Clinical Trials in Uveal Melanoma: Patient Characteristics and the Treatment of Intraocular Tumors

2003 ◽  
pp. 391-414
Keyword(s):  
Clinical Trials ◽  
Uveal Melanoma ◽  
Melanoma Patient ◽  
Patient Characteristics ◽  
Intraocular Tumors

scholarly journals Disparities in Uveal Melanoma: Patient Characteristics

2016 ◽  
Vol 31 (4) ◽  
pp. 296-303 ◽  
Author(s):  
Erin E. Nichols ◽  
Ann Richmond ◽  
Anthony B. Daniels
Keyword(s):  
Uveal Melanoma ◽  
Melanoma Patient ◽  
Patient Characteristics

scholarly journals Do patient characteristics matter when calculating sample size for eczema clinical trials?

2021 ◽  
Author(s):  
L. Howells ◽  
S. Gran ◽  
J. R. Chalmers ◽  
B. Stuart ◽  
M. Santer ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Patient Characteristics

scholarly journals A 25-year retrospective, single center analysis of 343 WHO grade II/III glioma patients: implications for grading and temozolomide therapy

2021 ◽  
Author(s):  
Eike Steidl ◽  
Katharina Filipski ◽  
Pia S. Zeiner ◽  
Marlies Wagner ◽  
Emmanouil Fokas ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Molecular Markers ◽  
Treatment Time ◽  
Real Life ◽  
Patient Characteristics ◽  
Low Grade ◽  
Who Grade ◽  
Idh1 R132h ◽  
Treatment Data ◽  
Grade Ii

Abstract Purpose Classification and treatment of WHO grade II/III gliomas have dramatically changed. Implementing molecular markers into the WHO classification raised discussions about the significance of grading and clinical trials showed overall survival (OS) benefits for combined radiochemotherapy. As molecularly stratified treatment data outside clinical trials are scarce, we conducted this retrospective study. Methods We identified 343 patients (1995–2015) with newly diagnosed WHO grade II/III gliomas and analyzed molecular markers, patient characteristics, symptoms, histology, treatment, time to treatment failure (TTF) and OS. Results IDH-status was available for all patients (259 mutant, 84 IDH1-R132H-non-mutant). Molecular subclassification was possible in 173 tumors, resulting in diagnosis of 80 astrocytomas and 93 oligodendrogliomas. WHO grading remained significant for OS in astrocytomas/IDH1-R132H-non-mutant gliomas (p < 0.01) but not for oligodendroglioma (p = 0.27). Chemotherapy (and temozolomide in particular) showed inferior OS compared to radiotherapy in astrocytomas (median 6.1/12.1 years; p = 0.03) and oligodendrogliomas (median 13.2/not reached (n.r.) years; p = 0.03). While radiochemotherapy improved TTF in oligodendroglioma (median radiochemotherapy n.r./chemotherapy 3.8/radiotherapy 7.3 years; p < 0.001/ = 0.06; OS data immature) the effect, mainly in combination with temozolomide, was weaker in astrocytomas (median radiochemotherapy 6.7/chemotherapy 2.3/radiotherapy 2.0 years; p < 0.001/ = 0.11) and did not translate to improved OS (median 8.4 years). Conclusion This is one of the largest retrospective, real-life datasets reporting treatment and outcome in low-grade gliomas incorporating molecular markers. Current histologic grading features remain prognostic in astrocytomas while being insignificant in oligodendroglioma with interfering treatment effects. Chemotherapy (temozolomide) was less effective than radiotherapy in both astrocytomas and oligodendrogliomas while radiochemotherapy showed the highest TTF in oligodendrogliomas.

scholarly journals Immunological Backbone of Uveal Melanoma: Is There a Rationale for Immunotherapy?

Cancers ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1055 ◽  
Author(s):  
Ernesto Rossi ◽  
Giovanni Schinzari ◽  
Ilaria Grazia Zizzari ◽  
Brigida Anna Maiorano ◽  
Monica Maria Pagliara ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Uveal Melanoma ◽  
Clinical Benefit ◽  
Standard Treatment ◽  
Checkpoint Inhibitors ◽  
Phase Iii ◽  
Phase Iii Clinical Trials

No standard treatment has been established for metastatic uveal melanoma (mUM). Immunotherapy is commonly used for this disease even though UM has not been included in phase III clinical trials with checkpoint inhibitors. Unfortunately, only a minority of patients obtain a clinical benefit with immunotherapy. The immunological features of mUM were reviewed in order to understand if immunotherapy could still play a role for this disease.

scholarly journals Molecular Insights and Emerging Strategies for Treatment of Metastatic Uveal Melanoma

Cancers ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2761
Author(s):  
Fabiana Mallone ◽  
Marta Sacchetti ◽  
Alessandro Lambiase ◽  
Antonietta Moramarco
Keyword(s):  
Clinical Trials ◽  
Uveal Melanoma ◽  
Treatment Options ◽  
Survival Rates ◽  
Metastatic Tumor ◽  
Clinical Use ◽  
Future Perspectives ◽  
Diagnosis And Prognosis ◽  
Novel Treatment ◽  
Combinational Therapies

Uveal melanoma (UM) is the most common intraocular cancer. In recent decades, major advances have been achieved in the diagnosis and prognosis of UM allowing for tailored treatments. However, nearly 50% of patients still develop metastatic disease with survival rates of less than 1 year. There is currently no standard of adjuvant and metastatic treatment in UM, and available therapies are ineffective resulting from cutaneous melanoma protocols. Advances and novel treatment options including liver-directed therapies, immunotherapy, and targeted-therapy have been investigated in UM-dedicated clinical trials on single compounds or combinational therapies, with promising results. Therapies aimed at prolonging or targeting metastatic tumor dormancy provided encouraging results in other cancers, and need to be explored in UM. In this review, the latest progress in the diagnosis, prognosis, and treatment of UM in adjuvant and metastatic settings are discussed. In addition, novel insights into tumor genetics, biology and immunology, and the mechanisms underlying metastatic dormancy are discussed. As evident from the numerous studies discussed in this review, the increasing knowledge of this disease and the promising results from testing of novel individualized therapies could offer future perspectives for translating in clinical use.

scholarly journals Evolution of psoriatic arthritis study patient population characteristics in the era of biological treatments

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000779 ◽  
Author(s):  
Ann-Sophie Vandendorpe ◽  
Kurt de Vlam ◽  
Rik Lories
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Patient Population ◽  
Patient Characteristics ◽  
Chronic Inflammatory Disease ◽  
Population Characteristics ◽  
Phase Iii ◽  
Study Patient

ObjectivesPsoriatic arthritis is a chronic inflammatory disease that affects the musculoskeletal system. It can include arthritis, spondylitis, dactylitis and enthesitis, and is strongly associated with the presence of psoriasis. The introduction of biological therapies as a treatment option has brought a significant improvement in disease control for patients with psoriatic arthritis. Here, we aimed to detect emerging differences in demographic and clinical characteristics of the psoriatic arthritis patient study population since the introduction of biologicals. We hypothesised that evolving views on control of disease activity and increased experience in the management of psoriatic arthritis have affected the patient population considered for clinical trials and that this may serve as a proxy for changes in clinical practice.MethodsWe systematically searched for and selected 12 phase II and phase III trials and divided them into three treatment periods based on different time periods and working mechanisms of the particular biologicals. We made a selection of patient and disease parameters for which data were available in all three periods, calculated those data per period and looked for statistically significant differences between the treatment periods.ResultsStatistical analysis showed significant differences in patient characteristics, disease characteristics, disease activity, disease effects and use of prior treatments between the patient populations of the three periods.ConclusionThis study shows a clear evolution of the patient population considered for clinical trials since the introduction of biologicals. Further research is needed to see if those changes can be detected in the daily clinical practice.

Natural, innate improvements in multiple sclerosis disability

2012 ◽  
Vol 18 (10) ◽  
pp. 1412-1421 ◽  
Author(s):  
Helen Tremlett ◽  
Feng Zhu ◽  
John Petkau ◽  
Joel Oger ◽  
Yinshan Zhao ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Observational Studies ◽  
Disease Duration ◽  
Patient Characteristics ◽  
Expanded Disability Status Scale ◽  
Younger Age ◽  
Disability Status ◽  
Immunomodulatory Drug ◽  
One Year

Background: Improvements in multiple sclerosis (MS) disability have recently been reported in immunomodulatory drug (IMD) clinical trials and observational studies. However, improvements have rarely been examined in natural history or IMD naive patients. We investigated annual and biennial improvements in Expanded Disability Status Scale (EDSS) scores in British Columbia, Canada. Methods: The British Columbian MS database was accessed for definite MS patients (1980–2009). Consecutive IMD-free EDSS scores one and two years apart (± 3 months) were examined; improvements (≥0.5,≥1,≥2 EDSS points) and sustained improvements (confirmed at one year) were described. The influence of patient characteristics on improvements was examined using logistic regression. Results: From 16,132 EDSS scores, 7653 yearly and 5845 biennial EDSS intervals were available for 2961 and 2382 patients respectively. Of the yearly intervals, 14.9% showed an improvement (≥0.5 points), 8.3% ≥1 point and 2.2% ≥2 point improvement, with nearly half being sustained. Corresponding worsenings were observed in 32.9%, 20.5% and 7.9% respectively, with stability in just over half (53%). Biennial findings were similar. Characteristics generally associated with improvements included: female sex, younger age, shorter disease duration, relapsing-onset and presence of moderate disability (compared with mild or advanced) and a previous episode of worsening (disassociated from a relapse). However, improvements were also observed after periods of stability and in primary-progressive MS. Conclusion: Improvements in MS disability over one or two years are not unusual. We suggest the term ‘innate improvements’. Our findings have implication for the design of clinical trials and observational studies in MS targeting improvements on the EDSS.

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