A Harmonization Study for the Use of 22C3 PD-L1 Immunohistochemical Staining on Ventana's Platform.

INTRODUCTION: Immunotherapy is a novel treatment for lung cancer. Pembrolizumab (Merck Sharp and Dohme, Kenilworth, NJ) is a monoclonal antibody against programmed cell death 1 that has been approved for use with NSCLC together with a companion diagnostic by Dako (Carpinteria, CA). Ventana's BenchMark XT (Ventana Medical Systems, Tucson, AZ) is a widely used immunohistochemical (IHC) platform. However, data on its reliability and reproducibility with the 22C3 antibody are scant. METHODS: We performed a comprehensive calibration of 22C3 programmed cell death ligand 1 (PD-L1) staining on the BenchMark XT platform using Dako's prediluted 22C3 anti-PD-L1 primary antibody with two of Ventana's detection systems. Forty-one random cases of NSCLC were then independently evaluated by two pathologists. Each case was scored using Dako- or Ventana-stained slides. The scores obtained with the two 22C3 Ventana assays were compared with those obtained using the Dako 22C3 IHC platform. RESULTS: The Dako IHC platform stratified eight, seven, and 26 cases as being strongly positive, weakly positive, and negative for PD-L1, respectively, whereas 36 of 41 cases (87.8%) had the same results with Ventana's UltraView 22C3 protocol (Pearson's correlation score 0.91, p < 0.0001). Moreover, 35 of 41 cases (85.3%) had the same results with Ventana's OptiView 22C3 protocol (Pearson's correlation score 0.89, p < 0.0001). CONCLUSIONS: The results of this study demonstrate that the same PD-L1 IHC algorithm can be reliably applied to Ventana's BenchMark XT platform. Furthermore, we were able to detect all of the strongly positive cases with high interobserver and intraobserver agreement by using the Ventana platform. These findings suggest that the Ventana platform can be used to stratify patients for pembrolizumab-based immunotherapy.

Who is willing to risk his life for a patient with a potentially fatal, communicable disease during the peak of A/H1N1 pandemic in Israel?

BACKGROUND: The willingness of healthcare workers to risk their lives for a patient with a potentially fatal, communicable disease is a major concern, especially during a pandemic where the need for adequate staffing is crucial and where the public atmosphere might enhance anxiety and fear of exposure. OBJECTIVE: To examine the relationships between the willingness of healthcare workers to risk their lives for a patient with a potentially fatal A/H1N1 flu, and knowledge of personal protection against infection, and trust in colleagues, workplace preparedness and the effectiveness of safety measures, during the winter A/H1N1 pandemic in Israel. MATERIALS AND METHODS: A questionnaire was distributed to healthcare workers in 21 hospitals in Israel between 26 November 2009 and 10 December 2009 (the peak of the winter A/H1N1 flu outbreak). The questionnaire was completed by 1147 healthcare workers. RESULTS: Willingness to risk one's life for a patient was significantly lower in females, respondents of younger age (18-24 years), administrative staff, and those with a non-academic education, as well as among those with a less knowledge about safety measures and among those with less trust in colleagues, in work place preparedness, and in the effectiveness of safety measures. CONCLUSIONS: Willingness to risk one's life for a patient is related to knowledge of safety measures, and trust in colleagues and work place preparedness. Education programs to enhance trust in colleagues, improve work place preparedness, and safety measures are recommended, especially for healthcare workers who are young, inexperienced, female, or administrative staff.