NIH Scoring Research Articles

Role of Ayurveda in rehabilitation of Abhighataja Pakshavadha - A Clinical Management

Traumatic cerebral haemorrhage is an increasingly recognized complication of severe blunt head or neck trauma, more common with patient with motor vehicle accidents, which may lead to complete paralysis, paraplegia, hemiplegia or severe conditions end up with coma. In the present case history, a 43 year aged male patient was in coma stage after he met with RTA and he recovered back with right hemiplegia. So, he was brought for Rehabilitation through Ayurvedic lines of management. Hence for the same, assessments were done through CNS examinations and NIH scoring was adopted to compare the effect before and after the treatment. And specific treatment was planned which includes Panchakarma, diet regimen, Physiotherapy, Shamanoushadhis and was successfully treated with Ayurveda interventions with reference to Pakshavadha line of management as a rehabilitative management and significant results were obtained after 3 follow ups (total duration for 112 days).

Enhancing review criteria for dissemination and implementation science grants

BackgroundThe existing grant review criteria do not consider unique methods and priorities of Dissemination and Implementation Science (DIS). The ImplemeNtation and Improvement Science Proposals Evaluation CriTeria (INSPECT) scoring system includes 10 criteria based on Proctor et al.’s “ten key ingredients” and was developed to support the assessment of DIS research proposals. We describe how we adapted INSPECT and used it in combination with the NIH scoring system to evaluate pilot DIS study proposals through our DIS Center.MethodsWe adapted INSPECT to broaden considerations for diverse DIS settings and concepts (e.g., explicitly including dissemination and implementation methods). Five PhD-level researchers with intermediate to advanced DIS knowledge were trained to conduct reviews of seven grant applications using both the INSPECT and NIH criteria. The INSPECT overall scores range from 0 to 30 (higher scores are better), and the NIH overall scores range from 1 to 9 (lower scores are better). Each grant was independently reviewed by two reviewers, then discussed in a group meeting to compare the experiences using both criteria to evaluate the proposal and to finalize scoring decisions. A follow-up survey was sent to grant reviewers to solicit further reflections on each scoring criterion.ResultsAveraged across reviewers, the INSPECT overall scores ranged from 13 to 24, while the NIH overall scores ranged from 2 to 5. Reviewer reflections highlighted the unique value and utility for each scoring criterion. The NIH criteria had a broad scientific purview and were better suited to evaluate more effectiveness-focused and pre-implementation proposals not testing implementation strategies. The INSPECT criteria were easier to rate in terms of the quality of integrating DIS considerations into the proposal and to assess the potential for generalizability, real-world feasibility, and impact. Overall, reviewers noted that INSPECT was a helpful tool to guide DIS research proposal writing.ConclusionsWe confirmed complementarity in using both scoring criteria in our pilot study grant proposal review and highlighted the utility of INSPECT as a potential DIS resource for training and capacity building. Possible refinements to INSPECT include more explicit reviewer guidance on assessing pre-implementation proposals, providing reviewers with the opportunity to submit written commentary with each numerical rating, and greater clarity on rating criteria with overlapping descriptions.

Efficiency and Toxicity of Imatinib Mesylate Combined with Atorvastatin Calcium for Steroid-Refractory Chronic Graft-Versus-Host Disease

Background: Chronic graft-versus-host disease (cGVHD) represents the most common long-term complication associated with allogeneic hematopoietic stem cell transplantation. Moreover, steroid-refractory cGVHD (SR-cGVHD) presents new challenges for treatment. Currently, while imatinib and statins drugs have been recognized to regulate T cell function, their effects and mechanism in combined treatment for cGVHD remain unknown. Methods: A total of 60 SR-cGVHD patients were entered into a clinical single-arm trial investigating the combination of imatinib mesylate and atorvastatin calcium for the treatment of SR-cGVHD. The efficacy, safety, and immune effects were evaluated after treatment using the 2014 NIH scoring system and changes in T cell subclones. The primary end points consisted of the overall response rate (ORR) after 6 months of treatment with imatinib mesylate and atorvastatin calcium, which were evaluated according to the NIH criteria. The secondary end point consisted of an evaluation of survival, the changes of T cell subsets and adverse events. Results: At baseline, 45% (27/60) of the patients had moderate cGVHD and 55.0% (33/60) patients had severe cGVHD. There were 32 (53.3%) patients with skin involvement, 31 (51.7%) patients with liver involvement, and 21 (35.0%) with clinical lung involvement, with compromised forced expiratory volume and/or diffusion capacity of the lung for carbon monoxide. There were 23 (38.3%) patients who exhibited oral mucosal involvement, 12 (20.0%) with joint and fascia involvement and 11 (18.3%) who exhibited gastrointestinal tract involvement, eyes 13 (21.7%), genitalia 2 (3.3%). The median follow up was 17 (4-25) months. At the 6 months follow-up, 70.0% of the patients achieved a clinical response, Complete response (CR) was achieved in 26.7% of the patients. After 6 months of treatment, the ORR rate of the liver, skin, eyes and oral cavity was 80.6%, 78.1%, 61.5%, and 60.9%, respectively, the liver was also the organ that achieved the highest CR of 58.1%. The cumulative overall survival rate, relapse and NRM for all treated patients was 78.9%, 15.5% and 11.7% (Fig A-C). Patients who achieved CR and PR showed a better survival outcomes (P= 0.0106) (Fig D). There was a decreased proportion of Th17 cells (P = 0.0171), whereas there was an increase in Treg cells (P = 0.0147) after 3 months in the clinical response patients. No toxic deaths were observed in this study, The main adverse was edema (13.3%) and nausea (10%). Conclusion: Imatinib mesylate and atorvastatin calcium combination treatment was effective for treating SR-cGVHD and significantly induced improvement in target organ injury, especially in the liver. T cell regulation may play an important role in this process.

Effect of tele-stroke application on length of stay and outcome of stroke unit inpatients

Abstract Background Despite advances in acute stroke treatment, stroke remains the second most common cause of death and the leading cause for long-term adult disability worldwide Telemedicine, a method of healthcare delivery and support using telecommunication technologies, is becoming increasingly popular across a wide range of health conditions. Tele stroke has grown significantly in the past decade and has entered mainstream care for patients with acute stroke. It enables such patients to be remotely evaluated, thereby allowing optimal treatment and management even in clinically underserved areas and removing geographical disparities in access to expert care. Objective Study the effectiveness of Tele-stroke regarding length of stay& stroke outcomes &occurrence of medical comorbidities in admitted patients by comparing these measures before and after tele stroke application in ain shams university specialized hospital(ASUSH) Methods Comparative observational study. we stratified patients into two groups: “Group 1”: patients admitted 3 months before application of tele stroke “Group 2”: patients admitted 3 months after application of tele stroke We compared between two groups regarding sociodemographic data , length of stay and NIH scoring on admission & discharge before and after implementation of tele stroke system Results regarding length of stay, it was ranged from 1 to 19 days with mean (4.3 ± 3.3) in group (I) comparing to range 1 to 12 with mean (3.5 ± 1.9) days in group (II) with significant decrease (p = 0.033*). By analysis of results by means for difference between NIH on admission and in discharge , the means difference in group I was 2.8±1.9 vs. 3.5±2.3 in group II with significant difference (p-value =0.29*) CONCLUSION Our study concluded that application of tele stroke had significant improvement in stroke unit care as regard length of stay, rapid improvement of patients according to NIH scoring and mRS

The management of gynecological complications in long-term survivors after allogeneic hematopoietic cell transplantation\u2014a single-center real-life experience

In everyday gynecological practice, there is an unmet need to manage survivors after allogeneic hematopoietic cell transplantation (allo-HCT). The major gynecological complications include premature ovarian insufficiency (POI), chronic graft-versus-host disease (cGVHD) of the anogenital zone (cGVHDgyn), and secondary neoplasms. Aiming to assess a real-life scale of problems associated with HCT, we performed a detailed analysis of a consecutive series of females after allo-HCT who were referred for a routine gynecological evaluation. The study includes 38 females after allo-HCT in whom gynecological examination with cervical smear and USG were performed, followed by colposcopy according to NCCN guidelines. NIH scoring system was used to classify a grade of cGVHDgyn. The incidence of cGVHD was 71% whereas GVHDgyn was 29%, including 5 patients with score 3 at the time of diagnosis. The other manifestations (frequently noted) included the skin, mucosa, eyes, and liver. Menopause was diagnosed in 93% females, and in 81% of them, POI criteria were fulfilled. Ovarian function resumed in 2 cases. The rate of abnormal cytology was 26%: 4 ASCUS, 1 AGUS, 1 LSIL, 3 HSIL/ASC-H, and one cytological suspicion of cervical cancer. GVHDgyn was documented in 10 patients, and 6 of them had abnormal cervical cytology. Early topical estrogen therapy led to a significant reduction in vaginal dryness (p < 0.05), dyspareunia (p < 0.05), and less frequent cGVHDgyn (p < 0.05). GVHDgyn develops in about 30% of long-term allo-HCT survivors. Topical estrogens and hormonal replacement therapy alleviate symptoms and prevent the occurrence of severe consequences of menopause.

SAT-413 LUPUS NEPHRITIS IN CHILDREN AND ADULTS FROM A RESOURCE LIMITED SETTING- A CLINICOPATHOLOGICAL COMPARISON

Childhood-onset systemic lupus erythematosus (SLE) differs from adult-onset disease in important ways especially renal manifestations. Pediatric Lupus Nephritis (ped LN) which is 30% more prevalent, causes significant morbidity and mortality. In general, treatment for ped LN is based on standard approaches in adults with Lupus Nephritis, because of the lack of large randomized trials in pediatric disease regarding the appropriate drug doses and treatment duration for children who have longer life expectancy and has the concerns of growth and development. Hence we aimed to compare the clinicopathological profile and response to induction treatment in ped LN with that of adults. Data was collected from 36 cases of ped LN and 55 adult LN cases from the year 2010 to 2016 (7 years). Clinicopathological findings at the time of presentation were noted. Renal biopsies were reported by the same renal pathologist and ISN/RPS (2003) classification was followed. The Activity Index (AI) and Chronicity Index (CI) were calculated using NIH scoring system. All patients received treatment as per NIH protocol. The correlation between clinical features, class of lupus nephritis, morphological indices and response to induction treatment in childhood lupus nephritis was assessed and compared in both the groups. Among 36 pediatric patients, 75% were females. 33.33% had nephrotic range proteinuria and 5.56 % had no proteinuria.63.9% had hematuria and 36.1 % had pyuria. Majority had proliferative lupus nephritis Class III- 41.67%, Class Iv- 44.44%). Mean AI was 5.4 (range (0 to 16). Majority were not having any chronicity. ( mean CI-0.33; Range - 0-3). Children who attained complete remission following 6 months induction treatment(n=25), had a mean AI of 4.98 while those who had only partial/no remission had a mean of 6.09. Out of 55 adults, Class IV was the commonest type and the mean AI was 7.83 and mean CI was 2.04. Patients who attained complete remission (n=30) had a mean AI of 7.15 and mean CI of 1.54. where as those adults who had only partial /no remission had higher mean AI (8.88) and CI (2.6) Though the distribution of major classes of LN were similar in both adults and children, ped LN has lesser activity and minimal or nil chronicity compered to adults. Morphological indices in renal biopsy are useful in predicting response to induction treatment. The finding of more chance of attaining complete remission in ped LN compared to adult LN needs validation in future larger studies.

Role of Contrast-Enhanced Ultrasound Sonography in the Medical Diagnostics of the Disease Activity in Patients With Takayasu Arteritis

The accurate diagnosis of Takayasu arteritis (TA) and the evaluation of its activity can bring significant challenges. In this paper, we sought to investigate a correlation between clinical activity and the enhancement of vessel wall acquired by contrast-enhanced ultrasound sonography (CEUS) in patients with TA, and to evaluate whether CEUS can be used to assess the disease activity of TA. Twenty TA patients with their carotid arteries affected were enrolled and divided into the active group and the inactive group according to the NIH scoring method. The white blood cell counts, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) were obtained. Conventional ultrasound was performed to acquire the external diameter of the artery (D), intima-media thickness of the arterial wall (IMT), percent area stenosis, peak systolic velocity, end diastolic velocity, and resistance index. CEUS was performed to acquire the enhanced intensity (EI), derived peak intensity (DPI), and time to peak. The analysis showed that compared with the inactive group, D and IMT were significantly higher in the active group ( $6.50~\pm ~1.80$ versus $9.20~\pm ~4.00$ mm, $1.80~\pm ~0.40$ versus $2.40~\pm ~0.70$ mm, $p ). EI and DPI were also significantly higher in the active group ( $38.20~\pm ~10.62$ versus $80.80~\pm ~23.60$ IU, $46.20~\pm ~10.20$ versus $90.30~\pm ~24.60$ IU, $p ). Meanwhile, EI and DPI showed good correlation with CRP and ESR. Therefore, our study demonstrated that CEUS can increase the effectiveness of conventional ultrasound in differentiating active and inactive TA.

Verification of the new grading scale for ocular chronic graft-versus-host disease developed by the German-Austrian-Swiss consensus conference on chronic GVHD.

The purpose of the study was to validate a recently proposed new grading system for ocular manifestations of chronic graft-versus-host disease (cGVHD). Diagnosis of cGVHD was based on the NIH consensus criteria. In addition, a grading scale was applied, which has been developed by the German-Austrian-Swiss Consensus Conference on Clinical Practice in cGVHD. Sixty-six patients (male n = 46, female n = 20, mean age 48 years) with ocular cGVHD were included. Application of the proposed Consensus Conference grading revealed inflammatory activity in all patients with mild (33 %), moderate (44 %), or severe inflammation (23 %). Clinical scoring by the NIH scoring system showed that 6 % of patients had mild symptoms; 59 % of patients had moderate dry eye symptoms partially affecting activities of daily living, without vision impairment; and 35 % of patients had severe dry eye symptoms significantly affecting daily activities. Clinical characterization and grading by the Consensus Conference grading scale revealed that ocular cGVHD (1) frequently leads to severe ocular surface disease based on impaired function of the lacrimal glands and involvement of cornea, conjunctiva, and lids; (2) is mostly associated with ongoing inflammatory activity; (3) often leads to functional impairment and reduced quality of life; and (4) is associated with an increased risk for severe, sight-threatening complications.

Treatment of Chronic Graft Versus Host Disease with a Combination of B-Cell Depletion and Tyrosine Kinase Inhibition

Chronic Graft Versus Host Disease (cGVHD) affects about 60% of all patients receiving an allogeneic hematopoietic stem cell transplantation (HSCT) and surviving beyond day 100. Incidence of cGVHD is rising because of the widespread use of Peripheral Blood Stem Cells (PBSC) as stemcell source. Chronic GVHD accounts for high morbidity and mortality rates. Affected patients require long term use of immunosuppressive drugs, mainly corticosteroids, which lead to development of severe side effects. Both the manifestations of cGVHD as the side effects from immune suppressive drugs account for a decrease in quality of life when cGVHD develops. Therefor new therapeutic strategies are urgently needed.Therapeutic approaches for cGVHD are limited. Generally recommended first line therapy consists of glucocorticoid therapy combined with a calcineurin inhibitor. Options for second line therapy are numerous but no consensus on the most favourable choice of agents has been reached.However as both monotherapy with rituximab and monotherapy with tyrosine kinase inhibition have shown to be effective in reducing cGVHD symptoms . We aimed to test whether the sequential therapy of the anti CD20 antibody rituximab followed by a 6 month treatment period with the tyrosine kinase inhibitor nilotinib is a good treatment strategy for patients with sclerotic cGVHD (EudraCT nr 2008-004125-42).We treated 26 patients with a combination of 4 weekly infusions of rituximab followed by a 6 month period of treatment with nilotinib (300mg b.i.d.). Patients were evaluated monthly for 13 months and sequential blood samples and skin biopsies were analyzed. All patients gave informed consent before enrollment.3 patients experienced severe side effects from either rituximab or nilotinib treatment and therefor were taken off study. Of the remaining 13 patients who thus far have completed the study protocol, 60% showed a (partial) response (3 patients went from NIH scoring 'severe' to 'moderate', 1 patient went from NIH scoring 'moderate' to 'no cGVHD'). There is also a significant decrease in cGVHD affected body surface area (Figure 1). Moreover, two out of four patients who suffered from severe ulcerations at the start of the study had a complete resolution of ulcers at the end of the treatment period. Patients with a (partial) response also showed a decrease in self attributed severity of cGVHD and their immunosuppressive drugs could be tapered.The sequential therapy of B-cell depletion and tyrosine kinase inhibition provides a new and interesting alternative treatment option for this difficult and heavily pretreated patient category.Table 1Baseline characteristics of participants.Patients26Male sex20Mean age in years(range)47,521-70Primary diagnosisAML7Multiple myeloma5ALL4Lymphoma4MDS2CLL1Myeloproliferative disorder2aplastic anemia1Mean days after allo SCT(range)1368411-3820Ulcerative chronic GvHD at start5NIH grade severity cGVHD at startsevere20moderate6 [Display omitted] DisclosuresOff Label Use: Anti CD20 antibody rituximab is used for sclerotic chronic GVHD. Tyrosine kinase inhibitor nilotinib is used for sclerotic chronic GVHD..

FRI0401 Quantification of Toll like Receptors Expression in Lupus Nephritis: Correlation with Activity and Chronicity Indices

BackgroundThe role of Toll Like Receptors (TLRs) in Systemic Lupus Erythematosus (SLE) pathogenesis has raised great interest as they recognize nucleic acids, main antigens of the disease. Several studies on...

MP37-06 MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING AND MRI/ULTRASOUND FUSION-GUIDED BIOPSY STRATIFY PATIENTS AT RISK FOR EXTRACAPSULAR EXTENSION AT RADICAL PROSTATECTOMY

INTRODUCTION AND OBJECTIVES: In patients with prostate cancer (CaP), preoperative identification of extracapsular extension (ECE) can provide vital information for the surgical planning of robotassisted radical prostatectomy (RARP). Historically, MRI has had limited sensitivity for ECE. We aim to evaluate which parameters on multiparametric MRI (MP-MRI) and MRI/ultrasound (MRI/US) fusionguided biopsy aid in the pre-operative assessment of ECE. METHODS: Between May 2007 and August 2013, 299 patients at our institution underwent 3T MP-MRI, MRI/US fusion-guided biopsy with standard 12-core biopsy, and RARP. Visualized lesions were identified as low, moderate, or high suspicion for CaP according to the previously validated NIH scoring system. Findings were characterized as “presence of ECE,” “extracapsular bulge,” or neither. MP-MRI findings were correlated with biopsy results, final RARP pathology and margin status. Univariate analysis was performed to evaluate preoperative predictors of ECE on final pathology. RESULTS: MRI was positive for ECE in 27 patients and negative in 272, with a sensitivity of 17.2% and a specificity of 93.2% when compared to final pathology. In all patients, the rate of positive surgical margins was 15.1%. This rate increased to 22.2% in the subset of patients with MRIs that were positive for ECE, but increased to 31.1% in those patients whose MRIs were false negatives. In the group of patients with negative MRIs, PSA, MRI suspicion score, presence of bulge, and highest Gleason score on MRI/US fusion-guided biopsy were all associated with ECE on final pathology (p<0.001, Table). This was not the case for standard 12-core biopsy. CONCLUSIONS: When ECE is correctly identified on MRI, margin involvement increases slightly as compared to that seen with low risk CaP. However, margin involvement increases much more substantially when the final pathology report of ECE was unexpected due to a false negative MRI. In the absence of visible ECE on MP-MRI, the lesion suspicion score, presence of extracapsular bulge, and Gleason score on MRI/US fusion-guided biopsy can help identify those patients who are most likely to harbor ECE. This may guide pre-operative surgical planning and reduce the occurrence of positive surgical margins after RARP.

V6-11 MAGNETIC RESONANCE IMAGING/TRANSRECTAL ULTRASOUND (MRI/TRUS) FUSION GUIDED BIOPSY OF THE PROSTATE TO DETECT HIGH GRADE CANCER

You have accessJournal of UrologyNovel Imaging/Prostate Oncology/Robotics1 Apr 2014V6-11 MAGNETIC RESONANCE IMAGING/TRANSRECTAL ULTRASOUND (MRI/TRUS) FUSION GUIDED BIOPSY OF THE PROSTATE TO DETECT HIGH GRADE CANCER Jennifer Logan, Andrew Gomella, Soroush Rais-Bahrami, Baris Turkbey, Peter Choyke, Bradford Wood, and Peter Pinto Jennifer LoganJennifer Logan More articles by this author , Andrew GomellaAndrew Gomella More articles by this author , Soroush Rais-BahramiSoroush Rais-Bahrami More articles by this author , Baris TurkbeyBaris Turkbey More articles by this author , Peter ChoykePeter Choyke More articles by this author , Bradford WoodBradford Wood More articles by this author , and Peter PintoPeter Pinto More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1874AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Multiparametric MRI has been shown to be a valuable adjunct to identifying suspicious lesions for prostate cancer diagnosis. Magnetic Resonance Imaging/Transrectal Ultrasound (MRI/TRUS) fusion platforms allow for the detail and information provided by MRI to be combined with the real-time capabilities of ultrasound in an office-based setting. Additionally, MRI/TRUS fusion platforms have demonstrated improved detection of clinically significant prostate cancer compared to systematic 12-core TRUS biopsies. METHODS This video demonstrates the MRI/TRUS fusion biopsy procedure of a 62 year old male with history of elevated serum PSAs in the setting of multiple negative TRUS biopsies. The patient was initially biopsied under the standard of care 12-core TRUS with no evidence of prostate cancer with subsequent TRUS biopsies also demonstrating no evidence of cancer. The patient then elected to undergo MRI/US fusion biopsy. A diagnostic pre-biopsy multiparametric MRI with surface and endorectal coils was taken and identified one lesion that was highly suspicious for prostate cancer based on NIH scoring criteria. The entire fusion biopsy procedure using the UroNav platform is depicted and includes: patient preparation, TRUS sweep, MRI/TRUS image co-registration, and targeted and standard biopsy. Screenshots of the UroNav platform during biopsy target acquisition and sampling are shown followed by an optional 12-core TRUS biopsy. RESULTS Four targeted biopsy cores were taken from the midline anterior apical central gland (two in the axial direction, two in the sagittal direction) with all cores detecting prostate adenocarcinoma. Three of the four targeted cores demonstrated Gleason 4+4=8 disease involving between 30-90% of the needle core. All 12 systematic cores failed to demonstrated evidence of prostate adenocarcinoma. Targeted biopsy lengthened total biopsy procedure time by a few minutes with no additional post-operative complications. CONCLUSIONS The UroNav MRI/TRUS fusion platform enables urologists to quickly and efficiently identify and biopsy MR suspicious lesions in an office-based setting. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e681-e682 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Jennifer Logan More articles by this author Andrew Gomella More articles by this author Soroush Rais-Bahrami More articles by this author Baris Turkbey More articles by this author Peter Choyke More articles by this author Bradford Wood More articles by this author Peter Pinto More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Impact of extracorporeal photopheresis on skin scores and quality of life in patients with steroid-refractory chronic GVHD

There are few prospective studies evaluating the role of extracorporeal photopheresis (ECP) in chronic GVHD (cGVHD) and only occasional reports of the effect of ECP on patients' quality of life (QoL). We report a single-centre prospective study of patients undergoing fortnightly ECP for moderate or severe cGVHD. Response was assessed after 6 months of treatment using NIH scoring criteria and reduction in immunosuppression. QoL assessments were undertaken at baseline and at 6 months using the chronic GVHD symptom scale (cGVHD SS) and dermatology life quality index (DLQI). An intention-to-treat analysis showed that 19/38 (50%) of patients had a complete or partial response. Twenty-seven out of 38 patients completed 6 months of ECP treatment and 70% (19/27) had a complete or partial response. Eighty per cent of patients who completed 6 months of ECP treatment had a reduction in immunosuppression dose. A subset of patients completed QoL questionnaires. Seventeen out of 18 patients (94%) showed an improvement in scores. The mean cGVHD SS and mean DLQI score were both significantly lower after 6 months of ECP (22 compared with 36, P=0.012 and 3.4 compared with 6.9, P=0.009, respectively). This study confirms that ECP can lead to objective clinical responses and, in addition, may lead to an improvement in QoL in cGVHD.

Utility of multiparametric MRI at 3 tesla and MRI/ultrasound fusion-guided biopsy in detecting seminal vesicle invasion by prostate cancer.

128 Background: We aim to evaluate the correlation between multiparametric prostate MRI (MP-MRI) suspicion for seminal vesicle invasion (SVI) and pathology on MRI/US fusion-guided biopsy, as well as radical prostatectomy (RP). Methods: 822 patients underwent MP-MRI and MRI/US fusion-guided biopsy. 24 patients underwent targeted seminal vesicle biopsies. 5 patients had MRI findings suspicious for bilateral SVI, for a total of 29 lesions. MP-MRI targets were scored as low, moderate, or high suspicion for PCa involvement according to the validated NIH scoring system. Patient demographics were reviewed and positive predictive values (PPVs) of pre-biopsy suspicion levels were calculated with respect to correlative biopsy pathology and final RP pathology. Results: At the time of MP-MRI, the median age was 64 years with a median PSA of 10.74 ng/ml (Table). Thirteen (54.2%) had not been previously diagnosed with PCa. Of the 29 SV lesions on imaging, MP-MRI suspicions of low, moderate, and high were assigned to 3, 18, and 8 lesions, respectively. The PPVs of these MRI suspicion levels, confirmed by MRI/US fusion biopsy, were 0%, 77.7%, and 62.5%, respectively. The 3 patients in the low suspicion cohort all underwent RP, confirming targeted biopsy findings. Of those with moderate or high suspicion of SVI on MP-MRI, only 5 underwent RP, with a targeted biopsy accuracy of 80%. The overall accuracy of targeted SV biopsy was 87.5% (7/8) on final RP pathology. Conclusions: MP-MRI suspicion of SVI correlates highly with findings on targeted SV biopsy and final RP pathology, thus potentially playing a vital role in future preoperative staging for PCa. [Table: see text]

Pretransplant Parathyroid Hormone Level Has No Correlation with Platelet Recovery After Stem Cell

AbstractAbstract 4495 BackgroundStem cell fate is influenced by specialized microenvironments called as stem cell niche. Osteoblasts are considerd to play very important role in stem cell niche. They are activated by parathyroid hormone (PTH) or PTH related protein through PTH/PTHrP receptor and produce hematopoietic growth factors. In few large animal studies PTH treatment after hematopoietic stem cell transplantation (HSCT) improved post-transplant platelet count and CD4 lymphocyte count. Effect of PTH on cord blood stem cell transplantation to improve engraftment is under clinical trial. Therefore, authors investigated on correlation between pre-transplant serum PTH level and platelet recovery after allogeneic HSCT. MethodsFrom January 2008 to December 2009, we measured pre-transplant serum PTH, ferritin of 28 patients who underwent allogeneic HSCT. Post-transplant platelet was checked at the point of post-transplant 14 days, 30 days, 60 days, 90 days and 180days. Surveillance of cytomegalovirus was done by weekly or biweekly CMV-PCR assay. Acute graft-versus-host disease (GVHD) was graded by IBMTR classification and chronic GVHD by NIH scoring system. ResultsFive patients received graft from partially matched donors and the others from fully matched donors, 15 from unrelated and 13 from related donors. Nineteen patients were in high risk at diagnosis. Nonmyeloablative conditioning was applied to 7 patients. Only 1 patient used bone marrow as stem cell source. Median dose of infused stem cell was 5.7×10∧6/kg (range 1.68 – 12.74). All patients were successfully engrafted. Acute GVHD more than grade 2 occurred in 15, and chronic GVHD more than moderate degree in 7. Five patients relapsed and 15 patients died of relapse or treatment related mortality. Pre-transplant serum PTH had no correlation with platelet count recovery. There was no correlation with pre-HSCT PTH and acute or chronic GVHD. However patient with lower PTH level had tendency to more frequent CMV reactivation (P=0.098). ConclusionOur hypothesis was that higher pre-transplant PTH would be related to better platelet recovery but failed to find correlation between two of them. There are various factors which affect engraftment and graft function. Role of PTH for engraftment should be evaluated in larger number of cases. Disclosures:No relevant conflicts of interest to declare.

Burden of Illness in Chronic Graft vs. Host Disease - A Prospective Cohort Study.

BACKGROUND: Chronic Graft vs. Host Disease (cGVHD) is a complex and prevalent complication in long term survivors after allogeneic stem cell transplant. The scope and severity of abnormalities in cGVHD have never been systematically described and are essential for health care delivery planning or testing new therapies.METHODS: Patients with cGVHD were studied in a cross-sectional prospective natural history protocol. They were systematically assessed by a multidisciplinary team specialized in cGVHD clinical research. A detailed history, organ-specific evaluations, functional performance and laboratory parameters were obtained using standardized measures. Questionnaires administered in strictly controlled conditions included clinician-administered NIH scoring (Filipovich et al, BMT 11:945, 2005) and measures of quality of life (FACT-BMT, SF-36, Lee cGVHD symptom scale). An exploratory statistical analysis was performed by grouping parameters into “predictors” (patient and transplant characteristics, laboratory data) and “outcomes” (cGVHD severity, functional performance, QOL) using descriptive statistics and correlation analysis (p<0.01 or correlation coefficient >0.70 as indicators of strong association).RESULTS: Cohort included 52 patients (29 male, median age 48) with cGVHD. Median time post-transplant was 27 mo and time from diagnosis of cGVHD 14 mo, 42 patients had a sibling donor, 47 received peripheral blood stem cells, 26 had progressive onset of cGVHD, 51 had extensive disease, 38 were on systemic immunosuppression (31 on two or more drugs). Median number of organ systems involved was 5, range from 2 to 9 (max possible 9 for women, 8 for men); median total NIH score was 7.5, range from 2 to 15 (max 27 for women, 24 for men); 22 patients had at least one organ with NIH score of 3 indicating seriously disabling manifestations. Unrelated donor transplant recipients had more organ systems involved (p=0.009) and higher total score (p=0.036). Male recipients with female donors had higher NIH scores (p<0.043). Myeloablative regimens were associated with higher scores for eye (p=0.004). Patients with longstanding cGVHD had higher scores for skin sclerosis (p<0.003), eye (p<0.005) and joint (p<0.0001) while those with early onset of cGVHD had higher mouth scores (p=0.005). Total white count and absolute lymphocyte count were associated with eye involvement (p=0.01 and 0.007 respectively), total cholesterol and LDL with mouth involvement (p=0.0004 and 0.003 respectively), complement C3 and IL-6 with skin sclerosis (p= 0.003 and 0.006 respectively). 26 patients had at least one auto-antibody present and 9 had two or more. Presence of anti-cardiolipin antibodies IgG type was associated with higher skin score (p=0.0008) and IgM with lower eye score (p=0.009). B-cell activating factor (BAFF) was higher in patients who were 9 mo or less from their transplant (p=0.024). BAFF was negatively associated with eye disease (p<0.05) and positively with beta-2-microglobulin (p=0.0001). There were no significant correlations between any predictor and QOL outcomes.CONCLUSION: Patients with cGVHD manifest wide range of clinical and laboratory abnormalities. Some abnormalities occur together and are time related suggesting heterogeneous and dynamic disease biology. Patient reported QOL measures may not be good correlates of cGVHD pathophysiology. A substantial number of associations are worthy of further exploration to better understand the mechanisms which generate the diverse clinical spectrum of cGVHD.