A phase III, randomized, multicenter, double-blind study to compare efficacy and safety of EG12014 (EirGenix trastuzumab) with Herceptin® as neoadjuvant treatment in combination with anthracycline/paclitaxel-based systemic therapy in patients with HER2-positive early breast cancer-a multinational phase III study conducted during the COVID-19 pandemic

Amplification and/or overexpression of HER2 in breast cancer (BCa) patients is associated with aggressive disease and poor prognosis. Herceptin® (trastuzumab), a monoclonal antibody targeting HER2, has an established role in the treatment of HER2 positive BCa. Addition of trastuzumab to anthracycline-and taxane-based neoadjuvant treatment in women with HER2-positive BCa has resulted in improvements in pathological complete response (pCR, a strong predictor for long-term clinical outcome), event-free survival (EFS) and overall survival (OS). This study is designed to compare efficacy (pCR) and safety between the originator Herceptin and the proposed trastuzumab biosimilar EG12014. The study is conducted during the COVID-19 pandemic (last patient in: March 2020, last patient last visit: planned Jan 2022) in Belarus, Chile, Colombia, Georgia, India, Russia, South Africa, South Korea, Taiwan, and the Ukraine. Methods: Neoadjuvant phase: 807 patients were randomized (1:1) into 2 arms receiving epirubicin (90 mg/m 2) and cyclophosphamide (600 mg/m2) every 3 weeks for 4 cycles, followed by EG12014 (arm 1) or Herceptin (arm 2) (both at loading dose: 8 mg/kg and maintenance dose: 6 mg/kg) and paclitaxel (175 mg/m2) every 3 weeks Sfor 4 cycles. Subsequently, the patients underwent surgery, and primary endpoint (pCR [ypT0/is ypN0]) was assessed. Adjuvant phase: After surgery, the patients received EG12014 or Herceptin (both at loading dose: 8 mg/kg and maintenance dose: 6 mg/kg) to complete 12 months of overall trastuzumab treatment. COVID-19 infections in the study population were not expected to affect primary endpoint analysis;thus, no sensitivity analysis was performed regarding COVID-19 status (symptomatic/asymptomatic). Differences between the 2 arms regarding delays in study treatments and procedures due to COVID-19 were assessed. Results (at interim data base lock, blinded as study is ongoing): Study population: the mean age was 50 years, the majority were white Europeans with tumor stage II, estrogen receptor positive and progesterone receptor negative. The median time from date of first diagnosis was 0.5 months. Primary endpoint pCR (ypT0/is ypN0) was reached with relative risk ratio (RR) for the full analysis set: 0.992 (90% CI 0.880 to 1.118) between the 2 treatment arms. Secondary pCR endpoints (defined as ypT0 ypN0 and ypT0/is) were also reached, with RR between the treatment arms: 0.917 and 0.992, respectively. Objective clinical response prior to surgery was similar for the 2 treatment arms: 83.8% and 83.6%, respectively. EFS, OS, safety endpoints (e.g., adverse events [most frequently reported: alopecia], serious adverse events, and deaths), and toxicity assessments, supported similarity between EG12014 and Herceptin. Sixty-two patients (7.7%) were infected with COVID-19;the infections were equally distributed between the 2 treatment arms. COVID-19 did not cause any discontinuations or deaths in the study. Among all reported COVID-19 events, 13 (21%) were asymptomatic, 11 (18%) were graded as 3 (severe), and 1 (1.6%) was graded as grade 4 (life threatening). Conclusion: EG12014 has shown equivalent efficacy to Herceptin in regard to clinical response (pCR) and has also demonstrated a similar safety profile. The impact of the COVID-19 pandemic has been comparable between the two treatment arms. The influence of the pandemic on this clinical study has been relatively low considering timing and the participating countries.

COVID-19 pandemic and American acupuncturists: Results of a national survey and lessons learned

Purpose: In the summer of 2020, the US professional acupuncture association, The American Society of Acupuncturists (ASA), surveyed their members concerning members' experiences of the effects of COVID-19 on themselves and their business practices. Our goal is to learn more about members' experiences and gather helpful suggestions that can be shared with other members. Methods: We used the SurveyMonkey platform to survey ASA members. Duplicate entries were removed by the ASA administrator before analysis by Dr. Conboy. With IRB oversight from Massachusetts College of Pharmacy and Health Sciences, we are analyzing responses to consider how the pandemic has influenced the profession. Simple tabulations are used for categorical responses, and grounded theory coding is being used for the free response. We plan to produce a manuscript for the profession and its members. A sociological manuscript will be designed to share experiences of how the pandemic influenced business practices. Results: We received over 5500 responses from ASA members across the United States. Qualitative analyses are finding that while many practitioners had concerns for their business, health of their patients, and their own health, approximately 30% reported hope that they would continue to practice and help patients during the pandemic. Still others saw the lockdown in a positive manner allowing time to help their colleagues, further their own education, and focus on their own self-care. Quantitative analyses suggest that practitioners apply responded to state and local practice guidelines. Conclusions: COVID-19 had unprecedented effects on the East Asian Medicine and Acupuncture Profession. Many practitioners were able to pivot to new methods of practicing, while for some it was devastating. The majority of acupuncturists demonstrated their ability to turn an uncertain period into one of opportunity and learning. Specific examples will be given.

A novel automated guided vehicle for guidance applications

In recent years, as a result of the significant development of information and communications technology, people have been paying much attention to automated guided vehicles (AGVs). In the ongoing global coronavirus disease 2019 (COVID-19) pandemic, hospital services have been seriously impacted. In the severe medical situation in hospitals, there is a serious shortage of human resources. This paper presents a novel automated guided vehicle (AGV) for guidance and service. The AGV is comprised of a microcontroller unit (MCU), a power unit, a human sensing unit, a collision warning unit, and a path sensing unit. The motion speed of the AGV and the distance between the AGV and the person being guided are determined by the MCU, the power unit, sensors, and an algorithm. The collision warning unit comprises three ultrasonic sensors and an infrared sensor in the front of the AGV in order to avoid obstacles. The trajectory results of the planned and actual paths are in good agreement. The AGV provides safe and effective guidance for people moving towards their destination. The AGV achieves excellent guidance results and shows great potential for guidance applications in hospitals. © 2021 Institute of Physics Publishing. All rights reserved.

EduPar Virtual Poster Session

This paper provides an overview of posters accepted for the EduPar 21 poster session. Poster sessions have been an important part of the EduPar workshops, providing an opportunity to facilitate interactions and fostering the community. After a hiatus caused by the COVID-19 pandemic we decided to resume the poster session tradition and to hold the first virtual poster session in EduPar's eleven years history.

COVID-19 in older adults: A focus on clinical characteristics and frail status

Worldwide attention has been drawn to the recent COVID-19 outbreak. Many studies have shown that under the pandemic, elderlies, especially those with chronic diseases, are more vulnerable than youths. Upon infection, older people tend to endure a higher hospitalization and mortality rate, and the mortality rate after acute hospitalization appears even higher for frail elderlies than non-frail ones. Moreover, older COVID-19 patients can exhibit different, atypical clinical manifestations such as falls, delirium, general weakness, functional decline, and other geriatric syndromes indicating frailty. Therefore, this review suggests that the most effective way to improve the prognosis of COVID-19 infection in the elderly is to avoid the occurrence of frailty.