Clinical features and outcomes of advanced HER2+ esophageal/GEJ cancer with brain metastasis.

BACKGROUND: Brain metastasis (BRM) is uncommon in gastroesophageal cancer. As such, clinicopathologic and molecular determinants of BRM and impact on clinical outcome remain incompletely understood. METHODS: We retrospectively analyzed clinicopathologic data from advanced esophageal/gastroesophageal junction (E/GEJ) patients at Johns Hopkins from 2003 to 2021. We investigated the association between several clinical and molecular features and the occurrence of BRM, with particular focus on human epidermal growth factor receptor 2 (HER2) overexpression. Survival outcomes and time to BRM onset were also evaluated. RESULTS: We included 515 patients with advanced E/GEJ cancer. Tumors were 78.3% esophageal primary, 82.9% adenocarcinoma, 31.0% HER2 positive. Cumulative incidence of BRM in the overall cohort and within HER2+ subgroup was 13.8% and 24.3%, respectively. HER2 overexpression was associated with increased risk of BRM [odds ratio 2.45; 95% confidence interval (CI) 1.10-5.46]. On initial presentation with BRM, 50.7% had a solitary brain lesion and 11.3% were asymptomatic. HER2+ status was associated with longer median time to onset of BRM (14.0 versus 6.3 months, P < 0.01), improved median progression free survival on first-line systemic therapy (hazard ratio 0.35, 95% CI 0.16-0.80), and improved median overall survival (hazard ratio 0.20, 95% CI 0.08-0.54) in patients with BRM. CONCLUSION: HER2 overexpression identifies a gastroesophageal cancer molecular subtype that is significantly associated with increased risk of BRM, though with later onset of BRM and improved survival likely reflecting the impact of central nervous system-penetrant HER2-directed therapy. The prevalence of asymptomatic and solitary brain lesions suggests that brain surveillance for HER2+ patients warrants prospective investigation.

The quality council: a catalyst for improvement.

Before quality improvement can occur, an environment must be created that demonstrates a decisive commitment to change. In this article, Sarah Tackett presents the concept of the "quality council," a structure that fosters employee participation and clearly defines the leadership roles needed to evaluate and implement improved processes. The quality council should be the first organizational step toward quality improvement because it will set the tone, establish policy, and create institutional readiness for the changes to come. Chaired by the organization's CEO, the council should consist of senior management and clinical department heads, administrators, and a quality advisor. Larger institutions may need several coordinated quality teams to focus on various areas. The author's lucid analysis of the process that the quality council should follow begins with the development of shared values that all employees can endorse. The next step is to select appropriate projects that have high interest and will result in an improved process, not just a new system or a predetermined solution to a problem. Ms. Tackett stresses the importance of picking the best possible team members, shifting workloads to allow a full focus on quality, and providing extra training in QI strategies to teams where needed. Finally, quality innovations should be recognized and shared throughout the institution.

Quality assurance versus QP(4)--the missing link.

First, quality is not easy. Second, basic process understanding, simplification and continuous improvement are equally difficult. We are vertically organized, yet our basic processes are horizontal with cross-functional boundaries. This recognition is the key to continued quality progress. Third, quality cascading is a key concept for progress. It is the most important factor in convincing the work force that we are serious about quality. Last, the concept of ownership is the most powerful force at work in our quality programs. Quality is not a destination, but a never-ending journey. We need to do things better today than yesterday. We need to be constantly on the lookout for ways to correct problems, prevent problems, and make improvements. Even when the customers' needs have been completely and precisely met, a better, more efficient approach may be possible. We need to take a broader view of the role that quality can play in achieving organizational and individual goals. We need to recognize that quality needn't cost more, yet it will improve customer satisfaction. Furthermore, quality involves more dimensions than just product or service; it applies to internal as well as external customers. We must recognize that everything the organization does has a quality component, and that everyone has a responsibility for quality. Accepting a new definition--and a new priority--for quality is essential, but not enough. For quality to become "the way we do business" in our organizations requires a break-through in action. We have to break out of established ways of thinking and acting. We have to learn new behaviors, and we need the skills to mandate and practice them.(ABSTRACT TRUNCATED AT 250 WORDS)