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Journal of Nuclear Medicine : Official... Jun 2016Neuroendocrine tumors (NETs) are uncommon tumors with increasing incidence and prevalence. Current reports suggest that (68)Ga-DOTATATE PET/CT imaging improves diagnosis... (Comparative Study)
Comparative Study Meta-Analysis Review
68Ga-DOTATATE Compared with 111In-DTPA-Octreotide and Conventional Imaging for Pulmonary and Gastroenteropancreatic Neuroendocrine Tumors: A Systematic Review and Meta-Analysis.
UNLABELLED
Neuroendocrine tumors (NETs) are uncommon tumors with increasing incidence and prevalence. Current reports suggest that (68)Ga-DOTATATE PET/CT imaging improves diagnosis and staging of NETs compared with (111)In-DTPA-octreotide and conventional imaging. We performed a systematic review of (68)Ga-DOTATATE for safety and efficacy compared with octreotide and conventional imaging to determine whether available evidence supports U.S. Food and Drug Administration approval.
METHODS
Medline, EMBASE, Web of Science, and Cochrane Reviews electronic databases were searched from January 1999 to September 2015. Results were restricted to human studies comparing diagnostic accuracy of (68)Ga-DOTATATE with octreotide or conventional imaging for pulmonary or gastroenteropancreatic NET and for human studies reporting safety/toxicity for (68)Ga-DOTATATE with 10 subjects or more thought to have NETs. Direct communication with corresponding authors was attempted to obtain missing information. Abstracts meeting eligibility criteria were collected by a research librarian and assembled for reviewers; 2 reviewers independently determined whether or not to include each abstract. If either reviewer chose inclusion, the abstract was accepted for review.
RESULTS
Database and bibliography searches yielded 2,479 articles, of which 42 were eligible. Three studies compared the 2 radiopharmaceuticals in the same patient, finding (68)Ga-DOTATATE to be more sensitive than octreotide. Nine studies compared (68)Ga-DOTATATE with conventional imaging. (68)Ga-DOTATATE estimated sensitivity, 90.9% (95% confidence interval, 81.4%-96.4%), and specificity, 90.6% (95% confidence interval, 77.8%-96.1%), were high. Five studies were retained for safety reporting only. Report of harm possibly related to (68)Ga-DOTATATE was rare (6 of 974), and no study reported major toxicity or safety issues.
CONCLUSION
No direct comparison of octreotide and (68)Ga-DOTATATE imaging for diagnosis and staging in an unbiased population of NETs has been published. Available information in the peer-reviewed literature regarding diagnostic efficacy and safety supports the use of (68)Ga-DOTATATE for imaging of NETs where it is available.
Topics: Humans; Intestinal Neoplasms; Lung Neoplasms; Neuroendocrine Tumors; Octreotide; Organometallic Compounds; Pancreatic Neoplasms; Pentetic Acid; Positron Emission Tomography Computed Tomography; Stomach Neoplasms
PubMed: 26769864
DOI: 10.2967/jnumed.115.165803 -
Journal of Nuclear Medicine : Official... Sep 2017Ga-DOTATOC, a somatostatin receptor-targeted ligand, has been used clinically in Europe over the past decade for imaging neuroendocrine tumors (NETs). It appears to be... (Meta-Analysis)
Meta-Analysis Review
Ga-DOTATOC, a somatostatin receptor-targeted ligand, has been used clinically in Europe over the past decade for imaging neuroendocrine tumors (NETs). It appears to be quite sensitive and effective for clinical management decision making. This metaanalysis summarizes the efficacy of Ga-DOTATOC for several distinct indications and is intended to support approval of this agent by the U.S. Food and Drug Administration. The major electronic medical databases were searched for relevant papers over the period from January 2001 to November 2015. Papers were selected for review in 3 categories: clinical trials that reported sensitivity and specificity, comparison studies with In-octreotide, and change of management studies. All the eligible papers underwent Quality Assessment of Diagnostic Accuracy Studies (QUADAS) assessment, which was useful in the final selection of papers for review. The initial search yielded 468 papers. After detailed evaluation, 17 papers were finally selected. Five types of studies emerged: workup of patients with symptoms and biomarker findings suggestive of NET, but with negative conventional imaging (3 papers, yield was only 13%); sensitivity (12 papers; sensitivity, 92%) and specificity (7 papers; specificity, 82%); identification of site of unknown primary in patients with metastatic NET (4 papers, yield was 44%); impact on subsequent NET patient management (4 papers, change in management in 51%); and comparison with In-octreotide (2 papers, sensitivity of DOTATOC on a per-lesion basis was 100%, for In-octreotide it was 78.2%; specificity was not available). Safety was not explicitly addressed in any study, but there were no reports of adverse events. Ga-DOTATOC is useful for evaluating the presence and extent in disease for staging and restaging and for assisting in treatment decision making for patients with NET. It is also effective in locating the site of an unknown primary in NET patients who present with metastatic NET, but no known primary tumor. It also appears to be more accurate than In-octreotide. Although Ga-DOTATOC would seem to be useful in evaluating patients with suggestive symptoms and biomarker findings, it does not perform well in this setting and has low yield. Overall, it appears to be an excellent imaging agent to assess patients with known NET and frequently leads to a change in management.
Topics: Diagnostic Imaging; Humans; Neuroendocrine Tumors; Octreotide; Organometallic Compounds; Sensitivity and Specificity
PubMed: 28280220
DOI: 10.2967/jnumed.117.191197 -
The Cochrane Database of Systematic... Sep 2017Hepatorenal syndrome is defined as severe renal failure occurring in people with cirrhosis and ascites. Systematic reviews of randomised clinical trials found that,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hepatorenal syndrome is defined as severe renal failure occurring in people with cirrhosis and ascites. Systematic reviews of randomised clinical trials found that, compared with placebo, terlipressin may reduce mortality and improve renal function in people with hepatorenal syndrome, but we need current evidence from systematic reviews on the benefits and harms of terlipressin versus other vasoactive drugs.
OBJECTIVES
To evaluate the beneficial and harmful effects of terlipressin versus other vasoactive drugs for people with hepatorenal syndrome.
SEARCH METHODS
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, and Science Citation Index Expanded; conducted manual searches of references in relevant literature; and wrote to experts and pharmaceutical companies (date of last search November 2016).
SELECTION CRITERIA
Randomised clinical trials comparing terlipressin versus any other type of vasoactive drugs for hepatorenal syndrome. We allowed albumin and other cointerventions if provided equally in the comparison groups.
DATA COLLECTION AND ANALYSIS
Three authors independently extracted data. The primary outcomes were mortality, hepatorenal syndrome (persistent hepatorenal syndrome despite treatment), and serious adverse events. We conducted meta-analyses and present the results as risk ratios (RR) with 95% confidence intervals (CI). We performed sensitivity, subgroup, and Trial Sequential Analyses and evaluated bias control based on the Cochrane Hepato-Biliary Group domains.
MAIN RESULTS
We included 10 randomised clinical trials with 474 participants. The trials compared terlipressin versus noradrenaline (seven trials), octreotide (one trial), midodrine and octreotide (one trial), or dopamine (one trial). All participants in both groups received albumin as cointervention. We classified two trials at low risk of bias and eight trials at high risk of bias in the assessment of mortality and all trials at high risk of bias for remaining outcomes. In five trials, investigators specifically stated that they did not receive funding from for-profit organisations. We had no information about the funding source from the remaining five trials.Terlipressin was not superior or inferior compared with other vasoactive drugs in regard to mortality when including the two trials with a low risk of bias (RR 0.92, 95% CI 0.63 to 1.36; 94 participants, very low quality evidence) or when including all 10 trials (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; I² = 0%; very low quality evidence). One meta-analysis including nine trials suggested a beneficial effect of terlipressin on hepatorenal syndrome (RR 0.79, 95% CI 0.63 to 0.99; 394 participants; I² = 26%; very low quality evidence). Due to the high mortality of hepatorenal syndrome, the registration of other serious adverse events is uncertain, but comparing terlipressin and other vasoactive drugs we found no significant difference (RR 0.96, 95% CI 0.88 to 1.06; 474 participants; I² = 0%; very low quality evidence). Several trials did not report systematically of adverse events, but terlipressin seemed to increase the risks of diarrhoea or abdominal pain, or both (RR 3.50, 95% CI 1.19 to 10.27; 221 participants; 5 trials, I² = 0%). However, Trial Sequential Analyses found insufficient evidence to support or refute any differences between interventions for all outcomes. Considering reversal of hepatorenal syndrome, subgroup analyses on the type of other vasoactive drugs found that terlipressin was superior compared with midodrine and octreotide (RR 0.47, 95% CI 0.30 to 0.72) or octreotide alone (RR 0.56, 95% CI 0.33 to 0.96), but each subgroup only included one small trial. None of the remaining subgroup or sensitivity analyses found differences between terlipressin and other vasoactive drugs. We downgraded the evidence to very low quality because of the high risk of bias, imprecision, and the results of the Trial Sequential Analyses.
AUTHORS' CONCLUSIONS
This review found insufficient evidence to support or refute beneficial or harmful effects of terlipressin and albumin versus other vasoactive drugs and albumin. Additional research is needed to evaluate if clinically meaningful differences exist between interventions.
Topics: Antihypertensive Agents; Dopamine; Hepatorenal Syndrome; Humans; Lypressin; Midodrine; Norepinephrine; Octreotide; Randomized Controlled Trials as Topic; Terlipressin; Vasoconstrictor Agents
PubMed: 28953318
DOI: 10.1002/14651858.CD011532.pub2 -
Medicine Jul 2017The use of octreotide prophylaxis in the prevention of complications after pancreatic resection remains controversial. The aim of this systematic review and... (Meta-Analysis)
Meta-Analysis Review
Efficacy of the prophylactic use of octreotide for the prevention of complications after pancreatic resection: An updated systematic review and meta-analysis of randomized controlled trials.
BACKGROUND
The use of octreotide prophylaxis in the prevention of complications after pancreatic resection remains controversial. The aim of this systematic review and meta-analysis was to evaluate the efficacy of octreotide prophylactic treatment to prevent complications after pancreatic resection.
METHODS
Five databases (PubMed, Medline, SinoMed, Embase, and Cochrane Library) were searched for eligible studies from 1980 to November 2016 with the limitation of human subjects and randomized controlled trials (RCTs). Data were extracted independently and were analyzed using RevMan statistical software version 5.3 (Cochrane Collaboration, http://tech.cochrane.org/revman/download). Weighted mean differences (WMDs), risk ratios (RRs), and 95% confidence intervals (CIs) were calculated. Cochrane Collaboration risk of bias tool was used to assess the risk of bias.
RESULTS
Twelve RCTs comprising 1902 patients were identified as eligible. The methodological quality of the trials ranged from low to moderate. A pooled analysis of effectiveness based on the data from each study revealed that octreotide could significantly reduce the rate of pancreatic fistula (PF) after pancreatic resection (RR = 0.75, 95% CI = 0.57-0.98, P = .04). The same findings were discovered in multicenter and European subgroups with a subgroup analysis; no obvious differences were noted in American, Asian, and single-center subgroup analyses. An equal effect was observed between the use or non-use of octreotide groups regarding mortality (RR = 1.24, 95% CI = 0.77-2.02, P = .38). Octreotide had no advantages in regards to mortality improvement. The total numbers of complications associated with the use or non-use of octreotide were similar (RR = 0.77, 95% CI = 0.58-1.03, P = .08). Among the high-risk group, octreotide was more effective in reducing complications (RR = 0.61, 95% CI = 0.46-0.82, P = .0009). Compared with the patients who did not receive prophylactic treatment, the patients who underwent pancreatic resection benefited from octreotide because it had better efficacy in preventing fluid collection and postoperative pancreatitis.
CONCLUSION
The prophylactic use of octreotide is suitable for preventing postoperative complications, especially PF and fluid collection as well as postoperative pancreatitis. However, no obvious differences were noted regarding mortality. In view of the clinical heterogeneity and varying definitions of PF, whether these conclusions are broadly applicable should be further determined in future studies.
Topics: Gastrointestinal Agents; Humans; Octreotide; Pancreatectomy; Postoperative Complications; Randomized Controlled Trials as Topic
PubMed: 28723761
DOI: 10.1097/MD.0000000000007500 -
Advances in Therapy Feb 2021Somatostatin analogs (SSAs) are used to treat neuroendocrine tumors (NETs) and acromegaly. Two first-generation SSAs, octreotide long-acting release (OCT LAR) and... (Review)
Review
Patient and Healthcare Provider Perspectives of First-Generation Somatostatin Analogs in the Management of Neuroendocrine Tumors and Acromegaly: A Systematic Literature Review.
INTRODUCTION
Somatostatin analogs (SSAs) are used to treat neuroendocrine tumors (NETs) and acromegaly. Two first-generation SSAs, octreotide long-acting release (OCT LAR) and lanreotide autogel/depot (LAN), are available. A systematic literature review (SLR) was conducted to investigate which characteristics beyond efficacy are most important in patient and healthcare practitioner (HCP) experience of LAN and OCT when used to treat acromegaly and NETs.
METHODS
MEDLINE, Embase, the Cochrane Library, and Database of Abstracts of Reviews of Effect were searched from database inception to January 2019 with terms for first-generation SSAs, NETs, acromegaly, preferences, decision-making, and human factors. Key congresses in 2016-2018 and SLR bibliographies were hand-searched. Two independent reviewers screened articles at title/abstract and full-text stage. Publications fulfilling pre-specified inclusion criteria reported patient or HCP perspectives of LAN or OCT, or any factors affecting treatment perspectives for NETs or acromegaly.
RESULTS
A total of 1110 unique records were screened, of which 21 studies were included, reporting from the perspectives of patients (n = 18) and/or HCPs (n = 9). Perspectives were collected using shared decision-making frameworks, questionnaires, informal patient opinion, and a Delphi panel. Where patient preference was specifically reported, LAN was preferred in 4/5 studies and OCT LAR in 1/5. Common factors underlying treatment experience included technical problems with injections and associated pain, emotional quality/anxiety of injections, time and convenience of treatment administration, and independence. Immediate aspects of injections appeared most important to patients, though the possibilities of extended dosing intervals and self-/partner-injection with LAN were also notable factors.
CONCLUSIONS
Study outcomes favored LAN in this SLR, with factors surrounding injection administration most influential in treatment experience. The findings of this SLR provide a basis that could inform development of decision-making criteria, with patient and HCP treatment perspectives considered. Future studies should utilize a common method to report preference and associated drivers.
Topics: Acromegaly; Health Personnel; Humans; Neuroendocrine Tumors; Octreotide; Somatostatin
PubMed: 33432541
DOI: 10.1007/s12325-020-01600-x -
Current Issues in Molecular Biology Nov 2022We compared head-to-head the most used radiolabeled peptides for single photon computed emission tomography (SPECT) and positron emission tomography (PET) imaging of... (Review)
Review
We compared head-to-head the most used radiolabeled peptides for single photon computed emission tomography (SPECT) and positron emission tomography (PET) imaging of neuroendocrine tumors (NETs). A comprehensive literature search was performed in PubMed, Web of Science, and Scopus databases. The following words, coupled two by two, were used: Ga-DOTATOC; Ga-DOTATATE; Ga-DOTANOC; Tc-EDDA/HYNIC-TOC; Cu-DOTATATE; and In-DTPA-octreotide. Moreover, a second-step search strategy was adopted by using the following combined terms: "Somatostatin receptor imaging,"; "Somatostatin receptor imaging" and "Functional,"; "Somatostatin receptor imaging" and "SPECT,"; and "Somatostatin receptor imaging" and "PET". Eligible criteria were: (1) original articles focusing on the clinical application of the radiopharmaceutical agents in NETs; (2) original articles in the English language; (3) comparative studies (head-to-head comparative or matched-paired studies). Editorials, letters to the editor, reviews, pictorial essays, clinical cases, or opinions were excluded. A total of 1077 articles were found in the three electronic databases. The full texts of 104 articles were assessed for eligibility. Nineteen articles were finally included. Most articles focused on the comparison between In-DTPA-Octreotide and Ga-DOTATOC/TATE. Few papers compared Cu-DOTATATE and Ga-DOTATOC/TATE, or SPECT tracers. The rates of true positivity were 63.7%, 58.5%, 78.4% and 82.4%, respectively, for In-DTPA-Octreotide, Tc-EDDA/HYNIC-TOC, Ga-DOTATATE/TOC and Cu-DOTATATE. In conclusion, as highly expected, PET tracers are more suitable for the in vivo identification of NETs. Indeed, in comparative studies, they demonstrated a higher true positive rate than SPECT agents.
PubMed: 36354685
DOI: 10.3390/cimb44110373 -
Medicine Sep 2019The use of octreotide prophylaxis following pancreatic surgery is controversial. We aimed to evaluate the effectiveness of octreotide for the prevention of postoperative... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The use of octreotide prophylaxis following pancreatic surgery is controversial. We aimed to evaluate the effectiveness of octreotide for the prevention of postoperative complications after pancreatic surgery through this systematic review and meta-analysis.
METHODS
Literature databases (including the MEDLINE, EMBASE, and Cochrane databases) were searched systematically for relevant articles. Only randomized controlled trials (RCTs) were eligible for inclusion in our research. We extracted the basic information regarding the patients, intervention procedures, and all complications after pancreatic surgery and then performed the meta-analysis.
RESULTS
Thirteen RCTs involving 2006 patients were identified. There were no differences between the octreotide group and the placebo group with regard to pancreatic fistulas (PFs) (relative risk [RR] = 0.79, 95% confidence interval [CI] = 0.62-0.99, P = .05), clinically significant PFs (RR = 1.01, 95% CI = 0.68-1.50, P = .95), mortality (RR = 1.21, 95% CI = 0.78-1.88, P = .40), biliary leakage (RR 0.84, 95% CI = 0.39-1.82, P = .66), delayed gastric emptying (RR = 0.83, 95% CI = 0.54-1.27, P = .39), abdominal infection (RR = 1.00, 95% CI = 0.66-1.52, P = 1.00), bleeding (RR = 1.16, 95% CI = 0.78-1.72, P = .46), pulmonary complications (RR = 0.73, 95% CI = 0.45-1.18, P = .20), overall complications (RR = 0.80, 95% CI = 0.64-1.01, P = .06), and reoperation rates (RR = 1.18, 95% CI = 0.77-1.81, P = .45). In the high-risk group, octreotide was no more effective at reducing PF formation than placebo (RR = 0.81, 95% CI = 0.67-1.00, P = .05). In addition, octreotide had no influence on the incidence of PF (RR = 0.38, 95% CI = 0.14-1.05, P = .06) after distal pancreatic resection and local pancreatic resection.
CONCLUSION
The present best evidence suggests that prophylactic use of octreotide has no effect on reducing complications after pancreatic resection.
Topics: Gastrointestinal Agents; Humans; Octreotide; Pancreas; Pancreatectomy; Postoperative Complications
PubMed: 31567967
DOI: 10.1097/MD.0000000000017196 -
Journal of Pain and Symptom Management May 2016Malignant respiratory tract tumors can lead to massive fluid production, known as bronchorrhea. This symptom can be very distressing itself, and it can lead to or... (Review)
Review
CONTEXT
Malignant respiratory tract tumors can lead to massive fluid production, known as bronchorrhea. This symptom can be very distressing itself, and it can lead to or aggravate other symptoms such as dyspnea and cough. Pharmacological treatment options have been reported in the literature. However, no systematic evaluation of their effectiveness has been conducted so far.
OBJECTIVES
To systematically identify, appraise, and evaluate the effectiveness of symptomatic pharmacological treatment of bronchorrhea in malignant disease in palliative care.
METHODS
A systematic literature review in Medline, Embase, and the Cochrane Database, as well as citation tracking, hand searches of selected journals, and reference lists of retrieved articles, was performed. For the purpose of this review, only symptomatic treatments were considered.
RESULTS
No controlled clinical studies could be identified. Twenty of 48 retrieved references were analyzed in detail. These 20 case reports and case series dealt with the symptomatic pharmacological management of bronchorrhea in malignant disease; the other 28 had to be excluded for various reasons. The majority of patients suffered from bronchioloalveolar carcinoma. Reported treatments comprise corticosteroids, macrolide antibiotics, inhaled indomethacin, octreotide, and tyrosine-kinase inhibitors. For some drugs, significant clinical impact on distressing symptoms associated with bronchorrhea was reported.
CONCLUSION
There are only very limited data on the pharmacological management of bronchorrhea in malignant disease. Because of the distressing nature of the symptom, a pragmatic management strategy is essential. This can include promising treatment options reported in the literature but should also take into account availability, individual tolerability, and costs. Further research is needed.
Topics: Bronchial Diseases; Humans; Respiratory System Agents; Respiratory Tract Neoplasms; Sputum
PubMed: 26979624
DOI: 10.1016/j.jpainsymman.2015.12.335 -
Cancers Mar 2022Therapeutic advancements in neuroendocrine tumors (NETs) have improved survival outcomes. This study aims to review the impact of the current therapeutics on... (Review)
Review
Therapeutic advancements in neuroendocrine tumors (NETs) have improved survival outcomes. This study aims to review the impact of the current therapeutics on health-related quality of life (HRQoL) in NET patients. A literature review was performed utilizing PubMed, The Cochrane Library, and EMBASE, using the keywords "Carcinoid", "Neuroendocrine tumor", "NET", "Quality of life", "Chemotherapy", "Chemoembolization", "Radiofrequency ablation", "Peptide receptor radionucleotide therapy", "PRRT", "Surgery", "Everolimus", "Octreotide", "Lanreotide", "Sunitinib", and "Somatostatin analog". Letters, editorials, narrative reviews, case reports, and studies not in English were excluded. Out of 2375 publications, 61 studies met our inclusion criteria. The commonly used instruments were EORTC QLQ-C30, FACT G, and EORTC- QLQ GI.NET-21. HRQoL was assessed in all pivotal trials that led to approvals of systemic therapies. All systemic therapies showed no worsening in HRQoL. The NETTER-1 study was the only study to show a statistically significant improvement in HRQoL in several domains. The trial examining sunitinib versus placebo in pancreatic NETs showed no change in QoL, except for worsening of diarrhea. In addition to clinical outcomes, patient-reported outcomes are a key element in making appropriate treatment decisions. HRQoL data should be readily provided to patients to assist in shared decision-making.
PubMed: 35326587
DOI: 10.3390/cancers14061428 -
Digestive Surgery 2015The use of somatostatin analogues (SAs) following pancreaticoduodenectomy (PD) is controversial. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The use of somatostatin analogues (SAs) following pancreaticoduodenectomy (PD) is controversial.
METHOD
Literature databases were searched systematically for relevant articles. A meta-analysis of all randomized controlled trials (RCTs) evaluating prophylactic SAs in PD was performed.
RESULTS
Fifteen RCTs involving 1,352 patients were included. There was a towards reduced incidences of pancreatic fistulas (p = 0.26), clinically significant pancreatic fistulas (p = 0.08), and bleeding (p = 0.05) in prophylactic SAs group. In subgroup analyses, prophylactic somatostatin significantly reduced the incidence of pancreatic fistulas(p = 0.02), with a nonsignificant trend toward reduced incidence of clinically significantly pancreatic fistulas (p = 0.06).Pasireotide significantly reduced the incidence of clinically significantly pancreatic fistulas (p = 0.03). Octreotide had no influence on the incidence of pancreatic fistulas.
CONCLUSION
The current best evidence suggests prophylactic treatment with somatostatin or pasireotide has a potential role in reducing the incidence of pancreatic fistulas, while octreotide had no influence on the incidence of pancreatic fistulas.High-quality RCTs assessing the role of somatostatin and pasireotide are required for further verification.
Topics: Gastrointestinal Agents; Humans; Models, Statistical; Octreotide; Pancreatic Fistula; Pancreaticoduodenectomy; Postoperative Complications; Postoperative Hemorrhage; Somatostatin; Treatment Outcome
PubMed: 25872003
DOI: 10.1159/000381032