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Clinical trials for metastatic melanoma

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https://www.readbyqxmd.com/read/29774094/selumetinib-based-therapy-in-uveal-melanoma-patient-derived-xenografts
#1
Didier Decaudin, Rania El Botty, Béré Diallo, Gerald Massonnet, Justine Fleury, Adnan Naguez, Chloé Raymondie, Emma Davies, Aaron Smith, Joanne Wilson, Colin Howes, Paul D Smith, Nathalie Cassoux, Sophie Piperno-Neumann, Sergio Roman-Roman, Fariba Némati
The prognosis of metastatic uveal melanoma (UM) is among the worst of all human cancers. The identification of near-ubiquitous GNAQ/GNA11 mutations and the activation of MAPK signaling in UM have raised hopes of more effective, targeted therapies, based on MEK inhibition, for example. We evaluated the potential of drug combinations to increase the efficacy of the MEK inhibitor selumetinib (AZD6244, ARRY-142886), in UM cell lines and Patient-Derived Xenografts. We first evaluated the combination of selumetinib and DTIC...
April 24, 2018: Oncotarget
https://www.readbyqxmd.com/read/29762855/real-world-treatment-practice-in-patients-with-advanced-melanoma-in-the-nivolumab-era-five-novel-italian-case-reports-and-a-literature-review
#2
R Depenni, C De Rossi, M De Tursi, R Marconcini, T Troiani
OBJECTIVE: The approval of the anti-PD1 antibody nivolumab has provided a significant therapeutic opportunity in the landscape of metastatic melanoma. In pivotal clinical trials, nivolumab improved clinical outcomes with a great safety profile. However, in real-world practice, the majority of the population with metastatic melanoma does meet one or more eligibility criteria of pivotal trials, since they have an ECOG-PS ≥ 2 or active/untreated known brain metastases. Waiting for larger real-wold studies that are currently lacking, but would be crucial to confirm the efficacy of nivolumab in challenging patients and to detect rare adverse events that could not be noticed in pivotal trials, this review collects both literature and unpublished case reports on nivolumab treatment in metastatic melanoma...
April 2018: European Review for Medical and Pharmacological Sciences
https://www.readbyqxmd.com/read/29762449/time-to-procedure-nuclear-imaging-and-clinicopathological-characteristics-as-predictive-factors-for-sentinel-lymph-node-metastasis-in-cutaneous-melanoma-a-single-center-analysis
#3
Ljiljana Jaukovic, Milica Rajović, Lidija Kandolf Sekulovic, Marija Radulovic, Nenad Stepic, Zeljko Mijuskovic, Nenad Petrov, Boris Ajdinovic
OBJECTIVE: Sentinel lymph node (SLN) biopsy is a widely accepted staging procedure for cutaneous melanoma patients who are at risk of clinically occult nodal metastases. Numerous predictive factors for regional lymph node metastases have been identified; however, few have been found to be reproducibly significant. Also, the role of blue dye in identification was questioned in recent trials. Time to procedure was also found to be predictive of SLN positivity, but this was not confirmed in other studies...
May 14, 2018: Annals of Plastic Surgery
https://www.readbyqxmd.com/read/29750749/vemurafenib-in-braf-mutant-metastatic-melanoma-patients-in-real-world-clinical-practice-prognostic-factors-associated-with-clinical-outcomes
#4
Maartje G Schouwenburg, Anouk Jochems, Brenda Leeneman, Margreet G Franken, Alfons J M van den Eertwegh, John B A G Haanen, Michiel C T van Zeijl, Maureen J Aarts, Alexander C J van Akkooi, Franchette W P J van den Berkmortel, Willeke A M Blokx, Jan Willem B de Groot, Geke A P Hospers, Ellen Kapiteijn, Rutger H Koornstra, Wim H Kruit, Marieke W J Louwman, Djura Piersma, Rozemarijn S van Rijn, Karijn P M Suijkerbuijk, Albert J Ten Tije, Gerard Vreugdenhil, Michel W J M Wouters, Jacobus J M van der Hoeven
The aim of this population-based study was to identify the factors associated with clinical outcomes in vemurafenib-treated patients and to evaluate outcomes across subgroups of patients with different risk profiles. Data were retrieved from the Dutch Melanoma Treatment Registry. Time to next treatment (TTNT) and overall survival (OS) of all metastatic melanoma patients who received vemurafenib between 2012 and 2015 were assessed using Kaplan-Meier estimates. A risk score was developed on the basis of all prognostic factors associated with TTNT and OS derived from multivariable Cox regression analyses...
May 10, 2018: Melanoma Research
https://www.readbyqxmd.com/read/29738114/oncogenic-signaling-in-uveal-melanoma
#5
REVIEW
John J Park, Russell J Diefenbach, Anthony M Joshua, Richard F Kefford, Matteo S Carlino, Helen Rizos
Uveal melanoma is the most common primary cancer of the eye, and despite rapidly emerging insights into the molecular profile of this disease, prognosis of patients with metastatic uveal melanoma remains poor with mortality rates unchanged in over 35 years. Early genetic events activate G-protein coupled receptor signaling in nearly all uveal tumors via mutually exclusive mutations in the GNAQ, GNA11, CYSLTR2 or PLCB4 genes. A multitude of signaling cascades downstream of G-protein activation, including protein kinase C and mitogen activated protein kinase activity are actionable and many ongoing clinical trials are targeting these pathways...
May 8, 2018: Pigment Cell & Melanoma Research
https://www.readbyqxmd.com/read/29729495/braf-in-non-small-cell-lung-cancer-nsclc-pickaxing-another-brick-in-the-wall
#6
REVIEW
Alessandro Leonetti, Francesco Facchinetti, Giulio Rossi, Roberta Minari, Antonia Conti, Luc Friboulet, Marcello Tiseo, David Planchard
Molecular characterization of non-small cell lung cancer (NSCLC) marked an historical turning point for the treatment of lung tumors harboring kinase alterations suitable for specific targeted drugs inhibition, translating into major clinical improvements. Besides EGFR, ALK and ROS1, BRAF represents a novel therapeutic target for the treatment of advanced NSCLC. BRAF mutations, found in 1.5-3.5% of NSCLC, are responsible of the constitutive activation of mitogen activated protein kinase (MAPK)/extracellular signal-regulated kinase (ERK) pathway...
April 24, 2018: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/29721378/a-phase-ii-study-of-combined-therapy-with-a-braf-inhibitor-vemurafenib-and-interleukin-2-aldesleukin-in-patients-with-metastatic-melanoma
#7
Meghan J Mooradian, Alexandre Reuben, Peter A Prieto, Mehlika Hazar-Rethinam, Dennie T Frederick, Brandon Nadres, Adriano Piris, Vikram Juneja, Zachary A Cooper, Arlene H Sharpe, Ryan B Corcoran, Keith T Flaherty, Donald P Lawrence, Jennifer A Wargo, Ryan J Sullivan
Background : Approximately 50% of melanomas harbor BRAF mutations. Treatment with BRAF +/- MEK inhibition is associated with favorable changes in the tumor microenvironment thus providing the rationale for combining targeted agents with immunotherapy. Methods : Patients with unresectable Stage III or IV BRAFV600E mutant melanoma were enrolled in a single-center prospective study (n = 6). Patients were eligible to receive two courses of HD-IL-2 and vemurafenib twice daily. The primary endpoint was progression-free survival (PFS) with secondary objectives including overall survival (OS), response rates (RR), and safety of combination therapy as compared to historical controls...
2018: Oncoimmunology
https://www.readbyqxmd.com/read/29714599/unresectable-and-metastatic-melanoma-of-the-skin-literature-review-of-clinical-trials-and-efficacy-endpoints-since-2000
#8
Susan Jin, Pallavi S Mishra-Kalyani, Rajeshwari Sridhara
Advanced and metastatic melanoma has historically been one of the most difficult cancers to treat, with few treatment options. For over 20 years, dacarbazine chemotherapy was the only treatment approved by the US Food and Drug Administration for melanoma. In recent years, breakthroughs have been made in the areas of monoclonal antibody immunotherapies and genetically targeted therapies, leading to FDA approval of several new drugs for metastatic melanoma that have demonstrated improved patient response and survival...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29707397/safe-administration-of-ipilimumab-pembrolizumab-and-nivolumab-in-a-patient-with-metastatic-melanoma-psoriasis-and-a-previous-guillain-barr%C3%A3-syndrome
#9
Alessio Cortellini, Alessandro Parisi, Maria Concetta Fargnoli, Katia Cannita, Azzurra Irelli, Giampiero Porzio, Claudio Martinazzo, Corrado Ficorella
Background: Patients with autoimmune diseases were not evaluated in clinical trials with immune checkpoint inhibitors (ICIs), since a history of immune disorders, such as Guillain-Barré syndrome (GBS) and psoriasis, is one of the major risk factors for the development of immune-related adverse events (irAEs). This risk cannot be defined; therefore, physicians are called to manage these patients in clinical practice. Case Report: We report the case of a 62-year-old male patient affected by metastatic melanoma, with a history of GBS and psoriasis, and treated with sequential ipilimumab, pembrolizumab, and nivolumab, without significant toxicities...
2018: Case Reports in Oncological Medicine
https://www.readbyqxmd.com/read/29689622/prognostic-value-of-chromosomal-imbalances-gene-mutations-and-bap1-expression-in-uveal-melanoma
#10
Serena Patrone, Irena Maric, Mariangela Rutigliani, Francesco Lanza, Matteo Puntoni, Barbara Banelli, Silvia Rancati, Giovanna Angelini, Adriana Amaro, Paolo Ligorio, Carlotta Defferrari, Mauro Castagnetta, Roberto Bandelloni, Carlo Mosci, Andrea DeCensi, Massimo Romani, Urlich Pfeffer, Silvia Viaggi, Domenico A Coviello
Uveal melanoma (UM) exhibits recurring chromosomal abnormalities and gene driver mutations, which are related to tumor evolution/progression. Almost half of the patients with UM develop distant metastases, predominantly to the liver, and so far there are no effective adjuvant therapies. An accurate UM genetic profile could assess the individual patient's metastatic risk, and provide the basis to determine an individualized targeted therapeutic strategy for each UM patient. To investigate the presence of specific chromosomal and gene alterations, BAP1 protein expression, and their relationship with distant progression free survival (DPFS), we analyzed tumor samples from 63 UM patients (40 men and 23 women, with a median age of 64 years), who underwent eye enucleation by a single cancer ophthalmologist from December 2005 to June 2016...
April 24, 2018: Genes, Chromosomes & Cancer
https://www.readbyqxmd.com/read/29688262/t-cells-isolated-from-patients-with-checkpoint-inhibitor-resistant-melanoma-are-functional-and-can-mediate-tumor-regression
#11
R Andersen, T H Borch, A Draghi, A Gokuldass, M A H Rana, M Pedersen, M Nielsen, P Kongsted, J W Kjeldsen, M C W Westergaard, H D Radic, C A Chamberlain, L R Hölmich, H W Hendel, M S Larsen, Ö Met, I M Svane, M Donia
Background: The majority of patients with metastatic melanoma obtain only short-term or no benefit at all from checkpoint inhibitor (CPI) immunotherapy. In this study, we investigated whether the immune system of patients progressing following CPI treatment was able to generate functional tumor-specific immune responses. Materials and methods: Tumor-infiltrating lymphocytes (TILs) were isolated and expanded from metastatic melanoma lesions which progressed during or after anti-PD-1 and anti-CTLA-4 treatment...
April 24, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29659371/real-world-use-safety-and-survival-of-ipilimumab-in-metastatic-cutaneous-melanoma-in-the-netherlands
#12
Anouk Jochems, Brenda Leeneman, Margreet G Franken, Maartje G Schouwenburg, Maureen J B Aarts, Alexander C J van Akkooi, Franchette W P J van den Berkmortel, Alfonsus J M van den Eertwegh, Gerard Groenewegen, Jan Willem B de Groot, John B A G Haanen, Geke A P Hospers, Ellen Kapiteijn, Rutger H Koornstra, Wim H J Kruit, Marieke W J Louwman, Djura Piersma, Rozemarijn S van Rijn, Albert J Ten Tije, Gerard Vreugdenhil, Michel W J M Wouters, Carin A Uyl-de Groot, Koos J M van der Hoeven
Phase III trials with ipilimumab showed an improved survival in patients with metastatic melanoma. We evaluated the use and safety of ipilimumab, and the survival of all patients with metastatic cutaneous melanoma (N=807) receiving ipilimumab in real-world clinical practice in The Netherlands using data from the Dutch Melanoma Treatment Registry. Patients who were registered between July 2012 and July 2015 were included and analyzed according to their treatment status: treatment-naive (N=344) versus previously-treated (N=463)...
April 13, 2018: Anti-cancer Drugs
https://www.readbyqxmd.com/read/29650221/lymph-node-dissection-in-patients-with-melanoma-and-sentinel-lymph-node-metastasis-an-updated-evidence-based-decision-algorithm
#13
D Moreno-Ramírez, A Boada, L Ferrándiz, E Samaniego, G Carretero, E Nagore, P Redondo, P Ortiz-Romero, J Malvehy, R Botella-Estrada
Recent publication of the results of clinical trials in which lymph node dissection was not associated with any survival benefit in patients with sentinel node metastasis makes it necessary to reconsider the treatment of patients with melanoma. This article provides an update on the available evidence on the diverse factors (routes of metastatic spread, predictors, adjuvant therapy, etc.) that must be considered when treating patients with sentinel node-positive melanoma. The authors propose a decision-making algorithm for use in this clinical setting...
April 9, 2018: Actas Dermo-sifiliográficas
https://www.readbyqxmd.com/read/29628796/immunotherapy-of-melanoma
#14
Iwona Lugowska, Pawel Teterycz, Piotr Rutkowski
The immunotherapy is currently changing the landscape of oncology. Nowadays the standard of care in metastatic or unresectable melanoma patients include immunomodulating modalities such as anti-PD-1 drugs (nivolumab, pembrolizumab) and anti-CTLA-4 antibody ipilimumab. The improvements of progression free survival and overall survival connected with those treatments were unprecedented and have been confirmed in stage III trials. The efficacy of immunotherapy in metastatic setting can be further upgraded in some groups of patients by combining both types of antibodies...
March 2018: Contemporary Oncology Współczesna Onkologia
https://www.readbyqxmd.com/read/29628780/emerging-treatment-options-for-braf-mutant-colorectal-cancer
#15
Carling Ursem, Chloe E Atreya, Katherine Van Loon
The personalization of cancer care is rooted in the premise that there are subsets of patients with tumors harboring clinically relevant targets for patient-specific treatments. Colorectal cancer (CRC) is a disease that has historically been notable for its dearth of biomarkers that are predictive of response to targeted therapies. In recent years, BRAF V600E -mutated CRC has emerged as a distinct biologic entity, typically refractory to standard chemotherapy regimens approved for the treatment of metastatic CRC and associated with a dismal prognosis...
2018: Gastrointestinal Cancer: Targets and Therapy
https://www.readbyqxmd.com/read/29615812/structure-function-analysis-and-therapeutic-efficacy-of-antibodies-to-fungal-melanin-for-melanoma-radioimmunotherapy
#16
J D Nosanchuk, A Jeyakumar, A Ray, E Revskaya, Z Jiang, R A Bryan, K J H Allen, R Jiao, M E Malo, B L Gómez, A Morgenstern, F Bruchertseifer, D Rickles, G B Thornton, A Bowen, A Casadevall, E Dadachova
Metastatic melanoma remains difficult to treat despite recent approvals of several new drugs. Recently we reported encouraging results of Phase I clinical trial of radiolabeled with188 Re murine monoclonal IgM 6D2 to melanin in patients with Stage III/IV melanoma. Subsequently we generated a novel murine IgG 8C3 to melanin. IgGs are more amenable to humanization and cGMP (current Good Manufacturing Practice) manufacturing than IgMs. We performed comparative structural analysis of melanin-binding IgM 6D2 and IgG 8C3...
April 3, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29595366/dabrafenib-in-combination-with-trametinib-in-the-treatment-of-patients-with-braf-v600-positive-advanced-or-metastatic-non-small-cell-lung-cancer-clinical-evidence-and-experience
#17
Arjun Khunger, Monica Khunger, Vamsidhar Velcheti
Mutations in the BRAF oncogene are found in 2-4% of all non-small cell lung cancer (NSCLC) patients. The most common activating mutation present within the BRAF oncogene is associated with valine substitution for glutamate at position 600 (V600E) within the BRAF kinase. BRAF-targeted therapies are effective in patients with melanoma and NSCLC harboring BRAF V600E mutation. In both melanoma and NSCLC, dual inhibition of both BRAF and the downstream mitogen-activated protein kinase (MEK) improves response rates compared with BRAF inhibition alone...
January 2018: Therapeutic Advances in Respiratory Disease
https://www.readbyqxmd.com/read/29594244/combining-radiotherapy-and-ipilimumab-induces-clinically-relevant-radiation-induced-abscopal-effects-in-metastatic-melanoma-patients-a-systematic-review
#18
REVIEW
Rodolfo Chicas-Sett, Ignacio Morales-Orue, Delvys Rodriguez-Abreu, Pedro Lara-Jimenez
Background: In the last years, limited studies have described that radiotherapy could produce important distant responses in unirradiated sites, the so-called "abscopal effect". Recent evidence suggests that radiotherapy induces antigen release from tumor, in this way activating the immune system. However, radiotherapy alone is rarely enough to induce the systemic response requested for control of the metastases. With the advent of immunotherapy, the immune checkpoint inhibitors (ICI) have demonstrated impressive efficacy in various metastatic cancers...
February 2018: Clinical and Translational Radiation Oncology
https://www.readbyqxmd.com/read/29593889/immunotherapy-combination-strategies-non-chemotherapy-in-non-small-cell-lung-cancer
#19
REVIEW
Sandrine Niyongere, Andreas Saltos, Jhanelle E Gray
Immune checkpoint inhibitors enhance the activation and antitumor activity of the immune system, resulting in durable response rates in a select group of patients. Cytotoxic T lymphocyte antigen 4 (CTLA4) inhibitors target the inhibitory interaction between CTLA4 and CD80 or CD86. Programmed death 1 (PD1) inhibitors target the interaction between PD1 receptors on T-cells and PD-ligand 1 (PD-L1) and PD-ligand 2, blocking the inhibitory signaling and resulting in activation of T-cell effector function. These therapeutic drugs were originally evaluated in patients with metastatic melanoma before expansion to all tumor types, including non-small cell lung cancer (NSCLC) with promising results...
February 2018: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/29575357/rasopathic-comedo-like-or-cystic-lesions-induced-by-vemurafenib-a-model-of-skin-lesions-similar-but-not-identical-to-those-induced-by-dioxins-madish
#20
G Kaya, N Saxer-Sekulic, A Kaya, O Sorg, A Boespflug, L Thomas, J H Saurat
BACKGROUND: Patients treated with vemurafenib for metastatic melanoma often develop skin lesions similar to those observed after exposure to dioxin-like compounds. We previously called these lesions MADISH (metabolizing acquired dioxin-induced skin hamartoma) when analysing a case of acute dioxin poisoning. OBJECTIVE: We performed a clinical trial aimed at comparing the skin lesions observed under vemurafenib treatment with MADISH in order to bring to light a possible cross-talk between vemurafenib and dioxin pathways...
March 24, 2018: Journal of the European Academy of Dermatology and Venereology: JEADV
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