The lancet oncology
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The lancet oncology · May 2023
ReviewSingle-arm studies involving patient-reported outcome data in oncology: a literature review on current practice.
Patient-reported outcomes (PROs) are increasingly used in single-arm cancer studies. We reviewed 60 papers published between 2018 and 2021 of single-arm studies of cancer treatment with PRO data for current practice on design, analysis, reporting, and interpretation. We further examined the studies' handling of potential bias and how they informed decision making. ⋯ Most studies (51; 85%) concluded that PRO results supported treatment. Conducting and reporting of PROs in cancer single-arm studies need standards and a critical discussion of statistical methods and possible biases. These findings will guide the Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Data in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI) in developing recommendations for the use of PRO-measures in single-arm studies.
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The lancet oncology · Apr 2023
Review Practice GuidelineMultinational Association of Supportive Care in Cancer (MASCC) clinical practice guidelines for the prevention and management of acute radiation dermatitis: international Delphi consensus-based recommendations.
Acute radiation dermatitis is a frequent adverse effect of radiotherapy, but standardisation of care for acute radiation dermatitis is lacking. Due to the conflicting evidence and variability in current guidelines, a four-round Delphi consensus process was used to compile opinions of 42 international experts on care for people with acute radiation dermatitis on the basis of the evidence in existing medical literature. Interventions for acute radiation dermatitis prevention or management that reached at least 75% consensus were recommended for clinical use. ⋯ Mepilex Lite dressings were recommended for the management of acute radiation dermatitis. Most interventions were not recommended due to insufficient evidence, conflicting evidence, or lack of consensus to support use, suggesting a need for further research. Clinicians can consider implementing recommended interventions in their practice to prevent and manage acute radiation dermatitis until additional evidence becomes available.
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The lancet oncology · Apr 2023
ReviewFrom the European Medicines Agency to Project Orbis: new activities and challenges to facilitate UK oncology drug approval following Brexit.
The departure of the UK from the European Union (EU) and affiliated European regulatory bodies, including the European Medicines Agency, on Dec 31, 2020, has resulted in the Medicines and Healthcare products Regulatory Agency becoming an independent national regulator. This change has required a fundamental transformation of the UK drug regulatory landscape, creating both opportunities and challenges for future development of oncology drugs. ⋯ In this Policy Review, we examine the new UK regulatory frameworks, policies, and global collaborations affecting new oncology drug approvals after departure from the EU. We explore some of the challenges that might lie ahead as the UK creates new and independent regulatory review and approval processes for the next generation of cancer medicines.
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The lancet oncology · Apr 2023
ReviewCurrent drug development and trial designs in neuro-oncology: report from the first American Society of Clinical Oncology and Society for Neuro-Oncology Clinical Trials Conference.
Successful drug development for people with cancers of the CNS has been challenging. There are multiple barriers to successful drug development including biological factors, rarity of the disease, and ineffective use of clinical trials. Based upon a series of presentations at the First Central Nervous System Clinical Trials Conference hosted by the American Society of Clinical Oncology and the Society for Neuro-Oncology, we provide an overview on drug development and novel trial designs in neuro-oncology. This Review discusses the challenges of therapeutic development in neuro-oncology and proposes strategies to improve the drug discovery process by enriching the pipeline of promising therapies, optimising trial design, incorporating biomarkers, using external data, and maximising efficacy and reproducibility of clinical trials.
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The lancet oncology · Apr 2023
Meta AnalysisPrevalence of human papillomavirus DNA and p16INK4a positivity in vulvar cancer and vulvar intraepithelial neoplasia: a systematic review and meta-analysis.
Human papillomavirus (HPV) DNA and p16INK4a positivity have crucial roles in the pathogenesis of vulvar cancer and vulvar intraepithelial neoplasia. We aimed to examine the pooled prevalence of HPV DNA and p16INK4a positivity in vulvar cancer and vulvar intraepithelial neoplasia worldwide. ⋯ Taishan Scholar Youth Project of Shandong Province, China.