Risultati per: Cardio-oncology: rivista open access

This study examines the use of single-arm trials for US Food and Drug Administration drug approvals.

Timely access to scientific research findings for the broadest possible audience is a principle on which sound science is based. Access to new findings helps other scientists adjust their hypotheses and open new lines of inquiry, thereby supporting and accelerating further discovery and innovation. For those who rely on newly generated evidence to develop policies and define practices that improve medicine and public health, rapid and equitable access is critical. The principle of broad access is a cornerstone of transparency, reinforces rigor and reproducibility, and ultimately, is critical to all stakeholders’ trust in science.

Timely access to scientific research findings for the broadest possible audience is a principle on which sound science is based. Access to new findings helps other scientists adjust their hypotheses and open new lines of inquiry, thereby supporting and accelerating further discovery and innovation. For those who rely on newly generated evidence to develop policies and define practices that improve medicine and public health, rapid and equitable access is critical. The principle of broad access is a cornerstone of transparency, reinforces rigor and reproducibility, and ultimately, is critical to all stakeholders’ trust in science.

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.

Timely access to scientific research findings for the broadest possible audience is a principle on which sound science is based. Access to new findings helps other scientists adjust their hypotheses and open new lines of inquiry, thereby supporting and accelerating further discovery and innovation. For those who rely on newly generated evidence to develop policies and define practices that improve medicine and public health, rapid and equitable access is critical. The principle of broad access is a cornerstone of transparency, reinforces rigor and reproducibility, and ultimately, is critical to all stakeholders’ trust in science.

This cohort study analyzes suicide rates among reproductive-aged women from 1974 to 2016 to determine their association with state-level legislative policies surrounding abortion and restricted access to reproductive care.

Introduction
Neoadjuvant chemotherapy (NAC) has been demonstrated effective in several tumours, but its benefit has not yet been elucidated in colorectal cancer, especially locally advanced colorectal cancer (LACRC).

Methods and analysis
This is a single-arm, open-label, prospective phase II exploratory clinical trial. Patients with LACRC will receive four cycles of NAC with 5-fluorouracil, oxaliplatin and irinotecan (FOLFOXIRI), followed by operation and then adjuvant chemotherapy with capecitabine and oxaliplatin for two to five cycles or single-agent capecitabine for five cycles, or observation. The primary endpoint is the rate of tumour regression grade (TRG) 0–2 in the resected tumour tissue, which is evaluated by experienced pathologists according to the Ryan R TRG grading system. Secondary endpoints include objective response rate, pathologic complete response, microscopically complete resection rate, progression-free survival, distant metastasis-free survival, overall survival, toxicity and compliance to study treatment, molecular markers, quality of life to study treatment and the number of patients with 30-day postoperative mortality. The objective of this study is to analyse the efficacy and safety of FOLFOXIRI as the NAC regimen in patients with LACRC and to identify a promising treatment strategy in this setting.

Ethics and dissemination
Written informed consent will be required from and provided by all patients enrolled. The study protocol has been approved by the independent ethics committee of West China Hospital, Sichuan University (approval number: 2021403). This study will demonstrate the potential benefit of NAC with the FOLFOXIRI regimen. Results will be shared with policymakers and the academic community to promote the clinical management of colon cancer.

Trial registration number
NCT05018182.

Introduction
Chronic cytomegalovirus (CMV) infection is very frequent in people living with HIV (PLWH). High anti-CMV IgG titres, which may be linked to transient CMV replication, have been associated with earlier mortality, CD8 T-cell expansion, lower CD4/CD8 ratio and increased T-cell senescence. We previously showed that anti-CMV IgG titres correlated with gut permeability in PLWH on antiretroviral therapy (ART), which was associated with microbial translocation, systemic inflammation and non-infectious/non-AIDS comorbidities. Letermovir, a novel anti-CMV drug with a good safety profile, was recently approved for anti-CMV prophylaxis in allogeneic haematopoietic stem cell transplant recipients. A drastic and selective reduction of both low-grade replication and clinically significant CMV infections, combined with an improved immune reconstitution have been reported. In vitro, letermovir prevented CMV-induced epithelial disruption in intestinal tissues. Based on these findings, we aim to assess whether letermovir could inhibit CMV subclinical replication in CMV-seropositive PLWH receiving ART and, in turn, decrease CMV-associated gut damage and inflammation.

Method and analysis
We will conduct a multi-centre, open-label, randomised, controlled clinical trial, including a total of 60 CMV-seropositive ART-treated PLWH for at least 3 years, with a viral load 400 cells/µL. Forty participants will be randomised to receive letermovir for 14 weeks and 20 participants will receive standard of care (ART) alone. Plasma, pheripheral blood mononuclear cells (PBMCs), and stool samples will be collected. Colon biopsies will be collected in an optional substudy. We will assess the effect of letermovir on gut damage, microbial translocation, inflammation and HIV reservoir size.

Ethics and dissemination
The study was approved by Health Canada and the Research Ethics Boards of the McGill University Health Centre (MUHC-REB, protocol number: MP37-2022-8295). Results will be made available through publications in open access peer-reviewed journals and through the CIHR/CTN website.

Trial registration number
NCT05362916.

New England Journal of Medicine, Volume 388, Issue 3, Page 281-283, January 2023.

About one third of these patients reported using cannabis, often with a decrease in use of other analgesics as a result.

Objective
This study explores sources of stress, conditions that help reduce stress levels and coping strategies among parents of children with cancer receiving chemotherapy at Tikur Anbessa Specialized Hospital (TASH) in Ethiopia.

Design
A qualitative phenomenological approach was used.

Setting
Parents of children receiving chemotherapy at the TASH paediatric oncology unit.

Participants
Fifteen semistructured in-depth interviews were conducted with nine mothers and six fathers of children with cancer from November 2020 to January 2021.

Results
Sources of stress related to child’s health condition as the severity of the child’s illness, fear of treatment side effects and loss of body parts were identified. Parents mentioned experiencing stress arising from limited access to health facilities, long waiting times, prolonged hospital stays, lack of chemotherapy drugs, and limited or inadequate information about their child’s disease condition and treatment. Other sources of stress were insufficient social support, stigmatisation of cancer and financial problems. Conditions decreasing parents’ stress included positive changes in the child’s health, receiving cancer treatment and access to drugs. Receiving counselling from healthcare providers, getting social support and knowing someone who had a positive treatment outcome also helped reduce stress. Coping strategies used by parents were religious practices including prayer, crying, accepting the child’s condition, denial and communication with health providers.

Conclusion
The main causes of stress identified by parents of children with cancer in Ethiopia were the severity of their child’s illness, expectations of poor treatment outcomes, unavailability of cancer treatment services and lack of social/financial support. Measures that should be considered to reduce parents’ stress include providing psycho-oncological care for parents and improving the counselling available to parents concerning the nature of the child’s illness, its treatment, diagnostic procedures and treatment side effects. It may also be helpful to establish and strengthen family support groups and parent-to-parent communication, improve the availability of chemotherapy drugs and offer more education on coping strategies.

Objectives
Globally, criminalisation has shaped sex workers’ structural exclusion from occupational protections, and this exclusion has been exacerbated during the COVID-19 pandemic. While community organisations aim to bridge this gap through providing health and safety resources for sex workers, many were forced to scale back services when Canadian provinces declared a state of emergency at the pandemic onset. As little empirical research has examined the impacts of sex work community services interruptions amid COVID-19, our objectives were to (1) examine the correlates of interrupted access to community services and (2) model the independent association between interrupted access to community services and changes in working conditions (ie, self-reported increases in workplace violence or fear of violence), among sex workers during the COVID-19 pandemic.

Design, setting and participants
As part of an ongoing community-based cohort of sex workers in Vancouver, Canada (An Evaluation of Sex Workers Health Access, 2010–present), 183 participants completed COVID-19 questionnaires between April 2020 and April 2021.

Analysis
Cross-sectional analysis used bivariate and multivariable logistic regression with explanatory and confounder modelling approaches.

Results
18.6% of participants (n=34) reported interrupted access to community services (closure/reduction in drop-in hours, reduced access to spaces offering sex worker supports and/or reduced access/contact with outreach services). In multivariable analysis, sex workers who had difficulty maintaining social supports during COVID-19 (adjusted OR, AOR 2.29, 95% CI 0.95 to 5.56) and who experienced recent non-fatal overdose (AOR 2.71, 95% CI 0.82 to 8.98) faced marginally increased odds of service interruptions. In multivariable confounder analysis, interrupted access to community services during COVID-19 was independently associated with changes in working conditions (ie, self-reported increases in workplace violence or fear of violence; AOR 4.00, 95% CI 1.01 to 15.90).

Conclusions
Findings highlight concerning implications of community service interruptions for sex workers’ labour conditions. Sustainable funding to community organisations is urgently needed to uphold sex workers’ occupational safety amid COVID-19 and beyond.

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Timely access to scientific research findings for the broadest possible audience is a principle on which sound science is based. Access to new findings helps other scientists adjust their hypotheses and open new lines of inquiry, thereby supporting and accelerating further discovery and innovation. For those who rely on newly generated evidence to develop policies and define practices that improve medicine and public health, rapid and equitable access is critical. The principle of broad access is a cornerstone of transparency, reinforces rigor and reproducibility, and ultimately, is critical to all stakeholders’ trust in science.

JAMA Oncology is committed to publishing influential original research, opinions, and reviews that advance the science of oncology and improve the clinical care of patients with cancer.