Mean Total Treatment Time Research Articles

Preliminary results of adjuvant image-guided vaginal brachytherapy alone for early stage endometrial carcinoma

ObjectiveThis retrospective study evaluated the preliminary outcomes of image-guided vaginal brachytherapy (IG-VBT) in the adjuvant treatment of high intermediate risk endometrial cancer. Materials and MethodsData were collected from 48 patients who underwent adjuvant IG-VBT between 2019 and 2022 at the Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Chiang Mai University. The vaginal cuff clinical target volume (CTV-VC) is composed of a 4-mm-thick band around vaginal cylinder at the upper 3 cm of the vaginal cuff. A total dose of 21 Gy in three fractions was delivered to the CTV-VC, and the dose to the bladder and rectum were evaluated. Treatment details, patient characteristics, and outcomes were analyzed. Descriptive statistics were used for analysis, and Kaplan-Meier method was employed for survival analysis. ResultsThe mean age was 62 years, with mainly endometrioid carcinoma pathology (96 %). All patients were at stage I, with 87.5 % receiving complete surgical staging. Mean total treatment time was 10 days with mean D90 of CTV-VC was 29.7 Gy, and D2cc of bladder, rectum, and sigmoid were 24.6 Gy, 21.0 Gy, and 7.7 Gy, respectively. At a median follow-up of 37 months, 3-year local control, disease-free survival, and overall survival rates were 100 %, 100 %, and 97.9 %. respectively. Two patients (4.2 %) experienced grade 1–2 gastrointestinal toxicity, while no genitourinary toxicity or serious adverse events were observed. ConclusionsThe preliminary results of IG-VBT in endometrial cancer demonstrated favorable outcomes in terms of vaginal control and toxicity. Further studies with larger cohorts and longer follow-up durations are warranted.

1.5T MR-Guided Daily Adaptive Radiotherapy: Preliminary Clinical Report of the First 5000 Fractions

1.5T MR-Linac improves target volume and adjacent OARs visualization, ensuring high precision in radiation treatment delivery. Daily MR-imaging allows on-table adapted planning and real-time intra-fraction imaging without additional exposure to radiation. Our department implemented the first high field MRgRT system in Italy and herein we present the preliminary report of the first 5000 fractions delivered. We aim to describe the clinical implementation, feasibility, toxicity and patient tolerability of daily adapted RT. Since October 2019, 1.5T MR-Linac has been available in our department. A prospective observational study for the clinical use of 1.5T MR-Linac is currently ongoing in our department: patients affected by prostate adenocarcinoma, pancreatic cancer, oligometastases and patients requiring retreatments were included. Two different workflows were used depending on the OARs daily anatomy: Adapt To Position (ATP) where the reference plan position is adjusted rigidly to match the position of the targets and OARs, and Adapt To Shape (ATS) where a new plan is created to better match the anatomy of the day. Toxicity and quality of life were assessed at baseline and after treatment using the CTCAE v5.0. Patient-reported outcomes of prostate cancer patients were investigated by means IPSS, ICIQ-SF, IIEF-5, EPIC-26, EORTC-QLQ-C30 and PR-25 questionnaires. Between October 2019 and June 2022, 590 patients with 675 target sites were treated with MR-guided radiation therapy in 5000 total fractions. Median patient age was 70 years (39-86). Among 675 tumor sites, the most frequently treated region was pelvis (n = 549, 81%). The most common diagnosis was prostate cancer (n = 326). On-table adaptive radiation therapy was used at every treatment session: ATP workflow in 63 fractions (1%) and ATS workflow in 4937 fractions (99%), respectively. Median prescribed dose was 35 Gy (20-67.5 Gy) in median 5 fractions (5-30). Mean total treatment time was 43 minutes (20-56). Treatments were well-tolerated and no acute G>3 toxicities were reported. Concerning the PROMS, all questionnaires showed no relevant deterioration between the pre-, post-RT and follow-up evaluations. MR-guided radiation treatment using 1.5T MR-Linac has been successfully implemented into clinical routine at our department. The data reported support an optimal profile of tolerability of daily on-table adaptive radiation therapy in acceptable time slots. These results are confirmed by PROMs.

A service evaluation of patients requiring growth modification in a public service setting.

Aim To conduct a service evaluation of patients who had functional appliance treatment to correct Class II malocclusions in a public orthodontic clinic. To evaluate the effect of prioritisation and earlier treatment of these patients on treatment duration and patient compliance. Methodology The prioritised treatment group (PTG) had twin block appliances fitted when they were 11 or 12 years old. In comparison, the routine treatment group (RTG) had twin block appliances fitted when they were 13 or 14. Electronic patient records were screened to find a sample of 100 patients from each cohort. The number of compliance issues, functional appliance treatment duration, fixed appliance treatment duration and total treatment duration was recorded retrospectively from patient charts. Results While mean total treatment time was similar across the two cohorts, the PTG did have significantly shorter fixed appliance treatment durations than the RTG. The PTG was also found to have better compliance than the RTG. Conclusion Prioritising patients who require functional appliance treatment does not reduce total treatment duration. A correlation between earlier treatment, improved patient compliance, and a shorter course of fixed appliance therapy can be seen, which may prove clinically beneficial. Further research in this area would be valuable.

Costs and duration of orthodontic-surgical treatment with mandibular advancement surgery.

The aim was to analyse the costs and duration of orthodontic-surgical treatment with mandibular advancement in the public health care sector in Finland. The study was conducted as a retrospective registry study in a public district hospital on all nonsyndromic patients that were ethnic Finns and treated with full fixed appliances and mandibular advancement surgery in 2016-2020. The mean treatment duration of the included 45 patients was 28.1 months, including 18.9 months pre and 9.2 months postoperative orthodontics. The median number of visits was 27, including 17 visits before and 9 visits after surgery. The mean total treatment time was 14.5 h. The mean total direct costs per course of treatment were 7574 € to the municipality and 947 € to the patient. The costs positively correlated with the duration of the treatment (rho = 0.71, P = .000), but were not associated to gender or age of patient. The mean surgery time was 78 minutes, and significantly less with an experienced surgeon (P = .002). It was calculated that the mean minimum treatment costs would be 45% of the present total, achievable with a patient with optimum dental arches at the start of treatment. The major limitation of the study is the relatively small number of study subjects. A 55% share of the costs is influenced by case- and operator-dependent factors. This indicates that the complexity and performance of the orthodontic phases of treatment are important determinants in the cost structure.

The relative efficacy and efficiency of single- and multi-session exposure therapies for specific phobia: A meta-analysis

Exposure therapy is the preferred treatment for specific phobia (SP), with evidence supporting its efficacy whether delivered over multiple sessions or as a single session, such as One-Session Treatment. In this meta-analysis, we compared the efficiency and effectiveness of single- and multi-session exposure for SP. PsycINFO, Embase, MEDLINE, and Cochrane were systematically searched for peer-reviewed articles reporting the effects of multi-session (k = 30) and/or single-session (k = 55) in vivo exposure on SP symptoms in clinical populations (n = 1758 participants). A random-effects model was used to synthesise and compare the pre-post treatment effects (Hedges’ g) on approach behaviour and self-reported SP symptoms. Mean total treatment time was significantly longer for multi-session exposure than for single-session. There were no significant differences in the pooled effect sizes of single-session and multi-session exposure at post-treatment and follow-up assessments; effect sizes were large for all outcomes. Phobia subtype significantly moderated the effect size for both treatment approaches, although the direction of association differed according to the outcome measures. Results suggest no evidence for differences in the effectiveness of single- and multi-session exposure, but single-session is more time efficient. These outcomes suggest that policies to facilitate access to single-session exposure would be beneficial.

Altta yatan Komorbiditeleri Olan Çocuklarda Herpes Zoster: 10 Yıllık Retrospektif Tek Merkez Deneyiminin Değerlendirilmesi

Aim: It was aimed to evaluate the complications and prognosis of pediatric patients diagnosed with Herpes zoster(HZ) with an underlying comorbidity. Materials and Methods: Between 01.01.2011-01.01.2021 in our clinic; patients aged 0-18 years, with underlying comorbidities and diagnosed with HZ, who were followed up and treated, were evaluated retrospectively. Sociodemographic characteristics, clinical findings, treatments applied during hospitalization, complications developed during follow-up and prognosis were obtained from hospital file archive records. Results: The mean age was 9.25±4.79 years, and 53.4% of patients were male. The most common symptom was rash, followed by pain and itching. Most commonly, 23 (51.1%) patients had thoracic dermatome involvement. Dissemination did not develop in any of the patients. 8.9% of the patients had chickenpox, 4.4% had varicella vaccine, and 48% had no history of varicella-zoster virus transmission. Acute leukemia and having had a bone marrow transplant were the most common co-existing conditions. Median time between onset of symptoms and diagnosis was 3 (min-max=1-10) days. Median length of hospitalization was 7 (min-max=3-21) days, and the mean total treatment time was 9.33±3.58 days. It was determined that only 4 patients developed secondary skin infection, 44 patients were cured, and 1 patient died due to the primary disease. Conclusion: While HZ is rare in healthy children, it can progress with serious complications in those with an underlying disease. To consider HZ in differential diagnosis of vesicles in immunocompromised patients, to start treatment with early diagnosis; It is of great importance in terms of complications and prognosis that may develop.

A Randomised Phase II Clinical Trial Comparing the Deliverability and Acute Toxicity of Wide Tangent versus Volumetric Modulated Arc Therapy to the Breast and Internal Mammary Chain

AimsInclusion of the internal mammary chain in the radiotherapy target volume (IMC-RT) improves disease-free and overall survival in higher risk breast cancer patients, but increases radiation doses to heart and lungs. Dosimetric data show that either modified wide-tangential fields (WT) or volumetric modulated arc therapy (VMAT) together with [AQ1]voluntary deep inspiration breath hold (vDIBH) keep mean heart doses below 4 Gy in most patients. However, the impact on departmental resources has not yet been documented. This phase II clinical trial compared the time taken to deliver IMC-RT using either WT and vDIBH or VMAT and vDIBH, together with planning time, dosimetry, set-up reproducibility and toxicity. Materials and methodsLeft-sided breast cancer patients requiring IMC-RT were randomised to receive either WT(vDIBH) or VMAT radiotherapy. The primary outcome was treatment time, powered to detect a minimum difference of 75 min (5 min/fraction) between techniques. The population mean displacement, systematic error and random error for cone beam computed tomography chest wall matches in three directions of movement were calculated. Target volume and organ at risk doses were compared between groups. Side-effects, including skin (Radiation Therapy Oncology Group), lung and oesophageal toxicity (Common Terminology Criteria for Adverse Events v 4.03) rates, were compared between the groups over 3 months. Patient-reported outcome measures, including shoulder toxicity at baseline, 6 months and 1 year, were compared. ResultsTwenty-one patients were recruited from a single UK centre between February 2017 and January 2018. The mean (standard deviation) total treatment time per fraction for VMAT treatments was 13.2 min (1.7 min) compared with 28.1 min (3.3 min) for WT(vDIBH). There were no statistically significant differences in patient set-up errors in between groups. The average mean heart dose for WT(vDIBH) was 2.6 Gy compared with 3.4 Gy for VMAT(vDIBH) (P = 0.13). The mean ipsilateral lung V17Gy was 32.8% in the WT(vDIBH) group versus 34.4% in the VMAT group (P = 0.2). The humeral head (mean dose 16.8 Gy versus 2.8 Gy), oesophagus (maximum dose 37.3 Gy versus 20.1 Gy) and thyroid (mean dose 22.0 Gy versus 11.2 Gy) all received a statistically significantly higher dose in the VMAT group. There were no statistically significant differences in skin, lung or oesophageal toxicity within 3 months of treatment. Patient-reported outcomes of shoulder toxicity, pain, fatigue, breathlessness and breast symptoms were similar between groups at 1 year. ConclusionVMAT(vDIBH) and WT(vDIBH) are feasible options for locoregional breast radiotherapy including the IMC. VMAT improves nodal coverage and delivers treatment more quickly, resulting in less breath holds for the patient. This is at the cost of increased dose to some non-target tissues. The latter does not appear to translate into increased toxicity in this small study.

Occlusal Plane Changes After Molar Distalization With a Pendulum Appliance in Growing Patients with Class II Malocclusion: A Retrospective Cephalometric Study.

This study aimed to evaluate the skeletal and dental changes after distalization with a pendulum appliance in growing patients with Class II malocclusion, focusing on the occlusal plane (OP). The sample included 24 patients with Class II malocclusion (10 boys, 14 girls); their mean age was 12.1 years. All patients underwent molar distalization and had 2 serial cephalograms traced at baseline (T1) and after distalization (T2). Angular and linear dental changes were calculated by taking the sella-nasion (SN), palatal plane (PP), and pterygoid vertical as reference. OP inclination was compared with SN, PP, and mandibular plane. The collected data were computed for all the tested variables, and one-way paired t-test was used to assess the significance of the differences between the time points. α was set at 0.05. Multiple linear regressions were used to predict the OP changes. The mean total treatment time was 8±2 months to obtain a super Class I molar relationship. In T1-T2 interval, statistically significant incisor buccal tipping of 5°±3.6° (p<0.05), first molar distal tipping of 8.9°±8.3° (p<0.001), and second molar tipping of 8.2°±8.1° (p<0.001) were observed. The maxillary first and second molars moved significantly backward by 2.8±3.2 mm (p<0.05) and 3.7±2.7 mm (p<0.001), respectively. Only the premolars showed a statistically significant anchorage loss of 2.7±3.3 mm (p<0.05); overjet increased significantly at 1.3±1.2 mm (p<0.05). Regarding the OP, none of the tested variables showed any statistically significant changes between T1-T2. The pendulum appliance showed efficacy in distalizing the maxillary first and second molars at the expense of anterior anchorage loss. The OP did not show statistically significant changes after molar distalization.

Acute ulnar osteotomy versus gradual distraction by external fixator to correct missed monteggia type 1 fracture-dislocation; A comparative study

Background: Monteggia fracture-dislocations are complex injuries. These injuries, especially neglected ones, remain a challenge for orthopedic surgeons. The aim of this study is to compare the results of acute and gradual ulnar lengthening osteotomies in treating chronic Monteggia fractures in children. Patients and Methods: The study includes two groups of patients, treated at our institution in the period from April 2014 to September 2018. The first group (Group A) included nine patients who were treated by an overcorrective ulnar osteotomy with acute lengthening with bone grafting. The second group (B) includes 11 children who were treated by Ilizarov distraction osteogenesis for differential lengthening of forearm bones. There were 14 boys and 6 girls. The left elbow was involved in five patients and the right elbow 15 patients. All fractures were classified as Bado type I with anterior radial head dislocation. The average age at the time of surgery was 7 years and 4 months. Results: The mean interval from the injury to surgical interference was 8.6 months. There was a significant improvement of the elbow range of motion and Mayo elbow performance score. In group B, the mean external fixation time was 9.7 weeks (range from 9 to 15 weeks). The mean total treatment time was 12.3 weeks (ranged from 12 to 16 weeks). Superficial pin-tract infection occurred in all cases and was managed without further sequelae. Conclusions: Both approaches yielded equally good results. The open surgery approach entails a more invasive procedure, but more convenient to the patient and no arduous postoperative follow-up is needed. On the contrary, differential lengthening of forearm bones is a percutaneous procedure with the application of Ilizarov principles in a controlled biological manner; with no graft materials needed. Both techniques effectively reduced the radial head.

First 500 Fractions Delivered with a Magnetic Resonance-guided Radiotherapy System: Initial Experience.

ObjectivesImproved soft-tissue visualization, afforded by magnetic resonance imaging integrated into a radiation therapy linear accelerator-based radiation delivery system (MR-linac) promises improved image-guidance. The availability of MR-imaging can facilitate on-table adaptive radiation planning and enable real-time intra-fraction imaging with beam gating without additional exposure to radiation. However, the novel use of magnetic resonance-guided radiation therapy (MRgRT) in the field of radiation oncology also potentially poses challenges for routine clinical implementation. Herein the early experience of a single institution, implementing the first MRgRT system in the country is reported. We aim to describe the workflow and to characterize the clinical utility and feasibility of routine use of an MR-linac system.MethodsThe ViewRay MRIdian MR-linac system consists of a split-magnet 0.35 T MR-imaging scanner with a double focused multi-leaf collimator (MLC) equipped 6MV linear accelerator. Unique to the system are the control console integrated on-table adaptive radiation therapy (oART) planning capabilities as well as automated beam gating based on real-time intra-fraction MR imaging. From the first day of clinical implementation, oART was performed according to physicians’ discretion when medically indicated. All fractions were delivered under real-time imaging with soft tissue-based automated beam gating with individualized gating boundary settings. Patients actively assisted in breath-hold beam gating with the help of custom designed prismatic glasses allowing sight of a computer monitor mounted on the back wall just behind the MRI system bore. Patient demographics and treatment experience, indications for MRgRT including diagnosis and disease site, radiation dose prescribed and fractionation scheme, utilization of oART, respiratory gating settings, as well as duration of each treatment phase were analyzed.ResultsBetween September 2018 and May 2019, 72 patients with 84 tumor sites were treated with MRgRT in 500 total fractions. Median patient age was 66 years (range: 28-83 years). Among 84 tumor sites, the most frequently treated regions were upper abdominal and pelvic (n = 36, 43% and n = 29, 34%, respectively). The most common diagnosis was prostate cancer, with 14 patients treated. In 69 patients (93.2%) oART was used at least once during a treatment course. Twenty-nine targets (43.1%) with significant breathing-related motion were treated in breath-hold with patient visual feedback. Median prescribed dose was 36.25 Gy (range: 24-70 Gy) in median five fractions (range: 3-28 fractions). A gating boundary of 3 mm around a gating region of interest (gROI) was most commonly used (range: 3-5 mm) with 95% of the gROI (range: 93-97%) required to be within the gating boundary for the beam to automatically engage. Mean total treatment time was 47 min (range: 21-125 min) and mean beam-on time was 16.7 min (range: 6-62 min).ConclusionsMRgRT afforded by an MR-linac system has been successfully implemented into routine clinical use at our institution as the first system of its kind in Turkey. While the overall number of patients treated and fractions delivered is still limited, we have demonstrated the feasibility of both on-table adaptive radiation therapy as well as automated real-time beam gating on a daily basis in acceptable time schedules.

Examining Radiation Treatment Appointment Times at a Canadian Cancer Centre: A Timing Study

IntroductionTechnological advancements in radiation therapy have led to more complex treatment techniques such as volumetric modulated arc therapy, and in turn, more daily image verification. As treatment complexity increases, it is important to consider what effect this may have on treatment time. Additional factors that may influence treatment times are patient-centered care and mobility status. The aim of this study is to determine optimal radiation treatment appointment times based on site, technique, imaging requirements, and patient needs. MethodsData from 535 fractions of radiation treatments were collected and analyzed between June 2016 and July 2017 by a team of eight radiation therapists at BC Cancer Vancouver Centre. Data collectors documented a number of data points, including treatment unit, scheduled appointment time, scheduled appointment duration (booked in 12 minute increments), treatment site, treatment technique, imaging modality, pre-treatment-related and post-treatment-related activity time, patient mobility status, etc. Student's t-test was performed for each site/technique to determine if the mean total treatment time was significantly different from the standard appointment time for that site. A two-sample unpaired t-test assuming unequal variance was used to compare average treatment times of the same site with different imaging modalities. Student's t-test was also used to compare average treatment times for ambulatory patients versus patients requiring some form of mobility assistance. ResultsAverage treatment times for 6 of the 10 sites used for data analysis were longer than standard booked times and showed statistical significance (prostate/prostate bed: n = 82, P < .001; chest: n = 32, P < .001, palliative 1 treatment site: n = 28, P < .05, gyne pelvis only treatment: n = 25, P < .001, head & neck: n = 56, P < .001, and rectum: n = 28, P < 0.05). The breast/chest wall + nodes site had a significantly shorter treatment time than the standard booked appointment time (n = 87, P < .001). Analysis of the prostate/prostate bed imaging showed a significant difference between daily cone beam computed tomography and daily kilovoltage treatment time, with cone beam computed tomography imaging taking 3.83 ± 1.36 (P < .001) minutes longer on average than kilovoltage imaging. Average treatment time for patients requiring mobility assistance was 20% longer than for patients requiring no assistance (P = .02). ConclusionThe majority of the most common sites and techniques treated at our centre were inappropriately booked. Radiation therapy appointment durations are influenced by several factors, including site, technique complexity, imaging, and patient care. It is recommended that radiation treatment centres evaluate appointment times regularly as technology, treatment delivery, and professional practice standards evolve to ensure high-quality patient care.

Posttraumatic distal radius growth arrest treatment by ilizarov distraction osteogenesis

Background: Posttraumatic distal radius growth arrest is a challenging orthopedic condition, due to a combination of several deformity components including shortening, angulation and joint line malorientation. It can drastically affect both the function and the shape of the wrist and forearm. However, little has been written about this problem. Patients and Methods: In this retrospective study, seven adolescent patients were operated in our department. All had posttraumatic distal radius growth arrest that resulted in shortening with or without angular deformity. The management consisted of distal radius metaphyseal osteotomy and distraction osteogenesis using Ilizarov frame. The patients' ages ranged from 12 to 15 years. The mean shortening of the radius was 2.2 cm. Correction was assessed radiologically (radial length, joint orientation line) and clinically by Mayo Wrist Score. Results: The mean external fixation time was 2.4 months (range from 2 to 3 months). The mean total treatment time was 12.3 weeks (range from 12 to 16 weeks). The mean bone healing index was 1.13 months/cm. The Mayo Wrist Score mean was 85.7 (range: 75–95) points. According to the Mayo Wrist Score, results were excellent in three patients, good in three patients, satisfactory in one patient with no unsatisfactory results. Superficial pin tract infection occurred in all cases and was managed without further sequelae. Conclusion: Distraction osteogenesis, by Ilizarov external fixator, addresses the sequelae of posttraumatic distal radius growth arrest by restoring the normal anatomy in a controlled biological manner, without further grafting procedures through a minimally invasive approach.

Automated psychological therapy using immersive virtual reality for treatment of fear of heights: a single-blind, parallel-group, randomised controlled trial

SummaryBackgroundEngaging, interactive, and automated virtual reality (VR) treatments might help solve the unmet needs of individuals with mental health disorders. We tested the efficacy of an automated cognitive intervention for fear of heights guided by an avatar virtual coach (animated using motion and voice capture of an actor) in VR and delivered with the latest consumer equipment.MethodsWe did a randomised trial of automated VR versus usual care. We recruited adults aged older than 18 years with a fear of heights by radio advertisements in Oxfordshire, UK. We diagnosed fear of heights if participants scored more than 29 on the Heights Interpretation Questionnaire (HIQ). We randomly allocated participants by computer in a 1:1 ratio to either automated VR delivered in roughly six 30-min sessions administered about two to three times a week over a 2-week period (intervention group) or to usual care (control group). Randomisation was stratified by severity of fear of heights. The research team, who were unaware of the random allocation, administered three fear-of-height assessments, at baseline (0 weeks), at the end of treatment (2 weeks), and at follow-up (4 weeks). The primary outcome measure was HIQ score (range 16–80, with higher scores indicating greater severity). This trial is registered with the ISRCTN registry, number ISRCTN11898283.FindingsBetween Nov 25, 2017, and Feb 27, 2018, 100 individuals were enrolled and underwent randomisation, of whom 49 were assigned to the VR treatment group and 51 to the control group. All participants completed the 4-week follow-up. The mean total treatment time in VR was 124·43 min (SD 34·23). Compared with participants in the control group, the VR treatment reduced fear of heights at the end of treatment (mean change score −24·5 [SD 13·1] in the VR group vs −1·2 [7·3] in the control group; adjusted difference −24·0, 95% CI −27·7 to −20·3; Cohen's d=2·0; p<0·0001). The benefit was maintained at follow-up (mean change score −25·1 [SD 13·9] in the VR group vs −1·5 [7·8] in the control group; adjusted difference −24·3, 95% CI −27·9 to −20·6; Cohen's d=2·0; p<0·0001). The number needed to treat to at least halve the fear of heights was 1·3. No adverse events were reported.InterpretationPsychological therapy delivered automatically by a VR coach can produce large clinical benefits. Evidence-based VR treatments have the potential to greatly increase treatment provision for mental health disorders.FundingOxford VR, and the National Institute of Health Research Oxford Health Biomedical Research Centre.

Integrated care pathway for rectal cancer treatment: health care resource utilization, costs, and outcomes.

Managed Flow C20 (MFC20) is an integrated care pathway (ICP) for rectal cancer implemented at a public teaching hospital. This study aims to quantify resource utilization and estimate direct costs and outcomes associated with the use of this ICP. We evaluated consecutive rectal cancer patients treated with neoadjuvant chemoradiotherapy (nCRT) followed by surgery, comparing the period before the ICP implementation (Pre-MFC20 group) and after (MFC20 group). We assessed times between treatment steps and quantified the resources utilized, as well as their costs. There were 112 patients in the Pre-MFC20 group and 218 in the MFC20 group. The mean treatment intervals were significantly shorter in the MFC20 group - from the first medical consultation to nCRT (48.3 vs. 87.5 days; P < 0.001); and from nCRT to surgery (14.8 vs. 23.0 weeks; P < 0.001) - as was the mean total treatment time (192.0 vs. 290.2 days; P < 0.001). Oncology consultations, computed tomography, MRI, and radiotherapy sessions were utilized more frequently in the Pre-MFC20 group (P < 0.001). The median per-patient cost was US$11 180.92 in the Pre-MFC20 group, compared with US$10 412.88 in the MFC20 group (P = 0.125). Daily hospital charges and consultations were the major determinants of the total cost of the treatment. There was no statistical difference in overall survival in the time periods examined. Implementation of a rectal cancer ICP reduced all treatment intervals and promoted rational utilization of oncology consultations and imaging, without increment in per-patient costs or detrimental effects in overall survival.

Pilot Study of the Mirabilis System Prototype for Rapid Noninvasive Uterine Myoma Treatment Using an Ultrasound-Guided Volumetric Shell Ablation Technique

Study ObjectiveThe primary objective of this pilot study was to evaluate the safety and acute tissue ablation efficacy of a transabdominal high-intensity focused ultrasound (HIFU) prototype device that uses ultrasound imaging guidance for rapid noninvasive ablation of uterine myomas. The secondary objective was to assess preliminary myoma-related symptom improvement and myoma volume reduction at 3 to 6 months post-treatment in subsets of patients. DesignMulticenter prospective single-arm pilot study (Canadian Task Force classification II-2). SettingUniversity-affiliated teaching hospital and private community hospital. PatientsWomen with a diagnosis of symptomatic uterine myomas planning to undergo hysterectomy. InterventionsSeventy-three women underwent transabdominal ultrasound-guided HIFU treatment using a volumetric ablation technique referred to as “shell ablation,” in which the HIFU energy is deposited in patterns that partially encapsulate the peripheral region of the targeted myoma(s). Patients were divided into 2 sequential cohorts, the development cohort (the first 37 patients treated) and the validation cohort (the final 36 patients treated). Development cohort treatments were performed for dose-ranging purposes to identify the optimum HIFU treatment parameters, whereas the validation cohort treatments were performed to validate these final settings. Sixty-five patients (89.0%) received only prophylactic oral, sublingual, or intramuscular analgesia before treatment, sometimes with oral anxiolytics. The remaining 8 patients (11.0%) were anesthetized before treatment. Sixty-seven patients (91.8%) then had scheduled hysterectomies between 0 and 179 days after treatment completion. Adverse events were monitored until study exit, which ranged from 10 to 191 days post-treatment. Measurements and Main ResultsThe primary efficacy endpoint measured in all 73 patients was the nonperfused volume (NPV) of tissue produced, which was assessed between 0 and 7 days post-treatment either by tissue sectioning after hysterectomy or by gadolinium-enhanced magnetic resonance imaging. Secondary efficacy endpoints were also measured in subsets of patients who were prospectively scheduled for delayed hysterectomies: Changes in menstrual blood loss (MBL), symptom severity (SS), and quality of life (QOL) scores were assessed using validated techniques at 3 months post-treatment in 10 patients and changes in treated myoma volume were assessed using magnetic resonance imaging at 3 to 6 months post-treatment in 14 patients. In all 73 patients, there were no reports of any serious adverse device effects, including no damage to any extrauterine collateral tissues or the abdominal skin. In the development cohort, a mean NPV of 17.9 ± 24.9 cm3 (range, 0–123.0) was produced in a mean total treatment time of 4.9 ± 2.4 minutes (range, 1.1–11.3). These metrics improved in the validation cohort, where a mean NPV of 44.9 ± 58.5 cm3 (range, 0–284.7) was produced in a mean total treatment time of 3.6 ± 2.1 minutes (range, 1.5–9.5). In the subsets of patients with data available, there was a significant improvement in QOL score (median, 16.5 point increase; p = .011), an improving trend in SS score (median, 13.5 point decrease; p = .254), and a significant improvement in treated myoma volume (mean, 24.0% decrease; p = .013). In 8 patients who had above-average MBL scores at baseline and regular menstrual cycle lengths during follow-up, there was also a significant improvement in MBL score (median, 40.8% decrease; p = .035). ConclusionUltrasound-guided HIFU ablation with the prototype device demonstrated an excellent safety profile and produced clinically relevant NPVs in a mean total treatment time of under 4 minutes using the final validated treatment settings. Short-term clinical efficacy metrics assessed in subsets of patients were encouraging, and larger studies should be conducted to confirm these results (ClinicalTrials.gov, NCT01946178).

P2.02-058 Moderately Hypofractionated Radiotherapy in Locally Advanced Non-Small Cell Lung Cancer: A Single Institution Retrospective Analysis

Radiation dose escalation using hypofractionation might improve clinical outcomes. Aim of the study was to evaluate outcomes, safety and feasibility of a moderately hypofractionated Radiotherapy (Hypo-RT) regimen for pts with LA-NSCLC. Between 2008 and 2015 44 consecutive pts with LA-NSCLC were treated using a HYPO-RT regimen. Thirty-two pts were male, 12 female. Mean age was 66.2 years. Primary tumor was adenocarcinoma in 16 pts, SCC in 27, Giant Cell neurendocrine Carcinoma in 1 pt. Three pts had clinical stage IIA-IIB, 19 pts IIIA and 22 IIIB. Chemotherapy was administered before Hypo-RT in 37 pts, 7 pts underwent exclusive RT. Mean total RT dose delivered to site of persistent disease was 61 Gy (range 45-66Gy) and mean total treatment time was 40 days in 5,7 weeks(range 3-8). Daily fraction ranged between 2.2 and 3 Gy. RT was temporarily interrupted in 3 pts due to acute toxicity. After a median follow up of 17.3 months, 19 pts were alive, whereas 25 pts had died (18 pts due to disease progression and 7 from other causes). Complete response was achieved in 6 pts, partial response in 16 and stable disease in 10 with an overall response rate (ORR) equal to 72,7%. Twenty-one pts showed locoregional relapse; 17 pts distant metastasis and 6 pts both of them. Median overall survival (OS) was 41.7 months while 1,3- and 5-year OS were 68.9% (±7,2%SE), 44.9% (±8.3%SE) and 25.1 (±9.0SE), respectively. At univariate analysis local failure, stage and response to CHT-RT treatment showed a statistically significant impact on OS with better prognosis for pts in stage IIIA, achieving a complete response and not experiencing locoregional relapse (p< 0.04, <0.05, <0.02 respectively). At the same interval progression free survival was 52.3% (ES±7.8), 17.8% (ES±6.6) and 11.9 (ES±6.5) while 3- and 5-years locoregional control was 24.6% (ES±5,5) and 11.7% (ES±4,7%).Acute toxicities were reported in 27 pts: 4 pts had G1-G2 skin dermatitis, 16 pts G1-G2 esophagitis and 4 pts G1-G2 pneumonitis. About late toxicities 7 pts experienced G1-G2 pneumonitis while 3 pts had G1-G2 esophagitis. No deaths related to the treatment were recorded. Hypo-RT proved to be a feasible and well tolerated treatment for pts with LA-NSCLC showing very promising results in terms of overall response rate and clinical outcomes. Further studies are needed to confirm these results and introduce HYPO-RT in the clinical routine.

Outcome of combined orthodontic-surgical treatment in a United Kingdom university dental institute.

This retrospective observational cohort study evaluated effectiveness of combined orthodontic-orthognathic surgical treatment in a UK University Dental Institute. Patients were identified from a database maintained prospectively throughout a 5-year period of observation. Demographic and clinical data included age, malocclusion, Index of Treatment Need, Index of Orthognathic Functional Treatment Need, orthodontist, surgeon, surgical procedure and treatment-time. Peer Assessment Rating (PAR) scores were generated from pre- and post-treatment dental study casts by a single calibrated examiner. One hundred and sixty two subjects began treatment during the period of observation, 92 completed, 14 elected to discontinue before surgery and 56 remained in treatment. Outcome data were available for 73, 16 males and 57 females (mean age 23.28 [SD, 7.92] years). Within this sample, 33 (45.2%) presented with class II division 1, 6 (8.2%) with class II division 2 and 34 (46.6%) with class III malocclusion. Isolated maxillary and mandibular surgery was carried out in 3 (4.1%) and 24 cases (32.8%), respectively; bimaxillary surgery was performed in 46 (63.1%). Mean total treatment time in fixed appliances was 920.28 days (30.7 months). Mean pre-treatment PAR score was 39.09 [SD, 9.42] and post-treatment 5.86 [SD, 4.25] with a mean 83.7% PAR score reduction, representing a greatly improved occlusal result. Kruskal-Wallis testing found no evidence of any relationship between independent variables and percentage PAR reduction; however, surgeon identity did significantly influence treatment length (P = 0.007). This investigation demonstrates that in terms of static occlusion combined orthodontic-orthognathic surgery is effective in correcting severe malocclusion.

Nature of intrafractional and interfractional prostate motion during stereotactic radiation.

152 Background: To characterize the intra-fraction and inter-fraction prostate motion as tracked by the X-ray images of the implanted gold fiducials during stereotactic radiotherapy with CyberKnife. The published data have analysed the linear and angular prostate motion intrafraction and interfraction prostate motion among patients. We sought to quantify the same within each patient. Methods: Twenty Five patients with localized prostate cancer treated with CyberKnife radiosurgery between January 2013 and August 2015 were studied retrospectively. A data set constitutes the deviations derived from X-ray images obtained between two consecutive couch motions. Results: Included in the analysis were 3926 data sets. A total of 210 non-coplanar fields were used per fraction. The mean total treatment time for all fields per fraction was 36.13 minutes. The detected and corrected movements over all were in a range of ± 10.1 mm in linear direction (Right: mean 1.1±0.4 mm; Left: mean 1.0±0.6 mm; Superior: mean 0.7±0.3 mm; Inferior: mean 1.6±0.6 mm; Anterior: mean 1.6±0.7 mm; Posterior: mean 0.5±0.3 mm with maximum (max) movement range of Right max 9.9±6.4 mm, Left max 7.1±3.4 mm, Superior max 8.6±5.4 mm, Inferior max 10.1±8.5 mm, Anterior max 9.2±6.5 mm, Posterior max 8.4±2.9 mm) and angular movements were in a range of ± 6.7 deg in all directions (Right Angle: mean 0.6±0.3 deg; Left Angle: mean 0.6±0.3 deg; Head Up(H-U): mean 1.3±0.6 deg; Head Down(H-D): mean 1.4±0.6 deg; Counter-Clockwise movement (CCW): mean 0.7±0.3 deg; Clockwise movement (CW): mean 0.5±0.3 deg with max rotation range of Right angle max 2.4±2 deg, Left angle max 2.7±2 deg, H-U max 10.2±3.5 deg, H-D max 6.7±4.8 deg, CCW 4±2.9 deg, CW max 2.8±2.4 deg). There was an unpredictable change in prostate motion inter-fraction in each patient. But, a unique observation is that a predictable pattern exists for prostate motion intra-fraction within a patient. Change in the linear or angular prostate motion intra-fraction in any direction is not erratic. Conclusions: The linear and rotational prostate motion intra-fraction in any direction has a predictable pattern and any change is gradual and not erratic. The motion shows secular trend during the course of treatment.

Burden of Phlebotomy in Patients with Polycythemia Vera in the United States: Baseline Data from the REVEAL Study

Background: Phlebotomy to maintain hematocrit <45% is considered one of the cornerstones for the management of polycythemia vera (PV). However, phlebotomy procedures may be inconvenient for or poorly tolerated by some patients, and often result in iron deficiency, which may be associated with additional quality-of-life burden, such as fatigue, impaired cognitive function and restless leg syndrome. The REVEAL study (ClinicalTrials.gov, NCT02252159) is being conducted to describe contemporary demographics, burden of disease, clinical management, patient-reported outcomes, and healthcare resource utilization among patients with PV in the US. This early analysis describes the patient self-reported burden of phlebotomy at the time of enrollment.Methods: REVEAL is a multicenter, noninterventional, nonrandomized, prospective, observational study of adult patients with PV who are currently under the care of a US physician. REVEAL collects physician assessments and patient-reported outcomes during a 36-month observation period. Phlebotomy-related burden is being assessed with a new 21-item phlebotomy burden questionnaire (PBQ-21) at enrollment and every 90 days thereafter; it assesses patient-reported phlebotomy frequency, practice setting, time required for phlebotomy, inconvenience, and phlebotomy-related adverse effects. Phlebotomy-related effects and bother/inconvenience (if experienced within 24 hours after a phlebotomy procedure) are graded on a 4-point scale of 1 (not at all) to 4 (extremely). Analyses of these preliminary data were descriptive.Results: At the time of data cutoff, 865 patients were enrolled (total planned enrollment, n=2000). Median age was 67 (range, 22-95) years, 55.5% were male, and 89.5% were white. Median time from PV diagnosis to study enrollment was 53 months. Overall, 748 patients completed the PBQ-21 at enrollment and 400 (53.5%) had received a phlebotomy within 3 months prior to enrollment. Mean number of phlebotomies in the past 3 months was 2.2 (SD, 1.7). Phlebotomy was most commonly performed at a doctor's office during a regular medical visit (37.8%), at an infusion center or special cancer care center (26.8%), or at a hospital (18.3%). Patients who had phlebotomy procedures within 90 days before enrollment reported a mean total treatment time of 4.2 (SD, 4.7) hours per phlebotomy procedure; for employed patients, the mean amount of work time missed was 4.6 (SD, 15.6) hours per procedure. Fatigue, bruising, dehydration, and dizziness were among the most commonly reported adverse effects of phlebotomy (Table 1). Twenty percent of patients reported that phlebotomy procedures were moderately or extremely bothersome, inconvenient (18.3%), or painful or physically uncomfortable (16.3%). Furthermore, some patients (8.8%) reported that their family and friends were moderately or severely inconvenienced by phlebotomy procedures.Conclusion: The PBQ-21 collects important and relevant patient-reported information to systematically assess the impact of phlebotomy on patients and caregivers. From the early view of REVEAL enrollment data, a considerable proportion of patients reported fatigue, bruising, dehydration, and dizziness resulting from phlebotomy procedures. Furthermore, patients reported spending a considerable amount of time (4 hours on average) per phlebotomy procedure, which is a sizeable burden for patients who are employed. In addition, some patients reported that phlebotomy procedures may be inconvenient, painful or uncomfortable, and bothersome. REVEAL provides important information for providers to understand and address when to prescribe phlebotomy for patients with PV. [Display omitted] DisclosuresBoccia:Incyte Corporation: Honoraria. Stein:Incyte Corporation: Consultancy, Membership on an entity's Board of Directors or advisory committees. Mesa:Genentech: Research Funding; Promedior: Research Funding; NS Pharma: Research Funding; CTI Biopharma: Research Funding; Gilead: Research Funding; Incyte Corporation: Research Funding; Novartis Pharmaceuticals Corporation: Consultancy; Pfizer: Research Funding. Naim:Incyte Corporation: Employment, Equity Ownership. Cordaro:Incyte Corporation: Employment, Equity Ownership. Peng:Incyte Corporation: Employment, Equity Ownership. Sun:Incyte Corporation: Employment, Equity Ownership. Parasuraman:Incyte Corporation: Employment, Equity Ownership. Moliterno:Incyte Corporation: Membership on an entity's Board of Directors or advisory committees.

Results of distraction callus osteogenesis in hand and foot in Iran: A 15-year experience.

Distraction osteogenesis (DS) is currently an important technique for lengthening shortened bones of the hand and foot. Authors report their experience in applying DS for various conditions of the hand and foot using a distractor that the senior author has designed. Records of patients who underwent DS for hand and foot conditions in a private clinic were retrieved between January 2001 and January 2015. Data concerning distraction, outcome, and complications were recorded. There were 17 patients, 7 males, and 10 females with a total 24 distractions. The mean length gained was 21.2 mm (1.69) and the mean total treatment time was 198.58 (15.88) days. Overall, complications occurred in 9 (37.5%) distractions. Major complications occurred in 2 (8.33%) of distractions. Minor complications occurred in 7 (29.2%) distractions. DS is an effective modality for lengthening bones of the hand and feet for both traumatic and congenital conditions. Joint stiffness/contracture is an important complication following DS of the metatarsals.