympiAD trial, which demonstrated the benefit of LYNPARZA over standard of care in physician’s choice chemotherapy in this patient population. LUCY is a Phase IIIb interim analysis aimed to evaluate the clinical effectiveness and safety of LYNPARZA in a real-world setting and has been expanded to include a group of patients with somatic
BRCA mutations.
A total of 252 patients with HER2-negative metastatic breast cancer with germline
BRCA mutations were enrolled in the open-label, single-arm, Phase IIIb study. Patients received a taxane and/or anthracycline in the (neo)adjuvant/metastatic setting, and ≤2 lines of chemotherapy.
The primary end point of the study was investigator-defined progression-free survival (PFS), and secondary end points included overall survival, time to first subsequent therapy or death, and investigator-assessed clinical response rate. The interim analysis was planned to take place after 160 progression-free survival events.
Overall, treatment lasted for a median of 7.9 months, and the median progression-free survival was 8.1 months (95% confidence interval of 6.9-8.7; 166 progression-free survival events).
In addition, the median time to first subsequent therapy or death was 9.7 months (95% confidence interval of 8.7-11.1) and the investigator-assessed clinical response rate was 48.6% (95% confidence interval of 42.2-55.0).
Adverse events of all grades were reported in >20% of patients were nausea, anemia, asthenia, vomiting, and fatigue. Grade ≥3 adverse events were reported in 24.6% of patients, and 4.4% of patients had an adverse event that led to treatment discontinuation.
(more…)
![MedicalResearch.com Interview with: Sarah Messiah, PhD, MPH Professor of epidemiology, human genetics, and environmental sciences UTHealth School of Public Health Dallas MedicalResearch.com: What is the background for this study? Response: Given that obesity is a prevalent, serious, complex, chronic, and relapsing disease, and severe obesity is a deepening crisis, it is important to pay special attention to these challenges during the COVID-19 pandemic. This will avoid placing an even greater burden on individuals, health systems, and society in the post-COVID-19 recovery phase. Thus, it is critically important to document, in real time, how socioecological determinants of health are impacting behaviors among those with obesity. Before our study, how the COVID-19 pandemic is impacting weight management, health behaviors, and psychosocial health in particular among people with obesity was unknown. MedicalResearch.com: What are the main findings? Response: A total of 123 patients (87% female, mean age 51.2 years, mean BMI 40.2, 49.2% Non-Hispanic white, 28.7% Non-Hispanic black, 16.4% Hispanic, 7% other ethnicity, 33.1% completed bariatric surgery were included). -Two patients tested positive for SARS-CoV-2 and 14.6% reported symptoms. -10% lost their job since the beginning of the pandemic -25% reported food insecurity in that they sometimes, or always could not afford to eat balanced meals -72.8% reported increased anxiety and 83.6% increased depression since stay-at-home orders were initiated. -69.6% reported more difficultly in achieving weight loss goals -47.9% reported less exercise time and 55.8% reported less intensity -49.6% reported increased stockpiling of food -61.2% reported stress eating -61.2% reported following healthy diet plans more challenging - Hispanics were less likely to report anxiety versus non-Hispanic whites MedicalResearch.com: What should readers take away from your report? Response: In a relatively short period of time, our results show that there have been substantial perceptions in changes in health behaviors among patients with obesity. Our sample described a decreases in positive health behaviors, increases in deleterious behaviors and associated deterioration in mental health. Even though actual COVID-19 disease burden was low (1.7% tested positive for COVID-19 and another 14.6% reported symptoms), the pandemic is having a significant impact on those without infections. The major strength of this study is that it is the first snapshot into how the COVID-19 pandemic has influenced health behaviors for patients with obesity. Prior to the pandemic, it has been reported that Americans consume 20% of their calories from restaurants and that there are worsening disparities in fast food meal quality by race/ethnicity, education, and income. Due to recent economic challenges, patients may be more likely to select cheaper foods, which are often energy dense and nutrient poor. Therefore, even though we found more patients are cooking at home, the type of foods that are being stockpiled are likely to be processed foods due to their longer shelf life. These are associated with greater intake of fat, carbohydrate, and calories, which facilitate greater weight gain when compared to more balanced diets. It is possible Americans may be trading one pattern of low-quality consumption for another by choosing cheaper processed foods instead of eating out. MedicalResearch.com: What recommendations do you have for future research as a result of this work? Response: These results have implications for clinical practice and management of patients with obesity as we now move into post-COVID-19 relief efforts. Due to the increase in obesogenic behaviors related to the COVID-19 pandemic that were found here, it is paramount that healthcare access is not disrupted for patients with obesity. Maintaining these vital services will prevent exacerbating the negative health and economic consequences of excess body weight. This includes access to primary care providers, Obesity Medicine specialists and bariatric surgery programs. In addition to asking about diet and exercise patterns, screening for indicators of mental health, loneliness, financial stressors and behaviors that may influence body weight should be implemented by healthcare teams to combat this problem. Disclosures: This work was funded by the National Institutes of Health, National Institute on Minority Health and Health Disparities (Grant #R01MD011686). This work was a joint collaboration among investigators from UTHealth School of Public Health, UT Southwestern Medical Center and Minimally Invasive Surgical Associates. Citation: Almandoz, J.P., Xie, L., Schellinger, J.N., Mathew, M.S., Gazda, C., Ofori, A., Kukreja, S. and Messiah, S.E. (2020), Impact of COVID ‐19 Stay‐at‐Home Orders on Weight‐Related Behaviors Among Patients with Obesity. Clin Obes. Accepted Author Manuscript. doi:10.1111/cob.12386 [subscribe] [last-modified] The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.](https://medicalresearch.com/wp-content/uploads/2020/06/Dr-Sarah-E.-Messiah.jpg)
