A cost comparison of radiotherapy and topical imiquimod for lentigo maligna treatment: Considerations for clinical decision-making
Abstract Background: Lentigo maligna (LM) is an in situ melanoma occurring on sun-damaged skin. Radiotherapy or topical imiquimod are potential alternatives to surgery; a recent randomized trial showed no difference in treatment failure between those approaches (underpowered because of pandemic disruption). Objective: To conduct an economic evaluation comparing radiotherapy versus topical imiquimod for treating LM. Methods: Based on no difference in clinical outcomes, a cost analysis was performed alongside the RADICAL trial, a multi-institutional randomized (1:1) phase 3 study (118/126 patients randomized completed treatment; 60 imiquimod and 58 radiotherapy) conducted in Australia, New Zealand, and Brazil. Direct medical costs and indirect costs [...]
International Dermoscopy Society consensus recommendations for the management of lentigo maligna
Abstract Lentigo maligna (LM) is a subtype of cutaneous melanoma in situ that develops on chronically sun-damaged skin in elderly individuals. Its diagnosis and management remain challenging due to its slow progression, frequent occurrence on cosmetically sensitive areas in frail individuals, and tendency for subclinical peripheral extension. Despite its potential for invasive transformation, the natural history of LM remains incompletely understood and evidence-based management strategies for this specific entity remain limited. This work aims to bridge the gap between scarce high-quality evidence and the clinicians' need for practical guidance on LM management by formulating evidence-based and expert consensus-driven recommendations [...]
Study protocol of a randomised phase II trial of concurrent stereotactic body radiotherapy with immunotherapy versus immunotherapy alone in patients with 1-5 extracranial melanoma oligometastases (AXIOM)
Abstract Background: Immunotherapy has significantly improved survival in patients with metastatic melanoma, achieving objective response rates of 45-60% and long-term survival. However, there is scope and a need to further improve outcomes. Preclinical and early clinical data suggest synergistic effects between stereotactic body radiotherapy (SBRT) and checkpoint inhibitor immunotherapy with an acceptable safety profile. Methods: AXIOM is a phase II, multicentre, randomised trial designed to evaluate the effectiveness and safety of upfront SBRT to all radiologically identified metastasis with immunotherapy over historical immunotherapy alone (standard of care) in patients with 1-5 extracranial melanoma oligometastases. The sample size calculation is based on [...]
Combined immunotherapy with nivolumab and ipilimumab with and without sequential or concomitant stereotactic radiotherapy in patients with melanoma brain metastasis: An international retrospective study.
Abstract Background: Ipilimumab plus nivolumab (COMBO) is the standard treatment in patients with asymptomatic melanoma brain metastases (MBM). We report a retrospective study aiming to assess the outcome of patients with MBM treated with COMBO with or without sequential/concomitant stereotactic radiotherapy (SRT). Methods: MBM patients treated with COMBO with or without SRT have been retrieved: demographics, steroid treatment, Central Nervous System [CNS]-related symptoms, BRAF status, radiotherapy (yes/no and timing) or surgery, number of MBM, maximum diameter of metastasis, overall response rate (ORR), progression-free (PFS) and overall survival (OS) have been analyzed. Results: 453 patients were included: 190 received [...]
Update of clinical practice guidelines for the management of patients with sarcoma.
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Impact of an online risk prediction tool for sentinel node metastasis on clinical decision-making in melanoma care: A mixed methods study.
Abstract Background The decision to perform a sentinel lymph node biopsy (SLNB) procedure can be guided by risk prediction tools. We aimed to investigate the impact of an online risk prediction tool for sentinel node metastasis on clinical decision-making. Methods We conducted a mixed methods study using an online questionnaire and semi-structured interviews between April 2022 and March 2023. Australian clinicians and patients/carers who were using the Melanoma Institute Australia risk prediction tool were invited to participate. Results Sixty-one participants completed the questionnaire (52 clinicians including 36 general practitioners of whom 32 worked at skin cancer clinics; 14 surgeons; [...]
Update of clinical practice guidelines for the management of patients with sarcoma
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Randomized Trial of Postoperative Radiation Therapy After Wide Excision of Neurotropic Melanoma of the Head and Neck (RTN2 Trial 01.09)
Abstract Background: Cutaneous neurotropic melanoma (NM) of the head and neck (H&N) is prone to local relapse, possibly due to difficulties widely excising the tumor. This trial assessed radiation therapy (RT) to the primary site after local excision. Methods: Participants from 15 international centers were randomized to observation or RT. The participants were required to have microscopically negative excision margins 5 mm wide or wider and no evidence of disease elsewhere. The primary outcome was time to local relapse. The secondary outcomes included time to any recurrence, overall survival (OS), and toxicity. Results: The trial ceased prematurely due to slow recruitment and [...]
Impact of whole brain radiotherapy after treatment of melanoma brain metastases on an individual’s employment and household income
Abstract Purpose: A cancer diagnosis can result in a considerable financial burden to individuals and their households. This study aimed to investigate this problem in patients treated for melanoma brain metastases. Methods: An economic evaluation was conducted as a sub-study of a randomised controlled trial of whole brain radiotherapy (WBRT) versus observation following surgery and/or stereotactic radiosurgery (SRS) for 1-3 melanoma brain metastases. Employment status and pre-tax household income were measured at baseline and every 2 months for 12 months. Outcomes included changes in employment status or household income category at 12 months. Results: Of 125 patients, 64 were [...]