Management of carcinoid syndrome (CS): A systematic review of systemic treatment options.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 516-516
Author(s):  
Edward M. Wolin ◽  
Al Bowen Benson
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Systemic Treatment ◽  
Treatment Options ◽  
Symptom Relief ◽  
Safety Data ◽  
Significant Heterogeneity ◽  
Carcinoid Heart Disease ◽  
Systemic Treatments ◽  
Symptom Response

516 Background: CS is a major cause of symptom burden (diarrhea/flushing) in patients (pts) with neuroendocrine tumors and is associated with shortened survival and severe complications such as carcinoid heart disease. We performed a systematic review of clinical evidence for CS systemic treatments. Methods: PubMed, Embase, and Cochrane databases were searched. Large ( > 60 pt) prospective clinical trials investigating the efficacy/safety of systemic treatment options for pts with CS were eligible for inclusion. Data extracted included study design, pt population, interventions, prior treatments, permitted concomitant medications, study endpoints/statistical analyses, and efficacy/safety outcomes. Results: Six large prospective clinical trials (total 953 pts) were identified from 144 search results. Significant heterogeneity existed in pt populations, control groups (placebo vs active comparator), duration of therapy, study endpoints, and efficacy/safety data reporting. Interventions assessed were long-acting and subcutaneous octreotide (OCT & OCT SC), lanreotide (LAN), telotristat ethyl (TE)+somatostatin analogues (SSA), pasireotide (PAS), and everolimus (EVE)+OCT. Symptom response was variably assessed by the frequency of diarrhea/flushing and/or receipt of rescue short-acting SSA in 5/6 studies; a significant improvement in at least one of these measures occurred in 4 studies (OCT and OCT SC; LAN; TE+SSA). Failure to meet symptom response criteria ranged from 29-82% in the studies. Reported reductions in CgA and/or 5-HIAA reached statistical significance in 3 studies (LAN; EVE+OCT; TE+SSA). Interventions were generally well tolerated. Two phase 3 trials focused specifically on management of CS symptoms refractory to SSA; strategies included switching to PAS or an increased dose of OCT (40 mg q28d) for refractory diarrhea/flushing, or receipt of TE with continued SSA for refractory diarrhea. Conclusions: SSA provide substantial symptom relief for pts with CS. For refractory symptoms, TE can be added, SSA dose increased, and metastasis debulking can be used (with surgery, hepatic artery embolization, ablation, and PRRT). The addition of biologic agents to SSA can further improve CS management.

scholarly journals P10 Reporting of offspring data in diabetes, HIV infection and hypertension trials during pregnancy: a systematic review

2019 ◽  
Vol 104 (6) ◽  
pp. e21.1-e21
Author(s):  
B Aurich ◽  
T Martin-Montoya ◽  
D Zhang ◽  
E Jacqz-Aigrain
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Hiv Infection ◽  
Pregnant Women ◽  
Health Care Professionals ◽  
Full Text ◽  
Treatment Options ◽  
Safety Data ◽  
Chronic Medication ◽  
Neonatal Deaths

BackgroundAccording to international guidelines clinical trials are conducted during pregnancy to evaluate benefits and risks of medicines for both the mother and her offspring. Consolidated Standards of Reporting Trials (CONSORT) reporting criteria apply to these trials and should include safety data on the offspring. The safety of maternal treatments is a key issue for health care professionals and parents. Diabetes, human immunodeficiency virus (HIV) infection and hypertension are among the most frequent chronic diseases worldwide in women of child bearing potential. The objective of this systematic review was to analyse offspring data reported in clinical trials conducted in pregnant women receiving chronic drug treatment for one of these conditions.MethodsPubmed and Embase (01/01/1997–31/12/2017) were searched for drug trials in pregnant women with diabetes, HIV infection or hypertension. Titles and abstracts were screened, followed by a full text review of eligible articles. Inclusion criteria were interventional clinical trials in pregnant women treated with chronic medication and full text in English. Trial characteristics, maternal and offspring data were extracted. Data was summarised by disease and study. Twelve key items were considered for the offspring. The protocol was registered on PROSPERO (CRD42017057024).ResultsOverall, 196 articles reporting 132 clinical trials (diabetes n=55; HIV n=59; hypertension n=18) were included. The number of births were frequently not reported (diabetes 40%; HIV 24%; hypertension 56%). Congenital malformations were infrequently reported with sufficient detail (diabetes 27%; HIV 34%; hypertension 6%). Similar observations were made for other key items (e.g. foetal losses, neonatal deaths, birth weight corrected for gestational age).ConclusionsUnderreporting of key data for the offspring was frequent in publications of clinical trials in pregnant women with diabetes, HIV infection or hypertension making the assessment of the benefit-risk ratio of treatment options during pregnancy difficult.Disclosure(s)Nothing to disclose

scholarly journals The ‘wave sign’ in hip arthroscopy: a systematic review of epidemiological factors, current diagnostic methods and treatment options

2020 ◽  
Author(s):  
Jason Derry Onggo ◽  
James Randolph Onggo ◽  
Mithun Nambiar ◽  
Andrew Duong ◽  
Olufemi R Ayeni ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Protective Factor ◽  
Treatment Options ◽  
Arthroscopic Surgery ◽  
Classification Systems ◽  
Diagnostic Methods ◽  
Suture Repair ◽  
Significant Heterogeneity ◽  
Epidemiological Factors

ABSTRACT This study aims to present a systematic review and synthesized evidence on the epidemiological factors, diagnostic methods and treatment options available for this phenomenon. A multi-database search (OVID Medline, EMBASE and PubMed) was performed according to PRISMA guidelines on 18 June 2019. All studies of any study design discussing on the epidemiological factors, diagnostic methods, classification systems and treatment options of the wave sign were included. The Newcastle–Ottawa quality assessment tool was used to appraise articles. No quantitative analysis could be performed due to heterogeneous data reported; 11 studies with a total of 501 patients with the wave sign were included. Three studies examined risk factors for wave sign and concluded that cam lesions were most common. Other risk factors include alpha angle >65° (OR=4.00, 95% CI: 1.26–12.71, P=0.02), male gender (OR 2.24, 95% CI: 1.09–4.62, P=0.03) and older age (OR=1.04, 95% CI: 1.01–1.07, P=0.03). Increased acetabular coverage in setting of concurrent cam lesions may be a protective factor. Wave signs most commonly occur at the anterior, superior and anterosuperior acetabulum. In terms of staging accuracy, the Haddad classification had the highest coefficients in intraclass correlation (k=0.81, 95% CI: 0.23–0.95, P=0.011), inter-observer reliability (k=0.88, 95% CI: 0.72–0.97, P<0.001) and internal validity (k=0.89). One study investigated the utility of quantitative magnetic imaging for wave sign, concluding that significant heterogeneity in T1ρ and T2 values (P<0.05) of acetabular cartilage is indicative of acetabular debonding. Four studies reported treatment techniques, including bridging suture repair, reverse microfracture with bubble decompression and microfracture with fibrin adhesive glue, with the latter reporting statistically significant improvements in modified Harris hip scores at 6-months (MD=19.2, P<0.05), 12-months (MD=22.0, P<0.05) and 28-months (MD=17.5, P<0.001). No clinical studies were available for other treatment options. There is a scarcity of literature on the wave sign. Identifying at risk symptomatic patients is important to provide prompt diagnosis and treatment. Diagnostic techniques and operative options are still in early developmental stages. More research is needed to understand the natural history of wave sign lesions after arthroscopic surgery and whether intervention can improve long-term outcomes. Level IV, Systematic review of non-homogeneous studies.

scholarly journals Tumor Reduction with Pazopanib in a Patient with Recurrent Lumbar Chordoma

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Maurício Fernando Silva Almeida Ribeiro ◽  
Micelange Carvalho de Sousa ◽  
Samir Abdallah Hanna ◽  
Marcos Vinicius Calfat Maldaun ◽  
Ceci Obara Kurimori ◽  
...  
Keyword(s):  
Kinase Inhibitors ◽  
Systemic Treatment ◽  
Treatment Options ◽  
Axial Skeleton ◽  
Low Grade ◽  
Complete Excision ◽  
Systemic Treatments ◽  
Tumor Reduction ◽  
Comprehensive Genomic Profiling ◽  
Multifocal Recurrence

Introduction. Chordomas are rare malignancies of bone origin that occur in the axial skeleton, typically the skull base and lumbar/sacral regions. Although often classified as low-grade neoplasms, its locally infiltrative behavior may result in significant morbidity and mortality. Optimal surgical resection may be curative, but up to 50% of the cases relapse within 5 years, and currently there are no systemic treatments approved in this setting. A large proportion of these tumors express stem-cell factor receptor (c-KIT) and platelet-derived growth factor receptors (PDGFRs), providing a rationale for the use of tyrosine-kinase inhibitors (TKIs). Case report. A 27-year-old male presented with recurrent chordoma of the lumbar spine 4 years after initial diagnosis. Salvage therapies in the interval included repeat resections and radiation therapy. He ultimately developed multifocal recurrence not amenable to complete excision or reirradiation. A comprehensive genomic profiling assay was performed and revealed nondrugable alterations. Decision was made to proceed with systemic treatment with pazopanib 800 mg/day, resulting in tumor reduction (−23.1% reduction in size) and prolonged disease control. Conclusion. For this patient with a multiple recurrent chordoma and limited treatment options, pazopanib resulted in sustained clinical benefit following initial tumor reduction.

scholarly journals Effect of Orthodontic Treatment on Tooth Autotransplantation: Systematic Review of Controlled Clinical Trials

2020 ◽  
Vol 14 (03) ◽  
pp. 467-482
Author(s):  
Rogério Lacerda-Santos ◽  
Rhaíssa Ferreira Canutto ◽  
José Lucas dos Santos Araújo ◽  
Fabiola Galbiatti de Carvalho ◽  
Eliseu Aldrighi Münchow ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Risk Of Bias ◽  
Significant Heterogeneity ◽  
Controlled Clinical Trials ◽  
Periodontal Tissues ◽  
Orthodontic Movement ◽  
Anterior Teeth

AbstractThis systematic review was focused on evaluating tooth autotransplantation, considering its impacts on the teeth, bone, soft tissues, and aesthetics in orthodontic patients. A bibliographic search was conducted without limitations on year of publication or language in the databases of PubMed, Web of Science, Scopus, Medline Complete, Cochrane, Clinical Trials, and Trials Central. For triage of articles, indications, surgical planning, orthodontic movement, risk factors for treatment, and long-term follow-ups were considered. For outcomes, the results with reference to teeth, alveolar bone, periodontal tissues, and esthetic satisfaction were considered. Risk of bias was evaluated using the methodological index for nonrandomized studies-MINORS. The results showed 10 controlled clinical trials, and no randomized clinical trials were found. The selected studies included 715 patients and 934 autotransplanted teeth among which there were premolars, molars, and anterior teeth evaluated in the long term, indicating that orthodontics associated with autotransplantation indicated a result that was generally clinically acceptable. The quality of the set of evidence was considered medium due to the presence of different methodological problems, risk of bias, and significant heterogeneity in the evaluated studies. There was a sufficient body of evidence that justified autotransplantation in patients who needed orthodontic movement. In teeth, there was an increase in root resorption influenced by orthodontics, but without impacting on the general clinical result in the long term. Bone and periodontal tissue do not appear to be affected by orthodontics. The patient’s aesthetic satisfaction was not considered in the studies.

scholarly journals 2018 update of the EULAR recommendations for the management of hand osteoarthritis

2018 ◽  
Vol 78 (1) ◽  
pp. 16-24 ◽  
Author(s):  
Margreet Kloppenburg ◽  
Féline PB Kroon ◽  
Francisco J Blanco ◽  
Michael Doherty ◽  
Krysia S Dziedzic ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Expert Opinion ◽  
Task Force ◽  
Treatment Options ◽  
Symptom Relief ◽  
Information Provision ◽  
Hand Osteoarthritis ◽  
Level Of Evidence ◽  
Eular Recommendations ◽  
Systemic Treatments

Since publication of the European League Against Rheumatism (EULAR) recommendations for management of hand osteoarthritis (OA) in 2007 new evidence has emerged. The aim was to update these recommendations. EULAR standardised operating procedures were followed. A systematic literature review was performed, collecting the evidence regarding all non-pharmacological, pharmacological and surgical treatment options for hand OA published to date. Based on the evidence and expert opinion from an international task force of 19 physicians, healthcare professionals and patients from 10 European countries formulated overarching principles and recommendations. Level of evidence, grade of recommendation and level of agreement were allocated to each statement. Five overarching principles and 10 recommendations were agreed on. The overarching principles cover treatment goals, information provision, individualisation of treatment, shared decision-making and the need to consider multidisciplinary and multimodal (non-pharmacological, pharmacological, surgical) treatment approaches. Recommendations 1–3 cover different non-pharmacological treatment options (education, assistive devices, exercises and orthoses). Recommendations 4–8 describe the role of different pharmacological treatments, including topical treatments (preferred over systemic treatments, topical non-steroidal anti-inflammatory drugs (NSAIDs) being first-line choice), oral analgesics (particularly NSAIDs to be considered for symptom relief for a limited duration), chondroitin sulfate (for symptom relief), intra-articular glucocorticoids (generally not recommended, consider for painful interphalangeal OA) and conventional/biological disease-modifying antirheumatic drugs (discouraged). Considerations for surgery are described in recommendation 9. The last recommendation relates to follow-up. The presented EULAR recommendations provide up-to-date guidance on the management of hand OA, based on expert opinion and research evidence.

scholarly journals Progress in the Systemic Treatment of Advanced Soft-Tissue Sarcomas

1998 ◽  
Vol 5 (1) ◽  
pp. 1-5 ◽  
Author(s):  
Scott H. Okuno ◽  
John H. Edmonson
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Systemic Treatment ◽  
Soft Tissue Sarcomas ◽  
Multimodality Treatment ◽  
Clinical Situation ◽  
Controlled Clinical Trials ◽  
Systemic Treatments ◽  
Review Current ◽  
Systemic Therapies

Background: Despite the plethora of chemotherapeutic remedies for advanced soft-tissue sarcomas, little evidence has developed to indicate that these efforts have been curative. No controlled comparison has yet proven that patients receiving multidrug regimens survive longer than those receiving doxorubicin alone. Methods: The authors review current systemic treatments and then discuss some investigational efforts now in progress. Also, they seek to demonstrate how the therapies currently available can be integrated with surgery and radiation therapy to accomplish more than might be anticipated from chemotherapy alone. Results: While working to develop better systemic therapies for advanced soft-tissue sarcomas, the integrated use of our best chemotherapy regimens in combination with selected surgical and radiotherapy efforts may provide patients with the best available therapy. Some recent observations involving the use of molgramostim plus chemotherapy have been intriguing. Conclusions: Progress in the systemic treatment of advanced soft-tissue sarcomas may be gradual, but it is real. Our daily challenge is to be certain that we offer each patient the best available multimodality treatment applicable to his or her clinical situation. Molgramostim should be made available for further study with chemotherapy in controlled clinical trials.

A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus

Vaccine ◽  
2013 ◽  
Vol 31 (35) ◽  
pp. 3628-3635 ◽  
Author(s):  
Cindy Tamminga ◽  
Michael Kavanaugh ◽  
Charlotte Fedders ◽  
Santina Maiolatesi ◽  
Neethu Abraham ◽  
...  
Keyword(s):  
Systematic Review ◽  
Human Immunodeficiency Virus ◽  
Clinical Trials ◽  
Safety Data ◽  
Data Reporting ◽  
Immunodeficiency Virus

scholarly journals The efficacy of topical, oral and surgical interventions for the treatment of tungiasis: A systematic review of the literature

2021 ◽  
Vol 15 (8) ◽  
pp. e0009722
Author(s):  
Ana Carolina Tardin Martins ◽  
Amanda Ramos de Brito ◽  
Patrícia Shu Kurizky ◽  
Rodrigo Gurgel Gonçalves ◽  
Yago Ranniere Teixeira Santana ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Observational Studies ◽  
Treatment Options ◽  
Sufficient Evidence ◽  
Tissue Destruction ◽  
Adequate Treatment ◽  
Surgical Interventions ◽  
Surgical Extraction ◽  
Quantitative Descriptive

Background Tungiasis is a neglected disease caused by Tunga penetrans that can be complicated by secondary infections and local tissue destruction. Adequate treatment is important, especially in vulnerable populations; potential treatment options proposed range from surgical extraction to the use of oral and topical medications. We aimed to perform a systematic review to assess the efficacy of topical, oral and surgical interventions for the treatment of tungiasis. Methodology/Principal findings The present review is registered in PROSPERO (CRD42021234741). On September 1, 2020, we searched PubMed, EMBASE, Scopus, Web of Science, Science Direct, Scielo and LILACS BVS. We included clinical trials and longitudinal observational studies that evaluated any topical, systemic or mechanical treatment for tungiasis. We used the Revised Cochrane Risk of Bias (RoB) Tool for Randomized Trials for clinical trial analysis. Qualitative and quantitative descriptive syntheses were performed. Our search strategy resulted in 3376 references. Subsequently, 2568 titles/abstracts and 114 full texts were screened. We finally included 19 articles; 9 were classified as clinical trials. Two and 3 articles presented low and some RoB, respectively, according to the tool. Only two articles tested the efficacy of oral medications (niridazole, ivermectin), with discouraging results. Six clinical trials evaluated topical products for the treatment of tungiasis; 2 evaluated dimeticone-based compounds and reported positive results in lesion reduction and cure. None reported significant adverse reactions. Surgical extraction was evaluated only in observational studies. Conclusions/Significance We conclude that, although surgical extraction is the most commonly used treatment, there is sufficient evidence supporting the use of occlusive agents, especially manufactured dimeticone-based products.

Glecaprevir/Pibrentasvir: The First 8-Week, Pangenotypic HCV Treatment Regimen for Patients 12 Years of Age and Older

2019 ◽  
Vol 54 (3) ◽  
pp. 262-276
Author(s):  
Jamie Huff ◽  
Rebecca Andersen
Keyword(s):  
Clinical Trials ◽  
Hepatitis C ◽  
English Language ◽  
Data Extraction ◽  
Treatment Options ◽  
Safety Data ◽  
Hcv Treatment ◽  
Cost Information ◽  
Additional Information ◽  
Compensated Cirrhosis

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, dosing, and cost information of glecaprevir/pibrentasvir in the treatment of hepatitis C virus (HCV). Data Sources: A literature search was conducted between September 2018 and July 2019 using PubMed and Google Scholar with the search terms glecaprevir, pibrentasvir, Mavyret, Maviret, and hepatitis C. Clinicaltrials.gov was searched using the same terms. References of published articles were assessed for additional information. Study Selection and Data Extraction: English-language preclinical and clinical studies on the chemistry, pharmacology, pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir were evaluated. Data Synthesis: Food and Drug Administration–approved glecaprevir/pibrentasvir is considered both safe and efficacious for the treatment of HCV genotypes 1 to 6 and in several patient populations, such as those with treatment-naïve or treatment-experienced HCV; with or without compensated cirrhosis, HIV-1 coinfection, or renal impairment; post–liver or post–kidney transplant; and ≥12 years of age. Sustained virological response rates ranged from 83% to 100% in clinical trials, and safety outcomes appear similar to other guideline-recommended HCV treatment options. Relevance to Patient Care and Clinical Practice: This review discusses the pharmacological, efficacy, and safety data found in glecaprevir/pibrentasvir clinical trials and relates this to guideline recommendations and the practical use of this medication for treatment of HCV. Conclusions: With HCV infection rates remaining elevated, it is important to have safe and efficacious treatment options. Glecaprevir/pibrentasvir is a safe and efficacious guideline-recommended, 8-week treatment for HCV in several patient populations, with these populations likely growing in the near future given ongoing and future studies.

A Treatment Algorithm for Moderate to Severe Atopic Dermatitis in Adults

2017 ◽  
Vol 22 (1) ◽  
pp. 78-83 ◽  
Author(s):  
Charles W. Lynde ◽  
Marc Bourcier ◽  
Melinda Gooderham ◽  
Lyn Guenther ◽  
Chih-ho Hong ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Systemic Treatment ◽  
Topical Therapy ◽  
Treatment Options ◽  
Treatment Algorithm ◽  
Current Evidence ◽  
Severe Atopic Dermatitis ◽  
Routine Practice ◽  
Clinical Criteria ◽  
Systemic Treatments

Background: Atopic dermatitis (AD) is a common and chronic inflammatory skin disease. Approximately 10% of adults with AD do not respond adequately to topical therapies and require phototherapy and/or systemic therapy. Objective: To provide a patient-focused approach to the identification and management of adults with AD who require systemic treatment. Methods: A working group of clinicians experienced in managing AD was convened to review and discuss current evidence on the identification and clinical management of adults with moderate to severe AD. Results: We propose a set of simple and practical clinical criteria for selecting candidates for systemic treatment of AD based on their response to first-line topical therapy and 4 clinical measures that are easily incorporated into routine practice. We also suggest a framework for evaluating systemic treatments according to attributes that are important from both a clinician’s and a patient’s perspective. An algorithm was developed proposing a pathway for treatment of moderate to severe AD in adults. Conclusion: Adults with moderate to severe AD that does not respond adequately to topical therapies currently have few safe and effective treatment options. A clinical algorithm could help guide treatment decisions.

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