BAUSSS biomarker improves melanoma survival risk assessment.

BACKGROUND: The American Joint Committee on Cancer (AJCC) method of staging melanoma is dated and inaccurate. It ignores important prognostic melanoma features, especially the patient's age. BAUSSS is more accurate in determining survival risk for primary cutaneous melanoma patients who have no clinical or imaging evidence of nodal or distant metastases. BAUSSS is an algorithm incorporating analysis of Breslow thickness, Age, Ulceration, Subtype of melanoma, Sex and Site. These are the six features from the patient history along with the details from the melanoma pathology report that are most predictive of mortality outcome. OBJECTIVE: To develop a single-page document that allows the clinician to determine BAUSSS biomarker-predicted prognosis in consultation with the patient. METHOD: From various data sources, we developed an algorithm to predict melanoma mortality using the BAUSSS biomarker system. The single-page algorithm was made available to download at https://globalmelanoma.net/bausss-survival-chart, thus being readily available without charge to all clinicians and their patients. RESULTS: BAUSSS method of determining melanoma prognosis is more accurate and less costly than the AJCC staging system. The only surgery the patient requires is wide local excision of the primary tumour. This method of ascertaining melanoma risk does not require added surgery, costs, hospitalization, tests and anaesthesia, such as would be required if sentinel lymph node biopsy was undertaken. BAUSSS can be a useful tool in determining which primary melanoma patients are at sufficiently high risk to be considered for adjuvant drug therapy. CONCLUSION: We encourage clinicians to download and print in colour this single-page BAUSSS mortality prediction tool, laminate it, and use it face to face with the patient in consultations. Not only will the patient be able to recognize his/her long-term prognosis but will also be able to see how their tumour severity compares with others.

Sentinel lymph node biopsy is unreliable in predicting melanoma mortality for both younger and older patients.

BACKGROUND: Melanoma disease patterns vary with patient age. AIM: To evaluate sentinel lymph node biopsy (SLNB) in managing melanoma at differing patient ages. METHODS: Online prediction tools were applied to compare SLNB positivity (SLNB+) and survival risk at patient ages 20-80. Tübingen melanoma data were used to determine variations in the hazard ratio of SLNB+ for mortality at different patient ages. RESULTS: Regardless of tumour thickness, predicted SLNB+ rates were markedly higher than mortality rates for 20-year-old patients. For 80-year-old patients, it is the opposite. DISCUSSION: If 1000 20-year-olds with a 0.4 mm thickness non-ulcerated melanoma underwent SLNB, 100 would likely be positive. If all 100 were to be offered adjuvant drug therapy (ADT), fewer than three more melanoma deaths in those 1000 patients would be avoided. In total, 97 patients would have received medication they may never have needed. If 1000 80-year-olds with a 3 mm thickness non-ulcerated melanoma underwent SLNB, only 40 would likely be positive. In total, 274 patients would be predicted to die of melanoma, 245 being SLNB negative and 29 SLNB+. ADT linked to SLNB+ could deny treatment to 89% of these high-risk patients. LIMITATIONS: The authors relied on published risk data. CONCLUSION: SLNB has poor specificity at predicting mortality in young melanoma patients and poor sensitivity in older patients. SLNB is not indicated in managing cutaneous melanoma for patients under 40 or over 60 years of age. Many such patients could be managed with wide local excision alone in their clinician's office-based practice. For all cutaneous melanoma patients at all ages, linking ADT to BAUSSS biomarker, (an algorithm of Breslow thickness, age, ulceration, subtype, sex and Site) rather than SLNB+ is likely more appropriate. BAUSSS provides a more accurate melanoma-specific mortality risk assessment for patients without burdening them with added surgery, hospitalization, costs or morbidity risk.

Revised Mohs surgery care guidelines for squamous cell carcinoma in-situ are overdue.

The treatment of cutaneous squamous cell carcinoma in situ by Mohs micrographic surgery is currently deemed as appropriate by the Mohs Appropriate Use Criteria. However, squamous cell carcinoma in situ is a very superficial, indolent, low-risk tumor amenable to destructive and non-surgical treatments. It is uncommon for squamous cell carcinoma in situ to have progressed to invasive malignancy subsequent to definitive management. The suggestion that squamous cell carcinoma in situ on certain anatomic locations has a poorer prognosis is widely assumed but lacks an evidence base. We recommend that most primary squamous cell carcinoma in situ in non-immunosuppressed patients be scored inappropriate or uncertain for Mohs micrographic surgery by the Mohs Appropriate Use Criteria. Multiple other efficacious treatment options exist for managing squamous cell carcinoma in situ, including curettage and cryotherapy, curettage and electrodessication, and topical therapies.

Novel photodynamic therapy does not prevent new skin cancers--randomized controlled trial.

OBJECTIVES: To determine whether field photodynamic therapy (PDT) of actinic keratoses using a novel preparation of 5-aminolevulonic acid (novel ALA) results in fewer subsequent invasive skin cancers developing on the face of individuals with previous facial cutaneous malignancy in a prospective randomized controlled trial. METHODS AND MATERIALS: Intervention patients received two treatments of novel ALA 2 weeks apart. Controls were observed. Patients were followed up with biopsy of any suspicious lesions for 3 years. RESULTS: The trial was suspended early because of problems with trial governance and the reporting of severe adverse events. Sixty-four patients who were recruited at that time at one center were monitored. Their average age was 71, and 57% were male. Patients were randomized to intervention (n = 34) or observation (n = 29). Over the subsequent 3 years, 13 intervention patients (38%) developed 30 new cutaneous malignancies in the field treated, and 11 control patients (38%) developed 22 new malignancies. Some intervention patients experienced prolonged adverse events, including permanent scarring. CONCLUSION: Novel ALA made no difference in the likelihood of new malignancies developing. The risks without benefit of this novel ALA are troubling. Lack of efficacy and safety of novel ALA cannot be extrapolated to other PDT products.

Prolonged adverse events following photodynamic therapy: regulatory implications.

OBJECTIVE: To determine whether field photodynamic therapy (PDT) of actinic keratoses (AKs) using a novel preparation of 5-aminolevulonic acid (ALA) would result in fewer subsequent invasive skin cancers developing on the face. DESIGN: A prospective multi-center randomized controlled trial. The protocol was approved by the Bond University Human Research Ethics Committee in accord with the TGA's Clinical Trial Notification Scheme. The trial was registered (12609000025235) on the Australian New Zealand Clinical Trials Registry. SETTING: Six centers in four states in Australia. PROTOCOL: Two treatments of ALA PDT, 2 weeks apart for each patient. Controls were observed. Patients were followed up with biopsies of any suspicious lesions every 6 months for 2 years. MAIN OUTCOME MEASURE(S): Development of new skin cancers. RESULTS: The trial was suspended after 3 months and closed after 6 months after ethics committee approval was withdrawn on the basis of a breakdown in trial governance. Over the following 2 years, some investigators noted and formally reported the continued occurrence of serious adverse events in excess of those described with other approved cutaneous PDT treatments. USA dermatologists with experience managing AKs with FDA approved ALA products subsequently confirmed prolonged and severe adverse events in 6 of the former trial intervention patients. DISCUSSION AND CONCLUSIONS: Adverse effects experienced by patients using the investigational ALA PDT appeared more severe than those experienced when an FDA-approved ALA product is used. We believe the former should be further evaluated for safety. It is of concern that this ALA product and lamp could be promoted and used widely in Australia following these reports of significant adverse events and continued lack of TGA approval.

Primary Cutaneous Melanoma-Management in 2024.

Background: Maximizing survival for patients with primary cutaneous melanomas (melanomas) depends on an early diagnosis and appropriate management. Several new drugs have been shown to improve survival in high-risk melanoma patients. Despite well-documented guidelines, many patients do not receive optimal management, particularly when considering patient age. Objective: to provide an update on melanoma management from the time of the decision to biopsy a suspicious skin lesion. Methods: We reviewed melanoma-management research published between 2018 and 2023 and identified where such findings impact and update the management of confirmed melanomas. Pubmed, Google Scholar, Ovid and Cochrane Library were used as search tools. Results: We identified 81 publications since 2017 that have changed melanoma management; 11 in 2018, 12 in 2019, 10 in 2020, 12 in 2021, 17 in 2022 and 18 in 2023. Discussion: Delayed or inaccurate diagnosis is more likely to occur when a partial shave or punch biopsy is used to obtain the histopathology. Wherever feasible, a local excision with a narrow margin should be the biopsy method of choice for a suspected melanoma. The Breslow thickness of the melanoma remains the single most important predictor of outcome, followed by patient age and then ulceration. The BAUSSS biomarker, (Breslow thickness, Age, Ulceration, Subtype, Sex and Site) provides a more accurate method of determining mortality risk than older currently employed approaches, including sentinel lymph node biopsy. Patients with metastatic melanomas and/or nodal disease should be considered for adjuvant drug therapy (ADT). Further, high-risk melanoma patients are increasingly considered for ADT, even without disease spread. Invasive melanomas less than 1 mm thick are usually managed with a radial excision margin of 10 mms of normal skin. If the thickness is 1 to 2 mm, select a radial margin of 10 to 20 mm. When the Breslow thickness is over 2 mm, a 20 mm clinical margin is usually undertaken. In situ melanomas are usually managed with a 5 to 10 mm margin or Mohs margin control surgery. Such wide excisions around a given melanoma is the only surgery that can be regarded as therapeutic and required. Patients who have had one melanoma are at increased risk of another melanoma. Ideal ongoing management includes regular lifelong skin checks. Total body photography should be considered if the patient has many naevi, especially when atypical/dysplastic naevi are identified. Targeted approaches to improve occupational or lifestyle exposure to ultraviolet light are important. Management also needs to include the consideration of vitamin D supplementary therapy.

Cutaneous melanoma: Latest developments.

BACKGROUND: Several new medications have shown improved survival rates in high-risk patients with melanoma. OBJECTIVE: The aim of this article is to discuss the new medications and outline their roles, the expected benefit from each and the risk of adverse events. We explain the place of sentinel lymph node biopsy (SLNB) and ultrasonography with fine needle aspiration (US-FNA) in assessing and treating patients with melanoma. DISCUSSION: Ipilimumab has limited efficacy and a very concerning complication profile. More than 50% of patients taking ipilimumab have severe or life-threatening adverse events. BRAF inhibitors have greater efficacy and fewer adverse events than ipilimumab. Combining BRAF inhibitors with mitogen-activated protein kinase inhibitors enhances their effect and improves the overall adverse event profile. BRAF inhibitors are only effective when the melanoma has a BRAF gene mutation, something that occurs in only 50% of cases. Programmed cell death protein 1 medications are also more effective and have a much more acceptable adverse event profile than ipilimumab. Both SLNB and US-FNA can detect early node involvement in patients with melanoma, although US-FNA is a safer procedure.

Management of invasive melanoma.

BACKGROUND: Maximising survival for patients with invasive melanoma hinges on early diagnosis of primary melanoma and appropriate management. Despite well-documented guidelines, many patients with melanoma have not been managed ideally. OBJECTIVE: The aim of this paper is to identify suboptimal aspects of melanoma management. DISCUSSION: Delayed or erroneous diagnosis is more likely to occur when a shave or punch biopsy is used to obtain histopathology. Wherever feasible, local excision with a narrow margin is the preferred biopsy choice for a suspected melanoma. The Breslow thickness of the primary melanoma remains the greatest predictor of outcome. Ulceration is associated with a poorer prognosis. Most invasive melanomas are managed with a margin of ≥10 mm of normal tissue. Patients who have developed one primary melanoma are at high risk of a second tumour. Ongoing management includes regular lifelong skin checks. Targeted approaches to improve occupational or lifestyle exposure to ultraviolet radiation are useful. Imaging is largely used when metastases are suspected on the basis of clinical symptoms or signs.

The characteristics of Mohs surgery performed by dermatologists who learned the procedure during residency training or through postgraduate courses and observational preceptorships.

Little is known about the practice characteristics of Mohs surgery performed by physicians who learned the procedure during their dermatology residency training or through postresidency courses and observational preceptorships. All published reports have investigated Mohs surgeons trained in postresidency fellowships. This report presents the results of a multicenter prospective cohort study evaluating 1834 consecutive Mohs surgery cases performed during the same 6-month period by 9 Mohs surgeons who learned the technique in residency or in postresidency courses and observational preceptorships. One major complication was reported, a hematoma requiring outpatient drainage in an emergency room. There were 54 (2.9%) short-term complications, including 20 (1.1%) infections, 17 (0.9%) wound dehiscences, 9 (0.5%) cases of skin flap necrosis, and 8 (0.4%) hematomas or postoperative bleeding episodes. These complication rates and the data evaluating tumor type, anatomic location, primary vs. recurrent tumor status, tumor size, postoperative wound size, number of Mohs surgery stages, and repair type compare favorably to previously published reports.

A method for working with displeased patients-blast.

Clinicians inevitably encounter patients with complaints and concerns about the quality of their care. This causes some to experience anxiety, fear, anger, resentment, guilt, and depression, especially when they believe they may have erred or caused harm. Lack of customer-service training and experience may contribute to these emotions. The "BLAST" technique is a complaint-resolution method that is useful in patient care and as a clinical teaching tool. The mnemonic stands for: Believe (what the patient is saying), Listen (actively, to assess and restate the patient's unmet expectations), Apologize (for the patient's unmet expectations), Satisfy (the patient), and Thank (the patient for expressing his/her concerns and providing a second chance to satisfy the patient). The technique appears to help clinicians become more at ease and confident when handling patient complaints. This may be especially helpful for clinicians who must routinely interact with post-treatment and post-procedure patients who commonly express surprise, concern, or complaints about their results and healing. BLAST may be an effective teaching tool enabling students, residents, and clinicians to become more comfortable and adept at working with displeased and concerned patients.