Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma.

BACKGROUND: Programmed cell death receptor-1 (PD-1)-blocking antibodies are approved to treat metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) cases ineligible for curative surgery or radiation. Notwithstanding, some patients experience inadequate responses or severe immune-related adverse events (AEs), indicating the need for improved therapies. Cosibelimab is a high-affinity programmed cell death-ligand 1 (PD-L1)-blocking antibody that activates innate and adaptive immunity by blocking PD-L1 interaction with PD-1 and B7-1 receptors. It is an unmodified immunoglobulin G1 subtype with a functional Fc domain capable of inducing antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Here, we present results of the pivotal study of patients with metastatic CSCC from an open-label, multicenter, multiregional, multicohort, phase 1 trial of cosibelimab. METHODS: In this trial, participants with metastatic CSCC received cosibelimab 800 mg intravenously every 2 weeks. Primary endpoint was objective response rate (ORR) by independent central review using Response Evaluation Criteria in Solid Tumors, V.1.1. Secondary endpoints included duration of response (DOR) and safety. RESULTS: Objective response was observed in 37 of 78 participants (47.4% (95% CI: 36.0% to 59.1%)), with median follow-up of 15.4 months (range: 0.4 to 40.5) as of data cut-off. Median DOR was not reached (range: 1.4+ to 34.1+ months), with response ongoing in 73.0% of participants. Common treatment-emergent AEs (≥15%) were fatigue (26.9%), rash (16.7%), and anemia (15.4%). Eighteen participants (23.1%) experienced immune-related AEs (grade 3: n=2 (2.6%); no grade 4/5). No treatment-related deaths were reported. CONCLUSIONS: Cosibelimab demonstrated clinically meaningful ORR and DOR and was associated with a manageable safety profile. TRIAL REGISTRATION NUMBER: NCT03212404.

Impact of a training program on hospital pharmacists' patient-centered communication attitudes and behaviors.

Background: Effective communication that integrates the value of patient-centered care is important in healthcare encounters. Communication skills training (CST) has been indicated as effective in improving patient-centered communication behaviors. However, there is a paucity of studies on the impact of CST among Malaysian hospital pharmacists. Objective: This study aimed to evaluate the effects of a patient-centered CST program on patient-centered communication scores, communication self-efficacy, and attitudes toward concordance among pharmacists in public hospitals. Methods: A communication skills training (CST) program was conducted among hospital pharmacists. This training intervention was developed based on patient-centered communication frameworks and techniques, namely the Four Habits Model and motivational interviewing. A pre-test/post-test quasi-experimental design was implemented for the evaluation. Pharmacists underwent pre-test/post-test audiotaped simulated consultations and completed questionnaires, including the Revised United States-Leeds Attitudes Toward Concordance scale (RUS-LATCon) and Communication Self-Efficacy scale. The Four Habits Coding Scheme (FHCS) was used to evaluate patient-centered communication scores from the audiotapes, and the Wilcoxon signed-rank test was used to analyze for differences in the pre- and post-intervention scores. Results: A total of 38 pharmacists from four tertiary hospitals participated in this study and completed the pre-test. However, due to the impact of COVID-19, only 23 pharmacists completed the post-test data collection. Improvements were noted in the FHCS scores post-training, including items related to exploring patients' concerns, acceptability, and barriers to treatment. Based on the questionnaire, there was an improvement in recognizing patients' needs and potential medication uncertainty and an increase in the overall communication self-efficacy scores after the training. Conclusions: CST may help improve the adoption of patient-centered communication in pharmacists' consultations with patients.

Plethora of Antibiotics Usage and Evaluation of Carbapenem Prescribing Pattern in Intensive Care Units: A Single-Center Experience of Malaysian Academic Hospital.

Excessive antibiotic consumption is still common among critically ill patients admitted to intensive care units (ICU), especially during the coronavirus disease 2019 (COVID-19) period. Moreover, information regarding antimicrobial consumption among ICUs in South-East Asia remains scarce and limited. This study aims to determine antibiotics utilization in ICUs by measuring antibiotics consumption over the past six years (2016−2021) and specifically evaluating carbapenems prescribed in a COVID-19 ICU and a general intensive care unit (GICU) during the second year of the COVID-19 pandemic. (2) Methods: This is a retrospective cross-sectional observational analysis of antibiotics consumption and carbapenems prescriptions. Antibiotic utilization data were estimated using the WHO Defined Daily Doses (DDD). Carbapenems prescription information was extracted from the audits conducted by ward pharmacists. Patients who were prescribed carbapenems during their admission to COVID-19 ICU and GICU were included. Patients who passed away before being reviewed by the pharmacists were excluded. (3) Results: In general, antibiotics consumption increased markedly in the year 2021 when compared to previous years. Majority of carbapenems were prescribed empirically (86.8%). Comparing COVID-19 ICU and GICU, the reasons for empirical carbapenems therapy in COVID-19 ICU was predominantly for therapy escalation (64.7% COVID-19 ICU vs. 34% GICU, p < 0.001), whereas empirical prescription in GICU was for coverage of extended-spectrum beta-lactamases (ESBL) gram-negative bacteria (GNB) (45.3% GICU vs. 22.4% COVID-19 ICU, p = 0.005). Despite microbiological evidence, the empirical carbapenems were continued for a median (interquartile range (IQR)) of seven (5−8) days. This implies the need for a rapid diagnostic assay on direct specimens, together with comprehensive antimicrobial stewardship (AMS) discourse with intensivists to address this issue.