The lancet oncology
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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
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
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
ReviewIntegrating cancer into crisis: a global vision for action from WHO and partners.
More than a billion people live in fragile, conflict-affected, and vulnerable settings requiring humanitarian support, where cancer is a substantial health issue. Despite its substantial effect on populations, cancer care remains underprioritised in emergency preparedness and response frameworks and humanitarian operational planning. This Policy Review summarises the perspectives and actionable recommendations from the First Global High-Level Technical Meeting on Non-communicable Diseases in Humanitarian Settings, with a focus on cancer. ⋯ Key solutions include: integrating the cancer care continuum into national preparedness and response plans to enhance health-care system resilience; integrating cancer into humanitarian responses efforts; addressing the specific needs of paediatric patients with cancer; improving cancer intelligence and surveillance systems; and developing strategies to navigate the logistical and financial challenges of providing cancer care during crises. Additionally, the paper outlines practical actions and next steps for international cooperation needed to drive a shift in global health priorities and elevate cancer in the global health security agenda. We hope the presented notions will help prevent millions of avoidable deaths among people with cancer.