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Background We evaluated whether the addition of docetaxel (D) to a combination comprising 5-fluorouracil/leucovorin (5-FU/LV) or capecitabine (C) plus oxaliplatin (O) (DOF/DOX) improved overall survival (OS) compared with 6 months of 5-fluorouracil (5-FU) or capecitabine in combination with oxaliplatin (FOLFOX/CAPOX) alone in advanced HER2-negative gastroesophageal junction and gastric adenocarcinomas (G/GEJ). Methods This study was an investigator-initiated, open-label, multi-institutional, randomized phase III trial in adult patients with HER2-negative advanced G/GEJs. The primary endpoint of the study was a comparison of median OS by Kaplan-Meier method. Next-generation sequencing was performed on tissue. Results Of the 324 patients randomly assigned between July 2020 and November 2022, 305 patients were evaluable for analysis (FOLFOX/CAPOX: 156; DOF/DOX: 149). With a median follow-up time of 19.2 months (95% Confidence Interval [CI] = 16.5 months to 21.9 months) for the entire cohort, the median OS was 10.1 months (95% CI = 9.2 to 10.9) for FOLFOX/CAPOX and 8.9 months (95% CI = 7.3 to 10.5) for DOF/DOX, and this difference was not statistically significant (P  = .70). An increased proportion of grade 3 or grade 4 neutropenia (21% vs 3%; P  < .001) and grade 2/3 neuropathy (17% vs 7%; P  = .005) was seen in patients receiving DOF/DOX. Genomic profiling revealed a low incidence of microsatellite instability (1%) and a high incidence of BRCA1 (8.4%) and BRCA2 (7.5%) somatic alterations. Conclusion FOLFOX or CAPOX chemotherapy for 6 months remains one of the standards of care in advanced HER2-negative gastroesophageal junction and gastric adenocarcinomas, with no additional survival benefit seen with the addition of docetaxel. Genomic profiling of patients revealed a higher than previously known incidence of somatic BRCA alterations, which requires further evaluation. CTRI (Clinical Trial Registry of India: CTRI/2020/03/023944). [ABSTRACT FROM AUTHOR]

The article discusses the Thromboembolic events in brain tumour patients on bevacizumab. Topics include evaluated the role of genetic and non-genetic factors in causation of Venous thromboembolism (VTE); and Bevacizumab alone or in combination with chemotherapy has been approved by U.S Food and Drug Administration (FDA) in recurrent and progressive GBM seeing the improved outcomes.

Background: Although cough is a common and distressing symptom in patients with lung cancer, there is almost no evidence to guide treatment. Aprepitant, a centrally acting neurokinin-1 inhibitor, significantly decreased cough frequency in a pilot study.Methods: Patients with advanced lung cancer and cough lasting over 2 weeks despite a cough suppressant were randomized 1:1 to aprepitant 125 mg orally on day 1 and then 80 mg orally on days 2 to 7 with physician's choice of antitussive; or to physician's choice of antitussive alone. Evaluation was at baseline and on days 3, 7, 9, and 12. The primary end point was subjective cough improvement on day 9, measured by the Visual Analog Scale and Manchester Cough in Lung Cancer Scale. Secondary end points included quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire and the EORTC Lung Cancer-Specific Quality of Life Questionnaire and toxicity.Results: Between 2017 and 2018, 128 patients were randomized. Median baseline cough duration was 90 days. Mean Visual Analog Scale scores (in mm) at baseline and day 9 were 68 and 39 in the aprepitant arm and 62 and 49 in the control arm, respectively (P < .001); mean Manchester Cough in Lung Cancer Scale scores at baseline and day 9 were 33 and 23 in the aprepitant arm and 30 and 25 in the control arm, respectively (P < .001). Overall QoL was not significantly different between the two arms; however, aprepitant led to a significant improvement in the cough-specific QoL domain (P = .017). Aprepitant did not increase severe adverse events.Conclusions: Aprepitant led to a significant improvement in cough in advanced lung cancer, without increasing severe side effects.Trial Registry: Clinical Trials Registry-India; No.: CTRI/2017/05/008691; URL: http://ctri.nic.in. [ABSTRACT FROM AUTHOR]

Assessment of risk of fall among elderly in selected community area, Kanchipuram district, Tamilnadu, India. The objectives are to assess the risk of fall among elderly in selected community area, To associate the risk of fall with demographic variables in selected community area. The resrarch approach used for the study was Quantitative Approach Purposive sampling technique was used to select 60 samples. The data were collected by using Fall Risk Assessment scale. The collected data were tabulated and analyzed. The level of significance selected was p<0.05 level. Descriptive and inferential statistics were used. The result showed that 62% of elderly had low level of risk where as 38% of elderly had moderate level of risk of fall. The showed that the demographic characteristics like Age (χ² -7.588), Blood Pressure (χ² - 2.00), Diabetes (χ² - 2.347), Vision (χ² - 3.45)have significant association where as demographic characteristics like Gender χ² - (0.020), Arthritis (χ² - 0.006) have no significant association . [ABSTRACT FROM AUTHOR]

Head and neck cancers (HNCs) are malignant tumors of the upper aerodigestive tract and are the sixth most common cancer worldwide. In India, around 30-40% of all cancers are HNCs. Even though there are global guidelines or recommendations for the management of HNCs, these may not be appropriate for Indian scenarios. In an effort to discuss current practices, latest developments and to come to a consensus to recommend management strategies for different anatomical subsites of HNCs for Indian patients, a group of experts (medical, surgical and radiation oncologists and dentists) was formed. A review of literature from medical databases was conducted to provide the best possible evidence base, which was reviewed by experts during a consensus group meeting (January, 2019) to provide recommendations. [ABSTRACT FROM AUTHOR]

Background: Comprehensive geriatric assessment (CGA) in routine practice is not logistically feasible. Short geriatric screening tools are available for selecting patients for CGA. However none of them is validated in India. In this analysis we aim to compare the level of agreement between three commonly used short screening tools (Flemish version of TRST (fTRST), G8 and VES-13.Methods: Patients ≥65 years with a solid tumor malignancy undergoing cancer directed treatment were interviewed between March 2013 to July 2014. Geriatric screening with G8, fTRST and VES-13 tools was performed in these patients. G8 score ≤14, fTRST score ≥1 and VES-13 score ≥3 were taken as indicators for the presence of a high risk geriatric profile respectively. R version 3.1.2 was used for analysis. Cohen kappa agreement statistics was used to compare the agreement between the 3 tools. p value of 0.05 was taken as significant.Results: The kappa statistics value for agreement between G8 score and fTRST, between VES-13 and fTRST and between VES-13 and G8 were 0.12 (P = 0.04), 0.16 (P = 0.07) and 0.05 (P = 0.45) respectively. It was found that maximum agreement was observed for VES-13 and fTRST. The agreement value of VES-13 and fTRST observed was 59.44 %(39.63% for high risk profile and 19.81% for low risk profile). The agreement value of G-8 and fTRST was 39.62% (2.83% only for high risk profile and 36.79% for low risk profile). The lowest agreement was between G8 and VES-13, 35.84% (7.54% for high risk detection and 28.30% for low risk detection).Conclusion: There was poor agreement (in view of kappa value been below 0.2) between the 3 short geriatric screening tools. Research needs to be directed to compare the agreement level between these 3 scales and CGA, so that the appropriate short screening tool can be selected for routine use. [ABSTRACT FROM AUTHOR]

Background Nonadherence of antiemetic prescriptions to evidence-based antiemetic guidelines is associated with an increased proportion of chemotherapy-induced nausea and vomiting. The current project was carried out to improve the quality of antiemetic prescriptions at our institute. Methods We initially performed a retrospective analysis of 1,211 consecutive antiemetic prescription records of adult patients with solid tumors who received outpatient chemotherapy regimens. The antiemetic prescription records were classified as either ASCO-guideline adherent or nonadherent, and the impact on emesis was studied. These data were used to educate clinicians regarding the importance of adherence to guidelines. We then revised our antiemetic prescription policies and made their use mandatory. In addition, a double-check system was introduced to ensure implementation. A reaudit was performed to study the impact of these interventions. Results ASCO-guideline-adherent prescriptions in the initial part of our study were associated with a lower rate of vomiting (6.6% v 21.9%; P < .001), emergency visits (2.6% v 5.8%; P = .006), and hospitalization for emesis (0.9% v 4.9%; P < .001). The proportion of prescriptions classified as ASCO-guideline adherent in the initial audit and the reaudit were 63.6% and 98.5%, respectively (P < .001). The proportion of patients for whom antiemetic prescriptions were overused was significantly lower on the reaudit (41.3% v 68.3% before the interventions; P = .001). Conclusion Mandatory, semirigid corrective steps as carried out in this audit led to an improvement in antiemetic-guideline adherence rate. [ABSTRACT FROM AUTHOR]

Purpose: The American Society of Clinical Oncology and the Oncology Nursing Society have proposed a set of standards for safe chemotherapy administration. The state of implementation of these standards in oncologic practices in India is not understood properly. Methods: An anonymized survey was designed that consisted of items from all 37 standards that were described in the 2013 update of the standards. The survey was distributed via e-mail as well as in paper format among oncologists working in various oncology practices in the country. A standard was considered as fully implemented if more than 90% of the items beneath it had the most positive response (Yes/ Always). Results: Responses were obtained from 75 of 114 (65.8%) of the institutions surveyed. Only one institution had fully implemented the standards, whereas only six (8.0%) institutions had implemented more than 90% of the standards fully. The general chemotherapy administration-related domain was implemented fully by the least number of institutions. Although characteristics such as location, funding, and type of institution (teaching or not) failed to influence implementation rates, institutions of respondents who were aware of chemotherapy practice–related standards reported full implementation of a larger number of standards. Lack of national-level guidelines/ policies was identified as the most common difficulty in implementing standards. Conclusion: This survey indicates that there is an urgent need to formulate national-level guidelines for safe chemotherapy administration. [ABSTRACT FROM AUTHOR]

Aim: To report the prevalence and outcomes of pressure ulcers (PU) seen in a cohort of cancer patients requiring home-based palliative care. Materials and Methods: All patients referred for home care were eligible for this prospective observational study, provided they were living within a distance of 35 km from the institute and gave informed consent. During each visit, caregivers were trained and educated for providing nursing care for the patient. Dressing material for PU care was provided to all patients free of cost and care methods were demonstrated. Factors influencing the occurrence and healing of PUs were analyzed using logistic regression. Duration for healing of PU was calculated using the Kaplan Meier method. P < 0.05 are taken as significant. Results: Twenty-one of 108 (19.4%) enrolled patients had PU at the start of homecare services. None of the patients developed new PU during the course of home care. Complete healing of PU was seen in 9 (42.9%) patients. The median duration for healing of PU was found to be 56 days. Median expenditure incurred in patients with PU was Rs. 2323.40 with a median daily expenditure of Rs. 77.56. Conclusions: The present model of homecare service delivery was found to be effective in the prevention and management of PUs. The high prevalence of PU in this cohort indicates a need for greater awareness for this complication. Clinical Trial Registry Number: CTRI/2014/03/004477 [ABSTRACT FROM AUTHOR]

Introduction: Lenvatinib is one of the approved treatments for radioiodine-refractory differentiated thyroid cancers. However, there is very limited data from India on real-world efficacy and adverse events of Lenvatinib and hence this analysis was performed. Methods: This was a retrospective analysis in which patients of radioiodine-refractory differentiated thyroid cancer as per the SELECT study criteria, who received lenvatinib, were selected for the study over the last 4 years. The baseline demographic characteristics, adverse events of lenvatinib, the date of progression and the date of overall survival (OS) were extracted from the electronic medical records of Tata Memorial Hospital. SPSS version 20 was used for analysis. Results: The median starting dose of lenvatinib was 20 mg. Fifteen events for progression had occurred and the median progression-free survival (PFS) was 12.2 months [95% CI: 4.4-not available (NA)]. The events for OS analysis were 12. The median OS was 35.3 months (95% CI: 11.4-NA). There was no impact on starting dose on PFS or OS. Conclusion: The real-world data of Lenvatinib suggest a lot of variability in the starting dose. In spite of this variability, the response rates and OS are similar to that noted in pivotal study. This suggests a case for need for more studies evaluating lower doses of Lenvatinib. [ABSTRACT FROM AUTHOR]

Background: Sickle cell disease (SCD) is characterized by chronic hemolytic anemia and vascular occlusion, causing recurrent painful episodes, neuro-cognitive deficits, organ failures and death in early adulthood. Besides the medical consequences, most of the families with a child of SCD have to cope with financial and social crisis. Quality of life (QOL) is a broad multidimensional concept that usually includes subjective evaluations of both positive and negative aspects of life. Other than health; emotional well being, social dysfunction, chronic pain and fatigability are also important aspects of overall quality of life that add to the complexity of its measurement. Aim: The present case control study was designed to determine the health related quality of life (HRQoL) in patients of sickle cell disease and to compare it with patients of other chronic non-communicable diseases. Setting and Design: Case control study conducted at tertiary health care facility of Central India. Material and Methods: The present study conducted to measure HRQoL among patients of SCD and patients of other chronic non-communicable diseases. A translated and pretested version of WHO SF-36 questionnaire was used to measure HRQoL. Results: We observed that there was significantly lower HRQoL among SCD patients. Conclusion: Besides merely pharmacotherapy, restoration of overall quality of life should be the mainstay of management of patients with SCD. [ABSTRACT FROM AUTHOR]

Background. Quantifying the interfraction dose variations in the organs at risk (OAR) in HDR intracavitary brachytherapy (HDR ICBT). Methods. Rectum and bladder were contoured in 44 patients of cervical carcinoma on CT after each fraction of HDR ICBT (9 Gy/2 fractions). Interfraction dose variations (VARact) were calculated. Rigid image registration of consecutive fraction images allowed quantification of the hypothetical variation in dose (VARhypo) arising exclusively due to changes in applicator placement and geometry VARhypo was regressed against the VARact to find out to what extent the applicator variation could explain the VARact in the OAR. The rest of the variation was assumed to be due to organ deformation. Results. The VARact in the dose to 2 cc of bladder and rectum were 1.46 and 1.16 Gy, respectively. Increased dose was seen in 16 and 23 patients in the subsequent fraction for bladder and rectum, respectively. Doses to OAR would have exceeded constraints in 16% patients if second fraction was not imaged. VARhypo explained 19% and 47% of the VARact observed for the bladder and rectum respectively. Conclusions. Significant interfraction variations in OAR doses can occur in HDR ICBT. Organ deformations are mostly responsible for this variation. [ABSTRACT FROM AUTHOR]

This study evaluates major factors (i.e. service quality, brand perception and perceived value) affecting on customers' satisfaction in e-banking service settings. This study also evaluates influence of service quality on brand perception, perceived value and satisfaction in e-banking. Required data was collected through customers' survey. For conducting customers' survey likert scale based questionnaire was developed after review of literature and discussions with bank managers as well as experts in customer service and marketing. Collected data was analyzed using principle component (PCA) using SPSS 19.0. A result indicates that, Perceived Value, Brand Perception, Cost Effectiveness, Easy to Use, Convenience, Problem Handling, Security/Assurance and Responsiveness are important factors in customers satisfaction in e-banking it explains 48.30 per cent of variance. Contact Facilities, System Availability, Fulfillment, Efficiency and Compensation are comparatively less important because these dimensions explain 21.70 per cent of variance in customers' satisfaction. Security/Assurance, Responsiveness, Easy to Use, Cost Effectiveness and Compensation are predictors of brand perception in e-banking and Fulfillment, Efficiency, Security/Assurance, Responsiveness, Convenience, Cost Effectiveness, Problem Handling and Compensation are predictors of perceived value in e-banking. [ABSTRACT FROM AUTHOR]

An outbreak of viral encephalitis occurred in northern India in 2006. Attempts to identify an etiologic agent in cerebrospinal fluid by using reverse transcription-PCR showed positivity to enterovirus (EV) in 66 (21.6%) of 306 patients. Sequencing and phylogenetic analyses of PCR products from 59 (89.3%) of 66 specimens showed similarity with EV-89 and EV-76 sequences. [ABSTRACT FROM AUTHOR]

The author discusses aspects of suicidal death and the progress of reducing suicidal rates in India via the slogan 'Connect, Communicate, and Care' by the International Association of Suicide Prevention. He reflects on the areas and networks of mental health professionals to work toward a mental health strategy on suicide prevention. The author cites viewpoints from experts who emphasize public health intervention and collaborative efforts to address suicide behaviors in the Indian community.

Objective: To assess the effects of tranexamic acid among patients undergoing cesarean delivery who were at high risk of postpartum hemorrhage.Methods: Between August 1, 2012, and April 30, 2013, a randomized controlled trial was performed at a tertiary care center in India. Women undergoing an elective or emergency cesarean delivery who were at high risk for postpartum hemorrhage were enrolled. They were randomly assigned using sealed, opaque envelopes to receive 10mg/kg tranexamic acid or normal saline 10min before skin incision. Anesthesiologists were not masked to group assignment, but patients and obstetricians were. The primary outcome was need for additional uterotonic drugs within 24h after delivery. Analyses were by intention to treat.Results: Thirty patients were assigned to each group. Additional uterotonic drugs were required in 7 (23%) patients assigned to tranexamic acid and 25 (83%) patients in the control group (P<0.001).Conclusion: Intravenous tranexamic acid, administered before skin incision, significantly reduced the requirement for additional uterotonics among women at increased risk for postpartum hemorrhage. Clinical Trials Registry India: CTRI/2015/05/005752. [ABSTRACT FROM AUTHOR]

Aim of the Study: To study the clinical profile, etiology, and imaging features of subjects presenting with cerebral sinus venous thrombosis (CVST) and to correlate the clinical findings with radiological findings., Materials and Methods: The study included 120 patients admitted with the diagnosis of CVST to Stanley Medical College and Hospital, Chennai. The study included patients of all age-groups presenting with cerebral venous thrombosis. The diagnosis was confirmed by imaging studies., Results: The mean age of presentation is 24.4, predominantly males. Headache (90.8%) was the most common presentation, followed by seizures (25%), and paresis (12%). The superior sagittal sinus (SSS) is the most common sinus involved, with multiple sinuses involved in 47% of patients. Magnetic resonance imaging (MRI) brain with magnetic resonance venography (MRV) is the investigation of choice. The most common risk factor for CSVT was alcohol intake, especially in males, and females, anemia, pregnancy, usage of oral contraceptive (OC) pills, and puerperium were the common risk factors. The causes of CSVT in this study were hyperhomocystenemia in 8%, anemia in 13%, and prothrombotic state in 6%., Conclusion: Cerebral sinus venous thrombosis is a cause of stroke in young individuals. Even though uncommon, it is underdiagnosed because of its extremely varied clinical presentation. The correct diagnosis of CSVT relies on a high index of suspicion and the availability of advanced imaging like MRI with MR venography., (© Journal of the Association of Physicians of India 2024.)

This study examined the pattern of resistance to widely applied synthetic pyrethroids, i.e., cypermethrin and deltamethrin, against larvae of Rhipicephalus microplus ticks sampled from Marathwada region in Maharashtra, India. The study also examined the role of α- and β-esterases and glutathione-S-transferase (GST) in resistance development. All eight R. microplus isolates tested were resistant to deltamethrin (RL IV), having RR 50 values from 6.88 to 131.26. LPT analysis exhibited the resistance level II deltamethrin resistance in Beed and Hingoli, III in Dharashiv, and IV in Sambhajinagar, Parbhani, Latur, Jalna, and Nanded isolates. The LIT analysis showed that Dharashiv field isolates had the lowest LC 50 value of 229.09 ppm against cypermethrin, while Sambhajinagar field isolates had the highest at 489.78 ppm. The RR 50 ranged from 1145.45 to 2448.9. Seven isolates were level I resistant to cypermethrin while the Jalna isolate was level II resistant. In larvae treated with deltamethrin and cypermethrin, the activity of α- and β-esterase enzymes increased significantly compared to control groups. The enzyme ratios in treated larvae ranged from 0.7533 to 1.7023 for α-esterase and 0.7434 to 3.2054 for β-esterase. The Hingoli isolate treated with cypermethrin exhibited the highest α-esterase activity (903.261), whereas Sambhajinagar isolate had the highest GST enzyme ratio (2.8224) after deltamethrin exposure. When exposed to cypermethrin, the Hingoli isolate showed the highest GST enzyme ratio, 2.0832. The present study provides the current resistance status in tick populations from Marathwada region indicating deltamethrin and cypermethrin to be ineffective for tick control. The results also suggest that SP compounds should be regulated in this region and alternative control strategies should be introduced., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: There is limited data on outcomes in cancer patients with coronavirus disease 2019 (COVID-19) from lower middle-income countries (LMICs)., Patients and Methods: This was an observational study, conducted between 12 April and 10 June 2020 at Tata Memorial centre, Mumbai, in cancer patients undergoing systemic therapy with laboratory confirmed COVID-19. The objectives were to evaluate cumulative 30-day all-cause mortality, COVID-19 attributable mortality, factors predicting mortality, and time to viral negativity after initial diagnosis., Results: Of the 24 660 footfalls and 7043 patients evaluated, 230 patients on active systemic therapy with a median age of 42 (1-75) years were included. COVID-19 infection severity, as per WHO criteria, was mild, moderate, and severe in 195 (85%), 11 (5%), and 24 (11%) patients, respectively. Twenty-three patients (10%) expired during follow-up, with COVID-19 attributable mortality seen in 15 patients (6.5%). There were no mortalities in the pediatric cohort of 31 (14%) patients. Advanced stage cancer being treated with palliative intent vs others [30-day mortality 24%% vs 5%, odds ratio (OR) 5.6, 95% CI 2.28-13.78, P < .001], uncontrolled cancer status vs controlled cancer (30-day mortality37.5%% vs 4%%, OR 14, 95% CI 4.46-44.16, P < .001) and severe COVID-19 vs mild COVID-19 (30-day mortality 71% vs 3%, OR 92.29, 95% CI 26.43-322.21, P < .001) were significantly associated with mortality. The median time to SARS-CoV-2 RT-PCR negativity was 17 days [interquartile range (IQR)17-28) in the cohort., Conclusions: The mortality rates in cancer patients with COVID-19 who are receiving systemic anti-cancer therapy in LMICSs are marginally higher than that reported in unselected COVID-19 cohorts with prolonged time to viral negativity in a substantial number of patients. The pediatric cancer patients tended to have favorable outcomes., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Objectives: To evaluate and compare efficacy and tolerability of Vilazodone with Escitalopram and Amitriptyline in patients of major depressive disorder(MDD)., Methods: This was a randomized, prospective, parallel-group, open label clinical study in which newly diagnosed patients of MDD were randomized to receive Tab Vilazodone 20 mg daily or Tab Escitalopram 20mg daily or Tab Amitriptyline 75mg daily for 12 weeks. Antidepressant activity was assessed by change in score from baseline to week 12 on HAMD-17 and MADRS scales while change in score on HAM-A scale was used to assess antianxiety effect. Change in scores on the three scales was also compared between the three treatment groups. Severity and causality of adverse events were assessed by the modified Hartwig & Siegel scale and Naranjo scale respectively. Data was analyzed in accordance with per protocol analysis., Results: Reduction in HAMD-17 and MADRS scores was significantly more in vilazodone group compared to the other two drugs indicating that vilazodone is more efficacious antidepressant. Number of remitters were also significantly more in the vilazodone group ( n =11) compared to escitalopram ( n =4) ( p <0.05) and amitriptyline ( n =0) ( p <0.001) at 12 weeks. Similar results were also obtained with HAM-A score. Number of patients showing MADRS sustained response at 12 weeks was statistically significantly more in vilazodone ( n =12) and escitalopram ( n =12) groups compared to amitriptyline ( n =01) ( p <0.001). Reported adverse events were constipation and sedation(amitriptyline group); nausea and headache(escitalopram and vilazodone groups). These adverse events were of mild severity. Most adverse events belonged to probable category., Conclusion: Vilazodone is more efficacious and well tolerated antidepressant compared to escitalopram and amitriptyline., Competing Interests: There are no conflicts of interest., (Copyright: © 2020 Indian Journal of Pharmacology.)

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Introduction: The current treatment of metastatic renal cell carcinoma (mRCC) revolves around targeted agents, which have resulted in a median overall survival of 22 to 26 months in registration trials. However, the outcomes in a non-trial, real-world Indian population have not yet been evaluated., Materials and Methods: The present study was a part of a prospective Clinical Trials Registry-India-registered study, the Kidney Cancer Registry, a prospectively maintained kidney cancer registry. The data of patients with a diagnosis of mRCC from February 2007 to August 2015 who were potential candidates for systemic therapy were extracted from the database and analyzed for treatment patterns and outcomes., Results: The data from 212 patients were eligible for analysis. Of these 212 patients, 204 (96.2%) received first-line systemic treatment with sunitinib (40.6%), sorafenib (37.7%), pazopanib (2.8%), temsirolimus (2.8%), or everolimus (1.9%). The risk status of 91% of the patients could be stratified using the Heng criteria into favorable (18.9%), intermediate (43.9%), and poor risk (28.3%) categories. The response rate, clinical benefit rate, median progression-free survival, and median overall survival with first-line targeted therapy were 22.5%, 60.7%, 7.09 months, and 12.87 months, respectively. The common adverse events seen included skin rash (31.7%), hypertension (29.4%), grade 3 hand-foot syndrome (27.4%), mucositis (26.4%), dyslipidemia (20%), and hyperglycemia (17.6%). Patients receiving second-line therapy (22.6%) had superior overall survival to patients who had not (16.46 vs. 10.67 months; P = .032)., Conclusion: The present registry-based study is the first, to the best of our knowledge, of its type from India and showed that the overall outcomes in this real-world cohort appear comparable to non-trial data worldwide. An increased incidence of metabolic adverse events that require monitoring during treatment was also found., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Our previous studies on West Nile virus (WNV) strains isolated from human patients in India suggested substantial variation at the genetic level reflecting their variable pathogenesis. This study describes the development of reverse genetics system for a neurovirulent WNV isolate 68856 and its characterization. Full length viral cDNA was cloned into bacterial artificial chromosome (BAC) under the transcription control of T7 promoter. The RNA transcripts obtained by in vitro transcription were infectious in mammalian cells upon transfection. Cytopathic effect caused by synthetic RNA transcripts in mammalian cells, detection of cell associated viral protein after transfection and recovery of genetic markers in the progeny virus genome marked the successful development of reverse genetics system for WNV. Replication potential and plaque morphology of newly expressed virus along with its antigenic cross reactivity with the parental virus suggests synthesis of biologically identical replicative virus. Comparative neuropathogenesis studies in murine model indicated that the three genetic changes occurred in the recombinant virus during in vitro transcription has no impact on viral pathogenesis. The stable infectious cDNA clone generated from the neurovirulent Indian WNV strain will serve as a valuable experimental tool to study the viral factors contributing towards pathogenesis, host-virus interaction and immune evasion., (Copyright © 2015. Published by Elsevier B.V.)

Background: Pelvic exenteration (PE) is a morbid procedure. Ours is a rural based cancer center limited trained surgical oncology staff. Hence, this audit was planned to evaluate morbidity and outcomes of all patients undergoing PE at our center., Methods: This is a IRB approved retrospective audit of all patients who underwent PE at our center from January 2010 to August 2013. The toxicity grades were retrospectively assigned according to the CTCAE version 4.02 criteria. Chi-square test was done to identify factors affecting grades 3-5 morbidity. Kaplan Meier survival analysis has been used for estimation of median PFS and OS., Results: 34 patients were identified, with the median age of 52 years (28-73 years). Total, anterior, posterior, and modified posterior exenterations were performed in 4 (11.8%), 5 (14.7%), 14 (41.2%), and 11 (32.4%) patients, respectively. The median time for surgery was 5.5 hours (3-8 hours). The median blood loss was 500 mL (200-4000 mL). CTCAE version 4.02 grades 3-4 toxicity was seen in nine patients (25.7%). The median estimated progression free survival was 31.76 months (25.13-38.40 months). The 2-year overall survival was 97.14%., Conclusion: PE related grades 3-5 morbidity of 25.7% and mortality of 2.9% at our resource limited center are encouraging.

Background: Tuberculosis had been declared by the World Health Organization (WHO) as 'public health emergency' in 1993. Extra pulmonary tuberculosis (E.P.T.B.) comprises 20-25% total burden of the disease in which genitourinary tuberculosis (GU.T.B.) is 4%. Timely diagnosis and treatment will prevent the sequelae of this disease., Aims: To know the varied clinical presentations, diagnostic modalities and management of G.U.T.B., Methods: During a 13-year-period, 117 retrospective cases of GUTB were admitted in the tertiary care centre. They were analyzed for clinical presentation, diagnostic modalities and management., Results: Young patients mainly in third decade of life were commonly affected with higher incidence in females. In our study, the most common presentation was irritative voiding symptoms (66.47%) followed by haematuria (47.60%). Although it can affect the entire organ in genito-urinary system but, in the present study, kidney was the most affected organ (64.9%) following ureter (27.35%), urinary bladder (17.09%), prostate (3.4%) and epididymis (5.19%). In this study, we had not encountered any case of testicular and penile tuberculosis. Among the different diagnostic modalities in this study, the diagnostic positivity rate was 41.6% for the urine AFB test, 55.4% for the urine M. tuberculosis culture test and 67.7% for PCR. Chest x-ray was positive in 25.6% (30). ESR was raised in 62.5% and Mantoux test was positive in 61.2% patients., Conclusion: A high index of suspicion and a wide range of investigations may be required to achieve a complete diagnosis of genitourinary tuberculosis. Though short course chemotherapy with four-drug-regimen for six-month-duration is the mainstay of treatment, surgical interventions were required in 60% of cases of this study.

Aims: Inverted papilloma (IP) is an uncommon benign neoplasm of the urinary tract. Its multiplicity, recurrence, and association with transitional cell carcinoma (TCC) leads to conflicting clinical conclusions regarding its biological behavior, and hence, the need for rigorous follow-up protocols. In this study, we review all cases of urinary bladder IP in our institution and determine the need for strict follow-up., Materials and Methods: We included consecutive patients from August 2004 to August 2008 with IP of the urinary bladder in this study who did not have prior or concurrent urothelial carcinoma. A single pathologist performed the histologic review. The patients had undergone strict a follow-up schedule every 6 months., Results: In our study of the 24 patients, the mean age at presentation was 53.5 (range 22-81) years. The mean follow-up period was 25.8 months (range 6-58 months). Of the 24 patients, 21 were men and 3 were women. No patient had a synchronous or previous bladder tumor. The most common presenting symptoms were macroscopic hematuria and dysuria. All were solitary tumors except one, most commonly found at the bladder neck and trigone. The average follow-up period was 2.5 years without any evidence of recurrence., Conclusions: We conclude that when diagnosed by strictly defined criteria, IP as benign urothelial neoplasm was with extremely low incidence of recurrence and good prognosis. It does not seem to be a risk factor for TCC, especially if located in the bladder. Therefore, a good transurethral resection is adequate therapy and follow-up protocol as rigorous as those for TCC may not be necessary.

During investigations into the outbreak of encephalitis in 1996 in the Kerala state in India, an arbovirus was isolated from a Culex tritaeniorhynchus mosquito pool. It was characterized as a Japanese encephalitis and West Nile virus cross-reactive arbovirus by complement fixation test. A plaque reduction-neutralization test was performed using hyperimmune sera raised against the plaque-purified arbovirus isolate. The sera did not show reactivity with Japanese encephalitis virus and were weakly reactive with West Nile virus. Complete open reading frame sequence analysis characterized the arbovirus as Bagaza virus (BAGV), with 94.80 % nucleotide identity with African BAGV strain DakAr B209. Sera collected from the encephalitic patients during the acute phase of illness showed 15 % (8/53) positivity for anti-BAGV neutralizing antibodies. This is the first report of the isolation of BAGV from India. The presence of anti-BAGV neutralizing antibodies suggests that the human population has been exposed to BAGV.

Background: Intensity-modulated radiotherapy using simultaneous integrated boost (SIB-IMRT) is an attractive method for the treatment of head and neck cancers with sparing of the salivary function., Aims: To assess the feasibility, toxicity, and tumor control using SIB-IMRT in locally advanced head and neck cancers in the Indian setting., Settings and Design: The study was conducted in a regional cancer center in northern India. A review of the treatment result of the first 20 patients is presented., Methods and Materials: SIB-IMRT was planned for 20 patients--14 patients were treated with the SIB-72 schedule delivering a dose of 72 Gy, 66 Gy, and 57 Gy to the PTV GTV , PTV CTV1 , and PTV CTV2 in 33 fractions. Six patients were treated with the SIB-66 schedule delivering 66 Gy, 60 Gy, and 54 Gy to the above-mentioned volumes in 30 fractions. Patients were monitored for toxicity using the CTCAE v 3.0 criteria. Descriptive analysis of toxicity and actuarial estimates of the loco-regional control and survival are presented., Results: Grade III mucositis was seen in 65% patients. None of the patients had Grade III dermatitis. The projected 2-year overall survival was 95%., Conclusion: SIB-IMRT schedules evaluated were found to be safe and effective and are being subjected to further prospective studies.

Clinical specimens from an encephalitis outbreak in the Lakhimpur area of Uttar Pradesh, India, were investigated for identification and characterization of the etiologic agent. IgM capture ELISA showed recent Japanese encephalitis virus (JEV) infection. JEV isolation was attempted from white blood cells (WBCs) separated from blood clots of 12 patients (9 IgM positive and 3 negative) by serial co-culturing with phytohemagglutinin P-stimulated peripheral blood mononuclear leukocytes (PBMCs) obtained from pre-screened JEV sero-negative healthy individuals. JEV was isolated from two IgM-positive blood clots. Isolate 014178 was detected in WBCs and in the first passage of PBMCs by ELISA and reverse transcriptase-polymerase chain reaction. Isolate 014173 was detectable only after a second passage in PBMC co-culture. Sequence analysis of 346 nt of the C-prM region showed homology with JEV strain GP78. This is the first report on isolation of JEV from patient blood clots. Our study shows that the co-cultures of PBMCs separated from patient blood clots provide an additional source for JEV isolation.