Casting in infantile idiopathic scoliosis as a temporising measure: A systematic review and meta-analysis

Objective: Treatment of infantile idiopathic scoliosis remains vague. Because implantation of temporary telescopic devices carries a high risk of complications, interest in the older technique of serial casting is growing as a temporising measure before invasive procedures. The goal of this review was to meta-analyse studies examining the effect and safety of casting in infantile idiopathic scoliosis. Methods: Two reviewers independently searched for relevant studies in PubMed and Embase databases through November 2018. The studies included were limited to infantile idiopathic scoliosis patients who underwent casting, had a mean Cobb angle of 20 or more and written in English. The methodological quality of the chosen studies was assessed. The primary outcome was the difference in Cobb angle means from before and after casting. The secondary outcome was adverse events of casting. Heterogeneity was explored and a funnel plot was drawn. Results: Of the 366 studies screened, 10 studies were included in the meta-analysis (243 subjects) and all were non-randomised. The casting was consistently associated with a reduction in the mean Cobb angle. The pooled mean difference was 24.85° (95% confidence interval: 19.25 to 30.46, p < 0.001). A number of reversible adverse events were reported, most commonly skin irritation and transient pulmonary symptoms. Heterogeneity between studies was high. In the meta-regression analysis, the starting Cobb angle did not influence Cobb angle change, but there was an inverse correlation between the mean difference in Cobb angle and mean age. Conclusion: Casting seems to be effective and safe in decreasing Cobb angle even in high curve magnitudes. In older patients, casting showed less Cobb angle correction.

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Effectiveness and Safety of Surgical Interventions for Treating Adolescent Idiopathic Scoliosis: a Bayesian Meta-analysis

10.21203/rs.2.20953/v1 ◽

2020 ◽

Author(s):

Long Chen ◽

Zeyu Sun ◽

Jingming He ◽

Yunwen Xu ◽

Zhuhai Li ◽

...

Keyword(s):

Adolescent Idiopathic Scoliosis ◽

Idiopathic Scoliosis ◽

Pulmonary Function ◽

Cobb Angle ◽

Meta Analysis ◽

Secondary Outcome ◽

Secondary Outcome Measure ◽

Practical Recommendation ◽

Surgical Interventions ◽

Post Operation

Abstract Background Adolescent idiopathic scoliosis (AIS) is the most common form of spinal deformity in children and adolescents which presents as complex three-dimensional (3D) deformity of the spine and rib cage. This study aimed to estimate the effectiveness and safety of surgical interventions for AIS using Bayesian meta-analysis.Methods The PubMed, EMBASE, and Cochrane Controlled Register of Trials were searched through Oct 1, 2019, without language restrictions. Relevant studies evaluating combined effectiveness and safety of surgical interventions for AIS were included according to eligibility criteria. The primary outcome measures included pulmonary function (change of absolute forced vital capacity and forced expiratory volume in one second from pre-operation to post-operation) and incidence of complications. The secondary outcome measure was change of Cobb angle from pre-operation to post-operation. Data was pooled using a random effects model in pairwise meta-analysis. Bayesian meta-analysis combined direct and indirect evidence using a Bayesian framework.Results 28 case-controlled studies with totally 1970 participants were included. This Bayesian meta-analysis combining direct and indirect evidences indicated that posterior fusion with instrumentation without thoracoplasty (PSF) had the highest probability to achieve better pulmonary function and lower complication rate; video assisted anterior fusion with instrumentation without thoracoplasty (VAT) had the highest probability to obtain better Cobb angle correction based on analysis of rank probability.Conclusion This Bayesian meta-analysis gives a practical recommendation of PSF as a primary surgical treatment for AIS. The results also support statistics that current surgeries adopted more PSF but less open anterior approach surgery and thoracoplasty. More research work is required to address the effectiveness and safety of VAT for treating AIS more convincingly.

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Effectiveness and Safety of Surgical Interventions for Treating Adolescent Idiopathic Scoliosis: a Bayesian Meta-analysis

10.21203/rs.2.20953/v2 ◽

2020 ◽

Author(s):

Long Chen ◽

Zeyu Sun ◽

Jingming He ◽

Yunwen Xu ◽

Zhuhai Li ◽

...

Keyword(s):

Idiopathic Scoliosis ◽

Pulmonary Function ◽

Cobb Angle ◽

Complication Rate ◽

Meta Analysis ◽

Secondary Outcome ◽

Surgical Interventions ◽

Lower Complication ◽

Lower Complication Rate ◽

Post Operation

Abstract BackgroundAdolescent idiopathic scoliosis (AIS) is the most common form of spinal deformity in children and adolescents which presents as complex three-dimensional (3D) deformity of the spine and rib cage. This study aimed to estimate the effectiveness and safety of surgical interventions for AIS using Bayesian meta-analysis. MethodsThe PubMed, EMBASE, and Cochrane Controlled Register of Trials were searched through Oct 1, 2019, without language restrictions. Relevant studies evaluating combined effectiveness and safety of surgical interventions for AIS were included according to eligibility criteria. The primary outcome measures included pulmonary function (change of absolute forced vital capacity and forced expiratory volume in one second from pre-operation to post-operation) and incidence of complications. The secondary outcome measure was change of Cobb angle from pre-operation to post-operation. Data was pooled using a random effects model in pairwise meta-analysis. Bayesian meta-analysis combined direct and indirect evidence using a Bayesian framework. Results28 case-controlled studies with totally 1970 participants were included. This Bayesian meta-analysis combining direct and indirect evidences indicated that posterior fusion with instrumentation without thoracoplasty (PSF) had the highest probability to achieve better pulmonary function and lower complication rate; video assisted anterior fusion with instrumentation without thoracoplasty (VAT) had the highest probability to obtain better Cobb angle correction based on analysis of rank probability. ConclusionThis Bayesian meta-analysis demonstrated that PSF had the highest probability to achieve better post-surgical pulmonary function and lower complication rate, which gives a practical recommendation of PSF as a primary surgical treatment for AIS. The results also support statistics that current surgeries adopted more PSF but less open anterior approach surgery and thoracoplasty. More research work is required to address the effectiveness and safety of VAT for treating AIS more convincingly.

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Does Premedication with Mucolytic Agents Improve Mucosal Visualization during Oesophagogastroduodenoscopy: A Systematic Review and Meta-Analysis

Surgery Research and Practice ◽

10.1155/2021/1570121 ◽

2021 ◽

Vol 2021 ◽

pp. 1-12

Author(s):

Eoghan Burke ◽

Patricia Harkins ◽

Frank Moriarty ◽

Ibrahim Ahmed

Keyword(s):

Systematic Review ◽

Adverse Events ◽

Meta Analysis ◽

Mean Difference ◽

Cochrane Central Register ◽

Central Register ◽

The Mean ◽

And Control ◽

The Impact ◽

Mucolytic Agents

Introduction. Gastric Cancer (GC) is the fourth most common malignancy worldwide and the second leading cause of cancer-related mortality for both sexes. The gold standard for diagnosing GC is oesophagogastroduodenoscopy (OGD). Excess mucus on the gastric mucosa impairs the detection of early GC. Aim. To synthesize available evidence of the effect of premedication with a mucolytic agent among adults undergoing elective nontherapeutic OGD, compared to placebo or other mucolytic agents, on mucosal visibility during OGD. Methods. A systematic review was conducted. PubMed, EMBASE, CINAHL, Cochrane central register of controlled trials (CENTRAL), and Web of Science were searched for relevant studies. A random-effects meta-analysis was performed to determine the mean difference in total mucosal visibility score (TMVS) between the pooled mucolytic agents and control. Subgroup analyses were performed to determine the mean TMVS difference for simethicone versus control and the impact of different timings and doses of mucolytic premedication. Results. 13 studies, involving 11,086 patients, including 6178 females (55.7%), with a mean age of 53.4 were identified and 6 of these were brought forward to meta-analysis. This revealed a mean difference of −2.69 (95% CI −3.5, −1.88) in total mucosal visibility scores (TMVS) between the pooled mucolytic agents and control. For simethicone, the mean difference was −2.68 (95% CI −4.94, −0.43). A simethicone dose of 133 mg was most effective with a mean difference of −4.22 (95% CI −5.11, −3.33). Assessing timing of administration across all mucolytic agents revealed a mean difference for the >20 minutes group of −3.68 (95% CI −4.77, −2.59). No adverse events were reported in any included trials. Conclusions. Regular use of premedication with mucolytic agents prior to routine OGD is associated with improved TMVS with no reported adverse events.

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Timely Revisit of Proprioceptive Deficits in Adolescent Idiopathic Scoliosis: A Systematic Review and Meta-Analysis

Global Spine Journal ◽

10.1177/21925682211066824 ◽

2021 ◽

pp. 219256822110668

Author(s):

Kenney K. L. Lau ◽

Karlen K. P. Law ◽

Kenny Y. H. Kwan ◽

Jason P. Y. Cheung ◽

Kenneth M. C. Cheung ◽

...

Keyword(s):

Systematic Review ◽

Adolescent Idiopathic Scoliosis ◽

Idiopathic Scoliosis ◽

Case Reports ◽

Data Extraction ◽

Meta Analysis ◽

Detection Threshold ◽

Mean Difference ◽

Case Control Studies ◽

Meta Analyses

Study Design Systematic review and meta-analysis Objectives The present review aimed to summarize the evidence regarding differences in proprioception between children with and without adolescent idiopathic scoliosis (AIS). Methods Seven electronic databases were searched from their inception to April 10, 2021. Articles were included if they involved: (1) AIS patients aged between 10 and 18 years, (2) measurements of proprioceptive abilities, and (3) comparisons with non-AIS controls. Animal studies, case reports, commentaries, conference proceedings, research protocols, and reviews were excluded. Two reviewers independently conducted literature screening, data extraction, risks of bias assessments, and quality of evidence evaluations. Relevant information was pooled for meta-analyses. Results From 432 identified citations, 11 case-control studies comprising 1121 participants were included. The meta-analyses showed that AIS participants displayed proprioceptive deficits as compared to non-AIS controls. Moderate evidence supported that AIS participants showed significantly larger repositioning errors than healthy controls (pooled mean difference = 1.27 degrees, P < .01). Low evidence substantiated that AIS participants had significantly greater motion detection threshold (pooled mean difference = 1.60 degrees, P < .01) and abnormal somatosensory evoked potentials (pooled mean difference = .36 milliseconds, P = .01) than non-AIS counterparts. Conclusions Consistent findings revealed that proprioceptive deficits occurred in AIS patients. Further investigations on the causal relationship between AIS and proprioception, and the identification of the subgroup of AIS patients with proprioceptive deficit are needed.

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P–328 Dienogest significantly decreases the size of the cyst and alters Anti-Müllerian Hormone concentration in patients with endometrioma

Human Reproduction ◽

10.1093/humrep/deab130.327 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

E Karataş ◽

B E Temiz ◽

S Mumusoglu ◽

H Yarali ◽

G Bozdag

Keyword(s):

Primary Outcome ◽

Statistical Significance ◽

Mean Difference ◽

Secondary Outcome ◽

Control Group ◽

Significant Drop ◽

Mean Size ◽

The Mean ◽

Respective Figure

Abstract Study question Does utilization of dienogest make any impact on the size of cyst and Anti-Müllerian Hormone (AMH) concentration in patients with endometrioma throughout 12-months? Summary answer Although dienogest makes a gradual reduction in the size of endometrioma cyst throughout 12-months, a significant drop in AMH serum concentration was also noticed. What is known already According to recent studies, pre-operative serum AMH levels might be illusively increased with parallel to the size of endometrioma which will be a misleading factor while deciding to operate the patient via cystectomy. Although dienogest is one of the medical options that might be commenced in patients with endometrioma cyst, there is limited data about its effect on the size of the endometrioma and hence serum AMH concentration throughout 12 months of follow up. Study design, size, duration The current observational cohort study was conducted among patients with endometrioma those treated with dienogest from January 2017 to January 2020. The primary outcome was alteration in diameter of endometrioma cyst at 6th and 12th months of treatment. Secondary outcome was alteration in serum AMH concentration in the same period. Of 104 patients treated with dienogest, 44 patients were excluded due to being treated with any type of surgical intervention during follow up period. Participants/materials, setting, methods A total of 60 patients were recruited for the final analysis. Of them, primary symptom was dysmenorrhea, chronic pelvic pain and menstrual irregularity in 16 (26.7%), 25 (41.7%) and 8 (13.3%) patients, respectively. Eighteen patients (30%) were asymptomatic. As 21 patients had bi-lateral endometrioma, size of the leading cyst was considered to be analyzed for the primary outcome measure. Paired-t test was used for comparison of numerical values and p ≤ 0.05 was taken as statistical significance. Main results and the role of chance The mean age was 31.5±8.0 years. In the time point when dienogest was started, the mean size of the endometrioma was 46.3±17.4 mm. The mean serum AMH concentration was 3.6±2.4 ng/ml. After 6 months of treatment, the mean size of the endometrioma decreased to 38.6±14.0 mm which corresponds to a mean difference of 7.8 mm (95% CI: 3.0 to 12.6; p: 0.003). The respective figure for AMH was 3.3±2.7 ng/ml which corresponds to a mean difference of 0.3 ng/ml (95% CI: –0.2 to 0.8; p: 0.23) at 6 months. After 12 months of treatment, the mean size of the endometrioma was 37.5±15.7 mm which corresponds to a mean difference of 8.9 mm (95% CI: 2.9 to 14.9; p: 0.005) at the end of 12 months. The respective figure for AMH was 2.7±1.9 ng/ml which corresponds to a mean difference of 0.9 ng/ml (95% CI: 0.1 to 1.7; p: 0.045) at the end of 12 months. The mean diameter of endometrioma and AMH concentration did not differ throughout the time period between 6th and 12th months of the treatment. Limitations, reasons for caution Although herein we present the largest data that depicts the alteration of endometrioma cyst and AMH concentration with the application of dienogest, the lack of control group is a limitation that avoids to perform any comparison. Wider implications of the findings: A shrinkage after commencement of treatment suggest that dienogest might present improvement in patients with endometrioma with respect to radiological findings, but further studies are required whether a decline in AMH concentration after 12 months refers to a genuine decrease in ovarian reserve or resolution of misleading high pre-treatment levels. Trial registration number not available

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Stereotactic Radiotherapy for Polypoidal Choroidal Vasculopathy: A Pilot Study

Ophthalmologica ◽

10.1159/000368561 ◽

2014 ◽

Vol 233 (2) ◽

pp. 82-88 ◽

Cited By ~ 4

Author(s):

Ugo Introini ◽

Giuseppe Casalino ◽

Giacinto Triolo ◽

Denis O''Shaughnessy ◽

E. Mark Shusterman ◽

...

Keyword(s):

Adverse Events ◽

Stereotactic Radiotherapy ◽

Polypoidal Choroidal Vasculopathy ◽

Low Voltage ◽

Secondary Outcome ◽

Intravitreal Ranibizumab ◽

Foveal Thickness ◽

X Ray ◽

The Mean ◽

Choroidal Vasculopathy

Purpose: To evaluate low-voltage X-ray stereotactic radiotherapy (SRT) delivered in conjunction with intravitreal ranibizumab for the treatment of active macular polypoidal choroidal vasculopathy (PCV). Methods: At baseline, all eyes received an intravitreal injection of ranibizumab, followed by 16-Gy X-ray SRT to the macula. Further ranibizumab injections were given pro re nata. The primary outcome measure was regression of the polyps assessed by indocyanine green angiography. Secondary outcome measures were best-corrected visual acuity (BCVA) and central foveal thickness (CFT) changes on optical coherence tomography. Local or systemic adverse events were evaluated as well. Results: We examined 12 eyes of 12 patients with PCV. At month 12, an angiographic regression of the polyps was observed in 10 of the 12 eyes. The mean BCVA improved by 7.6 letters: from 65.08 ± 11.4 to 72.7 ± 14.75 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The mean CFT decreased from 372.3 ± 79.6 to 215.9 ± 57.9 µm (p < 0.01). No local or systemic adverse events were reported. Conclusions: The preliminary data support the safety of low-voltage X-ray SRT for the treatment of macular PCV and show polyp closure, reduction in CFT and improvement in the mean BCVA. Additional research is warranted to confirm the efficacy and longer-term safety of this therapy in this population.

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The Role of Mean Platelet Volume as a Predictor of Mortality in Critically Ill Patients: A Systematic Review and Meta-Analysis

Critical Care Research and Practice ◽

10.1155/2016/4370834 ◽

2016 ◽

Vol 2016 ◽

pp. 1-8 ◽

Cited By ~ 8

Author(s):

Pattraporn Tajarernmuang ◽

Arintaya Phrommintikul ◽

Atikun Limsukon ◽

Chaicharn Pothirat ◽

Kaweesak Chittawatanarat

Keyword(s):

Systematic Review ◽

Critically Ill ◽

Critically Ill Patients ◽

Mean Platelet Volume ◽

Meta Analysis ◽

Small Sample ◽

Mean Difference ◽

Platelet Volume ◽

Significant Difference ◽

The Mean

Background. An increase in the mean platelet volume (MPV) has been proposed as a novel prognostic indicator in critically ill patients.Objective. We conducted a systematic review and meta-analysis to determine whether there is an association between MPV and mortality in critically ill patients.Methods. We did electronic search in Medline, Scopus, and Embase up to November 2015.Results. Eleven observational studies, involving 3724 patients, were included. The values of initial MPV in nonsurvivors and survivors were not different, with the mean difference with 95% confident interval (95% CI) being 0.17 (95% CI: −0.04, 0.38;p=0.112). However, after small sample studies were excluded in sensitivity analysis, the pooling mean difference of MPV was 0.32 (95% CI: 0.04, 0.60;p=0.03). In addition, the MPV was observed to be significantly higher in nonsurvivor groups after the third day of admission. On the subgroup analysis, although patient types (sepsis or mixed ICU) and study type (prospective or retrospective study) did not show any significant difference between groups, the difference of MPV was significantly difference on the unit which had mortality up to 30%.Conclusions. Initial values of MPV might not be used as a prognostic marker of mortality in critically ill patients. Subsequent values of MPV after the 3rd day and the lower mortality rate unit might be useful. However, the heterogeneity between studies is high.

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Perioperative outcome of severe rigid idiopathic scoliosis: Single-staged posterior spinal fusion utilizing a dual attending surgeon strategy. A report of 41 patients

Journal of Orthopaedic Surgery ◽

10.1177/2309499020936005 ◽

2020 ◽

Vol 28 (3) ◽

pp. 230949902093600

Author(s):

Chris Yin Wei Chan ◽

Weng Hong Chung ◽

Yuki Mihara ◽

Sin Ying Lee ◽

Pei Ying Ch’ng ◽

...

Keyword(s):

Idiopathic Scoliosis ◽

Hospital Stay ◽

Cobb Angle ◽

Perioperative Complications ◽

Postoperative Hospital Stay ◽

Transfusion Rate ◽

Perioperative Outcome ◽

Correction Rate ◽

Operation Duration ◽

The Mean

Purpose: Various surgical strategies including combined approach and spinal osteotomies in severe rigid scoliosis had been reported with significant perioperative complication rates. The use of single-staged posterior spinal fusion (PSF) utilizing a dual attending surgeon strategy for severe rigid scoliosis has not been widely reported. Methods: This was a retrospective study aimed to evaluate the perioperative outcome of single-staged PSF in severe rigid idiopathic scoliosis patients (Cobb angle ≥90° and ≤30% flexibility). Forty-one patients with severe rigid idiopathic scoliosis who underwent single-staged PSF were included. The perioperative outcome parameters were operation duration, intraoperative blood loss, intraoperative hemodynamic parameters, preoperative and postoperative hemoglobin, transfusion rate, patient-controlled anesthesia morphine usage, length of postoperative hospital stay, and perioperative complications. Radiological parameters included preoperative and postoperative Cobb angle, correction rate, side-bending flexibility, and side-bending correction index. Results: The mean age was 16.9 ± 5.6 years. The mean preoperative Cobb angle was 110.8 ± 12.1° with mean flexibility of 23.1 ± 6.3%. The mean operation duration was 215.5 ± 45.2 min with mean blood loss of 1752.6 ± 830.5 mL. The allogeneic blood transfusion rate was 24.4%. The mean postoperative hospital stay was 76.9 ± 26.7 h. The mean postoperative Cobb angle and correction rate were 54.4 ± 12.8° and 50.9 ± 10.1%, respectively. The readmission rate in this cohort was 2.4%. Four perioperative complications were documented (9.8%), one somatosensory evoke potential signal loss, one superficial infection, one lung collapse, and one superior mesenteric artery syndrome. Conclusions: Severe rigid idiopathic scoliosis treated with single-staged PSF utilizing a dual attending surgeon strategy demonstrated an average correction rate of 50.9%, operation duration of 215.5 min, and postoperative hospital stay of 76.9 h with a 9.8% perioperative complication rate.

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Benefits and harms of pregabalin in the management of neuropathic pain: a rapid review and meta-analysis of randomised clinical trials

BMJ Open ◽

10.1136/bmjopen-2018-023600 ◽

2019 ◽

Vol 9 (1) ◽

pp. e023600 ◽

Cited By ~ 15

Author(s):

Igho J Onakpoya ◽

Elizabeth T Thomas ◽

Joseph J Lee ◽

Ben Goldacre ◽

Carl J Heneghan

Keyword(s):

Neuropathic Pain ◽

Adverse Events ◽

Meta Analysis ◽

Peripheral Oedema ◽

Phase Iii ◽

Rapid Review ◽

Secondary Outcome ◽

Cord Injury ◽

Quality Evidence

ObjectiveTo assess the benefits and harms of pregabalin in the management of neuropathic pain.DesignRapid review and meta-analysis of phase III, randomised, placebo-controlled trials.ParticipantsAdults aged 18 years and above with neuropathic pain defined according to the International Association for the Study of Pain criteria.InterventionsPregabalin or placebo.Primary and secondary outcome measuresOur primary outcomes were pain (as measured using validated scales) and adverse events. Our secondary outcomes were sleep disturbance, quality of life, Patient Global Impression of Change, Clinician Global Impression scale, anxiety and depression scores, overall discontinuations and discontinuations because of adverse events.ResultsWe included 28 trials comprising 6087 participants. The neuropathic pain conditions studied were diabetic peripheral neuropathy, postherpetic neuralgia, herpes zoster, sciatica (radicular pain), poststroke pain and spinal cord injury-related pain. Patients who took pregabalin reported significant reductions in pain (numerical rating scale (NRS)) compared with placebo (standardised mean difference (SMD) −0.49 (95% CI −0.66 to −0.32, p<0.00001), very low quality evidence). Pregabalin significantly reduced sleep interference scores (NRS) compared with placebo (SMD −0.38 (95% CI −0.50 to −0.26, p<0.00001), moderate quality evidence. Pregabalin significantly increased the risk of adverse events compared with placebo (RR 1.33 (95% CI 1.23 to 1.44, p<0.00001, low quality evidence)). The risks of experiencing weight gain, somnolence, dizziness, peripheral oedema, fatigue, visual disturbances, ataxia, non-peripheral oedema, vertigo and euphoria were significantly increased with pregabalin. Pregabalin was significantly more likely than placebo to lead to discontinuation of the drug because of adverse events (RR 1.91 (95% CI 1.54 to 2.37, p<0.00001), low quality evidence).ConclusionPregabalin has beneficial effects on some symptoms of neuropathic pain. However, its use significantly increases the risk of a number of adverse events and discontinuation due to adverse events. The quality of the evidence from journal publications is low.

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ACTR-68. FEASIBILITY STUDY OF THE EMULATE THERAPEUTICS™ VOYAGER SYSTEM IN PATIENTS WITH RECURRENT GLIOBLASTOMA (GBM)

Neuro-Oncology ◽

10.1093/neuonc/noz175.109 ◽

2019 ◽

Vol 21 (Supplement_6) ◽

pp. vi29-vi29

Author(s):

Garni Barkhoudarian ◽

Michael Badruddoja ◽

Nicholas Blondin ◽

Ricky Chen ◽

Sajeel Chowdhary ◽

...

Keyword(s):

Overall Survival ◽

Adverse Events ◽

Skin Irritation ◽

Recurrent Glioblastoma ◽

Secondary Outcome ◽

Open Label ◽

Serious Adverse Events ◽

Radio Frequency Energy ◽

Long Term Treatment ◽

Recurrent Gbm

Abstract BACKGROUND The EMulate Therapeutics Voyager system is an investigational non-sterile, non-invasive, non-thermal, non-ionizing, portable, home-use medical device that uses a specific, localized ultra-low radio frequency energy (ulRFE®) cognate for the treatment of brain cancer. METHODS This ongoing, open-label, multi-center study (NAT-101) is being conducted in the US and Australia in patients with recurrent GBM. There are 3 treatment groups: 32 patients treated with Voyager alone, 43 patients treated with Voyager + Investigator’s choice of anti-cancer therapy, and 21 patients treated with Voyager+lomustine+/-bevacizumab. The objective of the study is to assess if the Voyager is a safe and feasible treatment for recurrent GBM. The primary outcome measure is safety, assessed by the incidence and evaluation of adverse events (AEs) associated with the Voyager. The secondary outcome measures are progression-free survival and overall survival. RESULTS Enrollment is closed, and long-term treatment and follow-up is ongoing. 96 patients were enrolled and treated. 82 patients reported at least one AE, and 18 AEs were assessed as device-related (mild-moderate; 12 headache, 2 vomiting, 1 nausea, 1 confusion, 1 insomnia, and 1 skin irritation). 31 patients reported at least one serious AE, and none were assessed as device-related. 33% of patients treated with Voyager alone and 36% of patients treated with Voyager + chemotherapy were progression-free after 6 months. 58% of patients treated with Voyager alone and 60% of patients treated with Voyager + chemotherapy remained alive after 6 months; median overall survival is 7 months (95% CI=4.4±14.3) in patients treated with Voyager alone and 10 months (95% CI=6.7±11.5) in patients treated with Voyager + chemotherapy. CONCLUSIONS The Voyager system appears to be safe and feasible for the treatment of recurrent GBM. Given that therapy is delivered non-invasively and no device-related serious adverse events were reported, further prospective study of the investigational device is planned.

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