Melanoma In Europe Research Articles

Adjuvant Use of Pembrolizumab for Stage III Melanoma in a Real-World Setting in Europe.

Although data on patients treated with pembrolizumab are available from clinical trials and single-country real-world reports, to our knowledge no multi-country real-world studies have investigated the use of pembrolizumab as an adjuvant treatment for stage III melanoma. We used the European Melanoma Registry (EUMelaReg), a disease entity-based registry specific for melanoma, to examine treatment and outcomes for adult patients with stage III melanoma with lymph node involvement who had complete resection and received adjuvant treatment with pembrolizumab. The primary objectives were to describe the demographic and clinical characteristics of the included patients as well as time on adjuvant pembrolizumab treatment (TOT), real-world recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) from adjuvant pembrolizumab initiation. Secondary objectives were time to next treatment (TTNT) after adjuvant use of pembrolizumab, next-line therapy for stage III and unresectable stage IV melanoma and overall survival (OS) from initiation of pembrolizumab. Patients were stratified according to age, sex, BRAF status, number of positive lymph nodes and disease substage. Median TOT was 11.1 (9.2-11.5) months, median RFS was 29.6 [18.7-not reached (NR)] months and median DMFS was 32.4 (22.7-NR) months. TTNT was 29.9 (22.2-NR) months, while median OS was not reached. The results of this study offer insights into the real-world use of pembrolizumab as an adjuvant therapy for melanoma in Europe.

The productivity cost of mortality due to lung cancer, breast cancer and melanoma in Europe across 2010, 2015 and 2019

BackgroundCancer caused an estimated 2.2 million deaths across Europe in 2020. This analysis estimated the cost of lost productivity due to premature deaths associated with lung, breast and melanoma cancer and investigated the temporal trends across European regions across 2010, 2015 and 2019. MethodThe human capital approach was used to estimate the indirect costs from lung, melanoma, and breast cancers (ICD-10 code: C33–34, C43, and C50, respectively) in Northern, Eastern, Southern, and Western Europe. Age-specific mortality, and country-specific wages and employment rates were used to calculate years of productive life lost (YPLL), YPLL/death and present value of future lost productivity (PVFLP). Data were sourced from the World Health Organization, Eurostat, and the World Bank. ResultsThe number of cancer deaths remained relatively stable from 2010 to 2019. YPLL/death decreased across all European regions and for all cancers between 2010 and 2019 (reported ranges across European regions; lung cancer: 25–42 %; breast cancer: 18–21 %; melanoma: 31–37 %). In Europe, the decrease in PVFLP in 2019 compared to 2010 was €2995M for lung cancer, €295M for melanoma, and €466M for breast cancer, with an overall reduction of productivity cost of €3756M in these cancer types. ConclusionThe results from this study illustrate a decreased trend in productivity costs from 2010 to 2019 which could be driven by deaths occurring at an older age, suggesting that advances in cancer prevention and the treatment landscape have extended the life of cancer patients, yielding less productivity losses. Policy summaryThe indirect economic costs modelled show the impact of past effective health policies and new treatments. Continued efforts to improve public health policies in supporting public awareness of risk factors and value of early diagnosis could lead to further reduction in these losses. Prevention, early diagnosis, and activation of early treatment pathways could serve to reduce loss of life and improve productivity.

Melanoma epidemiology in Europe: what is new?

Every year in Europe over 150,000 new cases of melanoma are reported and over 25,000 lives are lost to this tumor. Incidence has been rising rapidly, faster than for any other cancer, and it is expected to continue to do so in most regions. Mortality also crept up, decades-long, with only few very recent exceptions. Thus, melanoma remains a public health problem that will not go away soon, nor easy. Some notable progress has been made in the last decade in the fight against this tumor. Registration and reporting for skin cancers improved across Europe. Incidence trends have begun to plateau or even to descend in younger age groups, in some countries, and there are encouraging signs that mortality might do the same, after the recent therapeutic breakthroughs. Survival rates are on average above 80% at 5 years for European patients, while diagnosis trends toward ever thinner tumors. Yet this progress is far from uniform across the continent, with many Southern-and Eastern European countries still struggling with sub-optimal cancer reporting, delayed access to innovative treatments, late detection and insufficient healthcare funding, that push survival rates down to harrowing 50%. This article aims to give an updated overview of the epidemiological situation of melanoma in Europe, highlighting the progress but also the persisting disparities in tumor burden, prognosis and access to quality cancer care and surveillance between European countries, as a reminder that relentless efforts must continue in order to tackle this aggressive tumor in an effective and equitable manner.

A Meta-Analysis on the Impact of the COVID-19 Pandemic on Cutaneous Melanoma Diagnosis in Europe.

The COVID-19 pandemic has been the epicenter of healthcare attention globally for the past two years, and large-scale adaptations in healthcare provision have been required. This study aimed to investigate the impact of the pandemic and the resulting lockdowns on cutaneous melanoma diagnosis and tumor burdens in Europe. A relevant literature search in electronic databases was conducted from inception to September 2022. The inclusion criteria were: controlled studies published in a peer-reviewed journal evaluating cutaneous melanoma in Europe and reporting data on melanoma characteristics from diagnoses. The quality of studies was evaluated using the Cochrane ROBINS-I tool for assessing bias in non-randomized studies. Meta-analysis was conducted utilizing a random effects model to synthesize the data. A total of 25 studies involving 32,231 patients were included in the data analysis models. Statistically significant increases in mean Breslow thickness (0.29 mm (0.03-0.55 mm)), ulceration rates (OR = 1.66 (1.29-2.13)), and resultant tumor staging were observed in the PostCovid group, with subgroup analysis revealing that lockdown-derived data were responsible for this trend. This meta-analysis reported on the impact of COVID-19 restrictions on melanoma diagnosis in Europe, emphasizing the higher tumor burden and disease progression state provoked by healthcare adaptations in the pandemic period.

EMRseq: Registry-based outcome analysis on 1,000 patients with BRAF V600–mutated metastatic melanoma in Europe treated with either immune checkpoint or BRAF-/MEK inhibition.

9540 Background: In BRAF mutated metastatic melanoma, potential outcome differences for different choices of 1st line treatments including immunotherapy or BRAF-/MEK inhibition are not completely understood. We therefore analyzed the treatment patterns and outcome of systemic therapies for patients BRAF mutated metastatic melanoma. Methods: From the EUMelaReg treatment registry, patients fulfilling the following inclusion criteria were consecutively included until a number of 1,000 evaluable cases was reached. 1) Patients with metastatic melanoma and BRAF V600 mutation 2) First line treatment with either combined BRAF-/MEK or immune checkpoint inhibition (ICI) with PD-1 single agent or combined PD-1/CTLA-4 antibodies. Multivariable cox regression analysis as well as propensity score based weighting were used to control for bias from baseline imbalances. Primary outcomes of interest were overall survival (OS) and 2nd line PFS (PFS-2), stratified for upfront treatment decision of ICI versus targeted therapy. PFS-2 was defined as the interval from start of first line treatment to a progression after a 2nd line treatment or death of any cause. Further endpoints were evaluated including time on treatment (ToT), time to next treatment and 2nd line treatments. Results: In total 529 (52.9 %) patients received BRAF/MEK-i, and 471 (47.1%) ICI. For various co-variates there were significant imbalances between strata, including number of metastatic sites, AJCC substage, serum LDH, and ECOG performance status, with more favorable prognostic variables for patients receiving immunotherapy. The ORR for BRAF/MEK-i was significantly higher than for ICI (53.3% vs. 42.0%; p=0.0004), but for OS and PFS2 the adjusted hazard ratios were significantly in favor for ICI (HR 0.62 and 0.66, respectively; p <0.0001). In 2nd line, patients switching from ICI to BRAF/MEK-i had again markedly higher ORR than patients switching vice versa (57.7% vs. 19.9%; P<0.0001), and also significantly longer unadjusted PFS (8.1 vs. 3.1 months; p <0.0001) and OS (15.7 vs. 10.6 mths; p=0.01) after start of 2nd line treatment. Conclusions: The two cohorts had imbalances on key prognosis variables. After adjustment for these imbalances, upfront ICI still resulted in significantly longer OS as compared to BRAF/MEK-i. Due to the nature of real-world observational data causing inherent imbalances in the treatments cohorts and being unable to account for potential unknown confounders, outcome may still be biased despite adjustment efforts.[Table: see text]

Prevention and screening of melanoma in Europe: 20 years of the Euromelanoma campaign.

Euromelanoma is a Europe-wide, dermatologist-led organization that campaigns to have a public, scientific, and political impact on raising awareness of the prevention, early diagnosis, and treatment of skin cancer. The organization raises public awareness of skin cancer by providing practical support to participating countries for the roll out of yearly screening campaigns, and then builds on these campaigns by providing resources via its website to educate the general public on key skin cancer prevention measures, risk factors, and the importance of recognizing abnormal lesions through self-examination. Euromelanoma also provides a valuable platform for the scientific community, facilitating collaborations between countries and coordinating the collection of standardized data on the epidemiology, demographic and clinical characteristics, and risk factors for all forms of skin cancer. As our scientific understanding of skin cancer advances, Euromelanoma plays a key role in ensuring that the importance of skin cancer prevention, treatment, and diagnosis remains at the forefront of European and national healthcare policies. Since its creation in 1999, Euromelanoma has continued to evolve, adapt, and expand its approach to achieve these public, scientific, and political goals: the organization now has networks of dermatologists working in over 30 countries and has screened and gathered skin cancer data from around 420 000 subjects. This review highlights these achievements by providing an outline of the history of Euromelanoma and the benefits of the first decade of action and by describing the evolving approach over the past 20 years. Future Euromelanoma projects, which aim to evaluate skin cancer risk in specific populations (outdoor workers, organ transplant recipients, etc.) are also introduced, and current challenges for the Euromelanoma campaign are discussed, including the need to improve reporting of non-melanoma skin cancer cases and to raise awareness of melanoma subtypes, particularly the more difficult to diagnose nodular melanoma form.

Cost-effectiveness of adjuvant systemic therapies for patients with high-risk melanoma in Europe: a model-based economic evaluation

BackgroundThe introduction of adjuvant systemic treatment has significantly improved recurrence-free survival in patients with resectable high-risk melanoma. Adjuvant treatment with immune checkpoint inhibitors and targeted therapy, however, substantially impacts health care budgets, while the number of patients with melanoma who are treated in the adjuvant setting is still increasing. To evaluate the socioeconomic impact of the three adjuvant treatments, a cost-effectiveness analysis (CEA) was carried out.Materials and methodsData were obtained from the three pivotal registration phase III clinical trials on the adjuvant treatment of patients with resected high-risk stage III in melanoma (KEYNOTE-054, CheckMate 238, and COMBI-AD). For this CEA, a Markov model with three health states (no evidence of disease, recurrent/progressive disease, and death) was applied. From a societal perspective, different adjuvant strategies were compared according to total costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. To evaluate model uncertainty, sensitivity analyses (deterministic and probabilistic) were carried out.ResultsIn the adjuvant setting, total costs (per patient) were €168 826 for nivolumab, €194 529 for pembrolizumab, and €211 110 for dabrafenib-trametinib. These costs were mainly determined by drug acquisition costs, whereas routine surveillance costs varied from €126 096 to €134 945. Compared with routine surveillance, LYs improved by approximately 1.41 for all therapies and QALYs improved by 2.02 for immune checkpoint inhibitors and 2.03 for targeted therapy. This resulted in incremental cost-effectiveness ratios of €21 153 (nivolumab), €33 878 (pembrolizumab), and €37 520 (dabrafenib-trametinib) per QALY gained.ConclusionsThis CEA compared the three EMA-approved adjuvant systemic therapies for resected stage III melanoma. Adjuvant treatment with nivolumab was the most cost-effective, followed by pembrolizumab. Combination therapy with dabrafenib-trametinib was the least cost-effective. With the increasing number of patients with high-risk melanoma who will be treated with adjuvant treatment, there is an urgent need to reduce drug costs while developing better prognostic and predictive tools to identify patients who will benefit from adjuvant treatment.

Which medical disciplines diagnose and treat melanoma in Europe in 2019? A survey of experts from melanoma centres in 27 European countries.

The incidence of melanoma is increasing. This places significant burden on societies to provide efficient cancer care. The European Cancer Organisation recently published the essential requirements for quality melanoma care. The present study is aimed for the first time to roughly estimate the extent to which these requirements have been met in Europe. A web-based survey of experts from melanoma centres in 27 European countries was conducted from 1 February to 1 August 2019. Data on diagnostic techniques, surgical and medical treatment, organization of cancer care and education were collected and correlated with national health and economic indicators and mortality-to-incidence ratio (MIR) as a surrogate for survival. Univariate linear regression analysis was performed to evaluate the correlations. SPSS software was used. Statistical significance was set at P<0.05. The MIR was lower in countries with a high health expenditure per capita and with a higher numbers of general practitioners (GPs) and surgeons (SURG) per million inhabitants. In these countries, GPs and dermatologists (DER) were involved in melanoma detection; high percentage of DER used dermatoscopy and were involved in the follow-up of all melanoma stages; both medical oncologists (ONC) and dermato-oncologists administered systemic treatments; and patients had better access to sentinel lymph node biopsy and were treated within multidisciplinary tumour boards. Based on these first estimates, the greater involvement of GPs in melanoma detection; the greater involvement of highly trained DER in dermatoscopy, dermatosurgery, follow-up and the systemic treatment of melanoma; and the provision of ongoing dermato-oncology training for pathologists, SURG, DER and ONC are necessary to provide an optimal melanoma care pathway. A comprehensive analysis of the melanoma care pathway based on clinical melanoma registries will be needed to more accurately evaluate these first insights.

Risk Factors for Malignant Melanoma in Romania

In all ages of population in the recent decades, Malignant melanoma is the most dangerous type of skin cancer in the whole world. Its incidence has increased worldwide and that for and earlier diagnosis programs, who reduce the morbidity and mortality of the malignant disease . The Parisian physician Rene Laennac’s was the first who reported 200 years ago, the presence of melanoma in Europe

Incidence and Survival of Patients With Conjunctival Melanoma in Europe

Conjunctival melanoma (CM) is a rare ocular tumor. Estimates of incidence and survival of patients with CM are important to researchers and policy makers. To estimate incidence and survival of patients with CM in Europe. This population-based cohort study used data from 41 European cancer registries adhering to the RARECAREnet project. All individuals diagnosed as having malignant CM from January 1995 to December 2007 coded according to the International Classification of Diseases for Oncology, Third Edition codes C69.0 (conjunctiva) and 8720-8780 (melanoma) were included. Analysis began March 2019. Trend estimates for incidence and for 5-year relative survival (the ratio of the measured survival of patients to the expected survival in the general population for the same country, age, sex, and calendar year). Crude, age-standardized, and bayesian incidence rates were calculated. Five-year relative survival was calculated by the Ederer II method with the cohort and period approach. A total of 724 patients 15 years or older (512 [70.7%] were 55 years or older; 366 [50.6%] were female) were analyzed with an overall crude incidence of CM (per 1 000 000 person/y) of 0.46 (95% CI, 0.42-0.49). Crude incidence was similar in men and women (0.48; 95% CI, 0.44-0.54 and 0.46; 95% CI, 0.41-0.51, respectively) and increased with age. Age-standardized incidence increased over time only in men and was the highest in Norway and the Netherlands (more than 0.70). Only 1 case in 14 years was estimated to occur in Iceland vs about 20 cases per year in large countries such as France and Germany. Percentage of 5-year survival (83.5 overall; 95% CI, 78.6-87.3) was not different between adult and elderly patients but showed large geographical disparities across European regions (range, 66-89) and improved markedly in male patients (from 76 in 1995-1998 to 86 in 2003-2007, with a difference of 10.2 [95% CI, 1.3-19.2]; P < .05) becoming similar to that of women in the last period. Although these data are only available through 2007 and based on registries not uniformly covering the European population, the study provides the first Europe-wide estimates of the incidence and relative survival of patients with CM using population-based data. Geographical differences in survival indicate room for outcome improvement in Southern, Northern, and Eastern European countries.

PCN66 A COST-UTILITY ANALYSIS OF NIVOLUMAB IN THE ADJUVANT TREATMENT OF MELANOMA IN FRANCE

The anti-PD1 nivolumab, as monotherapy, is indicated for adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. We conducted a cost-utility analysis with the objective of evaluating nivolumab efficiency in France. A 3-state partitioned survival model, comprising recurrence-free survival (RFS), post-recurrence survival and death simulated a cohort of French patients within the adjuvant indication over 20 years. Standard recommended comparators, matching the population of indication, were observation and low dose interferon (LD-IFN). The model used clinical data from pivotal phase III trial Checkmate 238 comparing nivolumab to ipilimumab. Ipilimumab, not approved for adjuvant treatment of melanoma in Europe, was used as connecting strategy within the network meta-analysis used to estimate relative efficacy of nivolumab versus comparators. RFS and overall survival (OS) were extrapolated with parametric distributions using as reference the placebo arm from study CA184-029. As OS data is not available in CheckMate 238 to date, a predictive model based on RFS-OS correlation equation was used; as scenario, nivolumab OS was conservatively assumed equivalent to ipilimumab OS in CA184-029. Utilities were derived from EQ-5D data collected in Checkmate 238. Costs consisted of acquisition and administration, monitoring, subsequent therapies, palliative care, adverse events and transportation. Costs for active treatments were based on drug public prices. In both base case and conservative scenarios, nivolumab respectively resulted in a discounted total of 9.62 and 8.47 life-years and 7.76 and 6.97 quality-adjusted life years (QALY). The efficiency frontier consisted of observation, LD-IFN and nivolumab. The incremental cost-utility ratio (ICUR) of nivolumab was respectively 34,620 €/QALY and 68,928 €/QALY versus LD-IFN (incremental costs: 44,992 € and 35,667 €, incremental QALY: 1.30 and 0.52). Using two different scenarios, this analysis suggested that nivolumab was a cost-effective strategy as adjuvant treatment of adults with melanoma in France.

Cost-of-illness of melanoma in Europe - a systematic review of the published literature.

Malignant melanoma accounts for the vast majority of skin cancer deaths. Primary prevention is used to increase knowledge about skin cancer and set incentives for a change in behaviour, which leads to a decrease in cases. Primary prevention may be cost-effective or even cost saving. Cost-of-illness (COI) studies provide information on such potential savings. The purpose of this study is to give an overview on COI studies in European countries and to compare the COI in total and by cost categories. The results can be used to model potential cost savings from prevention. We conducted a systematic literature research in PubMed using the PRISMA checklist. All costs were converted into Euro and adjusted for the reference year 2012. For the ranking of countries according to their COI, all costs were adjusted for the purchasing power parity. All studies focusing on stage III-IV melanoma include information on hospital, hospice, and outpatient treatment. Costs for the treatment of advanced melanoma range between €2972 in Italy and €17408 in Sweden after adjusting for purchasing power parity. Most studies on stage I-IV melanoma include costs of hospitalization, outpatient treatment and general practitioner consultation. Direct costs range from €923 in Sweden to €9829 in Denmark. Three articles also include information on indirect costs. Mortality costs vary between €3511 in Sweden and €20408 in England, morbidity costs between €103 in Sweden and €4550 in England. We showed that costs for the treatment of skin cancer are moderately high in the included countries. Since after publication of the articles new costly drugs were approved in Europe, treatment costs of melanoma in Europe may be expected to have risen in the last few years, which means that there is a high expectable potential for prevention programmes to become cost-effective or even cost saving.

Modelling first-year cost-of-illness of melanoma attributable to sunbed use in Europe.

Melanoma is a life-threatening disease of the skin with an increasing incidence of approximately 87000 new cases treated per year in the European Union and the European Free Trade Association statesresulting in considerable costs for the society. Since the use of sunbeds is known to be a risk factor, which can be easily avoided, costs of malignant melanoma attributable to sunbed use are modelled in the present study. Costs-of-illness of melanoma were calculated and compared for all member states of the European Union and the European Free Trade Association states using an established modelling approach. Calculations were based on a systematic literature research. For countries with no available information on cost-of-illness the gross domestic product, health expenditures and gross national income served as a basis for extrapolation of costs. International comparison was enabled by adjusting costs by the national purchasing power parity. After adjusting melanoma treatment costs for the purchasing power parity, direct costs per patient vary between € 1056 in Romania and € 10215 in Luxembourg. Costs due to morbidity range from € 102 per patient in Sweden and € 5178 in the UK resulting in total costs of € 1751-€ 12611 per patient. Average weighted total costs per patient amount for € 6861-€ 6967 annually. In total, in 2012 approximately 4450 new cases of melanoma have been induced by sunbed use in the 31 included countries, which corresponds to 5.1% of all incident melanoma cases. National attributable melanoma costs range from €1570 in Malta to €11.1million in Germany and sum up to an amount of €32.5-€33.4million for all countries. This article provides a first estimation on costs of melanoma in Europe. It illustrates the contribution of exposure to artificial ultraviolet light in the economic burden of malignant melanoma.

Trends in incidence of thick, thin and in situ melanoma in Europe

BackgroundWe analysed trends in incidence for in situ and invasive melanoma in some European countries during the period 1995–2012, stratifying for lesion thickness. Material and methodsIndividual anonymised data from population-based European cancer registries (CRs) were collected and combined in a common database, including information on age, sex, year of diagnosis, histological type, tumour location, behaviour (invasive, in situ) and lesion thickness. Mortality data were retrieved from the publicly available World Health Organization database. ResultsOur database covered a population of over 117 million inhabitants and included about 415,000 skin lesions, recorded by 18 European CRs (7 of them with national coverage). During the 1995–2012 period, we observed a statistically significant increase in incidence for both invasive (average annual percent change (AAPC) 4.0% men; 3.0% women) and in situ (AAPC 7.7% men; 6.2% women) cases. DiscussionThe increase in invasive lesions seemed mainly driven by thin melanomas (AAPC 10% men; 8.3% women). The incidence of thick melanomas also increased, although more slowly in recent years. Correction for lesions of unknown thickness enhanced the differences between thin and thick cases and flattened the trends. Incidence trends varied considerably across registries, but only Netherlands presented a marked increase above the boundaries of a funnel plot that weighted estimates by their precision. Mortality from invasive melanoma has continued to increase in Norway, Iceland (but only for elder people), the Netherlands and Slovenia.

Sun-related knowledge and attitudes of primary and secondary schoolchildren in western Switzerland.

Switzerland, particularly its western region, has the highest incidence of melanoma in Europe. Although the risk of melanoma increases with sun overexposure during childhood, sun-related knowledge and attitudes of Swiss children are scarcely documented. We report the first investigation of the knowledge of the danger of ultraviolet radiation, attitudes towards a suntan and parental influence of schoolchildren in western Switzerland. All fifth, eighth and eleventh graders (average ages of 9, 12 and 15, respectively) in the 18 primary (fifth grade, n=431) and secondary (eighth and eleventh grades, n=837) public schools of La Chaux-de-Fonds were surveyed during regular school classes. The response rate was 91% (1154/1268). Sun-related knowledge was high overall. Eight out of 10 children knew about the risk of skin cancer and recognized the most susceptible phototype. Knowledge increased significantly with age. Girls, older children, fair-skinned participants and those who preferred a tanned skin obtained the highest knowledge score. The main source of information on ultraviolet radiation and sun protection was their parents (76%), followed by the school (11%) and the media (9%). Multivariate logistic regression analyses identified higher sun-related knowledge, lower familial socioprofessional status and skin phototypes III-IV to be associated with a tan-seeking attitude. Parental sensitization (56%) and encouragement (61%) towards sun protection were more common among fair-skinned children and those of higher familial socioprofessional status. The high awareness of the risk of skin cancer among Swiss schoolchildren does not translate into appropriate attitudes. Community-wide intervention programmes involving parents, teachers, peers and primary care clinicians could be considered for Swiss prevention campaigns to improve children's sun behaviour and change their current pro-tan attitude.

More than 5000 patients with metastatic melanoma in Europe per year do not have access to recommended first-line innovative treatments

BackgroundDespite the efficacy of innovative treatments for metastatic melanoma, their high costs has led to disparities in cancer care among different European countries. We analysed the availability of these innovative therapies in Europe and estimated the number of patients without access to first-line recommended treatment per current guidelines of professional entities such as the European Society for Medical Oncology (ESMO), the European Organisation for Research and Treatment of Cancer (EORTC), the European Association of Dermato-Oncology (EADO), and European Dermatology Forum (EDF). Materials and methodsWeb-based online survey was conducted in 30 European countries with questions about the treatment schedules from 1st May 2015 to 1st May 2016: number of metastatic melanoma patients, registration and reimbursement of innovative medicines (updated data, as of 1st October 2016), percentage of patients treated and availability of clinical studies and compassionate-use programmes. ResultsThe recommended BRAF inhibitor (BRAFi) + MEK inhibitor (MEKi) combination was both registered and fully reimbursed in 9/30 (30%) countries, and in 13/30 (43%) (all from Eastern Europe) not reimbursed. First-line immunotherapy with anti-PD1 antibodies was registered and fully reimbursed in 14/30 (47%) countries, while in 13/30 (43%) (all from Eastern Europe) not reimbursed. It was estimated that in Europe 19,600 patients with metastatic melanoma are treated, and 5238 (27%) do not have access to recommended first-line therapy. Significant correlation was found between human development index (HDI, UNDP report 2015), (r = 0.662; p < 0.001), health expenditure per capita (r = 0.695; p < 0.001) and the Mackenbach score of health policy performance (r = 0.765; p < 0.001) with the percentage of patients treated with innovative medicines and a number of reimbursed medicines. ConclusionsGreat discrepancy exists in metastatic melanoma treatment across Europe. It is crucial to increase the awareness of national and European policymakers, oncological societies, melanoma patients' associations and pharma industry.

Surgical outcomes in patients with cutaneous malignant melanoma in Europe - a systematic literature review.

There is limited comparative evidence of the outcomes of different types of surgical management in patients with malignant melanoma in Europe. To address that gap we conducted a systematic literature review to summarize studies reporting outcomes of surgical procedures in patients with malignant melanoma in Europe. Medline was searched for European studies published in English, between 2004 and 2014 reporting surgical outcomes in adults with cutaneous malignant melanoma. We identified 23 studies that evaluated 18332 patients treated surgically between 1979 and 2009 from 11 European countries. Most of the studies (21/23) were observational; the two remaining studies were randomized controlled trials (RCTs). Studies compared the effect of a range of surgical interventions on a range of clinical outcomes, more commonly overall survival (OS) and disease-free survival (DFS)/recurrence-free survival (RFS). Wider excisions were not associated with improved survival in patients with melanoma thickness ≥2mm in both studies (RCTs), however, recent results based on long-term follow-up data associate 3cm excision margins (vs. 1cm) with favourable survival outcomes. There was some evidence that complete lymph node dissection after positive sentinel lymph node offers survival benefits over therapeutic lymph node dissection. Sentinel lymph node biopsy was not shown to be associated with significant OS benefits, however, it was overly related with higher rates of DFS/RFS. This review highlights the difficulties of making comparisons between different types of surgical procedures for malignant melanoma. As surgery remains the main treatment, this is an important field, and further evidence, particularly from RCTs, is needed.

1389O_PR - More than 5000 patients with metastatic melanoma in Europe per year do not have access to new life-saving drugs

1389O_PR - More than 5000 patients with metastatic melanoma in Europe per year do not have access to new life-saving drugs

Stage-specific survival and recurrence in patients with cutaneous malignant melanoma in Europe - a systematic review of the literature.

BackgroundGiven the increasing incidence in cutaneous malignant melanoma (CMM) and the recent changes in the treatment landscape, it is important to understand stage-specific overall and recurrence-free survival patterns in Europe. Despite publications such as EUROCARE-5, there is limited information on stage-specific survival for CMM in Europe.MethodWe carried out a systematic literature review to provide an up-to-date summary of stage-specific survival and recurrence-free survival patterns in patients with CMM in Europe. Studies were included if they were published in Medline during the past 12 years and included information on stage-specific survival and/or recurrence in CMM.ResultsOf the 8,749 studies identified, 26 studies were included, representing nine countries. Collectively, the studies covered a population of 152,422 patients and included data from 1978 to 2011. Randomized clinical trials and single-center observational studies comprised the most common study designs, including five large registry-based studies. Stage-specific information for survival and recurrence varied: 5-year overall survival: 95%–100% (stage I), 65%–92.8% (stage II), 41%–71% (stage III), and 9%–28% (stage IV); 5-year relapse-free survival was reported less frequently: 56% (stage II), and 28%–44% (stage III). Studies reporting survival by sentinel node (SN) status reported 5-year overall survival as 80%–95% for negative SN (stage I/II) and 35%–75% for positive SN (stage III) status; recurrence-free survival at 5 years: 76%–90% for negative and 35%–58% for positive SN status. Some studies included comparisons of survival by key patient sociodemographic characteristics, suggesting that these have a substantial influence on survival and recurrence estimates.ConclusionThe studies identified in this review show large variations in stage-specific overall and recurrence-free survival by study type and by country. Owing to differing study designs and populations, it is difficult to make detailed comparisons. Large population-based studies that include stage-specific survival and recurrence in Europe are therefore important.

Survival of patients with skin melanoma in Europe increases further: Results of the EUROCARE-5 study

BackgroundIn Europe skin melanoma (SM) survival has increased over time. The aims were to evaluate recent trends and differences between countries and regions of Europe. MethodsRelative survival (RS) estimates and geographical comparisons were based on 241,485 patients aged 15years and over with a diagnosis of invasive SM in Europe (2000–2007). Survival time trends during 1999–2007 were estimated using the period approach, for 213,101 patients. Age, gender, sub-sites and morphology subgroups were considered. ResultsIn European patients, estimated 5-year RS was 83% (95% confidence interval, CI 83–84%). The highest values were found for patients resident in Northern (88%; 87–88%) and Central (88%; 87–88%) Europe, followed by Ireland and United Kingdom (UK) (86%; 85–86%) and Southern Europe (83%; 82–83%). The lowest survival was in Eastern Europe (74%; 74–75%). Within regions the intercountry absolute difference in percentage points of RS varied from 4% (North) to 34% (East). RS decreased markedly with patients’ age and was higher in women than men. Differences according to SM morphology and skin sub-sites also emerged. Survival has slightly increased from 1999 to 2007, with a small improvement in Northern and the most pronounced improvement in Eastern Europe. DiscussionSM survival is high and still increasing in European patients. The gap between Northern and Southern and especially Eastern European countries, although still present, diminished over time. Differences in stage distribution at diagnosis may explain most of the geographical differences. However, part of the improvement in survival may be attributed to overdiagnosis from early diagnosis practices.