In situ and localized primary invasive pregnancy-associated melanoma: Maternal and perinatal outcomes.

Background: Pregnancy-associated melanoma (PAM) is melanoma diagnosed during pregnancy or the 12 months postpartum. There is long-standing debate regarding the impact of pregnancy on melanoma prognosis. Previous studies have analysed pooled data from PAM diagnoses of all stages, so findings may not reflect outcomes associated with the diagnosis of in situ or localized PAM that are more commonly diagnosed than later stage PAM.

My Back Exercise app: an automated exercise intervention supported by educational notifications, a sleep programme and diet advice to improve function in people with chronic non-specific low back pain - protocol for a superiority, adaptive multi-arm multi-stage randomised controlled trial.

Introduction: As chronic low back pain (LBP) remains one of the most pressing global health challenges, digital health emerges as an opportunity to deliver evidence-based care at scale. In this context, the My Back Exercise app has been developed to support people with LBP in self-managing their condition. This study aims to determine the effectiveness of the My Back Exercise app to improve physical function in people with chronic non-specific LBP.

Radiotherapy versus imiquimod for complex lentigo maligna: A phase 3 randomized clinical trial.

Background: For patients with lentigo maligna who are not suitable for surgery, radiotherapy, or topical imiquimod are alternative nonsurgical treatments.

Objective: This trial aimed to assess the efficacy, safety, and patient-reported health-related quality of life (HRQL).

Methods: A multiinstitutional, phase 3, randomized trial conducted between August 2015 and November 2021.

Discovery and Validation of an Ancillary Genomic Test of Malignancy for Primary Melanocytic Tumors.

Purpose: Pathologic diagnosis of melanocytic tumors can be difficult and prone to error. More accurate ancillary tools are needed. We present a genomic model for distinguishing benign (nevi) from malignant (melanoma) melanocytic skin tumors.

Transforming Clinical Trials in Skin Cancer Research: Exploring the Potential of Flexible and Innovative Designs.

Over the past 2 decades, innovations in trial design have significantly advanced the field of clinical research. Methodological developments, such as adaptive designs, basket trials, umbrella trials, and platform trials, along with technological advancements such as virtual studies have proven effective in tackling complex research questions and managing resource constraints. These approaches enable prospectively planned modifications to trial designs and facilitate addressing multiple research questions within a single infrastructure, with technological advancements such as virtual studies enhancing accessibility, efficiency, and patient engagement.

Predictive performance of the clinicopathologic gene expression profile (CP-GEP) in identifying cutaneous melanoma patients for whom sentinel lymph node biopsy is unnecessary: A systematic review and meta-analysis.

Context & Aim: Sentinel lymph node biopsy (SLNB) is an invasive procedure that detects microscopic nodal metastasis, crucial for accurate staging and optimal management. In melanoma, most patients who undergo the procedure have no sentinel lymph node (SLN) metastasis detected. The CP-GEP model (Merlin Assay) was developed to identify patients who do not have SLN metastases and who may therefore safely forgo SLNB, based upon clinicopathologic and gene expression features of the primary tumour.

Cartilage Resection in the Surgical Management of Ear Melanoma.

Background: Melanoma of the ear accounts for approximately 1% of cutaneous melanomas. Management recommendations are based on small retrospective series and case reports. Resection of melanoma of the ear requires a delicate balance between disease clearance, preservation of function, and aesthetics.

Longitudinal Analysis Reveals Dynamic Changes in Histopathologic Features in Responders to Neoadjuvant Treatment in a Stage III BRAF-Mutant Melanoma Cohort.

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.

Global Applicability of a Risk Prediction Tool for Sentinel Node Positivity in Patients With Primary Cutaneous Melanoma.

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.

Molecular Analysis of Cutaneous Sarcomatoid Neoplasms Frequently Identifies Melanoma Driver Variants.

Primary cutaneous neoplasms that lack definitive histologic and immunophenotypic evidence of differentiation are a heterogeneous group of tumors with diverse prognoses and management options. These include undifferentiated and dedifferentiated melanoma (UM/DM), atypical fibroxanthoma (AFX), pleomorphic dermal sarcoma (PDS), and sarcomatoid squamous cell carcinoma. Diagnosis requires careful correlation between the clinicopathologic and molecular features, and the finding of a MAPK pathway variant commonly associated with melanoma may support the diagnosis of melanoma over other tumors in this group.

Absolute Risk of Developing a Second Primary Cancer After a First Primary Melanoma: An Australian Population-Based Cohort Study.

Understanding the absolute risk of developing a second primary cancer is important to guide patient surveillance and education. We aimed to examine the cumulative incidence and factors associated with development of a second primary cancer (melanoma versus other) after diagnosis of a first primary melanoma (invasive or in situ). We analysed a population-based study cohort of 154,695 people diagnosed with a first primary melanoma in New South Wales, Australia, between 1982-2019.

FDG-PET associations with pathological response and survival with neoadjuvant immunotherapy for melanoma.

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.

Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: 5-year outcomes of the randomized DYNAMIC trial.

Early data from the DYNAMIC study of circulating tumor DNA (ctDNA)-guided adjuvant chemotherapy (ACT) versus standard approach met its primary outcome demonstrating reduced ACT use without compromising 2-year recurrence-free survival (RFS) for stage II colon cancer. We report here other prespecified analyses of overall survival, ctDNA clearance and ctDNA level. At a median follow-up of 59.

Ipilimumab plus nivolumab versus nivolumab alone in patients with melanoma brain metastases (ABC): 7-year follow-up of a multicentre, open-label, randomised, phase 2 study.

Background: Patients with melanoma brain metastases respond well to immunotherapy, but long-term comparative survival data are scarce. We aimed to assess the efficacy of ipilimumab plus nivolumab versus nivolumab alone in patients with melanoma brain metastases at 7 years.

Methods: This open-label, randomised, phase 2 study was conducted at four sites (two research institute cancer centres and two university teaching hospitals) in Australia.

Clinical outcomes and management following progressive disease with anti-PD-(L)1 therapy in patients with advanced Merkel Cell Carcinoma.

Aim: Merkel Cell Carcinoma (MCC) is a rare skin cancer with a rising incidence worldwide. Anti-programmed death-1/ligand-1 (anti-PD-(L)1) therapies are effective for the treatment of advanced MCC. This study examines patterns of response / progression of advanced MCC to anti-PD-(L)1 therapies and describes subsequent management.

Outcomes for smokers who develop melanoma: a systematic review and meta-analysis.

Background: There is compelling evidence that the incidence of melanoma in cigarette smokers is substantially lower than in non-smokers. However, the risks of both recurrence and death appear to be higher in smokers if melanoma does develop. The magnitude of these increased risks is poorly documented.

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.

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.

Variation in initial biopsy technique for primary melanoma diagnosis: A population-based cohort study in New South Wales, Australia.

Background: Factors associated with nonadherence to guideline-recommended complete excision of suspicious cutaneous lesions are unclear.

Objective: The purpose of this study was to analyze patient, melanoma, and clinician factors associated with initial diagnostic biopsy type and determine whether unwarranted variation from guidelines occurred.

Methods: This population-based, cohort study involved the analysis of data from questionnaires completed by clinicians who managed patients with newly diagnosed, histopathologically confirmed primary invasive cutaneous melanomas reported to the New South Wales Cancer Registry between 2006 and 2007.