Colorado Permanente Medical Group

IntroductionThis study evaluated the real-world effectiveness and safety of biosimilar trastuzumab-anns to the reference trastuzumab in a United States (U.S.) population.MethodsThis observational, multicenter, non-inferiority cohort study used electronic medical records from an integrated U.S. healthcare system. Eligible patients were HER2 + breast cancer patients treated with trastuzumab-anns (August 2019-December 2020) or trastuzumab (March 2017-July 2018). Patients were stratified by treatment setting (curative or palliative) and followed for up to 12 months, death, or end of membership, whichever occurred first. The effectiveness outcome was treatment failure, a composite of all-cause mortality or treatment change. The NI margin was set with an upper limit of 5% and multivariate Cox proportional hazards models were used. The safety was assessed by the incidence of cardiomyopathy and neutropenia. Sensitivity analysis was conducted using stabilized inverse probability of treatment weighting.ResultsOf the 4,111 patients eligible, 1,784 met the inclusion criteria with 893 patients in the trastuzumab-anns group and 891 in the reference trastuzumab group. For the composite of treatment failure, trastuzumab-anns was non-inferior to trastuzumab at 7.7% and 5.6%, respectively (90% CI: 0.0% to 4.0%; p < 0.01). A two-way analysis with Cox proportional hazard models showed no significant difference in the risk of treatment failure (adjusted hazards ratio 0.88, 95% CI: 0.6 to 1.3; p = 0.52). Rates of cardiomyopathy and neutropenia were comparable between groups.ConclusionIn this real-world U.S. population, trastuzumab-anns was non-inferior to reference trastuzumab in the treatment of HER2 + breast cancer.

Reflexiones de ayer y de hoy sobre la enseñanza del derecho

Sin resumen

Periods of civil unrest pose significant operational and security challenges to those seeking to provide emergency care to patients. For emergency departments (EDs) and their staff, effectively operating in this potentially hostile environment requires careful planning. Understanding the challenges posed during periods of civil unrest is paramount for emergency medicine staff and emergency planners to ensure continuity of care. To provide ED and hospital staff with an understanding of the challenges faced during periods of civil unrest and to offer recommendations to maintain safety and operational viability. Preplanning before any anticipated civil unrest is essential to a well-coordinated response. During the period of civil unrest, maintaining effective communication between command elements and clinicians in the ED is vital to ensure bidirectional sharing of information. Deviations from normal operating procedures should be expected and relayed to clinicians as quickly as possible. Similarly, staff may need to shelter in place or relocate to a more secure area within the hospital. Civil unrest is highly dynamic, and hospital leadership must follow developments closely to protect staff and facilities. This review provides ED and hospital staff with an understanding of the significant challenges during periods of civil unrest.