Superselective transcatheter arterial embolization in patients with acute peripancreatic bleeding complications: review of 44 cases

Purpose

To evaluate the efficacy of superselective transcatheter arterial embolization (TAE) in the treatment of acute peripancreatic bleeding complications.

Methods

During a 9-year period, 44 patients with acute bleeding of the peripancreatic arteries underwent TAE in our institution. Thirty-eight patients were treated using microcatheters and 6 patients with a diagnostic catheter. Embolic agents included coils (n = 38), polyvinyl alcohol (PVA) particles (n = 2), isobutyl cyanoacrylate (n = 2), coils plus PVA particles (n = 1), and coils plus isobutyl cyanoacrylate (n = 1). Outcome measures included technical success, clinical success, and the rate of complications.

Results

Identified bleeding sources included gastroduodenal artery (n = 14), splenic artery (n = 9), pancreaticoduodenal artery (n = 6), common hepatic artery (n = 5), superior mesenteric artery branches (n = 4), proper hepatic artery (n = 3), and dorsal/transverse pancreatic artery (n = 3). Technical success with effective control of active bleeding was achieved in 41/44 patients (93 %). Clinical success attributed to TAE alone was documented in 40/44 patients (91 %). The rate of major complications was 2 % including death in one patient.

Conclusions

Superselective TAE allows effective, minimally invasive control of acute peripancreatic bleeding complications with a low rate of therapeutically relevant complications.

     

Partially-covered stent placement versus surgical gastrojejunostomy for the palliation of malignant gastroduodenal obstruction secondary to pancreatic cancer

Purpose

To compare the outcomes of partially covered self-expandable metallic stent (SEMS) placement with surgical gastrojejunostomy (GJ) in patients with gastroduodenal obstruction caused by pancreatic cancer.

Methods

The medical records of 107 patients with gastroduodenal obstruction caused by pancreatic cancer who underwent fluoroscopic partially covered SEMS placement (n = 75) or surgical GJ (n = 32) at our institution were reviewed.

Results

The technical (100% vs. 100%; P > 0.999) and clinical (98.7% vs. 96.9%; P = 0.511) success rates were similar between the SEMS and GJ group. The mean gastric outlet obstruction scoring system score was higher in the SEMS group at 1 week after treatment (2.3 ± 0.5 vs. 1.2 ± 0.4; P < 0.001) but was similar between the two groups at 1 month (2.7 ± 0.5 vs. 2.8 ± 0.5; P = 0.242). The median hospital stay was shorter in the SEMS group than in the GJ group (7 vs. 14 days; P < 0.001). The overall complication (22.7% vs. 28.1%; P = 0.547) and reintervention (21.3% vs. 25.0%; P = 0.677) rates were similar between the two groups. The median patency (99 vs. 138 days; P = 0.102) and survival (106 vs. 140 days; P = 0.245) were also similar between the two groups.

Conclusion

The outcomes of partially covered SEMS placement seem to be more favorable than surgical GJ in patients with gastroduodenal obstruction caused by pancreatic cancer.

     

The prognostic significance of extramural venous invasion detected by multiple-row detector computed tomography in stage III gastric cancer

Purpose

To determine the 1-year progression-free survival (PFS) of extramural venous invasion (EMVI), detected with contrast-enhanced multiple-row detector computed tomography (ceMDCT), in patients with stage III gastric cancer.

Methods

Between January 2009 and December 2013, 117 patients with pathological-proved stage III gastric cancer based on the criteria of the AJCC 7th were included in this retrospective study. All patients underwent adjuvant chemotherapy postoperatively and had been monitored with the follow-up chest/abdomen/pelvis ceMDCT on 3, 6, and 12 months post-operation. Two radiologists reviewed preoperative images regarding the presence of EMVI, categories of tumor and categories of lymph node. Conventional prognostic histological factors including pathological T/N status, tumor location/growth pattern, histological type/tumor differentiation, and tumor size were also recorded. Disease progression was defined as the presence of radiological or/and pathology-confirmed metachronous metastases, local recurrence, or gastric cancer-related death. The 1-year PFS for both EMVI-positive and EMVI-negative was calculated using the Kaplan–Meier product limit. Hazard ratios for 1-year PFS were generated using a Cox proportional hazard regression on ceMDCT tumor characteristics.

Results

The prevalence of EMVI detected with ceMDCT was 43.6% (51/117) in patients with stage III gastric cancer. The EMVI-positive patients had significantly lower 1-year PFS rates (45.1%), than the EMVI-negative patients (75.8%), (Log-rank test, P = 0.0008). In a Cox proportional hazards regression analysis, EMVI and tumor location/growth pattern were identified as independent prognostic factors of 1-year PFS with hazard ratio of 2.272 (95% CI 1.133–4.556, P = 0.021) and 1.982 (95% CI 1.040–3.780, P = 0.039), respectively.

Conclusion

EMVI status, detected with ceMDCT, could be used to counsel patients regarding ongoing risks of metastatic disease, implications for surveillance, and systemic chemotherapy.

     

Effect of synbiotic therapy on the incidence of ventilator associated pneumonia in critically ill patients: a randomised,double-blind,placebo-controlled trial

Objective

To investigate the effect of enteral Synbiotic 2000 FORTE^® (a mixture of lactic acid bacteria and fibre) on the incidence of ventilator associated pneumonia (VAP) in critically ill patients.

Design

Prospective, randomised, double blind, placebo controlled trial.

Setting

Tertiary referral centre, general Adult Intensive Care Unit (ICU).

Patients and participants

259 enterally fed patients requiring mechanical ventilation for 48 h or more were enrolled.

Intervention

All patients were enterally fed as per a standard protocol and randomly assigned to receive either synbiotic 2000 FORTE^® (twice a day) or a cellulose-based placebo for a maximum of 28 days.

Measurements and results

Treatment group (n = 130) was well matched with placebo group (n = 129) for age (mean 49.5 and 50 years, respectively) and APACHE II score (median 17 for both). Oropharyngeal microbial flora and colonisation rates were unaffected by synbiotics. The overall incidence of VAP was lower than anticipated (11.2%) and no statistical difference was demonstrated between groups receiving synbiotic and placebo in the incidence of VAP (9 and 13%, P = 0.42), VAP rate per 1,000 ventilator days (13 and 14.6, P = 0.91) or hospital mortality (27 and 33%, P = 0.39), respectively.

Conclusions

Enteral administration of Synbiotic 2000 FORTE^® has no statistically significant impact on the incidence of VAP in critically ill patients.

     

Long-term Efficacy of Safinamide on Parkinson’s Disease Chronic Pain

Introduction

Chronic pain is an important yet overlooked non-motor symptom of Parkinson’s disease (PD), caused by an imbalance of the dopaminergic and glutamatergic systems. Safinamide has a multimodal mechanism of action, dopaminergic (reversible MAO-B inhibition) and non-dopaminergic (modulation of the abnormal glutamate release), that might be beneficial for both motor and non-motor symptoms.

Objectives

To investigate the long-term (2-year) efficacy of safinamide on PD chronic pain and to confirm the positive effects observed after 6 months of treatment.

Methods

This is a post hoc analysis of the data from the 2-year study 018, focused on the reduction of concomitant pain treatments and on the scores of pain-related items of the Parkinson’s disease quality of life questionnaire (PDQ-39).

Results

Safinamide, compared with placebo, significantly improved the PDQ-39 items 37 (“painful cramps or spasm,” p?=?0.0074) and 39 (“unpleasantly hot or cold,” p?=?0.0209) and significantly reduced the number of concomitant pain treatments by 26.2% (p?=?0.005). A significantly greater proportion of patients in the safinamide group was not using pain drugs after 2 years of treatment (p?=?0.0478).

Conclusions

The positive effects of safinamide on PD chronic pain were maintained in the long term. Further investigations are desirable to confirm their clinical relevance.

Funding

Zambon SpA.

     

Association of Performance Status and Pain in Metastatic Bone Pain Management in the Spanish Clinical Setting

Introduction

Bone metastasis is the most common cause of cancer-related pain, and metastatic bone pain (MBP) is not only severe but also progressive in many patients. The aim of this study was to investigate the association between pain management and performance status in patients with metastatic bone cancer in the Spanish clinical setting.

Methods

A 3-month follow-up prospective, epidemiologic, multicenter study was conducted in 579 patients to assess the evolution of their performance, the impact of pain control on sleep and functionality, and the degree of pain control according to analgesic treatment.

Results

In patients with MBP, Eastern Cooperative Oncology Group (ECOG) status (1.5 ± 0.7–1.3 ± 0.7 and 1.3 ± 0.8; p < 0.001) and pain (6.5 ± 1.4–2.8 ± 1.9 and 2.1 ± 1.9; p < 0.001) improved significantly from baseline to months 1 and 3, as did functionality and sleep, after a treatment change consisting of increasing the administration of opioids. Evolution of ECOG and pain were closely related. ECOG and pain outcomes were significantly more favorable in patients treated with opioids versus non-opioid treatment, and in patients who did not need rescue medication versus those who did.

Conclusions

MBP is currently poorly managed in Spain. ECOG improvement is closely and directly related to pain management in MBP. Opioid treatment and a lack of requirements for rescue medication are associated with better ECOG and pain outcomes in MBP patients.

Funding

Mundipharma Pharmaceuticals S.L.

     

Ist die Supplementierung der Ohrakupunktur bei operativer Zahnentfernung in Lokalanästhesie effektiv?

Background

The application of ear acupuncture can contribute to a reduction of acute pain. Data on the application of ear acupuncture following oral surgery in odontology is insufficient.

Objective

This study investigated the effectiveness of ear acupuncture as an auxiliary analgesic treatment in addition to local anesthesia for operative tooth removal.

Methods

In this prospective open non-randomized pilot study (in accordance with the CONSORT publication) 2 cohorts of 50 patients each with the indications for an operative tooth removal either with or without the application of ear acupuncture in addition to local anesthesia with articain were observed. Patients were allocated to the groups according to their preference. Pain intensity while resting and while chewing was recorded as the primary parameter for a period of 10 days. The secondary parameters were the subjective experience of anxiety and symptoms, such as headaches, dizziness and nausea.

Results

The two groups did not differ significantly with respect to demographic variables or the use of local anesthetics. At the various measurement intervals, pain intensity while resting or chewing differed significantly between the two groups (ANOVA, p = 0.004, p = 0.007, respectively). Furthermore, the experience of anxiety (ANOVA, p = 0.0001), the number of patients taking analgesics (χ²-test, p = 0.017) and the total postoperative consumption of analgesics (t-test, 0.001) revealed significant differences. In both groups the numerical rating scales (NRS) for postoperative headaches, dizziness and nausea were low.

Discussion and conclusion

Despite a potential bias and methodological limitations of the study design, the results of this investigation suggest that ear acupuncture influences the experience of pain and anxiety in the postoperative period after tooth removal. As a treatment method with low adverse effects ear acupuncture can contribute to postoperative pain control, especially in patients with preoperative anxiety.

     

Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors

Purpose

Cancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of mindfulness-based stress reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms.

Methods

Breast (n = 60) and colorectal (n = 11) cancer survivors (stage 0–III) with clinically significant CRF after completing chemotherapy and/or radiation therapy an average of 28 months prior to enrollment were randomized to MBSR or psychoeducation/support groups (PES). MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, vitality, depression, anxiety, sleep disturbance, and pain. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3) using intent-to-treat analysis.

Results

Between-group differences in CRF interference were not significant at any time point; however, there was a trend favoring MBSR (d = ?0.46, p = 0.073) at T2. MBSR participants reported significantly greater improvement in vitality (d = 0.53, p = 0.003) and were more likely to report CRF as moderately to completely improved compared to the PES group (χ2 (1) = 4.1765, p = 0.041) at T2. MBSR participants also reported significantly greater reductions in pain at T2 (d = 0.53, p = 0.014). In addition, both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes, depression, anxiety, and sleep at T2 and T3 compared to T1.

Conclusion

MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted.

Trial Registration

ClinicalTrials.gov Identifier: NCT01724333.

     

Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews

Introduction

To improve understanding of the diabetic gastroparesis (DGP) patient experience and inform the patient-reported outcome measurement strategy for future trials in DGP, qualitative interviews were conducted with participants in a phase 2 clinical trial of a novel DGP treatment.

Methods

Trial participants were invited to participate in interviews at both the pretreatment visit (PTV) and the end-of-treatment visit (EOTV). The interviews were conducted by experienced qualitative researchers and followed a semistructured interview guide. The PTV interviews focused on patients’ DGP symptoms and the impact of DGP on their lives, and the EOTV interviews focused on any symptom changes patients experienced during the trial.

Results

Of 90 enrolled trial participants, 78 (86.7%) opted to participate in the interview study. Bloating, stomach fullness, upper abdominal pain, vomiting, constipation, and heartburn or reflux were each reported spontaneously by a majority of the 73 PTV interview participants with evaluable data. These patients commonly reported bloating (n = 20), upper abdominal pain (n = 12), and nausea (n = 11) as their most bothersome DGP symptom. Of 51 EOTV interview participants, 44 (86.3%) reported improvement in at least one DGP symptom either spontaneously or when asked about specific symptoms reported during their PTV interview.

Conclusion

Bloating, abdominal pain, nausea, constipation, stomach fullness, vomiting, and heartburn were frequently reported by patients as the most bothersome and important-to-treat symptoms. These results support the assessment of these symptoms in future DGP clinical trials, whether for symptom improvement or worsening.

Funding

Ironwood Pharmaceuticals.

Trial Registration

ClinicalTrials.gov identifier NCT02289846.

     

Clinical recommendations for pain,sedation, withdrawal and delirium assessment in critically ill infants and children: an ESPNIC position statement for healthcare professionals

Background

This position statement provides clinical recommendations for the assessment of pain, level of sedation, iatrogenic withdrawal syndrome and delirium in critically ill infants and children. Admission to a neonatal or paediatric intensive care unit (NICU, PICU) exposes a child to a series of painful and stressful events. Accurate assessment of the presence of pain and non-pain-related distress (adequacy of sedation, iatrogenic withdrawal syndrome and delirium) is essential to good clinical management and to monitoring the effectiveness of interventions to relieve or prevent pain and distress in the individual patient.

Methods

A multidisciplinary group of experts was recruited from the members of the European Society of Paediatric and Neonatal Intensive Care (ESPNIC). The group formulated clinical questions regarding assessment of pain and non-pain-related distress in critically ill and nonverbal children, and searched the PubMed/Medline, CINAHL and Embase databases for studies describing the psychometric properties of assessment instruments. Furthermore, level of evidence of selected studies was assigned and recommendations were formulated, and grade or recommendations were added on the basis of the level of evidence.

Results

An ESPNIC position statement was drafted which provides clinical recommendations on assessment of pain (n = 5), distress and/or level of sedation (n = 4), iatrogenic withdrawal syndrome (n = 3) and delirium (n = 3). These recommendations were based on the available evidence and consensus amongst the experts and other members of ESPNIC.

Conclusions

This multidisciplinary ESPNIC position statement guides professionals in the assessment and reassessment of the effectiveness of treatment interventions for pain, distress, inadequate sedation, withdrawal syndrome and delirium.

     

Correlation between the combination of apparent integrated backscatter–spectral centroid shift and bone mineral density

Purpose

To introduce a new diagnostic parameter: the linear combination of apparent integrated backscatter and spectral centroid shift.

Methods

Ultrasonic backscatter measurements were performed at the calcanei of 1262 volunteers in vivo. The hip and spine bone mineral densities of the volunteers were measured using dual X-ray absorptiometry. The apparent integrated backscatter and spectral centroid shift were calculated. A new diagnostic parameter, i.e., the linear combination of apparent integrated backscatter and spectral centroid shift, was introduced and its correlation to bone mineral density was analyzed.

Results

The results show that the combination of apparent integrated backscatter and spectral centroid shift is significantly correlated to bone mineral density (R = 0.73–0.84, n = 1262, p < 0.05), and that this correlation is more significant than the correlation between the apparent integrated backscatter and bone mineral density or the correlation between spectral centroid shift and bone mineral density (R = 0.48–0.69, p < 0.05).

Conclusion

The combination of apparent integrated backscatter and spectral centroid shift can provide the complementary information of attenuation of the two parameters and predict more information about cancellous bone, and may be employed to assess cancellous bone status.

     

Intrapartum transperineal ultrasound for evaluating uterine contraction intensity in the second stage of labor

Purpose

To clarify whether intrapartum transperineal ultrasound (ITU) can be used to evaluate uterine contraction intensity, and whether the intensity is associated with the duration of the second stage.

Methods

A prospective observational study was performed involving 86 women with a normal singleton term fetus and more than three contractions every 10 min. ITU was performed for contractile and non-contractile periods of labor at the beginning of the second stage, and one representative “angle of progression (AoP)” image was selected for each period. The Mann–Whitney U test was used to compare ?AoP, the difference between the two angles, depending on the duration of the second stage. Receiver operating characteristic curves were used to evaluate the probability of duration of the second stage ≤50 min in nulliparous women.

Results

Among nulliparous women, ΔAoP differed significantly according to the duration of the second stage (52.5° ± 5.0° for ≤50 min vs. 30.9° ± 2.1° for >50 min; P < 0.001). Receiver operating characteristic curve analysis showed that approximately 85% of nulliparous women with ΔAoP greater than 40° delivered within 50 min.

Conclusion

These findings could be utilized in the evaluation of uterine contraction intensity, and ?AoP measurement could be used to predict the duration of the second stage of labor in nulliparous women.

     

Clinical application of navigator-gated three-dimensional balanced turbo-field-echo magnetic resonance cholangiopancreatography at 3 T: prospective intraindividual comparison with 1.5 T

Objective

To evaluate and compare the clinical utility of balanced turbo-field-echo (BTFE) magnetic resonance cholangiopancreatography (MRCP) sequences obtained at 3 and 1.5 T.

Methods

We acquired three-dimensional (3D) BTFE MRCP scans with a navigator-gated technique at 3 T on a different day after 1.5 T in 39 consecutive patients. Two radiologists independently rated the image quality and visibility of anatomical structures (right and left hepatic duct, cystic duct, gallbladder, common bile duct, and main pancreatic duct) using a four-point scale. For quantitative analysis, the signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and acquisition time were evaluated.

Results

All visual scores tended to be higher for 1.5 T than 3 T images. There was a significant difference in the image quality and the depiction of the main pancreatic duct (p < 0.01). The image acquisition time was significantly shorter for 3 T than 1.5 T (199.3 ± 40.1 vs. 264.0 ± 86.5 s, p < 0.01). There was no significant difference in SNR and CNR.

Conclusions

3D-BTFE MRCP scans acquired at 3 T were of sufficient image quality with respect to the biliary tree. SNR and CNR were comparable on 3 and 1.5 T scans, although the acquisition time was significantly shorter with the 3 T scanner.

     

Measurement of pancreatic cystic lesions on magnetic resonance imaging: efficacy of standards in reducing inter-observer variability

Purpose

The purpose of this study is to assess inter-observer variability in the measurement of pancreatic cystic lesions with MRI and to determine the impact of measurement standards.

Materials and methods

In this IRB-approved, HIPAA-compliant study with waiver of informed consent, 144 MRI examinations, containing pancreatic cystic lesions measuring between 5 and 35 mm, were reviewed independently by two radiology attendings and two abdominal imaging fellows. Measurements were repeated by the same reviewers 12 weeks later after the introduction of measurement standards. Results were analyzed using within-subject standard deviation, intraclass correlation coefficient, and kappa.

Results

Prior to standardization, the within-subject standard deviation, showing measurement variability in each cyst, was 4.0 mm, which was reduced to 3.3 mm after introduction of measurement standards (p < 0.01). Overall inter-observer agreement, kappa, improved from 0.59 to 0.65 (p = 0.04). The frequency of all four reviewers agreeing on size category increased from 51% to 60%. The intraclass correlation coefficient increased from 0.81 to 0.86.

Conclusions

There is significant and frequent inter-observer variability in the measurement of pancreatic cystic lesions with MRI which could affect clinical management. Implementation of measurement standards reduces measurement variability and aids in preventing erroneous reporting of growth and potentially unwarranted changes in management.

     

A Randomized Trial Investigating the Pharmacokinetics,Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects

Introduction

Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects.

Methods

In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to semaglutide 0.5 mg (n = 8), 1.0 mg (n = 8), placebo 0.5 mg (n = 3) or 1.0 mg (n = 3). The primary endpoint was semaglutide exposure at steady state [area under the curve (AUC_0–168h)].

Results

Steady-state exposure of semaglutide was similar for both populations: AUC_0–168h estimated race ratio (ERR), Japanese/Caucasian: 0.5 mg, 1.06; 1.0 mg, 0.99; maximum concentration (C_max) ERR: 0.5 mg, 1.06; 1.0 mg, 1.02. Exposure after the first dose (0.25 mg) was slightly higher in Japanese versus Caucasian subjects (AUC_0–168h ERR 1.11; C_max ERR 1.14). Dose-dependent increases in AUC_0–168h and C_max occurred in both populations. Accumulation was as expected, based on the half-life (t_1/2, ~ 1 week) and dosing interval of semaglutide. Significant body weight reductions were observed with semaglutide 0.5 mg and 1.0 mg in Japanese (both p ≤ 0.05) and Caucasian (both p ≤ 0.05) subjects versus placebo. No new safety issues were identified.

Conclusions

The pharmacokinetic, pharmacodynamic, and safety profiles of semaglutide were similar in Japanese and Caucasian subjects, suggesting that no dose adjustment is required for the clinical use of semaglutide in Japanese subjects.

Funding

Novo Nordisk A/S, Denmark.

Trial registration

ClinicalTrials.gov identifier NCT02146079. Japanese trial registration number JapicCTI-142550.

     

Feasibility of Using an Enzymatically Activatable Fluorescence Probe for the Rapid Evaluation of Pancreatic Tissue Obtained Using Endoscopic Ultrasound-Guided Fine Needle Aspiration: a Pilot Study

Purpose

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the most reliable method for the histological diagnosis of pancreatic tumors. Rapid on-site fluorescence-guided histological diagnosis was evaluated by topically applying an enzymatically activatable probe onto the EUS-FNA samples; the probe fluoresces in the presence of γ-glutamyltranspeptidase (GGT).

Procedures

We evaluated GGT expression in pancreatic cancer cell lines in vitro. EUS-FNA was performed in 10 pancreatic tumors. After topical application of the probe, signal intensity was measured using a fluorescence imaging system for 13 min.

Results

GGT was expressed in Panc-1, AsPC-1, and AR42J, but not in KP4 cells. In samples from six cases, several regions of the specimens fluoresced and contained adequate tissue for pathological diagnosis. The remaining four non-fluorescent samples contained very small amounts of carcinoma, normal epithelial cells, or no epithelial cells. The signal intensity at 5 min was 25.5?±?7.7 and 7.7?±?0.5 in fluorescent and non-fluorescent regions, respectively (p?<?0.05).

Conclusions

Application of enzymatically activatable probe onto EUS-FNA samples would be feasible for the rapid evaluation of tissues suitable for histological diagnosis.

     

Low-level laser therapy prevents severe oral mucositis in patients submitted to hematopoietic stem cell transplantation: a randomized clinical trial

Purpose

The purpose of this study is to evaluate the effectiveness of low-level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic stem cell transplantation.

Methods

This is a randomized, parallel, superiority trial including 35 patients divided into the following: laser (n?=?17) and sham (n?=?18). The variables assessed were oral mucositis (grade 2 of the World Health Organization oral toxicity scale), severe oral mucositis (grade 3 or 4), and pain (according to a visual analogue scale). In the laser group, a InGaAlP laser, wavelength of 650 nm, power 100 mW, energy per point of 2 J, time 20 s by point, extremity fiber optic 0.028 cm², and energy density 70 J/cm², was used, applied the first day of conditioning until D + 5, while the sham group received simulated laser over the same period.

Results

No statistically significant difference was found in the incidence of oral mucositis (p?=?0.146). Severe mucositis was found in 40 % of the patients (14/35), 3 in the intervention group (17.65 %) and 11 in the sham group (61.11 %) (p?=?0.015). The cumulative probability of survival with respect to the development of severe oral mucositis was >0.6 for the intervention group and 0 for the control group (p?=?0.0397). On the day on which pain was considered the worst, patients in the sham group were more likely to classify their pain as severe compared to those in the laser group (p?=?0.041).

Conclusion

Low-level laser therapy proved effective for the prevention of severe oral mucositis and intense oral pain in patients submitted to hematopoietic stem cell transplantation.

     

<Emphasis Type="Italic">nab</Emphasis>-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial

Introduction

The phase III MPACT trial in patients with metastatic pancreatic cancer (MPC) demonstrated superior efficacy of nab-paclitaxel (nab-P) plus gemcitabine (Gem) compared with Gem monotherapy, including the primary endpoint of overall survival (OS; median 8.7 vs. 6.6 months; hazard ratio [HR] 0.72; P < 0.001). A significant treatment difference favoring nab-P + Gem over Gem was observed for OS in patients treated in North America. The majority of patients were from the US (88%) with only 12% from Canada. Healthcare systems and treatment patterns are different between the 2 countries, and there is limited published information on outcomes of Canadian patients treated with first-line nab-P + Gem. This analysis evaluated efficacy and safety outcomes in Canadian patients in the MPACT trial.

Methods

Treatment-naive patients with MPC (N = 861) received either nab-P 125 mg/m² + Gem 1000 mg/m² on days 1, 8, and 15 every 4 weeks or Gem 1000 mg/m² weekly for the first 7 of 8 weeks (cycle 1) and then on days 1, 8, and 15 every 4 weeks (cycle ≥2).

Results

The MPACT trial enrolled 63 patients in Canada. Baseline characteristics were well balanced and comparable with those of the intent-to-treat population. Both OS (median 11.9 vs. 7.1 months; HR 0.76; P = 0.373) and progression-free survival (median 7.2 vs. 5.2 months; HR 0.65; P = 0.224) were numerically longer and overall response rate (27% vs. 17%; P = 0.312) was numerically higher with nab-P + Gem vs. Gem. The most common grade ≥3 adverse events with nab-P + Gem vs. Gem were neutropenia (22% vs. 10%), fatigue (34% vs. 33%), and neuropathy (25% vs. 0%).

Conclusion

This subanalysis confirmed that nab-P + Gem is an efficacious treatment option and has a manageable safety profile in patients with MPC treated in Canada.

Trial registration

ClinicalTrials.gov identifier, NCT00844649.

Funding

Celgene Corporation, Summit, NJ, USA.

     

Does severe obstructive sleep apnea syndrome alter retrobulbar blood flow? A color Doppler ultrasound study

Purpose

To evaluate extraocular orbital vessels with color Doppler ultrasound (CDU) and investigate the effects of severe obstructive sleep apnea (OSA) on retrobulbar blood flow.

Methods

Between February 2014 and September 2015, 30 patients with severe OSA (apnea–hypopnea index (AHI) > 30) and 28 controls were prospectively included in this study. Intraocular pressure (IOP) was measured with a Goldmann applanation tonometer, and CDU was used to evaluate the retrobulbar vessels.

Results

The mean AHI score for the OSA group was 63.2 ± 21.5 per hour. The IOP values were significantly higher in the severe OSA group (p < 0.05). The central retinal artery peak systolic velocity (PSV) (p < 0.05) and end-diastolic velocity (EDV) (p < 0.02), and the ophthalmic artery (OA) PSV and EDV, were found to be significantly lower in the OSA group (p < 0.05).

Conclusion

Severe OSA causes an increase in IOP and a decrease in flow velocity in the retrobulbar circulation.