Pub Date : 2025-12-01Epub Date: 2025-02-17DOI: 10.1080/20450885.2025.2461963
Sarah Alsadiq, Adi Kartolo, Elaine McWhirter, Wilma Hopman, Tara Baetz
Background: Adjuvant immunotherapy and targeted therapy are now the standard of care for patients with resected stage IIIA-IV melanoma. However, little is known regarding its efficacy in real-world patients who were not represented in these landmark trials.
Methods: This retrospective study included all patients with resected stage IIIA-IV melanoma who received adjuvant systemic therapy between January 1 2018 and December 31 2020, in two Canadian academic cancer. Primary outcome was the proportion of trial non-eligible patients in the real-world setting. Survival and safety analyses were also conducted.
Results: Of the total 113 patient, 99 (88%) were trial non-eligible patients. Most common reasons for trial non-eligible criteria was having no baseline CLND (72%), followed by outside of treatment window >12 weeks (30%), stage IIIA (14%), unknown primary (9%), stage IV (14%), and baseline AD on immunosuppressants (3%). There were no significant RFS (P = 0.731) or OS (P = 0.110) differences in the overall population of trial eligible vs. non-eligible. Safety profiles were similar between the trial eligible vs. non-eligible groups.
Conclusion: Our study suggested a high proportion of real-world patients would have been deemed non-eligible for clinical trials. Regardless, adjuvant systemic therapy delivered similar survival and toxicity outcomes in both groups.
{"title":"Efficacy and safety of adjuvant systemic therapies in trial non-eligible resected stages III and IV melanoma patients.","authors":"Sarah Alsadiq, Adi Kartolo, Elaine McWhirter, Wilma Hopman, Tara Baetz","doi":"10.1080/20450885.2025.2461963","DOIUrl":"10.1080/20450885.2025.2461963","url":null,"abstract":"<p><strong>Background: </strong>Adjuvant immunotherapy and targeted therapy are now the standard of care for patients with resected stage IIIA-IV melanoma. However, little is known regarding its efficacy in real-world patients who were not represented in these landmark trials.</p><p><strong>Methods: </strong>This retrospective study included all patients with resected stage IIIA-IV melanoma who received adjuvant systemic therapy between January 1 2018 and December 31 2020, in two Canadian academic cancer. Primary outcome was the proportion of trial non-eligible patients in the real-world setting. Survival and safety analyses were also conducted.</p><p><strong>Results: </strong>Of the total 113 patient, 99 (88%) were trial non-eligible patients. Most common reasons for trial non-eligible criteria was having no baseline CLND (72%), followed by outside of treatment window >12 weeks (30%), stage IIIA (14%), unknown primary (9%), stage IV (14%), and baseline AD on immunosuppressants (3%). There were no significant RFS (P = 0.731) or OS (P = 0.110) differences in the overall population of trial eligible vs. non-eligible. Safety profiles were similar between the trial eligible vs. non-eligible groups.</p><p><strong>Conclusion: </strong>Our study suggested a high proportion of real-world patients would have been deemed non-eligible for clinical trials. Regardless, adjuvant systemic therapy delivered similar survival and toxicity outcomes in both groups.</p>","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2461963"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11834428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143442369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-03-01DOI: 10.1080/20450885.2025.2463830
Taylor Gardner, Jacob Duncan, Griffin K Hughes, Ryan McIntire, Brooke Gardner, Andriana Peña, Chase Ladd, Kelsey Snider, Ryan Ottwell, Jordan Tuia, Alyson Haslam, Vinay Prasad, Matt Vassar
Background: Vemurafenib (Zelboraf®, Roche), approved by the FDA in 2011 for unresectable and metastatic melanoma and Erdheim-Chester Disease, has been explored in trials for other BRAF-mutated cancers. Despite 12 years of clinical use, the risk-benefit profile for off-label indications remain unclear.
Research design and methods: This study systematically reviewed clinical trials utilizing vemurafenib in adult malignancies, with responses assessed using RECIST or similar criteria. On May 25, 2023, we searched PubMed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. Screening and data extraction were performed in a masked, duplicate fashion, collecting data on trial characteristics, adverse events, progression-free survival, overall survival, and objective response rates.
Results: Vemurafenib was tested in 15 cancers beyond its FDA-approved indications. A 0% complete response rate was observed in colorectal cancer, non-small cell lung cancer, and papillary thyroid cancer. Adverse events were more frequent in non-melanoma cancers, with 5,205 grade 3-5 events reported, equating to two severe events for every three participants. Only metastatic melanoma consistently demonstrated efficacy, aligning with its FDA approval.
Conclusions: Although vemurafenib showed efficacy in metastatic melanoma, off-label use resulted in limited benefit and increased adverse events. Unclear endpoints and underreported adverse events highlight the need for improved clinical trial design.
{"title":"Assessing patient risk, benefit, and outcomes in drug development: a decade of vemurafenib clinical trials.","authors":"Taylor Gardner, Jacob Duncan, Griffin K Hughes, Ryan McIntire, Brooke Gardner, Andriana Peña, Chase Ladd, Kelsey Snider, Ryan Ottwell, Jordan Tuia, Alyson Haslam, Vinay Prasad, Matt Vassar","doi":"10.1080/20450885.2025.2463830","DOIUrl":"10.1080/20450885.2025.2463830","url":null,"abstract":"<p><strong>Background: </strong>Vemurafenib (Zelboraf<sup>®</sup>, Roche), approved by the FDA in 2011 for unresectable and metastatic melanoma and Erdheim-Chester Disease, has been explored in trials for other BRAF-mutated cancers. Despite 12 years of clinical use, the risk-benefit profile for off-label indications remain unclear.</p><p><strong>Research design and methods: </strong>This study systematically reviewed clinical trials utilizing vemurafenib in adult malignancies, with responses assessed using RECIST or similar criteria. On May 25, 2023, we searched PubMed/MEDLINE, Embase, Cochrane CENTRAL, and ClinicalTrials.gov. Screening and data extraction were performed in a masked, duplicate fashion, collecting data on trial characteristics, adverse events, progression-free survival, overall survival, and objective response rates.</p><p><strong>Results: </strong>Vemurafenib was tested in 15 cancers beyond its FDA-approved indications. A 0% complete response rate was observed in colorectal cancer, non-small cell lung cancer, and papillary thyroid cancer. Adverse events were more frequent in non-melanoma cancers, with 5,205 grade 3-5 events reported, equating to two severe events for every three participants. Only metastatic melanoma consistently demonstrated efficacy, aligning with its FDA approval.</p><p><strong>Conclusions: </strong>Although vemurafenib showed efficacy in metastatic melanoma, off-label use resulted in limited benefit and increased adverse events. Unclear endpoints and underreported adverse events highlight the need for improved clinical trial design.</p>","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2463830"},"PeriodicalIF":0.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145744987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-09-29DOI: 10.1080/20450885.2025.2564060
Chaitra Subramanyam, Nimrit Gahoonia, Catherine Shachaf, Raja Sivamani
Aims: Skin biopsy remains the diagnostic gold standard for assessing melanocytic lesions, yet its use is influenced by provider experience and scope of practice. This study evaluated patient attitudes toward biopsy, barriers such as discomfort and needle phobia, and interest in noninvasive alternatives.
Patients and methods: A cross-sectional survey of 506 adults assessed prior biopsy experience, biopsy-related discomfort, recovery time, anesthesia pain, needle fear and willingness to pay for noninvasive tools.
Results: Twenty-eight percent of respondents had undergone biopsy. Of these, two-thirds reported discomfort and 28% rated it moderate to high. Recovery lasted ≥1 week for 59%, ≥2 weeks for 18%, and ≥1 month for 7%. Anesthesia was moderately to very painful for 33%. Common concerns included pain, scarring, infection risk and prolonged healing. Among those with biopsy experience, 53% expressed strong interest in noninvasive diagnostics, and 82% were willing to pay out-of-pocket.
Conclusions: Patient-reported pain, needle fear and prolonged recovery contribute to hesitancy toward biopsy. Strong interest in noninvasive methods underscores the need to advance alternatives such as reflective confocal microscopy, tape stripping and electrical impedance spectroscopy, while future studies should examine socioeconomic and access-related influences.
{"title":"Beliefs and attitudes toward skin biopsy as a diagnostic tool: a cross-sectional survey among US patients.","authors":"Chaitra Subramanyam, Nimrit Gahoonia, Catherine Shachaf, Raja Sivamani","doi":"10.1080/20450885.2025.2564060","DOIUrl":"10.1080/20450885.2025.2564060","url":null,"abstract":"<p><strong>Aims: </strong>Skin biopsy remains the diagnostic gold standard for assessing melanocytic lesions, yet its use is influenced by provider experience and scope of practice. This study evaluated patient attitudes toward biopsy, barriers such as discomfort and needle phobia, and interest in noninvasive alternatives.</p><p><strong>Patients and methods: </strong>A cross-sectional survey of 506 adults assessed prior biopsy experience, biopsy-related discomfort, recovery time, anesthesia pain, needle fear and willingness to pay for noninvasive tools.</p><p><strong>Results: </strong>Twenty-eight percent of respondents had undergone biopsy. Of these, two-thirds reported discomfort and 28% rated it moderate to high. Recovery lasted ≥1 week for 59%, ≥2 weeks for 18%, and ≥1 month for 7%. Anesthesia was moderately to very painful for 33%. Common concerns included pain, scarring, infection risk and prolonged healing. Among those with biopsy experience, 53% expressed strong interest in noninvasive diagnostics, and 82% were willing to pay out-of-pocket.</p><p><strong>Conclusions: </strong>Patient-reported pain, needle fear and prolonged recovery contribute to hesitancy toward biopsy. Strong interest in noninvasive methods underscores the need to advance alternatives such as reflective confocal microscopy, tape stripping and electrical impedance spectroscopy, while future studies should examine socioeconomic and access-related influences.</p>","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2564060"},"PeriodicalIF":0.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145187101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-08-29DOI: 10.1080/20450885.2025.2550234
Erol Benlier, Fatih Akyar, Kübra Afşaroğlu Zöhra
Primary dermal melanoma (PDM) is a rare subtype of cutaneous melanoma, with involvement of the dermis/subcutaneous tissue or both, but no involvement of the epidermis. PDM could not be distinguished histologically from metastasis of primary cutaneous melanoma. PDM has a longer life expectancy compared to cutaneous metastatic melanoma. Therefore, it is important to recognize PDM and make a correct diagnosis. We present a case of primary dermal melanoma on the left leg of a 38-year-old woman.
{"title":"Primary dermal melanoma: a rare subtype of cutaneous melanoma.","authors":"Erol Benlier, Fatih Akyar, Kübra Afşaroğlu Zöhra","doi":"10.1080/20450885.2025.2550234","DOIUrl":"10.1080/20450885.2025.2550234","url":null,"abstract":"<p><p>Primary dermal melanoma (PDM) is a rare subtype of cutaneous melanoma, with involvement of the dermis/subcutaneous tissue or both, but no involvement of the epidermis. PDM could not be distinguished histologically from metastasis of primary cutaneous melanoma. PDM has a longer life expectancy compared to cutaneous metastatic melanoma. Therefore, it is important to recognize PDM and make a correct diagnosis. We present a case of primary dermal melanoma on the left leg of a 38-year-old woman.</p>","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2550234"},"PeriodicalIF":0.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12407635/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144973254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-27DOI: 10.1080/20450885.2025.2570631
Grace Rabinowitz, Braxton R Schuldt, Andrew L Ji, Nicholas Gulati
{"title":"Brain organoid technology in melanoma metastasis to the brain.","authors":"Grace Rabinowitz, Braxton R Schuldt, Andrew L Ji, Nicholas Gulati","doi":"10.1080/20450885.2025.2570631","DOIUrl":"10.1080/20450885.2025.2570631","url":null,"abstract":"","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2570631"},"PeriodicalIF":0.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12562659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145379330","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-08-28DOI: 10.1080/20450885.2025.2545167
Christoffer Gebhardt, Dirk Debus, Peter Rohrer, Katharina C Kähler, Lukas Koch, Patrick Terheyden, Van Anh Nguyen
The management of advanced, unresectable, or metastatic BRAFV600-mutated melanoma is complex, particularly regarding therapy sequencing with targeted therapies (TT) and immune checkpoint inhibitors (ICI). The REMINISCENCE project aimed to enhance individualized therapy approaches by analyzing case reports of patients undergoing encorafenib and binimetinib (EB) therapy. This report discusses three melanoma patients with brain metastases treated in Germany and Austria, emphasizing personalized treatment strategies in BRAFV600-mutated melanoma, particularly when both ICI and TT are available. The timing for transitioning between therapies remains contentious, with many patients experiencing disease progression during or after adjuvant therapy. Findings from clinical trials like DREAMseq, SECOMBIT, EBIN, and ImmunoCobiVem may not directly apply to this evolving clinical landscape due to the impact of prior therapies on the tumor microenvironment. The variations in trial designs further complicate sequencing strategies. Emerging methods, such as early circulating tumor DNA (ctDNA)-guided approaches, present potential pathways for personalized treatment. Ongoing research into sequencing therapy is crucial for improving clinical outcomes. To determine the most effective treatment sequences based on individual medical histories, genetic profiles, and treatment goals, there is an urgent need for prospective biomarker-driven clinical trials.
{"title":"Personalized therapies in advanced BRAFV600-mutated melanoma: review based on 3 case reports of the REMINISCENCE project.","authors":"Christoffer Gebhardt, Dirk Debus, Peter Rohrer, Katharina C Kähler, Lukas Koch, Patrick Terheyden, Van Anh Nguyen","doi":"10.1080/20450885.2025.2545167","DOIUrl":"10.1080/20450885.2025.2545167","url":null,"abstract":"<p><p>The management of advanced, unresectable, or metastatic BRAFV600-mutated melanoma is complex, particularly regarding therapy sequencing with targeted therapies (TT) and immune checkpoint inhibitors (ICI). The REMINISCENCE project aimed to enhance individualized therapy approaches by analyzing case reports of patients undergoing encorafenib and binimetinib (EB) therapy. This report discusses three melanoma patients with brain metastases treated in Germany and Austria, emphasizing personalized treatment strategies in BRAFV600-mutated melanoma, particularly when both ICI and TT are available. The timing for transitioning between therapies remains contentious, with many patients experiencing disease progression during or after adjuvant therapy. Findings from clinical trials like DREAMseq, SECOMBIT, EBIN, and ImmunoCobiVem may not directly apply to this evolving clinical landscape due to the impact of prior therapies on the tumor microenvironment. The variations in trial designs further complicate sequencing strategies. Emerging methods, such as early circulating tumor DNA (ctDNA)-guided approaches, present potential pathways for personalized treatment. Ongoing research into sequencing therapy is crucial for improving clinical outcomes. To determine the most effective treatment sequences based on individual medical histories, genetic profiles, and treatment goals, there is an urgent need for prospective biomarker-driven clinical trials.</p>","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2545167"},"PeriodicalIF":0.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12407833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144973262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-18DOI: 10.1080/20450885.2025.2570112
Luis Vaz, Shital Vekeria, Amal Sadou, Alissar Moussallem, Alejandro Noval, Xavier Guillaume, Grant Cairns
<p><strong>Aim: </strong>To understand patient preferences for treatment attributes in adjuvant and metastatic melanoma in the UK.</p><p><strong>Materials and methods: </strong>Patients with stages II-IV melanoma completed an online survey from November 2022 to February 2023 comprising two discrete choice experiments (DCE) exploring efficacy, safety, and dosing regimen.</p><p><strong>Results: </strong>Out of 104 respondents, 100 and 102 patients completed DCEs for adjuvant (Adj-DCE) and metastatic (Met-DCE) settings, respectively. 4-year relapse-free survival (RFS) for Adj-DCE (33%), and 4-year overall survival (OS) for Met-DCE (40%) had the highest relative attribute importance (RI), followed by risk of grade ≥3 adverse events (29% versus 26%, respectively). Patients with advanced melanoma or BRAF mutation had significantly higher RI for RFS and OS.</p><p><strong>Conclusion: </strong>Patients, especially those with advanced melanoma or BRAF mutation, perceive efficacy as the most important factor in determining choice of treatment.ARTICLE HIGHLIGHTSIn the UK, melanoma is the 5<sup>th</sup> most common cancer with around 19,921 newly diagnosed cases in 2022. Fortunately, treatment options for patients with melanoma have expanded significantly over the past few years. Each of these new therapies carries a different benefit-to-risk profile and varies with regard to different aspects of patient convenience.The aim of this study was to understand patient preferences for adjuvant and metastatic treatment attributes in stage II/III and stage IV melanoma in the UK and to determine predictive factors for treatment preferences in different subpopulations.A discrete-choice experiment (DCE) was conducted via an online quantitative treatment preference survey to elicit patients' relative preferences for treatment attributes, including safety, dosing regimen, and efficacy for adjuvant and metastatic settings, respectively.Analysis of the DCE data using Hierarchical Bayesian (HB) model revealed distinct preferences among the 104 survey respondents.Efficacy, as assessed by 4-year RFS in the adjuvant setting and 4-year OS in the metastatic setting, was the most important attribute, followed by severe adverse events (AEs) and dosing regimen.Immune checkpoint inhibitors (ICI) were consistently ranked as the preferred options across all patient segments. Based on the hypothetical drug profile presented in the DCE, the fixed dose combination of nivolumab and relatlimab was the preferred regimen in the metastatic disease setting while either pembrolizumab or nivolumab were preferred in the adjuvant setting.Our study highlights the importance of considering patients' prioritization of treatment efficacy as the primary factor when making decisions about melanoma care, both in the adjuvant and metastatic settings. Although efficacy and safety were attributed to have relatively similar importance for treatment preference in the adjuvant setting, patients with more advanc
{"title":"Patient preferences for stages II-IV melanoma treatments in the UK: results from a cross-sectional study.","authors":"Luis Vaz, Shital Vekeria, Amal Sadou, Alissar Moussallem, Alejandro Noval, Xavier Guillaume, Grant Cairns","doi":"10.1080/20450885.2025.2570112","DOIUrl":"10.1080/20450885.2025.2570112","url":null,"abstract":"<p><strong>Aim: </strong>To understand patient preferences for treatment attributes in adjuvant and metastatic melanoma in the UK.</p><p><strong>Materials and methods: </strong>Patients with stages II-IV melanoma completed an online survey from November 2022 to February 2023 comprising two discrete choice experiments (DCE) exploring efficacy, safety, and dosing regimen.</p><p><strong>Results: </strong>Out of 104 respondents, 100 and 102 patients completed DCEs for adjuvant (Adj-DCE) and metastatic (Met-DCE) settings, respectively. 4-year relapse-free survival (RFS) for Adj-DCE (33%), and 4-year overall survival (OS) for Met-DCE (40%) had the highest relative attribute importance (RI), followed by risk of grade ≥3 adverse events (29% versus 26%, respectively). Patients with advanced melanoma or BRAF mutation had significantly higher RI for RFS and OS.</p><p><strong>Conclusion: </strong>Patients, especially those with advanced melanoma or BRAF mutation, perceive efficacy as the most important factor in determining choice of treatment.ARTICLE HIGHLIGHTSIn the UK, melanoma is the 5<sup>th</sup> most common cancer with around 19,921 newly diagnosed cases in 2022. Fortunately, treatment options for patients with melanoma have expanded significantly over the past few years. Each of these new therapies carries a different benefit-to-risk profile and varies with regard to different aspects of patient convenience.The aim of this study was to understand patient preferences for adjuvant and metastatic treatment attributes in stage II/III and stage IV melanoma in the UK and to determine predictive factors for treatment preferences in different subpopulations.A discrete-choice experiment (DCE) was conducted via an online quantitative treatment preference survey to elicit patients' relative preferences for treatment attributes, including safety, dosing regimen, and efficacy for adjuvant and metastatic settings, respectively.Analysis of the DCE data using Hierarchical Bayesian (HB) model revealed distinct preferences among the 104 survey respondents.Efficacy, as assessed by 4-year RFS in the adjuvant setting and 4-year OS in the metastatic setting, was the most important attribute, followed by severe adverse events (AEs) and dosing regimen.Immune checkpoint inhibitors (ICI) were consistently ranked as the preferred options across all patient segments. Based on the hypothetical drug profile presented in the DCE, the fixed dose combination of nivolumab and relatlimab was the preferred regimen in the metastatic disease setting while either pembrolizumab or nivolumab were preferred in the adjuvant setting.Our study highlights the importance of considering patients' prioritization of treatment efficacy as the primary factor when making decisions about melanoma care, both in the adjuvant and metastatic settings. Although efficacy and safety were attributed to have relatively similar importance for treatment preference in the adjuvant setting, patients with more advanc","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2570112"},"PeriodicalIF":0.7,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12536637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145318747","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-05-05DOI: 10.1080/20450885.2025.2494977
Viktor T Gill, Shiva Sabazade, Gustav Stålhammar
Aim: The collaborative ocular melanoma study (COMS) reported similar survival between plaque brachytherapy (a type of interventional radiotherapy) and enucleation for medium-sized choroidal melanomas. We aimed to quantify the mortality differences required to achieve statistical significance and assess the robustness of these thresholds.
Methods: We reanalyzed 12-year mortality data from COMS using threshold analysis to determine how many additional or fewer deaths in either treatment arm would shift the lower bound of the 95% confidence interval (CI) for the risk ratio above 1.
Results: At 12 years, there were 105 melanoma-related deaths in the brachytherapy arm and 98 in the enucleation arm (risk ratio 1.08, 95% CI 0.82-1.42). Achieving statistical significance would have required 31 additional deaths in the brachytherapy arm or 23 fewer in the enucleation arm; conversely, favoring brachytherapy would have necessitated 34 additional deaths in the enucleation arm or 27 fewer in the brachytherapy arm. These thresholds remained consistent across power levels and sensitivity scenarios.
Conclusions: The COMS trial did not reveal a clinically meaningful survival difference. Our findings underscore the substantial mortality shifts required for statistical significance and highlight the challenges in detecting modest treatment effects in uveal melanoma trials.
目的:眼部黑色素瘤联合研究(COMS)报告了斑块近距离放疗(一种介入放疗)和去核治疗中等脉络膜黑色素瘤的生存率相似。我们的目的是量化达到统计显著性所需的死亡率差异,并评估这些阈值的稳健性。方法:我们使用阈值分析重新分析了COMS的12年死亡率数据,以确定两个治疗组中增加或减少的死亡人数会改变风险比大于1的95%置信区间(CI)的下限。结果:12年时,近距离放疗组有105例黑色素瘤相关死亡,去核组有98例(风险比1.08,95% CI 0.82-1.42)。达到统计学显著性需要近距离放疗组增加31例死亡或去核组减少23例死亡;相反,选择近距离放疗会使去核组增加34例死亡,近距离放疗组减少27例死亡。这些阈值在功率水平和灵敏度情况下保持一致。结论:COMS试验未显示有临床意义的生存差异。我们的研究结果强调了统计显著性所需的大量死亡率变化,并强调了在葡萄膜黑色素瘤试验中检测适度治疗效果的挑战。
{"title":"Threshold analysis of mortality outcomes in the collaborative ocular melanoma study (COMS).","authors":"Viktor T Gill, Shiva Sabazade, Gustav Stålhammar","doi":"10.1080/20450885.2025.2494977","DOIUrl":"https://doi.org/10.1080/20450885.2025.2494977","url":null,"abstract":"<p><strong>Aim: </strong>The collaborative ocular melanoma study (COMS) reported similar survival between plaque brachytherapy (a type of interventional radiotherapy) and enucleation for medium-sized choroidal melanomas. We aimed to quantify the mortality differences required to achieve statistical significance and assess the robustness of these thresholds.</p><p><strong>Methods: </strong>We reanalyzed 12-year mortality data from COMS using threshold analysis to determine how many additional or fewer deaths in either treatment arm would shift the lower bound of the 95% confidence interval (CI) for the risk ratio above 1.</p><p><strong>Results: </strong>At 12 years, there were 105 melanoma-related deaths in the brachytherapy arm and 98 in the enucleation arm (risk ratio 1.08, 95% CI 0.82-1.42). Achieving statistical significance would have required 31 additional deaths in the brachytherapy arm or 23 fewer in the enucleation arm; conversely, favoring brachytherapy would have necessitated 34 additional deaths in the enucleation arm or 27 fewer in the brachytherapy arm. These thresholds remained consistent across power levels and sensitivity scenarios.</p><p><strong>Conclusions: </strong>The COMS trial did not reveal a clinically meaningful survival difference. Our findings underscore the substantial mortality shifts required for statistical significance and highlight the challenges in detecting modest treatment effects in uveal melanoma trials.</p>","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2494977"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12054375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144055396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-04-28DOI: 10.1080/20450885.2025.2494979
Zhen Yu Wong, Aisha Chaudry, Samuel Teklay, Zhen Ning Wong, Oluwatobi Adegboye, Pojsakorn Danpanichkul, Ryan Faderani, Muholan Kanapathy, Afshin Mosahebi
Background: This bibliometric analysis aims to describe research trends and assess the methodological quality of the highest-impact SLNB research in melanoma.
Methods: We identified the 90 most cited publications on SLNB in melanoma using Web of Science, covering all available journal years (from 2005 to date). The Oxford Center for Evidence-Based Medicine (OCEBM) Levels of Evidence (LOE) were used to assess the methodological quality of each study.
Results: The 90 most cited publications on SLNB in melanoma collectively garnered 10,314 citations. Citation counts per publication ranged from 44 to 1,405 (mean 114.6 ± 185.2), with the highest-cited study authored by Professor Donald Morton et al. The majority of publications was classified as LOE 3 (n = 36). The United States of America (USA) led in publication output with 43 articles. Professors Merrick Ross (USA) and John Thompson (Australia) were the leading authors by publication count. The University of Sydney (Australia), University of Texas System, and Anderson Cancer Center (USA) were the top contributing institutions. Annals of Surgical Oncology published most articles.
Conclusions: This bibliometric analysis provides a comprehensive overview and valuable reference for future researchers in the field of SLNB in melanoma.
背景:本文献计量学分析旨在描述研究趋势并评估黑色素瘤中影响最大的SLNB研究的方法学质量。方法:我们使用Web of Science检索了90篇被引用最多的关于黑色素瘤SLNB的论文,涵盖了所有可获得的期刊年份(从2005年至今)。采用牛津循证医学中心(OCEBM)证据水平(LOE)评估每项研究的方法学质量。结果:90篇被引最多的关于黑色素瘤SLNB的论文共被引10314次。每份出版物的引用数从44到1405(平均114.6±185.2)不等,引用率最高的研究由Donald Morton教授等人撰写。大多数出版物被归类为loe3 (n = 36)。美利坚合众国(美国)以43篇文章的出版数量居首位。Merrick Ross教授(美国)和John Thompson教授(澳大利亚)的论文发表量位居前列。悉尼大学(澳大利亚)、德克萨斯大学系统和安德森癌症中心(美国)是贡献最多的机构。Annals of Surgical Oncology发表的文章最多。结论:本文的文献计量学分析为今后SLNB在黑色素瘤中的研究提供了全面的综述和有价值的参考。
{"title":"A bibliometric analysis of sentinel lymph node biopsy in melanoma of the top 90 cited publications.","authors":"Zhen Yu Wong, Aisha Chaudry, Samuel Teklay, Zhen Ning Wong, Oluwatobi Adegboye, Pojsakorn Danpanichkul, Ryan Faderani, Muholan Kanapathy, Afshin Mosahebi","doi":"10.1080/20450885.2025.2494979","DOIUrl":"https://doi.org/10.1080/20450885.2025.2494979","url":null,"abstract":"<p><strong>Background: </strong>This bibliometric analysis aims to describe research trends and assess the methodological quality of the highest-impact SLNB research in melanoma.</p><p><strong>Methods: </strong>We identified the 90 most cited publications on SLNB in melanoma using Web of Science, covering all available journal years (from 2005 to date). The Oxford Center for Evidence-Based Medicine (OCEBM) Levels of Evidence (LOE) were used to assess the methodological quality of each study.</p><p><strong>Results: </strong>The 90 most cited publications on SLNB in melanoma collectively garnered 10,314 citations. Citation counts per publication ranged from 44 to 1,405 (mean 114.6 ± 185.2), with the highest-cited study authored by Professor Donald Morton et al. The majority of publications was classified as LOE 3 (n = 36). The United States of America (USA) led in publication output with 43 articles. Professors Merrick Ross (USA) and John Thompson (Australia) were the leading authors by publication count. The University of Sydney (Australia), University of Texas System, and Anderson Cancer Center (USA) were the top contributing institutions. <i>Annals of Surgical Oncology</i> published most articles.</p><p><strong>Conclusions: </strong>This bibliometric analysis provides a comprehensive overview and valuable reference for future researchers in the field of SLNB in melanoma.</p>","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2494979"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12039427/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-05-28DOI: 10.1080/20450885.2025.2510194
Marc Østergaard Nielsen, Johan Erik Larsson, Linus Daniel Leonhard Duchstein, Lars Thorbjørn Jensen
Background: Advances in cancer therapy have improved patient outcomes, but cardiotoxicity remains a significant risk. In melanoma patients treated with BRAF and MEK inhibitors, monitoring left ventricular ejection fraction (LVEF) during treatment is recommended to detect cardiac dysfunction. Despite the widespread use of FDG-PET in oncology, its potential for concurrent cardiac assessment remains underexplored.
Methods: A 42-year-old male undergoing treatment for disseminated melanoma underwent measurements of LVEF using four modalities: 3D-MUGA, 3D echocardiography, Rb-PET, and gated FDG-PET.
Results: LVEF was within the normal range across all modalities: 60% (3D-MUGA), 61% (3D echocardiography), 63% (Rb-PET), and 65% (FDG-PET).
Conclusion: This case presents an estimation of LVEF derived from a clinically indicated, FDG-PET scan, performed alongside three conventional modalities on the same day. This approach may be particularly useful in melanoma patients who undergo frequent FDG-PET scans. While the findings are promising, broader validation is needed.
{"title":"Case report of LVEF derived from gated FDG-PET: potential to streamline cardiotoxic surveillance in melanoma patients.","authors":"Marc Østergaard Nielsen, Johan Erik Larsson, Linus Daniel Leonhard Duchstein, Lars Thorbjørn Jensen","doi":"10.1080/20450885.2025.2510194","DOIUrl":"10.1080/20450885.2025.2510194","url":null,"abstract":"<p><strong>Background: </strong>Advances in cancer therapy have improved patient outcomes, but cardiotoxicity remains a significant risk. In melanoma patients treated with BRAF and MEK inhibitors, monitoring left ventricular ejection fraction (LVEF) during treatment is recommended to detect cardiac dysfunction. Despite the widespread use of FDG-PET in oncology, its potential for concurrent cardiac assessment remains underexplored.</p><p><strong>Methods: </strong>A 42-year-old male undergoing treatment for disseminated melanoma underwent measurements of LVEF using four modalities: 3D-MUGA, 3D echocardiography, Rb-PET, and gated FDG-PET.</p><p><strong>Results: </strong>LVEF was within the normal range across all modalities: 60% (3D-MUGA), 61% (3D echocardiography), 63% (Rb-PET), and 65% (FDG-PET).</p><p><strong>Conclusion: </strong>This case presents an estimation of LVEF derived from a clinically indicated, FDG-PET scan, performed alongside three conventional modalities on the same day. This approach may be particularly useful in melanoma patients who undergo frequent FDG-PET scans. While the findings are promising, broader validation is needed.</p>","PeriodicalId":44562,"journal":{"name":"Melanoma Management","volume":"12 1","pages":"2510194"},"PeriodicalIF":1.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12123959/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}