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AnteayerBMJ Open

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

Association between health anxiety and self-triage decisions: evidence from a cross-sectional study with Australian emergency department non-urgent patients

Por: Egoda Kapuralalage · T. N. · Chan · H. F. · Hughes · J. · Torgler · B. · Whyte · S.
Objective

The aim of this exploratory study was to investigate the association between health anxiety and self-triage decisions among emergency department non-urgent patients.

Design

Cross-sectional single-centre study

Setting

Emergency department in the Princess Alexandra Hospital in Brisbane, Australia

Participants

Between 13 December 2022 and 30 August 2023, an exhaustive recruitment strategy was deployed to recruit 400 patients. Eligible participants were patients aged 18 years or above who belonged to the Australasian Triage Scale category four or five (non-urgent), were physically and mentally capable of participating in the study and presented to the emergency department between 6:00 a.m. and 23:00 p.m. during the study period.

Main outcome measures

The primary outcome was accurately self-triaged decisions, while the secondary outcome was inaccurately self-triaged decisions, including both overtriaged and undertriaged decisions. Self-triage decisions were assessed using six hypothetical medical scenarios.

Results

Regression results revealed that health anxiety was not associated with accurately self-triaged decisions. However, compared with non-urgent patients exhibiting no health anxiety, those in the third and fourth quartiles (the upper two quartiles) of the Whiteley Index-6 were expected to make 0·29 (95% CI 0·09 to 0·50) and 0·25 (95% CI 0·07 to 0·44) more overtriaged decisions (mean=0·42; SD=0·71), respectively. In contrast, negative associations between health anxiety and undertriaged decisions were observed. Subgroup analyses by age showed statistically significant associations between health anxiety and inaccurately self-triaged decisions among the older adult patient group (aged 35–79 years). Moreover, analyses stratified by sex revealed that female and male patients in the fourth quartile of the Whiteley Index-6 were expected to make 0·26 (95% CI 0·02 to 0·49) and 0·27 (95% CI 0·05 to 0·48) more overtriaged decisions, respectively, compared with those with no health anxiety.

Conclusions

Our results suggest no significant association between health anxiety and accurately self-triaged decisions. In contrast, health anxiety was associated with inaccurately self-triaged decisions. This implies that patients with health anxiety overestimate the need for healthcare and therefore could substantially impact the misuse of health services, particularly emergency departments.

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