The lancet oncology
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The lancet oncology · Feb 2025
ReviewManagement of immune checkpoint inhibitor-associated toxicities in older adults with cancer: recommendations from the International Society of Geriatric Oncology (SIOG).
Immune checkpoint inhibitors (ICIs) have substantially advanced the treatment landscape for a wide variety of malignancies. Older adults represent a large and rapidly growing demographic, among whom ICIs are widely prescribed. Management of ICI-associated toxicity among older adults, particularly in the presence of frailty and comorbidity, poses unique challenges. In this Policy Review, developed by the International Society of Geriatric Oncology (SIOG), we offer an evidence-based framework for health-care providers, caregivers, and policy makers for treating older adults with ICIs, focusing on unique considerations for this population that are not adequately addressed by existing guidelines, and expanding them to encompass geriatric oncology principles.
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The lancet oncology · Feb 2025
ReviewCommon Sense Oncology principles for the design, analysis, and reporting of phase 3 randomised clinical trials.
Common Sense Oncology (CSO) prioritises treatments providing meaningful benefits for people with cancer. Here, we describe CSO principles aimed at improving the design, analysis, and reporting of randomised, controlled, phase 3 clinical trials evaluating cancer treatments. ⋯ We include checklists to guide compliance with these principles. By encouraging adherence, CSO aims to ensure that clinical trials yield results that are scientifically robust and meaningful to patients.
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The lancet oncology · Feb 2025
Review Comparative StudyDifferences in the on-label cancer indications of medicinal products between Europe and the USA.
The definition of a therapeutic indication formulated by regulatory agencies is a decisive element for the marketing authorisation of medicinal products and for patient access. Trotta and colleagues found that oncological indications granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the period between 1999 and 2008 were clinically different in about 10% of cases. In this Policy Review, we compared the 162 therapeutic indications of 80 medicinal products for solid tumours and blood cancers authorised by the EMA between January, 2015, and September, 2022, with the corresponding labels approved by the FDA. ⋯ These differences lead to a different population for which drugs can be prescribed on label, with the FDA granting broader indications more often than the EMA. Therapeutic indications are a legal basis that define the eligible population to specific treatments. The fact that about half of the indications are different between the USA and Europe affect patient access to medications and should stimulate a debate on the weight that uncertainty plays in regulatory decisions.
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Advances in molecular biology, genetics, and epigenetics have refined our understanding of metastatic brain cancer and underscored the need for better classification and targeted approaches. The heterogeneity of brain metastases highlights the differences from their primary source of origin and contributes to therapeutic resistance. Before colonising the brain, tumour cells acquire specialised proficiencies that enable them to capitalise on the unique microenvironment of the brain. ⋯ These adaptations facilitate tumour survival, growth, and treatment resistance. Recognising metastatic brain cancer as a distinctive CNS disease, rather than an extension of the primary cancer, would support the development of rational approaches that target its molecular and genetic features and improve research funding in this area. Here, we delve into the distinct genetic and phenotypic characteristics of metastatic brain cancer, and reflect on how a change in the perception of this disease could accelerate the development of more effective therapies and drive continued progress in the field of neuro-oncology.
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The lancet oncology · Jan 2025
ReviewThe changing global landscape of national cancer control plans.
Global efforts to highlight cancer and non-communicable diseases (NCDs) as a growing burden were first raised in 2005 World Health Assembly Resolution 58.22 and reinforced with Resolution 70.12 and the Global NCD action plan in 2017. One common thread for addressing cancer burden was the need to articulate cancer priorities within a comprehensive national cancer control plan (NCCP). ⋯ The global review included 16 new questions related to cancer equity, pandemic preparedness, global WHO initiatives, evidence-based recommendations, and other emerging trends. The findings can guide country-level decision makers on improvements to deliver person-centred cancer services to reduce the cancer burden.