Diagnostic Potential of 68Ga-NeoB PET/CT with Estrogen Receptor- and Progesterone Receptor-Positive Breast Cancer Undergoing Staging or Restaging for Metastatic Disease.
Abstract Background: 18F-FDG PET/CT has low sensitivity for estrogen receptor and progesterone receptor (ER/PR)-positive breast cancer. By contrast, gastrin-releasing peptide receptor is overexpressed in ER/PR-positive breast cancer. This study assessed the diagnostic potential of 68Ga-NeoB PET/CT in staging or restaging metastatic ER/PR-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Methods: Patients with ER/PR-positive and HER2-negative breast cancer with clinical suspicion for metastatic disease undergoing staging or restaging were prospectively enrolled. All patients underwent 68Ga-NeoB PET/CT, in addition to standard 18F-FDG PET/CT. ER/PR-positive and HER2-negative status was confirmed in prior biopsy samples (primary or metastatic). Conventional imaging (18F-FDG PET/CT, bone scan, and [...]
Longitudinal Analysis Reveals Dynamic Changes in Histopathologic Features in Responders to Neoadjuvant Treatment in a Stage III BRAF-Mutant Melanoma Cohort.
Abstract Despite advances in systemic therapies, cutaneous melanoma remains a highly deadly disease. Patients with high-risk stage III melanoma have a significant likelihood of recurrence following surgery. Although adjuvant immunotherapy has been the standard of care, recent evidence demonstrates that neoadjuvant immunotherapy is more effective for higher-risk stage III patients, showing superior survival outcomes compared with adjuvant immunotherapy. This has led to an immediate paradigm shift in clinical practice toward neoadjuvant therapy for this cohort. The NeoTrio clinical trial assessed the efficacy of sequential or combination BRAF-targeted therapy with anti-programmed cell death-1 in the neoadjuvant setting. However, research on [...]
Global Applicability of a Risk Prediction Tool for Sentinel Node Positivity in Patients With Primary Cutaneous Melanoma.
Abstract Importance: The Melanoma Institute Australia (MIA) sentinel node (SN) metastasis risk calculator provides estimates of positivity for individual patients based on 6 standard clinicopathological parameters and the full 6-parameter model has been externally validated previously using US data. However, given its geographically widespread use, further validation is required to ensure its applicability to other populations. Objective: To further externally validate the MIA SN metastasis risk calculator and increase its precision by refinement of the 95% CIs. Design, setting, and participants: A retrospective multicenter cohort study was carried out using data from 4 continents, including the national Danish Melanoma Database and cancer [...]
FDG-PET associations with pathological response and survival with neoadjuvant immunotherapy for melanoma.
Abstract Background: Neoadjuvant immunotherapy has become the new standard of care for stage III melanoma. This study sought to describe the metabolic changes seen with fludeoxyglucose-18-positron emission tomography (FDG-PET) following neoadjuvant immunotherapy in patients with melanoma and explore associations with pathological response and recurrence-free survival (RFS). Methods: Data from patients with macroscopic stage III nodal melanoma treated with neoadjuvant checkpoint inhibitor therapy were pooled from five melanoma centers. All patients underwent baseline and preoperative FDG-PET and CT assessments, and all had surgery. Pathological response was determined using the International Neoadjuvant Melanoma Consortium criteria, radiological response using Response Evaluation Criteria in Solid [...]
Economic Evaluation of Inguinal Versus Ilio-inguinal Lymphadenectomy for Patients with Stage III Metastatic Melanoma to Groin Lymph Nodes: Evidence from the EAGLE FM Randomized Trial.
Abstract Purpose: We compared health outcomes and costs of inguinal lymphadenectomy (IL) versus ilio-inguinal lymphadenectomy (I-IL) for removal of metastatic melanoma to lymph nodes of the groin in adults with stage III melanoma. Methods: A within-trial cost-utility analysis was performed alongside an international randomized trial (EAGLE-FM) with 36 months follow-up from a health system perspective. Healthcare costs were measured by using trial records, and effectiveness measured in quality-adjusted life years (QALYs). Deterministic sensitivity analyses assessed the impact of changes in costs or quality of life on overall results. Statistical bootstrapping was employed to estimate confidence intervals around the cost-utility ratio. Results: Among [...]
Multiomic profiling of checkpoint inhibitor-treated melanoma: Identifying predictors of response and resistance, and markers of biological discordance.
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Clinical significance of intra-thoracic and intra-abdominal sentinel lymph nodes detected on lymphoscintigraphy in truncal melanoma patients.
Abstract Background: Although most melanomas drain to the more common major lymph node basins (axilla, groin, neck), rarely they drain to deep SLN locations such as intra-abdominal and intra-thoracic (including intercostal and internal mammary) sites, which pose a higher surgical risk and complexity for procurement. Our study is aimed at determining the rate of positivity and likelihood of recurrence in these nodal sites to guide management decisions for patients with truncal melanomas which drain to these 'deep' SLN locations. Methods: Retrospective data collected between May 2008 and May 2022 including all patients with truncal melanomas who underwent lymphoscintigraphy resulting in the [...]
Patient and Staff Experiences of Embedding Electronic Patient Reported Outcome Measures for Distress Screening and Quality of Life Assessment, Into Routine Melanoma Care: A Mixed-Methods Study.
Abstract Objective: Patient reported outcome measures (PROMs) are commonly collected in melanoma research. However, they are not used to guide immediate clinical care in Australia. This study explored the views and experiences of patients with Stage III melanoma and clinic staff during implementation of an electronic Patient-Reported Outcome Measures in melanoma (ePROMs-MEL) pilot to assess distress and quality of life. Methods: A prospective mixed-methods study in specialist melanoma clinics in Sydney, Australia between May 2021 and February 2023. Forty-two post-ePROMs implementation surveys and 17 semi-structured interviews were undertaken among patients and staff (including oncologists, melanoma nurses and clinic managers). Survey responses [...]
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; [...]
Impact of personalized response-directed surgery and adjuvant therapy on survival after neoadjuvant immunotherapy in stage III melanoma: Comparison of 3-year data from PRADO and OpACIN-neo.
Abstract Background: Pathologic response following neoadjuvant immune checkpoint blockade (ICB) in stage III melanoma serves as a surrogate marker for long-term outcomes. This may support more personalized, response-directed treatment strategies. Methods: The OpACIN-neo and PRADO trials were phase 2 studies evaluating neoadjuvant treatment with ipilimumab and nivolumab in stage III melanoma. In OpACIN-neo, all patients underwent therapeutic lymph node dissection (TLND) without subsequent adjuvant therapy. In contrast, PRADO explored a response- directed strategy, where patients achieving a major pathologic response (MPR) omitted TLND and adjuvant therapy, while those without a pathologic response (pNR) received TLND and adjuvant therapy. Here, we provide [...]