Rural service coordination programming for women using substances and their families.

BACKGROUND: Women experiencing substance use during their pregnancies or after the birth of a child report being fearful of losing their children based on care, stigmatized when seeking assistance, and barriers to care such as having to provide the same information to different providers, and having to repeat their lived experiences with substance use in detail. Particularly these service barriers can be confusing, complicated, and difficult to follow, which could lead to non-compliance or not seeking services. OBJECTIVES: We evaluated components of a service coordination program for women experiencing substance use, their children, and larger families who help with caregiving. We examined stakeholder interest in the program, feasibility providing services over time, and initial program effectiveness. DESIGN: Participant enrollment and outcomes as well as service coordination activities provided over a 4-year period was gathered across three demonstration site locations (a birthing hospital, reunification program, and home visiting program). METHODS: Program information was gathered from needs assessment data, health survey data from enrolled caregivers and infants, training evaluations, and budget recordings of direct aid. In this mixed method design, we examined potential differences between baseline and the last assessment for women and children enrolled in the program. We also utilized univariate analyses of variance to examine the main effects of maternal and infant characteristics on final maternal and infant outcomes. RESULTS: Three sites enrolled 182 women and families for program services. Patient navigators provided direct aid, training, goal setting, and service coordination and planning. Families remained in the program, on average, 655 days and were satisfied with the services received. Respondents thought the program elements were easy to implement within the rural setting. The program effectively addressed basic needs, violence (p < 0.001; η2 = 0.34 (0.05-0.53)), infant development (p < 0.02; η2 = 0.51 (0.13-0.61)), and maternal depression (p < 0.05; η2 = 0.9 (0.00-0.22)). Select outcomes did differ by site. CONCLUSION: A service coordination model utilizing a patient navigator role to coordinate client services coupled with an approach that serves the infant and caregiver needs was feasible and desirable by all stakeholders within a rural setting. Service coordination effectively impacted select caregiver and infant outcomes.

Study using various reports from women who have, or still are, using substances, their family members, and providers about a service coordination structure designed to complement existing services for women and families in the rural setting.Why was the study done? Services for women who have, or still use, substances and their families are limited in rural settings. When they do exist, they are often disjointed, duplicative, and difficult to navigate. We hypothesized that a service coordination program with a key role available to help families navigate services would improve caregiver and family outcomes in many areas.What did the researchers do? The research team identified specific services offered in one program over the past five years. The program was given to women and families who had infants two years or younger and lived in rural communities. Caregivers and providers offered feedback about their experiences in the program. Caregiver and infant health were assessed and used to see if the program had a positive impact.What did researchers find? 182 families successfully enrolled in the program and stayed involved for an average of two years. Families and providers thought the program was easy to provide and navigate. They valued the role of the patient navigator and money offered to pay for essentials, if needed, was thought to be a key benefit, especially during COVID.What do the findings mean? Families may experience greater benefits from services if they have support for daily needs, when crises occur, someone to help navigate multiple services, and access to information when needed. These services are easy to provide and could be offered in rural communities.

Magnetic Resonance Imaging of Iron Metabolism with T2* Mapping Predicts an Enhanced Clinical Response to Pharmacologic Ascorbate in Patients with GBM.

PURPOSE: Pharmacologic ascorbate (P-AscH-) is hypothesized to be an iron (Fe)-dependent tumor-specific adjuvant to chemoradiation in treating glioblastoma (GBM). This study determined the efficacy of combining P-AscH- with radiation and temozolomide in a phase II clinical trial while simultaneously investigating a mechanism-based, noninvasive biomarker in T2* mapping to predict GBM response to P-AscH- in humans. PATIENTS AND METHODS: The single-arm phase II clinical trial (NCT02344355) enrolled 55 subjects, with analysis performed 12 months following the completion of treatment. Overall survival (OS) and progression-free survival (PFS) were estimated with the Kaplan-Meier method and compared across patient subgroups with log-rank tests. Forty-nine of 55 subjects were evaluated using T2*-based MRI to assess its utility as an Fe-dependent biomarker. RESULTS: Median OS was estimated to be 19.6 months [90% confidence interval (CI), 15.7-26.5 months], a statistically significant increase compared with historic control patients (14.6 months). Subjects with initial T2* relaxation < 50 ms were associated with a significant increase in PFS compared with T2*-high subjects (11.2 months vs. 5.7 months, P < 0.05) and a trend toward increased OS (26.5 months vs. 17.5 months). These results were validated in preclinical in vitro and in vivo model systems. CONCLUSIONS: P-AscH- combined with temozolomide and radiotherapy has the potential to significantly enhance GBM survival. T2*-based MRI assessment of tumor iron content is a prognostic biomarker for GBM clinical outcomes. See related commentary by Nabavizadeh and Bagley, p. 255.

Recurrent heterotopic ossification following open radical nephrectomy.

A 46-year-old male presented with a localized left renal mass and underwent an open radical nephrectomy via a midline incision. He recovered uneventfully and was discharged. After one month he reported persistent incisional pain; CT demonstrated heterotopic bone formation under the fascial closure. He underwent resection of calcified preperitoneal fat. Final pathology revealed benign bone tissue. He received a course of celecoxib. The patient developed recurrence of a smaller calcification. He underwent a second resection and was treated with adjuvant radiation. The patient had improvement of pain and no ossification visualized on CT imaging at 1-year follow up.

Smell-related quality of life changes after total laryngectomy: a multi-centre study.

PURPOSE: A total laryngectomy creates an alternate airway for gas exchange that bypasses the upper aerodigestive tract. The subsequent reduction in nasal airflow, and therefore, reduction in deposition of particles to the olfactory neuroepithelium leads to hyposmia or anosmia. The aim of this study was to assess the quality of life impairment conferred by anosmia following laryngectomy and identify any specific patient-related risk factors that are associated with poorer outcomes. METHODS: Consecutive patients with a total laryngectomy presenting for review at three tertiary head and neck services (in Australia, the United Kingdom and India) over a 12-month period were recruited. Patient demographic and clinical data were collected, and each subject completed the validated assessment of self-reported olfactory functioning and olfaction-related quality of life questionnaire (ASOF). Dichotomous comparisons were performed using the student's unpaired t-test for continuous variables (SRP), a chi-squared test for categorical variables, and a Kendall's tau-b for ordinal variables (SOC) to assess for a correlation with poorer questionnaire scores. RESULTS: A total of 66 laryngectomees (13.4% female; age 65.7 ± 8.6 years) were included in the study. The mean SRP score of the cohort was found to be 15.6 ± 7.4, while the mean ORQ score was noted to be 16.4 ± 8.1. No other specific risk factors associated with poorer quality of life were identified. CONCLUSION: A significant quality of life detriment from hyposmia is conferred following laryngectomy. Further research to assess treatment options and the patient population that would best benefit from these interventions is required.

Clinical Implementational and Site-Specific Workflows for a 1.5T MR-Linac.

MR-guided adaptive radiotherapy (MRgART) provides opportunities to benefit patients through enhanced use of advanced imaging during treatment for many patients with various cancer treatment sites. This novel technology presents many new challenges which vary based on anatomic treatment location, technique, and potential changes of both tumor and normal tissue during treatment. When introducing new treatment sites, considerations regarding appropriate patient selection, treatment planning, immobilization, and plan-adaption criteria must be thoroughly explored to ensure adequate treatments are performed. This paper presents an institution's experience in developing a MRgART program for a 1.5T MR-linac for the first 234 patients. The paper suggests practical treatment workflows and considerations for treating with MRgART at different anatomical sites, including imaging guidelines, patient immobilization, adaptive workflows, and utilization of bolus.

A Recursive Partitioning Analysis Demonstrating Risk Subsets for 8-Year Biochemical Relapse After Margin-Positive Radical Prostatectomy Without Adjuvant Hormone or Radiation Therapy.

PURPOSE: The cohort of patients with locally advanced prostate cancer (PC) and positive surgical margin(s) at radical prostatectomy (RP) who would benefit from salvage or adjuvant treatment is unclear. This study examines the risk of prostate-specific antigen (PSA) relapse in a large population of men with PC after margin-positive RP. METHODS AND MATERIALS: Using a multi-institutional database, patients with clinically localized PC who underwent RP between 2002 and 2010 with recorded follow-up PSA were retrospectively selected. Patients were excluded for pathologic seminal vesicle or lymph node involvement, metastatic disease, pre-RP PSA ≥ 30, or adjuvant (nonsalvage) radiation therapy or hormone therapy. The primary endpoint was biochemical relapse free survival (bRFS), where PSA failure was defined as PSA > 0.10 ng/mL and rising, or at salvage intervention. The Kaplan-Meier method was employed for bRFS estimates; recursive partitioning analysis using cumulative or single maximal margin extent (ME) and Gleason grade (GG) at RP was applied to identify variables associated with bRFS. RESULTS: At median follow-up of 105 months, 210 patients with positive margins at RP were eligible for analysis, and 89 had experienced PSA relapse. Median age was 61 years (range, 43-76), and median pre-RP PSA 5.8 ng/mL (1.6-26.0). Recursive partitioning analysis yielded 5 discrete risk groups, with the lowest risk group (GG1, ≤ 2 mm ME) demonstrating a bRFS of 92% at 8 years compared with the highest risk group (GG3-5, ≥ 3 mm ME) of 11%. CONCLUSIONS: This retrospective study suggests that it may be possible to risk-stratify patients undergoing margin-positive RP using commonly acquired clinical and pathologic variables. Patients with low-grade tumors and minimally involved margins have a very low recurrence risk and may be able to forego postprostatectomy radiation. Meanwhile, those with higher grade and greater involvement could benefit from adjuvant or early salvage radiation therapy.

Metastatic Renal Cell Carcinoma to the Spine: Outcomes and Morbidity: Single-Center Experience.

BACKGROUND: Renal cell carcinoma with metastases to the spine (RCCMS) requires a multidisciplinary approach. We reviewed our institutional experience with RCCMS patients undergoing spinal surgery in order to identify factors that may affect clinical outcomes, survival, and complications. METHODS: Patients with RCCMS who underwent operative intervention from 2007 to 2020 were reviewed retrospectively. RESULTS: Forty-four patients with the diagnosis of RCCMS were identified. Pain was the most common symptom, and neurologic dysfunction was present in one third of cases. Thoracic spine was the most common location (N = 27), followed by the lumbar (N = 12) and cervical (N = 5) regions. The overall survival from diagnosis of renal cell carcinoma was 25 (2 - 194) months and 8 (0.3 - 92) months after spinal surgery. Gender, age, spinal level, postoperative radiation, and nephrectomy had no bearing on survival. Survival for patients with a Tokuhashi score of 0 - 8, 9 - 11, and 12 - 15 was 6.5 (1.5 - 23.5), 8.9 (0.3 - 91.6), and 23.4 (2.5 - 66) months, respectively (P = 0.03). The postoperative American Spinal Cord Injury Association score of E (hazard ratio 0.109 [95% confidence interval 0.022 - 0.534, P = 0.006) also bore a significant influence on survival. There was a total of 10 complications in 7 of 44 (16%) patients. CONCLUSIONS: Median postoperative survival of patients with RCCMS was 8 (0.3 - 92) months. Higher Tokuhashi score and ASIA E score at follow-up correlated with improved overall survival. Complication rate was 16%. Spinal surgery in RCCMS is indicated for the preservation of function and prevention of neurologic deterioration. Multimodality therapy with improved chemotherapy and stereotactic spinal radiation is expected to impact quality and length of survival positively.

Magnetic resonance imaging (MRI) of pharmacological ascorbate-induced iron redox state as a biomarker in subjects undergoing radio-chemotherapy.

Pharmacological ascorbate (P-AscH-) combined with standard of care (SOC) radiation and temozolomide is being evaluated in a phase 2 clinical trial (NCT02344355) in the treatment of glioblastoma (GBM). Previously published data demonstrated that paramagnetic iron (Fe3+) catalyzes ascorbate's oxidation to form diamagnetic iron (Fe2+). Because paramagnetic Fe3+ may influence relaxation times observed in MR imaging, quantitative MR imaging of P-AscH--induced changes in redox-active Fe was assessed as a biomarker for therapy response. Gel phantoms containing either Fe3+ or Fe2+ were imaged with T2* and quantitative susceptibility mapping (QSM). Fifteen subjects receiving P-AscH- plus SOC underwent T2* and QSM imaging four weeks into treatment. Subjects were scanned: pre-P-AscH- infusion, post-P-AscH- infusion, and post-radiation (3-4 h between scans). Changes in T2* and QSM relaxation times in tumor and normal tissue were calculated and compared to changes in Fe3+ and Fe2+ gel phantoms. A GBM mouse model was used to study the relationship between the imaging findings and the labile iron pool. Phantoms containing Fe3+ demonstrated detectable changes in T2* and QSM relaxation times relative to Fe2+ phantoms. Compared to pre-P-AscH-, GBM T2* and QSM imaging were significantly changed post-P-AscH- infusion consistent with conversion of Fe3+ to Fe2+. No significant changes in T2* or QSM were observed in normal brain tissue. There was moderate concordance between T2* and QSM changes in both progression free survival and overall survival. The GBM mouse model showed similar results with P-AscH- inducing greater changes in tumor labile iron pools compared to the normal tissue. CONCLUSIONS: T2* and QSM MR-imaging responses are consistent with P-AscH- reducing Fe3+ to Fe2+, selectively in GBM tumor volumes and represent a potential biomarker of response. This study is the first application using MR imaging in humans to measure P-AscH--induced changes in redox-active iron.

Stereotactic radiotherapy of appropriately selected meningiomas and metastatic brain tumor beds with gamma knife icon versus volumetric modulated arc therapy.

PURPOSE: To determine if the gamma knife icon (GKI) can provide superior stereotactic radiotherapy (SRT) dose distributions for appropriately selected meningioma and post-resection brain tumor bed treatments to volumetric modulated arc therapy (VMAT). MATERIALS AND METHODS: Appropriately selected targets were not proximal to great vessels, did not have sensitive soft tissue including organs-at-risk (OARs) within the planning target volume (PTV), and did not have concave tumors containing excessive normal brain tissue. Four of fourteen candidate meningioma patients and six of six candidate patients with brain tumor cavities were considered for this treatment planning comparison study. PTVs were generated for GKI and VMAT by adding 1 mm and 3 mm margins, respectively, to the GTVs. Identical PTV V100% -values were obtained for the GKI and VMAT plans for each patient. Meningioma and tumor bed prescription doses were 52.7-54.0 in 1.7-1.8 Gy fractions and 25 Gy in 5 Gy fractions, respectively. GKI dose rate was 3.735 Gy/min for 16 mm collimators. RESULTS: PTV radical dose homogeneity index was 3.03 ± 0.35 for GKI and 1.27 ± 0.19 for VMAT. Normal brain D1% , D5% , and D10% were lower for GKI than VMAT by 45.8 ± 10.9%, 38.9 ± 11.5%, and 35.4 ± 16.5% respectively. All OARs considered received lower maximum doses for GKI than VMAT. GKI and VMAT treatment times for meningioma plans were 12.1 ± 4.13 min and 6.2 ± 0.32 min, respectively, and, for tumor cavities, were 18.1 ± 5.1 min and 11.0 ± 0.56 min, respectively. CONCLUSIONS: Appropriately selected meningioma and brain tumor bed patients may benefit from GKI-based SRT due to the decreased normal brain and OAR doses relative to VMAT enabled by smaller margins. Care must be taken in meningioma patient selection for SRT with the GKI, even if they are clinically appropriate for VMAT.

Microvascular Decompression versus Stereotactic Radiosurgery for Trigeminal Neuralgia: A Single-Institution Experience.

OBJECTIVE: Microvascular decompression (MVD) is the standard surgical procedure for patients with medically refractory trigeminal neuralgia (TN). Stereotactic radiosurgery (SRS) has gained increasing popularity as a less invasive technique. We report our institution's outcome in the surgical treatment of TN (MVD vs. SRS), taking patient's age and gender into consideration. METHODS: We retrospectively reviewed a prospectively collected database of patients undergoing MVD or SRS for type 1 idiopathic TN between 2004 and 2019 at the University of Iowa. Standardized data collection focused on preoperative clinical characteristics and postoperative outcomes including the Barrow Neurological Institute (BNI) Pain Intensity Score. RESULTS: A total of 111 patients underwent MVD and 103 patients underwent SRS for TN. Patients were younger in the MVD (median, 60 years) than SRS (median, 72 years) group. More females (58%) than males (42%) had TN. Multivariate ordinal regression analysis showed that an outcome of BNI score I-II (P = 0.365) and III (P = 0.736) can be achieved with either MVD or SRS; however, BNI score IV (P = 0.031) and V (P = 0.022) were more associated with SRS. Six percent of patients in the MVD group and 26% in the SRS group developed pain recurrence and required a second operation. Nine of 10 patients who underwent MVD after failed SRS had complete pain relief. CONCLUSIONS: Factoring in patients' age and gender, both MVD and SRS can achieve a favorable outcome for medically refractory TN, although BNI scores of IV and V were more common with SRS.

Colonization rates of tracheostomy tubes associated with the frequency of tube changes.

BACKGROUND: Tracheostomy-tube change protocols are implemented primarily due to concern regarding infections. Currently changes vary from within 4 weeks post-insertion to 3 monthly thereafter. However, currently no evidence-based guidelines exist to justify these protocols. This study aims to assess the colonization of tracheostomy-tubes associated with the frequency of changes. METHODS: A prospective cohort study over 18-months of adult tracheostomy patients at a single institution (inpatient/outpatients). Patients were grouped based on whether tubes were changed at ≤4 weeks or >4 weeks and microbiology swabs sent for microscopy, culture and sensitivities. RESULTS: A total of 65 patients were enrolled. No statistically significant difference in colonization in patients undergoing tube changes more than every 4 weeks to those less than every 4 weeks was found (56.2% versus 57.1%, χ2 = 0.004, P = 0.95). CONCLUSION: The timing of tracheostomy-tube changes may not affect colonization and infection rates. Routine changes for the purpose of reducing infection risk may not be needed unless clinically indicated.

Use of Purastat, a novel haemostatic matrix based on self-assembling peptides in the prevention of nasopharyngeal adhesion formation.

INTRODUCTION: Purastat is a novel haemostatic agent that has recently been used effectively in nasal procedures, specifically in functional endoscopic endonasal surgery in the prevention of post-operative epistaxis while minimising adhesion formation. This study presents a case of successful application of Purastat following division of a nasopharyngeal/palatal stenosis following radiotherapy. PRESENTATION OF CASE: A 49-year-old male developed severe nasopharyngeal stenosis following concurrent chemoradiotherapy with curative intent a HPV positive base of tongue squamous cell carcinoma. Following treatment, while the patient experienced excellent metabolic response, he began to progressive nasal obstruction which he reported to be significantly affecting his quality of life. Following multidisciplinary team discussion, division of the stenosis was considered appropriate. Under general anaesthesia, the patient was positioned lying supine with the neck extended. A Boyle-Davis gag with lip and teeth protection was placed and a Y-suction catheter inserted to lift the palate from the posterior pharyngeal wall. Coblation using a PDW wand was used to divide the area of fibrosis bilaterally toward the superior tonsillar pillar until palatopharyngeus musculature was visible. Injection of 4 mg of Dexamethasone with a hypodermic needle was then performed followed by application of 4 ml of topical Purastat onto the raw surfaces after haemostasis was confirmed. The patient was discharged the same day on simple analgesia and instructions to avoid exertion for two weeks. He attended follow-up in the outpatient department two months later and reported persisting resolution of his nasal obstructive symptoms. No evidence of recurrence or residual adhesion tissue was noted.

Risk factors associated with microbial colonisation and infection of tracheostomy tubes.

BACKGROUND: A long-term tracheostomy tube has the potential to cause significant morbidity and mortality in both hospitalised patients and those in the community. This study aims to assess the rates of microbial colonisation and infection of tracheostomy tubes. MATERIALS AND METHODS: Consecutive patients were enrolled from both inpatient and outpatient settings during their routine tracheostomy changes. During changes, culture swabs were taken from the cuff/outer-cannula and inner-cannula. Analysis were performed to compare culture results with risk factors. RESULTS: 65 patients were enrolled in the study. Inpatients (65.9% vs 38.1%, χ2 4.48, p = 0.03), increasing acuity of care (from outpatient; ward; HDU; and ICU in increasing acuity) (τb = 0.289, p = 0.012), cuffed tracheostomy tubes, (66.7% vs 39.1%; χ2 4.59, p = 0.032); diabetics (64.6% vs 35.3%; χ2 4.39, p = 0.036); and males were associated with increased colonisation (72.4% vs 44.4%; χ2 5.12, p = 0.024). CONCLUSION: Factors associated with an increase in colonisation and infection of tracheostomy tubes were location, and in males, diabetics and in cuffed tubes.

Arytenoid vertical height discrepancy in predicting outcomes after unilateral vocal cord medialization.

OBJECTIVES/HYPOTHESIS: Unilateral vocal fold paralysis is a structural abnormality that often occurs secondary to dysfunction of the recurrent laryngeal nerve and typically presents as a breathy voice. Medialization laryngoplasty is a constellation of procedures that improves apposition of the vocal cords. Many patients, however, fail to experience sufficient improvement in vocal quality postoperatively despite apparent glottic closure on stroboscopy. This suggests that asymmetry in other cord characteristics may also have acoustic consequences. Our hypothesis is that arytenoid height symmetry may play a significant role in vocal quality. To our knowledge there are no human observational studies examining this topic. We therefore aimed to correlate asymmetry in arytenoid height and patient-reported satisfaction in voice quality after thyroplasty. STUDY DESIGN: Retrospective cohort analysis. METHODS: A retrospective review of prospectively collected data on consecutive patients who underwent medialization thyroplasty at a tertiary Sydney, Australia hospital was performed. Data collected included age, sex, onset of symptoms, as well as well as preoperative and 3-month postoperative maximum phonation time and Voice Handicap Index (VHI). Preoperative computed tomography scans were assessed for discrepancy of arytenoid vertical height discrepancy. RESULTS: Twenty-three patients (56.5% female) with mean age of 52.4 ± 14.9 years were included. Most patients underwent injection thyroplasty (78.3%, n = 5), whereas the remaining underwent an open approach. A statistically significant inverse correlation was found between increasing height discrepancy and VHI improvement (r = -0.6, P = .003.) Revision surgery was associated with increased height discrepancy. CONCLUSIONS: Findings of this study may affect future recommendations to address height discrepancy in surgery to treat unilateral vocal cord paralysis. LEVEL OF EVIDENCE: 3 Laryngoscope, 130:418-422, 2020.

Comparison of arytenoid vertical height discrepancy in normal versus patients with vocal cord palsy.

OBJECTIVE: Cadaveric experiments and more recently clinical data have demonstrated that patients with vertical height discrepancy between their arytenoids experience poorer voice outcomes in patients with unilateral vocal cord palsy (UVP) after medialisation laryngoplasty. However, the presence or severity of height discrepancy in normal patients without UVP has not yet been clearly defined. STUDY DESIGN: Case-control study. SETTING: Tertiary Australian hospitals. SUBJECTS AND METHODS: A retrospective review was performed on patients who underwent high computed tomography imaging of the neck. Scans were assessed for discrepancy in arytenoid vertical height discrepancy and compared to a cohort with known UVP. RESULTS: 44 normal patients (50% female, mean age 57.6 ±â€¯14.8 years) were compared to 23 patients with UVP (43.4% female, mean age 52.3 ±â€¯14.9 years.) Normal patients were found to have a smaller height discrepancy compared to UVP patients (student's t-test,2.00 mm ±â€¯0.00 vs 2.39 mm ±â€¯0.72, p < .001.) CONCLUSION: This study suggests that discrepancy is pathologic, and it is plausible that this results in acoustic consequences.

First-in-Human Phase I Clinical Trial of Pharmacologic Ascorbate Combined with Radiation and Temozolomide for Newly Diagnosed Glioblastoma.

PURPOSE: Standard treatment for glioblastoma (GBM) includes surgery, radiation therapy (RT), and temozolomide (TMZ), yielding a median overall survival (OS) of approximately 14 months. Preclinical models suggest that pharmacologic ascorbate (P-AscH-) enhances RT/TMZ antitumor effect in GBM. We evaluated the safety of adding P-AscH- to standard RT/TMZ therapy. PATIENTS AND METHODS: This first-in-human trial was divided into an RT phase (concurrent RT/TMZ/P-AscH-) and an adjuvant (ADJ) phase (post RT/TMZ/P-AscH- phase). Eight P-AscH- dose cohorts were evaluated in the RT phase until targeted plasma ascorbate levels were achieved (≥20 mmol/L). In the ADJ phase, P-AscH- doses were escalated in each subject at each cycle until plasma concentrations were ≥20 mmol/L. P-AscH- was infused 3 times weekly during the RT phase and 2 times weekly during the ADJ phase continuing for six cycles or until disease progression. Adverse events were quantified by CTCAE (v4.03). RESULTS: Eleven subjects were evaluable. No dose-limiting toxicities occurred. Observed toxicities were consistent with historical controls. Adverse events related to study drug were dry mouth and chills. Targeted ascorbate plasma levels of 20 mmol/L were achieved in the 87.5 g cohort; diminishing returns were realized in higher dose cohorts. Median progression-free survival (PFS) was 9.4 months and median OS was 18 months. In subjects with undetectable MGMT promoter methylation (n = 8), median PFS was 10 months and median OS was 23 months. CONCLUSIONS: P-AscH-/RT/TMZ is safe with promising clinical outcomes warranting further investigation.

Thyroidectomy in octogenarians is not associated with poorer postoperative outcomes.

BACKGROUND: The elderly represents one of the most rapidly growing subsets of the population. This population experiences a higher incidence of thyroid pathology. However, there are concerns that the elderly also experiences increased perioperative complications and are poor candidates for thyroidectomy. METHODS: Patients who underwent thyroidectomy over the age of 80 years at three tertiary head and neck units were included. Data regarding age, sex, presenting symptoms, comorbidities, preoperative investigations, type of surgery, postoperative complications, and final thyroid pathology were retrieved from hospital records. RESULTS: Of a total of 39 patients (69% women, mean age 83.1), the majority (40.1%) presented with a combination of symptoms: shortness of breath, feeling of pressure in the neck, dysphagia, or tiredness. Two (5.1%) were asymptomatic. Low rates of postoperative complications were encountered and were minor (n = 5). No intensive care unit admissions or mortality was experienced. CONCLUSION: Thyroid surgery in octogenarians carries an acceptable complication profile.

Validity of narrow band imaging in the detection of oral and oropharyngeal malignant lesions: A systematic review and meta-analysis.

BACKGROUND: This meta-analysis describes the validity of narrow band imaging (NBI) in the assessment of suspicious oral lesions. METHODS: Medline, EMBASE, and Scopus were searched for trial studies comparing NBI with conventional modalities in the oral cavity (OC) and oropharynx (OP) for the detection of dysplastic and malignant change. RESULTS: Seven studies were found, and generally supported the utility of NBI in different clinical settings, although there were exceptions. Pooled data from 4 studies of NBI validity demonstrated high summary specificity and sensitivity for a wide range of suspicious lesions of the OC or OP (75.7% with 95% CI 65.1%-83.9%, and 91.5% with 95% CI 81.8%-96.3%, respectively). Summary positive likelihood ratio (LR+) was 8.91 (95% CI 4.1-19.6) and 0.27 (95% CI 0.18-0.39), respectively. CONCLUSIONS: NBI is a promising diagnostic and surveillance tool for suspicious lesions in the OC or OP; however, higher powered studies will define precise NBI criterion and clinical recommendations.

Is More Always Better? An Assessment of the Impact of Lymph Node Yield on Outcome for Clinically Localized Prostate Cancer with Low/Intermediate Risk Pathology (pT2-3a/pN0) Managed with Prostatectomy Alone.

The clinical impact of lymph node dissection extent remains undetermined in the contemporary setting, as reflected in care pattern variations. Despite some series demonstrating a direct relationship between number of lymph nodes identified and detection of nodal involvement, the correlation between lymph node yield and disease control or survival outcomes remains unclear. Patients with clinically localized prostate cancer, pre-RP PSA <30, and pT2-3a/N0 disease at RP were retrospectively identified from two databases for inclusion. Those who received pre- or post-RP radiotherapy or hormone therapy were excluded. Kaplan-Meier method was employed for survival probability estimation. Cox regression models were used to assess bRFS differences between subsets. From 2002 to 2010, 667 eligible patients were identified. The median age was 61 yrs. (range, 43-76), with median PSA 5.6 ng/dL (0.9-28.0). At RP, most patients had pT2c (64%) disease with Gleason Score (GS) ≤6 (43%) or 7 (48%); 218 (33%) patients had positive margins (M+). At median clinical and PSA follow-up of 96 and 87 months, respectively, 146 patients (22%) experienced PSA failure with an estimated bRFS of 81%/76% at 5/8 years. For patients who underwent LND, univariable analysis identified PSA (at diagnosis), higher GS (≥7, at biopsy or RP), intermediate/high risk stratification, M+ as adversely associated with bRFS (all p < 0.01). A higher number of LNs excised was not associated with improved bRFS for the entire cohort (HR = 0.97, p = 0.27), nor for any clinical risk stratum, biopsy GS, or RP GS subgroup. This study did not demonstrate an association between LN yield and bRFS in patients with clinically localized pT2-3a/pN0 prostate cancer managed with RP alone, either in the entire population or with substratification by clinical risk stratum or GS.