Ulrike Leiter

• MD
• Professor at University of Tübingen

Plain language summary Study comparing real-world survival and treatment response in stage III melanoma patients using talimogene laherparepvec or interleukin 2 Why was the study done? Talimogene laherparepvec (T-VEC) and interleukin-2 (IL-2) are both used for the intralesional treatment of melanoma skin metastases. T-VEC received regulatory approv...

Background Adjuvant treatment with anti‐PD1 antibodies has been shown to effectively reduce the risk of recurrence in patients with resected metastatic melanoma. Whether a full 12‐month duration of treatment is needed to achieve full clinical benefit is not known. This study investigated the survival outcome depending on the duration of adjuvant an...

Background Although systemic therapies have improved considerably over the last decade, up to 50% of patients with metastatic melanoma still die due to disease progression. Oncological treatment at the end-of-life phase is challenging. The aim of this study was to investigate the frequency and type of systemic therapy received by melanoma patients...

Background Modern therapeutic strategies have significantly improved the prognosis of advanced melanoma patients. Predictive factors of therapy response include serum LDH; however, predictive markers for long-term survival are currently largely lacking. Patients and methods Patients diagnosed with stage IV melanoma (AJCCv8) of cutaneous origin or...

Background Despite durable responses achieved with Immune Checkpoint Inhibitors (ICIs), data about optimal duration of treatment, especially in the context of adverse events, remain scarce. Objective To systematically review the evidence concerning the impact of treatment discontinuation with ICIs for reasons other than progressive disease (PD) on...

Background Following the pivotal phase II trial BOLT, the Hedgehog (Hh) inhibitor sonidegib was approved in the EU to treat locally advanced basal cell carcinoma (laBCC) in patients not amenable to surgery or radiotherapy. We report safety data from the interim analysis of the real-world NISSO study. Methods NISSO is an ongoing non-interventional,...

Background Uveal melanoma is the most common malignant tumor of the eye in adults. About half of the patients develop distant metastases, most commonly liver metastases (>90%). These are associated with poorer overall survival compared to patients with extrahepatic metastases. Patients and methods In this retrospective study, patients diagnosed wi...

Background The introduction of anti-programmed cell death protein 1 (PD-1) immunotherapy has revolutionized the treatment landscape for melanoma, enhancing both response rates and survival outcomes in patients with advanced stages of the disease. Despite these remarkable advances, a noteworthy subset of patients (40%-60%) does not derive advantage...

It is known, that different metastatic organ systems respond differently to immune checkpoint inhibitors (ICIs). In this study, we aimed to investigate the extent to which skin/subcutaneous metastases respond to ICI or targeted therapies (TTs) and whether the response rate differs from that of distant metastases in the same patient. Patients with m...

This study investigated whether adjuvant treatments in stage III cutaneous melanoma (CM) influenced patterns of recurrence. Patients with primary (n = 1033) or relapsed CM (n = 350) who received adjuvant therapies with Nivolumab (N), Pembrolizumab (P), or Dabrafenib and Trametinib (D + T) were extracted from the prospective multicenter real‐world s...

Zusammenfassung Talgdrüsenkarzinome sind seltene maligne kutane Adnextumoren mit sebozytärer Differenzierung. Der typische Prädilektionsbereich ist die Kopf‐Hals‐Region; hier sind die Talgdrüsenkarzinome die häufigsten malignen Adnextumoren der Haut. Nach ihrer Lokalisation unterscheidet man periokuläre und extraokuläre Talgdrüsenkarzinome. Ein Mui...

Sebaceous gland carcinomas are rare malignant cutaneous adnexal tumors with sebocytic differentiation. The typical predilection area is the head and neck region, where sebaceous gland carcinomas are the most common malignant adnexal tumors of the skin. According to their localization a distinction is made between periocular and extraocular sebaceou...

A collaboration of multidisciplinary experts from the European Association of Dermato‐Oncology, the European Dermatology Forum, the European Academy of Dermatology and Venereology, and the European Union of Medical Specialists was formed to develop European recommendations on AK diagnosis and treatment, based on current literature and expert consen...

Simple Summary The incidence of keratinocyte skin cancer has rapidly been increasing over the last five decades in fair skinned populations throughout the world. About 20% account for squamous cell carcinoma (SCC), and mainly the elderly are affected. Although the mortality rate is low, keratinocyte skin cancer is associated with a high morbidity,...

Purpose Since the introduction of immune checkpoint inhibitors (ICI) and targeted therapies (TT), survival rates of metastatic melanoma patients have increased significantly and complete remissions are no longer rarities. Consequently, there is an increasing number of long-term survivors who have not yet been comprehensively characterized. Methods...

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 haz...

Introduction Combined immune checkpoint inhibition (ICI) with ipilimumab and nivolumab is a widely used treatment regimen for metastatic melanoma with non-resectable metastases. Nevertheless, the standard dose of ipilimumab 3 mg/kg bw and nivolumab 1 mg/kg bw is associated with a high rate of treatment-related adverse events (trAEs) (59% grade 3–4)...

https://doi.org/10.1016/j.ejca.2023.113425

Background Adjuvant therapy with immune-checkpoint inhibitors (CPI) or BRAF/MEK-directed targeted therapy (TT) improves recurrence-free survival (RFS) for patients with advanced, BRAFV600-mutant (BRAFmut) resected melanoma.1–6 However, 40% of these patients will develop distant metastasis (DM) within 5 years, which require systemic treatments.2 5 L...

Zusammenfassung Aktinische Keratosen (AK) sind häufige Hautveränderungen bei hellhäutigen Menschen mit dem Potenzial, in ein kutanes Plattenepithelkarzinom (PEK) überzugehen. Beide Erkrankungen können mit erheblicher Morbidität verbunden sein und stellen eine große Krankheitslast insbesondere in der älteren Bevölkerung dar. Um eine evidenzbasierte...

Actinic keratosis (AK) are common lesions in light‐skinned individuals that can potentially progress to cutaneous squamous cell carcinoma (cSCC). Both conditions may be associated with significant morbidity and constitute a major disease burden, especially among the elderly. To establish an evidence‐based framework for clinical decision making, the...

Zusammenfassung Hintergrund und Ziele Die Melanom‐Leitlinie basiert hauptsächlich auf dem AJCC‐Stadium. Hierbei wird nicht zwischen den histologischen Subtypen wie dem superfiziell spreitenden Melanom (SSM), dem Lentigo‐maligna‐Melanom (LMM) oder dem nodulären malignen Melanom (NM) unterschieden. Ziel der Studie war es zu untersuchen, ob sich Pati...

Actinic keratosis (AK) are common lesions in light‐skinned individuals that can potentially progress to cutaneous squamous cell carcinoma (cSCC). Both conditions may be associated with significant morbidity and constitute a major disease burden, especially among the elderly. To establish an evidence‐based framework for clinical decision making, the...

Background Genomic characterisation has led to an improved understanding of adult melanoma. However, the aetiology of melanoma in children is still unclear and identifying the correct diagnosis and therapeutic strategies remains challenging. Methods Exome sequencing of matched tumour-normal pairs from 26 paediatric patients was performed to study...

Simple Summary The outcome of patients with advanced melanoma has profoundly improved over the last 15 years. Novel medications blocking BRAF, a protein involved in stimulating cell division, or inhibiting immune checkpoints associated with T-cell activation significantly improved overall survival. Mutations of the BRAF protein kinase cause cells t...

Background Adjuvant therapy with immune-checkpoint inhibitors (CPI) or BRAF/MEK-directed targeted therapy (TT) improves recurrence-free survival (RFS) for patients with advanced, BRAFV600-mutant (BRAFmut) resected melanoma. However, 40% of these patients will develop distant metastases (DM) within 5 years, which require systemic therapy. Little dat...

Background: Lentigo maligna melanoma is mainly localised in the head and neck region in elderly patients. Due to its slow horizontal growth, it has a good prognosis compared to other melanoma subtypes, but specific data are rare. Objectives: The aim of this study was to investigate sentinel lymph node biopsy in lentigo maligna melanoma under loc...

Background and objectives: The melanoma guideline is mainly based on the AJCC stage. There is no difference according to histological subtypes such as superficial spreading melanoma (SSM), lentigo maligna melanoma (LMM) or nodular malignant melanoma (NM). We aimed to evaluate whether patients with LMM have a different clinical course from patients...

In German-speaking countries, follow-up care of patients with malignant melanoma is carried out in a risk-adapted manner over a period of 10 years. In addition to regular total body examinations, further examinations such as ultrasound of draining lymph nodes, staging with CT or MRI scans and analysis of the tumor marker S100 are performed in a sta...

Metastases of uveal melanoma (UM) spread predominantly to the liver. Due to low response rates to systemic therapies, liver-directed therapies (LDT) are commonly used for tumor control. The impact of LDT on the response to systemic treatment is unknown. A total of 182 patients with metastatic UM treated with immune checkpoint blockade (ICB) were in...

b>Kurzzusammenfassung: Eine abnorme Aktivierung des Hedgehog-Signalwegs führt beim Basalzellkarzinom zu unkontrolliertem Tumorwachstum. Hedgehog-Signalweg-Inhibitoren sind eine wirksame Behandlungsoption für Tumoren, die durch lokale Therapien nicht mehr kontrollierbar sind. Allerdings kann die behandlungsbedingte Toxizität bei der Langzeitbehandlu...

Background: Merkel cell carcinoma (MCC) is an immunogenic but aggressive skin cancer. Even after complete resection and radiation, relapse rates are high. PD-1 and PD-L1 checkpoint inhibitors showed clinical benefit in advanced MCC. We aimed to assess efficacy and safety of adjuvant immune checkpoint inhibition in completely resected MCC (ie, a se...

Basal cell carcinoma (BCC) is the most common malignant tumour in white populations. Multidisciplinary experts from European Association of Dermato-Oncology (EADO), European Dermatology Forum, European Society for Radiotherapy and Oncology (ESTRO), Union Européenne des Médecins Spécialistes, and the European Academy of Dermatology and Venereology d...

e21566 Background: Since 2018, adjuvant immune checkpoint inhibitors (ICI) have been available for patients with resected stage III/IV melanoma. The Checkmate 238 and Keynote 054 studies showed a survival benefit in patients receiving adjuvant ICI. However, there is no validated biomarker to identify patients at high risk of relapse, despite receiv...

e21591 Background: Adjuvant therapy for melanoma patients (pts) is now available for pts from stage IIB onwards. Pts with cutaneous melanoma in early stages stage IB/IIA have low risk of relapse. However, this group still contributes to the most melanoma deaths in absolute numbers. Therefore, it is important to identify pts in stage IB/IIA that cou...

Background: Immune checkpoint inhibition (ICI) has changed the melanoma treatment spectrum. Few studies have examined the characteristics and long-term outcomes of patients achieving complete response (CR) under ICI. Materials and methods: We evaluated patients with unresectable stage IV melanoma treated with first-line ICI. The characteristics...

Zusammenfassung Superfizielle Leiomyosarkome (LMS) sind seltene Tumoren (circa 2–3% aller kutanen Sarkome), die von dermal gelegenen Haarbalgmuskeln, Dartosmuskeln beziehungsweise areolären Muskeln (dermale LMS) oder der Muskulatur der Gefäße des subkutanen Fettgewebes (subkutane LMS) ausgehen. Diese superfiziellen LMS werden von den LMS der tiefen...

Background Despite the availability of effective systemic therapies, a significant number of advanced melanoma patients develops brain metastases. This study investigated differences in incidence and time to diagnosis of brain metastasis and survival outcomes dependent on the type of first-line therapy. Methods Patients with metastatic, non-resect...

Aim of the study: Cutaneous squamous cell carcinoma (cSCC) incidences are increasing but scarcely available separated. We analysed incidence rates of cSCC over three decades with an extrapolation to 2040. Methods: Cancer registries from the Netherlands, Scotland and two federal states of Germany (Saarland/Schleswig-Holstein) were sourced for sep...

Zusammenfassung Das Plattenepithelkarzinom (PEK) der Haut ist eine der häufigsten Krebsarten in hellhäutigen Bevölkerungsgruppen und umfasst 20% aller Hauttumoren. Seit 2019 liegt eine S3‐Leitlinie des deutschen Leitlinienprogramms Onkologie vor, die 2022 aktualisiert wurde. Die Diagnose des PEK basiert auf der klinischen Untersuchung. Exzision und...

Background: Melanomas frequently harbour somatic mutations in BRAF (40%) or NRAS (20%). Impact of NRAS mutations on the therapeutic outcome of immune checkpoint inhibitors (ICI) remains controversial. Potential correlation of the NRAS mutational status and programmed cell death ligand-1 (PD-L1) expression in melanoma is unknown. Patients and meth...

Superficial leiomyosarcomas (LMS) are rare skin cancers (2-3% of cutaneous sarcomas) that originate from dermally located hair follicle muscles, dartos or areolar muscles (cutaneous/dermal LMS), or from vascular muscle cells of the subcutaneous adipose tissue (subcutaneous LMS). These superficial LMS are distinct from LMS of the deep soft tissues....

Squamous cell carcinoma of the skin (cSCC) is one of the most common cancers of the Caucasian population and accounts for 20% of all cutaneous tumors. An S3 guideline from the German Guideline Program in Oncology has been available since 2019 and was updated in 2022. The diagnosis of cSCC is based on clinical examination. Excision and histological...

Use of immune checkpoint inhibitors (ICIs) in solid organ transplant recipients (SOTRs) with advanced skin cancers presents a significant clinical management dilemma. SOTRs and other immunosuppressed patients have been routinely excluded from ICI clinical trials with good reason: immune checkpoints play an important role in self- and allograft-tole...