Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial
Abstract Based on RELATIVITY-047, nivolumab plus relatlimab is approved for advanced melanoma. Here, to address a current unmet need for more efficacious adjuvant regimens for completely resected melanoma, the phase 3, double-blind RELATIVITY-098 trial compared adjuvant nivolumab plus relatlimab to nivolumab after complete resection of stage III/IV melanoma. Patients were randomized 1:1 to receive nivolumab 480 mg plus relatlimab 160 mg (n = 547) or nivolumab 480 mg (n = 546) intravenously every 4 weeks for ≤1 year; safety populations totaled 543 and 545 patients, respectively. The primary endpoint was recurrence-free survival (RFS), and the key secondary was overall [...]
Effectiveness of a stepped-care model to address fear of cancer recurrence in patients with early-stage melanoma: results at 6- and 12-month follow-up
Abstract Purpose: To investigate the effectiveness of the Melanoma Care Program, an evidence-based, psychological intervention delivered through a stepped-care model, to address fear of cancer recurrence (FCR) in patients with early-stage melanoma at 6- and 12-month follow-up, when implemented into routine practice. Methods: Individuals with stage 0-II melanoma participated in FCR severity screening using the Fear of Cancer Recurrence Inventory. Participants with an FCR severity score of ≤ 12 were offered usual care. Participants with an FCR severity score of ≥ 13 were offered a psychoeducational booklet and a stepped-care model offering participants up to 5 psychotherapeutic telehealth sessions with a [...]
A protocol for development of a microsimulation model platform to evaluate the potential benefits, harms, and cost-effectiveness of risk-tailored melanoma screening
Abstract In populations of European descent, melanoma is a high burden cancer in terms of incidence and healthcare costs, with early detection linked to better prognosis. There is no organised population screening program for melanoma in most countries, as more information is required about the potential benefits, harms and costs of population-based screening to develop policy. To assess the cost-effectiveness of a potential risk-tailored organised melanoma screening program in Australia, we have developed a protocol for a comprehensive microsimulation model (Policy1-Melanoma) that can evaluate multiple potential screening strategies. We outline the development of Policy1-Melanoma, a natural history model developed [...]
Evaluation of clonality in lentigo maligna
Abstract Lentigo maligna (LM), a type of in situ melanoma, has a high rate of local recurrence after surgical resection. Although recurrences might represent inadequately excised incident LMs, apparent recurrences could be new primary LMs developing from distinct melanocytic clones in the same UVR-damaged anatomical region. Because distinguishing these possibilities has implications for patient management, we tested genetic relationships between incident and recurrent LMs. Incident LMs with histologically clear margins and their recurrent LMs and invasive LM melanomas were laser microdissected for DNA extraction. Tumor and matched germline DNA underwent whole-exome sequencing. Clonal relationships between incident and recurrent LMs [...]
Independent Dutch Validation Study of CP-GEP (Merlin Assay) for the Prediction of Nodal Metastasis and Long-Term Outcome in Patients with Primary Cutaneous Melanoma
Abstract Background: Currently, sentinel lymph node biopsy (SLNB) is considered standard staging for patients with stage IB-II melanomas. Owing to recent systemic therapy advances, SLNB is once again being scrutinized. The aim of the current study was to validate the diagnostic accuracy of the clinicopathological gene expression profile (CP-GEP) for risk of sentinel node metastases and recurrence. Patients and methods: Samples and clinical data of 252 patients with newly diagnosed clinical stage I/II melanoma between 2007 and 2015 were obtained. CP-GEP included eight target genes associated with tumor development (i.e., MLANA, GDF15, CXCL8, LOXL4, TGFBR1, ITGB3, PLAT, and SERPINE2) and two [...]
Tumor miRNA Signatures Associate with Outcomes of Patients with Stage II/III Melanoma
Abstract Purpose: Patients with stage II and resected stage III melanomas have variable clinical outcomes, providing evidence of underlying biological differences in tumors and/or the patients themselves, beyond stage. The approval of adjuvant immunotherapy for stage IIB/C and resected stage III/IV disease (and adjuvant targeted therapy for resected stage III disease) has created a pressing need to develop biomarkers to accurately distinguish patients at low risk versus high risk for recurrence and death from melanoma. miRNAs are promising biomarkers because of their stability in tissues and fluids and their demonstrated functional and prognostic roles in melanoma. We hypothesized that miRNA [...]
Real-World Outcomes of Adjuvant Therapy in Stage III Melanoma and the Impact of Somatic Mutations
Abstract Purpose: A significant proportion of patients with locoregional (stage III) cutaneous melanoma recur despite adjuvant systemic therapy. Staging criteria and surgical nodal management have changed since the trials were completed. Data assessing the effect of systemic therapy compared to surveillance are limited, and factors associated with recurrence are unclear. We assessed the efficacy of adjuvant systemic therapy in real-world patients and assessed whether baseline genomic characteristics could prognosticate or predict benefit from therapy. Methods: We collected demographic, histopathologic, clinical, and genomic data for patients diagnosed with stage III cutaneous melanoma. Outcomes of interest were recurrence-free survival (RFS) and distant-metastasis-free survival [...]
ASO Author Reflections: Global Perspectives on Index Lymph Node Surgery after Neoadjuvant Therapy for Stage III Melanoma
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Global, Regional, and National Burden of Cardiovascular Diseases and Risk Factors in 204 Countries and Territories, 1990-2023.
Abstract Background: Cardiovascular diseases (CVDs) are the leading cause of mortality and are among the foremost causes of disability globally. CVD burden has continued to increase in most countries since 1990, with trends driven by changing exposures to harmful risk factors, population growth, and population aging. Objectives: We report estimates of global, national, and subnational CVD burden, including 18 subdiseases and 12 associated modifiable risk factors. We analyzed change in CVD burden from 1990 to 2023 and identified drivers of change including population growth, population aging, and risk factor exposure. Methods: The Global Burden of Disease (GBD) 2023 study, a multinational collaborative [...]
Practice Guidelines for Teledermatology in Australia: 2025 Update
Abstract In 2020, [the Australasian College of Dermatologists] released its first teledermatology practice guidelines for Australia, with a commitment to regular updates. This article presents the revised guidelines, aimed at educating dermatologists on the benefits and limitations of telehealth, while promoting safer, higher-quality patient care. The updated guidelines harmonise with the Medical Board of Australia's 2023 telehealth guidelines. They address the growing use of telephone consultations-boosted by Medicare subsidies introduced during the COVID-19 pandemic. The latest guidelines provide recommendations on the appropriate choice of modality (telephone versus video) for teleconsultation. They also include updated guidance on clinical image acquisition. [...]