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Maintenance with niraparib in patients with stage III, stage IV, chemo-naïve recurrent or platinum-sensitive recurrent uterine serous carcinoma: study protocol for a phase II clinical trial

Por: Frimer · M. · Katcher · A. · Blustein · P. · Sison · C. · Girda · E. · Nizam · A. · Tymon-Rosario · J. · Goldberg · G. L. · Menzin · A. · Valea · F. · Scanlon · L. · Whyte · J. S. · Sakaris · A. · Pereira · E. · Villella · J. · Kuo · Y.-s. D. · Lee · J. · Siebel · M. · Danziger · N. · Elvin
Introduction

Uterine serous carcinoma (USC) accounts for 40% of endometrial cancer-related deaths. The standard of care for stages III and IV USC yields a 20%–30% survival at 2 years and a 10%–20% survival at 3–5 years. Recent advances in the second-line treatment of advanced or recurrent USC are rapidly evolving. Targeted therapeutic approaches with the use of lenvatinib plus pembrolizumab, as well as the use of trastuzumab deruxtecan, offer new hope for successful second-line therapies for patients. However, further investigation into novel targeted therapeutic approaches is warranted, given the high burden of disease associated with this aggressive histological subtype. USC shares clinical and genomic similarities with epithelial ovarian cancer, suggesting a correlation with ‘BRCAness’. Niraparib, a potent PARP1 and PARP2 inhibitor, was shown to have a positive impact on platinum-sensitive recurrent ovarian cancer, regardless of the presence or absence of BRCA status. Our hypothesis is that patients with stage III, stage IV and platinum-sensitive recurrent USC receiving niraparib maintenance in addition to standard therapy for USC may have an improved progression-free survival.

Methods and analysis

Participating sites include the primary site, Northwell Health Zucker Cancer Centre, and secondary site, Rutgers Cancer Institute of NJ. Females over the age of 18 with stage III, stage IV or platinum-sensitive recurrent USC will be recruited and enrolled based on inclusion/exclusion criteria. 24 subjects will be enrolled during phase 1 and 21 subjects will be enrolled during phase 2, over a total of 3 years. Patients will receive an individualised dose of niraparib daily every 28 days per cycle for 1 year or until progression of disease. Follow-up of disease status will continue for 5 years poststudy treatment. This phase II clinical trial will employ a Simon two-stage minimax design to test the null hypothesis that the 1 year response rate is

Ethics and dissemination

Ethical approval was granted by Northwell Health Cancer Institute institutional review board (reference number: 19–0380) and PRMS. Alongside journal publications, results will be available publicly on completion of the study as approved by the sponsor investigator.

Trial registration number

NCTN04080284

Involvement of common risk factors in the associations between lifetime unemployment exposure, major health outcomes and mortality: a retrospective and prospective study in a large population-based French cohort

Por: Sanchez Rico · M. · Wiernik · E. · Renuy · A. · Kab · S. · Hoertel · N. · Goldberg · M. · Zins · M. · Meneton · P.
Objectives

Uncertainty exists as to what extent common risk factors are involved in the associations of unemployment with major health outcomes and mortality.

Design

A retrospective and prospective observational study.

Setting

A large population-based French cohort (CONSTANCES).

Participants

99 430 adults at baseline who have been exposed to unemployment during their lifetime and 54 679 of them who were followed for 7 years after baseline.

Primary outcome measures

Testing the mediating roles of several risk factors at baseline in the associations of lifetime unemployment exposure with cardiovascular disease, cancer and mortality rates during a 7-year follow-up. Direct and indirect effects were calculated for each risk factor and all together using logistic regression models adjusted for major confounders including sex, age, parental histories of cardiovascular disease and cancer, social position and working conditions.

Results

Estimates (95% CIs) of the direct and indirect effects for smoking are 0.0083 (0.0044 to 0.0122), p

Conclusions

These analyses show that common risk factors such as smoking, alcohol consumption, depressive symptoms, leisure-time physical inactivity and blood triglycerides mediate up to 10% of the associations of lifetime unemployment exposure with cardiovascular disease, cancer and mortality rates when tested separately and approximately 20% when tested all together. This highlights the existence of other major mediating pathways that have yet to be identified.

Assessing the fulfillment of nurses' full potential in diverse geriatric settings—moving towards change

Abstract

Background

In response to the aging population, the Department for Professional Development in the Nursing Division at the Israeli Ministry of Health has invested significant resources in training registered nurses for post-basic certification in the field of geriatrics. However, little is known about how the nurses implement the scope of practice in the field and how they maximize their full potential following the training.

Aims and objectives

To assess whether nurses' full potential is maximized in geriatric acute and long-term geriatric care, and community settings in Israel.

Design

A quantitative, cross-sectional study.

Methods

The study population is a convenience sample of registered nurses who completed post-basic certification in geriatric care (n = 287). The participants completed a self-administered questionnaire addressing socio-demographic and occupational characteristics, implementation of the scope of practice, and a professional satisfaction questionnaire.

Baseline demographic variables were summarized using means and counts, with frequency counts and percentages used for the scope of practice. A one-way ANOVA was utilized to examine the differences between the workplace and the scope of practice. Chi-square was used to examine practice types and the workplace.

Results

Nurses in all surveyed geriatric settings reported average to high overall performance in independent decision-making activities and delegated duties. The majority (66%) reported very high satisfaction with the completion of the post basic certification education However overall performance differed significantly between the different geriatric settings.

Conclusion

Most of the nurses with a post-basic geriatric certification are satisfied with their scope of practice, feel valued by colleagues and managers, and are able to practice independently within their professional scope. This can have a positive impact on the care of the older adult population.

Clinical Relevance

Administrators should ensure that nurses with a post-basic geriatric certification are able to maximize their scope of practice. Specifically, we recommend nurse managers to leverage the results of this study and advocate for nurses to fulfill their full potential in their scope of practice.

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