Access to systemic treatment of non-melanoma skin cancer in Spain: a survey analysis.

BACKGROUND: Novel and highly effective drugs for non-melanoma skin cancer (NMSC) improve patient outcomes, but their high cost strains healthcare systems. Spain's decentralized public health system, managed by 17 autonomous communities (AaCc), raises concerns about equitable access. METHODS: A cross-sectional survey (July-September 2023) was sent to Spanish Multidisciplinary Melanoma Group (GEM Group) members to assess access to new drugs. FINDINGS: Fifty physicians from 15 Spanish AaCc responded to the survey. Access for drug with approved public reimbursement, Hedgehog inhibitors in basal-cell carcinoma and anti PD-L1 antibody in Merkel carcinoma, was observed in 84% and 86% of centers, respectively. For other EMA-approved treatments, but without reimbursement in Spain access decreased to 78% of centers. Heterogeneity in access was mainly observed intra regions. CONCLUSION: Unequal financial support for drugs for NMSC with creates a patchwork of access across Spanish hospitals, with variations even within the same AaCc.

Access to melanoma drugs in Spain: a cross-sectional survey.

BACKGROUND: The development of highly active drugs has improved the survival of melanoma patients, but elevated drug prices place a significant burden on health care systems. In Spain, the public health care system is transferred to the 17 autonomous communities (AACC). The objective of this study is to describe the situation of drug access for melanoma patients in Spain and how this decentralized system is affecting equity. METHODS: From July to September 2023, a cross-sectional survey was sent to members of the Spanish Multidisciplinary Melanoma Group (GEM Group). The questionnaire consulted about the real access to new drugs in each hospital. The responses were collected anonymously and analyzed according to several variables, including the AACC. RESULTS: The survey was answered by 50 physicians in 15 AACC. No major differences on access between AACC were observed for indications that are reimbursed by the Spanish Health Care System (adjuvant immunotherapy for stage IIIC-IIID and resected stage IV melanoma). Important differences in drug access were observed among AACC and among centers within the same AACC, for most of the EMA indications that are not reimbursed (adjuvant immunotherapy for stages IIB-IIC-IIIA-IIIB) or that are not fully reimbursed (ipilimumab plus nivolumab in advanced stage). Homogeneously, access to adjuvant targeted drugs, TIL therapy and T-VEC, is extremely low or non-existing in all AACC. CONCLUSIONS: For most indications that reimbursement is restricted out of the EMA indication, a great diversity on access was found throughout the different hospitals in Spain, including heterogeneity intra-AACC.

SEOM-GEM clinical guidelines for cutaneous melanoma (2023).

Cutaneous melanoma incidence is rising. Early diagnosis and treatment administration are key for increasing the chances of survival. For patients with locoregional advanced melanoma that can be treated with complete resection, adjuvant-and more recently neoadjuvant-with targeted therapy-BRAF and MEK inhibitors-and immunotherapy-anti-PD-1-based therapies-offer opportunities to reduce the risk of relapse and distant metastases. For patients with advanced disease not amenable to radical treatment, these treatments offer an unprecedented increase in overall survival. A group of medical oncologists from the Spanish Society of Medical Oncology (SEOM) and Spanish Multidisciplinary Melanoma Group (GEM) has designed these guidelines, based on a thorough review of the best evidence available. The following guidelines try to cover all the aspects from the diagnosis-clinical, pathological, and molecular-staging, risk stratification, adjuvant therapy, advanced disease therapy, and survivor follow-up, including special situations, such as brain metastases, refractory disease, and treatment sequencing. We aim help clinicians in the decision-making process.

Cardiovascular toxicity of checkpoint inhibitors: review of associated toxicity and design of the Spanish Immunotherapy Registry of Cardiovascular Toxicity.

Immune checkpoint inhibitors (ICI) have changed the prognosis of many tumors. However, concerning associated cardiotoxicity has been reported. Little is known about the real-life incidence-specific surveillance protocols or the translational correlation between the underlying mechanisms and the clinical presentation of ICI-induced cardiotoxicity. The lack of data from prospective studies led us to review the current knowledge and to present the creation of the Spanish Immunotherapy Registry of Cardiovascular Toxicity (SIR-CVT), a prospective registry of patients receiving ICI that aims to examine the role of hsa-miR-Chr8:96, (a specific serum biomarker of myocarditis) in the early diagnosis of ICI-induced myocarditis. An exhaustive prospective cardiac imaging study will be performed before and during the first 12 months of treatment. The correlation between clinical, imaging, and immunologic parameters may improve our understanding of ICI-induced cardiotoxicity and enable simpler surveillance protocols. We assess ICI-induced cardiovascular toxicity and describe the rationale of the SIR-CVT.

SARS-CoV-2 infection in patients with melanoma: results of the Spanish Melanoma Group registry.

BACKGROUND: The Spanish Melanoma Group (GEM) developed a national registry of patients with melanoma infected by SARS-CoV-2 ("GRAVID"). METHODS: The main objective was to describe the COVID-19 fatality rate in patients with melanoma throughout the pandemic, as well as to explore the effect of melanoma treatment and tumor stage on the risk of COVID-19 complications. These are the final data of the register, including cases from February 2020 to September 2021. RESULTS: One hundred-fifty cases were registered. Median age was 68 years (range 6-95), 61 (40%) patients were females, and 63 (42%) patients had stage IV. Thirty-nine (26%) were on treatment with immunotherapy, and 17 (11%) with BRAF-MEK inhibitors. COVID-19 was resolved in 119 cases, including 85 (57%) patients cured, 15 (10%) that died due to melanoma, and 20 (13%) that died due to COVID-19. Only age over 60 years, cardiovascular disorders, and diabetes mellitus increased the risk of death due to COVID-19, but not advanced melanoma stage nor melanoma systemic therapies. Three waves have been covered by the register: February-May 2020, August-November 2020, and December 2020-April 2021. The first wave had the highest number of registered cases and COVID-19 mortality. CONCLUSION: Tumor stage or melanoma treatments are non-significant prognostic factors for COVID-19 mortality. During the pandemic in Spain there was a downward trend in the number of patients registered across the waves, as well as in the severity of the infection. GOV IDENTIFIER: NCT04344002.

When is it worth performing lymphadenectomy in patients with melanoma micrometastases? A 20-year experience retrospective analysis.

INTRODUCCIÓN: Actualmente existe controversia respecto a los beneficios de realizar linfadenectomía en pacientes de melanoma con una biopsia selectiva de ganglio centinela (BSGC) positiva. La carga tumoral > 1 mm se ha propuesto como el parámetro mas relevante asociado a una linfadenectomía positiva y un deterioro de la supervivencia libre de enfermedad. MATERIAL Y MÉTODOS: Se analizaron los datos de 119 pacientes de melanoma con BSGC positiva atendidos en el periodo entre Junio de 1997 y Junio de 2017. Los pacientes se clasificaron según la carga tumoral en dos grupos: ≤ 1 mm and > 1 mm. RESULTADOS: La linfadenectomía resultó positiva en sólo 6 (10%) pacientes con una carga tumoral ≤ 1 mm, y en 23 (37.7%) pacientes con carga tumoral > 1 mm (p < 0.001). En análisis univariante, la carga tumoral fue el único factor predictivo de linfadenectomía positiva (OR 5.24 (1.94-14.13)). En análisis multivariante, la carga tumoral fue la única variable independiente de supervivencia específica de melanoma (SEM). CONCLUSION: Aunque la realización de linfadenectomía debe individualizarse en cada caso, la carga tumoral > 1 mm puede ser un factor predictivo de la presencia de ganglios no centinelas positivos en piezas de linfadenectomía, y un factor pronostico independiente importante para la SEM. BACKGROUND: The benefits of complete lymph node dissection (CLND) in melanoma patients with a positive sentinel lymph node biopsy (SLNB) have been recently questioned. Sentinel node (SN) tumor burden > 1 mm has been proposed as the most reliable parameter associated with positive CLND and poorer disease-free survival. MATERIAL AND METHODS: Between June 1997 and June 2017, data from 119 melanoma patients with positive SLNB were analyzed. Patients were classified by SN burden in two groups: ≤ 1 mm and > 1 mm. RESULTS: CLND was positive in 6 (10%) patients with SN tumor burden ≤ 1 mm and in 23 (37.7%) patients with > 1 mm (p < 0.001). In univariable analysis, SN tumor burden was the only predictive factor of positive CLND (OR 5.24 [1.94-14.13]). In multivariable analysis, SN tumor burden was the only independent factor of melanoma-specific survival (MSS). CONCLUSION: Although CLND should still be considered individually in patients with positive SLNB, SN tumor burden >1 mm might be a good predictive factor of additional positive non-sentinel nodes and a strong independent prognostic factor in melanoma-specific survival.

Primary ovarian Burkitt lymphoma.

Primary ovarian Burkitt lymphoma (BL) is a rare neoplasm in adults. We report a 30-year-old woman diagnosed with primary bilateral ovarian BL. She presented features of a twisted ovarian cyst and underwent bilateral salpingo-oophorectomy. The histopathologic evaluation yielded the diagnosis of BL and subsequently she received chemoimmunotherapy with CODOX-M-IVAC plus rituximab (anti-CD20 monoclonal antibody).