40 results on '"Rishi Jain"'
Search Results
2. Psychological distress in patients with metastatic cancer enrolling on phase I clinical trials
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Alexandra Hunt, Matthew Blau, Yana Chertock, Carolyn Y. Fang, Elizabeth Handorf, Rishi Jain, and Michael J. Hall
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medicine.medical_specialty ,Problem list ,Phases of clinical research ,Psychological distress ,Disease ,Anxiety ,Article ,03 medical and health sciences ,0302 clinical medicine ,Neoplasms ,Internal medicine ,Phase I clinical trials ,medicine ,Humans ,030212 general & internal medicine ,Depression (differential diagnoses) ,Social stress ,Oncology (nursing) ,business.industry ,Clinical trial ,Distress ,Oncology ,030220 oncology & carcinogenesis ,Quality of Life ,medicine.symptom ,business ,Stress, Psychological - Abstract
Purpose Psychological distress is common in patients with cancer and is associated with lower quality-of-life (QOL). Although distress among oncology outpatients undergoing standard therapy has been widely studied, few studies have evaluated distress among patients enrolling on Phase I therapeutic clinical trials. Thus, we aimed to characterize levels of distress and types of stressors in patients enrolling on Phase I clinical trials. Methods Participants completed the National Comprehensive Cancer Network Distress Thermometer (NCCN DT) and Problem list and measures of anxiety and depression at the time of Phase I clinical trial initiation. Results We enrolled 87 patients (95% with metastatic/incurable disease) who were initiating a Phase I clinical trial. Analyses revealed a high prevalence of distress (51%) and anxiety (28%). There were significant correlations between overall distress and practical problems (r = 0.31, p = 0.016), family problems (r = 0.35, p = 0.006), and emotional problems (r = 0.64, p < 0.001), but not physical problems (r = 0.17, p = 0.206). Conclusions Patients may be better prepared to manage physical stressors but not practical, emotional, or family stressors at the time of Phase I trial enrollment. Implications for Cancer Survivors Phase I trial patients experience high levels of distress which may be due to the rigors of previous therapies therapy and related emotional and social stressors related to the poor prognosis of their advanced cancer diagnosis. Distress may go unidentified without screening which is not standard practice at the time of Phase I trial consideration. Future studies should evaluate strategies to routinely identify and intervene upon addressable stressors in patients participating in Phase I clinical trials. more...
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- 2021
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Catalog
3. Toxicity and outcomes in older versus younger patients treated with trimodality therapy for locally advanced rectal cancer
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Eddie Zhang, D.Y. Lee, Joshua E. Meyer, Efrat Dotan, Rishi Jain, J. Karen Wong, Jeffrey M. Farma, Harry S. Cooper, and Elizabeth Handorf
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medicine.medical_specialty ,Rectal Neoplasms ,Colorectal cancer ,business.industry ,Rectum ,Locally advanced ,MEDLINE ,Chemoradiotherapy ,medicine.disease ,Neoadjuvant Therapy ,Article ,Oncology ,Older patients ,Internal medicine ,Toxicity ,medicine ,Humans ,Geriatrics and Gerontology ,business ,Aged ,Neoplasm Staging - Published
- 2020
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4. NCCN Guidelines Insights: Colorectal Cancer Screening, Version 2.2020
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Robert J. Mayer, Folasade P. May, Kathryn M. Glaser, Jennifer M. Weiss, Lillias H. Maguire, Reid M. Ness, Shivan J. Mehta, Swati G. Patel, Rishi Jain, Priyanka Kanth, Amy L. Halverson, Trilokesh D. Kidambi, Dayna S. Early, Mark Friedman, Ndiya Ogba, Francis M. Giardiello, Mary A. Dwyer, Audrey J. Lazenby, Arnold J. Markowitz, Gregory S. Cooper, Xavier Llor, Shajan Peter, Jennifer Keller, Jonathan P. Terdiman, Rachel B. Issaka, Peter P. Stanich, Dawn Provenzale, Suryakanth R. Gurudu, and Benjamin Abbadessa more...
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Oncology ,Average risk ,medicine.medical_specialty ,Modalities ,Genetic syndromes ,Colorectal cancer ,business.industry ,MEDLINE ,Context (language use) ,medicine.disease ,digestive system diseases ,03 medical and health sciences ,0302 clinical medicine ,Increased risk ,Colorectal cancer screening ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,030212 general & internal medicine ,business - Abstract
The NCCN Guidelines for Colorectal Cancer (CRC) Screening describe various colorectal screening modalities as well as recommended screening schedules for patients at average or increased risk of developing sporadic CRC. They are intended to aid physicians with clinical decision-making regarding CRC screening for patients without defined genetic syndromes. These NCCN Guidelines Insights focus on select recent updates to the NCCN Guidelines, including a section on primary and secondary CRC prevention, and provide context for the panel’s recommendations regarding the age to initiate screening in average risk individuals and follow-up for low-risk adenomas. more...
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- 2020
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5. Open-label, Phase I Study of Nivolumab Combined with nab-Paclitaxel Plus Gemcitabine in Advanced Pancreatic Cancer
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Larry Lyons, Martin Guiterrez, Aparna Kaylan, Sibabrata Banerjee, Rafia Bhore, Teng Jin Ong, David M. Waterhouse, Chrystal U. Louis, Daniel W. Pierce, Ben George, Rishi Jain, Edward J. Kim, Hatem Soliman, Daniel R. Carrizosa, Thomas Lila, David J. Reiss, Zev A. Wainberg, Aparna Raj Parikh, Peter J. O'Dwyer, E. Gabriela Chiorean, and Howard S. Hochster more...
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0301 basic medicine ,Hepatitis ,Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.disease ,Gastroenterology ,Confidence interval ,Gemcitabine ,Discontinuation ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Oncology ,Respiratory failure ,030220 oncology & carcinogenesis ,Internal medicine ,Pancreatic cancer ,Medicine ,Nivolumab ,business ,Adverse effect ,medicine.drug - Abstract
Purpose: Assess safety and efficacy of nivolumab plus nab-paclitaxel and gemcitabine in patients with locally advanced/metastatic pancreatic cancer in a two-part, open-label, phase I trial. Patients and Methods: Fifty chemotherapy-naive patients received nab-paclitaxel 125 mg/m2 plus gemcitabine 1,000 mg/m2 (days 1, 8, and 15) and nivolumab 3 mg/kg (days 1 and 15) in 28-day cycles. The primary endpoints were dose-limiting toxicities (DLTs; part 1) and grade 3/4 treatment-emergent adverse events (TEAEs) or treatment discontinuation due to TEAEs (parts 1/2). Secondary efficacy endpoints were progression-free survival (PFS), overall survival (OS), and response. Assessment of programmed cell death-ligand 1 (PD-L1) expression was an exploratory endpoint; additional biomarkers were assessed post hoc. Results: One DLT (hepatitis) was reported in part 1 among six DLT-evaluable patients; 48 of 50 patients experienced grade 3/4 TEAEs and 18 discontinued treatment due to TEAEs. One grade 5 TEAE (respiratory failure) was reported. Median [95% confidence interval (CI)] PFS/OS was 5.5 (3.25–7.20 months)/9.9 (6.74–12.16 months) months, respectively [median follow-up for OS, 13.6 months (95% CI, 12.06–23.49 months)]. Overall response rate (95% CI) was 18% (8.6%–31.4%). Median PFS/OS was 5.5/9.7 months (PD-L1 Conclusions: The safety profile of nivolumab plus nab-paclitaxel and gemcitabine at standard doses in advanced pancreatic cancer was manageable, with no unexpected safety signals. Overall, the clinical results of this study do not support further investigation. more...
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- 2020
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6. Six Months Comparative Evaluation of Efficacy and Safety of Wockhardt's Biosimilar Insulin Glargine (Glaritus®) with Reference Insulin Glargine (Lantus®) in Type 2 Diabetes Mellitus in India: Results of Interim Analysis
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K. G. Prakash, G. Bhatia, S. Ingole, P. Khosla, P. Mukhopadhyay, Rishi Jain, G. Chhaya, H. Bora, V. Pavithran, S. K. Sharma, P. D. Supe, and A. K. Ajmani
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Embryology ,education.field_of_study ,medicine.medical_specialty ,Intention-to-treat analysis ,Insulin glargine ,business.industry ,Incidence (epidemiology) ,Population ,Type 2 Diabetes Mellitus ,Cell Biology ,Interim analysis ,Internal medicine ,Clinical endpoint ,medicine ,Anatomy ,Adverse effect ,education ,business ,Developmental Biology ,medicine.drug - Abstract
Objective: To compare the change in immunogenic response, safety and efficacy of insulin glargine in Glaritus® and Lantus® treatment arms from baseline to six months in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Material and methods: In an ongoing prospective, open-label, randomized, parallel-group, comparative, multicenter, phase IV study, adult patients with uncontrolled T2DM are treated with either Glaritus® once daily or Lantus® once daily for six months, both given subcutaneously. Glaritus® treatment arm is to be continued for another six months. The primary endpoint for the study was the percentage change in anti-insulin antibodies (AIA) titer to glargine in both treatment arms from baseline to six months. Results: Ninety patients were randomized to each group. Baseline characteristics were comparable between the groups (p>0.05). There was no significant difference in percent change in the AIA titer between the two treatment arms at the end of six months in ITT (intent-to-treat) and mITT(modified intent to treat) population (LS mean diff [95% CI]: 2.2% (-15.1%, 19.6%), p=0.7987 and 3.4% (-15.1%, 21.9%), p=0.7181, respectively). No significant between-group difference was seen in change in the HbA1c level at the end of six months in ITT and mITT population [LS mean diff (95% CI): -0.2 (-0.4, 0.0), p=0.1072 for ITT population; and -0.1 (-0.3, 0.1), p=0.2283, for mITT population]. There was also no significant difference between two groups for the incidence of adverse events [Glaritus® 17 (18.9%) and Lantus® 20 (22.2%) p=0.5800]. Conclusion: Glaritus® was found to be non-inferior to Lantus® in glycaemic control and comparable in immunogenic response and safety at the end of six months in patients with T2DM uncontrolled on OADs. more...
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- 2020
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7. Treatment-related toxicity and outcomes in older versus younger patients with esophageal cancer treated with neoadjuvant chemoradiation
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Cherry Au, Rishi Jain, Jia-Llon Yee, Joshua E. Meyer, Efrat Dotan, Talha Shaikh, and Elizabeth Handorf
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Oncology ,medicine.medical_specialty ,education.field_of_study ,business.industry ,medicine.medical_treatment ,Standard treatment ,Population ,Locally advanced ,Cancer ,Disease ,Esophageal cancer ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,Esophagectomy ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,030212 general & internal medicine ,Geriatrics and Gerontology ,education ,business ,Treatment related toxicity - Abstract
Background Neoadjuvant chemoradiation (nCRT) followed by esophagectomy is the standard treatment for locally advanced esophageal cancer. Older patients are often felt to be poor candidates for nCRT. Limited data is available to guide the use of nCRT in this population. Methods A retrospective review of patients treated at a tertiary cancer center between 2002 and 2014 was conducted grouping patients by age (≥ 65 or Results 125 patients were identified for this study (67 aging Conclusions Older patients who underwent nCRT followed by esophagectomy had similar toxicities and outcomes as younger patients suggesting that nCRT before esophagectomy is safe in select older adults with esophageal cancer. PLR and NLR may serve as prognostic markers of aging, toxicity, and outcomes. Further research is warranted to optimize the therapy of older patients with this disease. more...
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- 2020
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8. An open labelled prospective clinical study to evaluate the efficacy, safety and cost analysis of Pidotimod as add-on drug for maintenance therapy in Paediatric Recurrent Acute Respiratory tract Infections
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Porchelvan S, Karthik N, Rishi Jain, Snehal Muchhala, and Nagaraju K
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medicine.medical_specialty ,Respiratory tract infections ,medicine.drug_class ,business.industry ,Standard treatment ,Lymphocyte ,Antibiotics ,Clinical trial ,Immune system ,medicine.anatomical_structure ,Maintenance therapy ,Internal medicine ,medicine ,General Pharmacology, Toxicology and Pharmaceutics ,business ,Pidotimod ,medicine.drug - Abstract
Recurrent acute respiratory tract infections (ARTI) are the commonest form of infections affecting children irrespective of socioeconomic status and geographical limits. Immaturity of immune response involving neutrophils, NK cells, T and B cells, in the early childhood, is often cited as a reason for this RRTI. There is a comparatively high incidence of ARTI in South East Asian countries when compared with global statistics. The possibility of using immune stimulation as a method of reducing the recurrence of ARTI prompted the use of Pidotimod as an add on drug. We tried to explore the safety, efficacy and a cost benefit analysis of Pidotimod as add-on treatment for paediatric use. After registering for Clinical trial and getting IEC approval, we started an open labelled prospective single arm interventional study by recruiting 65 children between 2-12 years with ARTI to receive 800 mg daily for 15 days and 400 mg for 45 days and was followed up for 6 months. Study revealed a significant reduction in number and duration of RRTI as well as reduction in episodes requiring antibiotics and reduction in duration of treatment. The reduction in number of school days lost and treatment expenses were statistically significant. There was a significant increase in mean absolute count in CD45, CD3, CD4, CD8 and lymphocyte counts at 6 months follow-up. Hence, we conclude that 60day Pidotimod therapy has immunostimulatory activity preventing the RRTI in paediatric population when considered as an add-on therapy to standard treatment. more...
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- 2020
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9. A Prospective, Randomized, Open Label, Single-Centre Study for Assessment of Safety and Effectiveness of Recombinant Human Insulin 30/70 + Insulin Glulisine compared to Recombinant Human Insulin NPH + Regular in the Management of Type 2 Diabetes Mellitus Patients in the Philippines
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Ashish Mane, Gaurav Puppalwar, Rishi Jain, Anand Vasam, Mary Jane Tanchee-Ngo, Leilani B. Mercado-Asis, Erick S. Mendoza, and Agam Shah
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Insulin glulisine ,medicine.medical_specialty ,business.industry ,Type 2 Diabetes Mellitus ,law.invention ,Single centre ,Endocrinology ,law ,Internal medicine ,Human insulin nph ,Human insulin ,Recombinant DNA ,Medicine ,Open label ,business ,medicine.drug - Published
- 2019
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10. Refining Immunotherapy for the Treatment of Gastric Cancer With High Microsatellite Instability
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Efrat Dotan, Rishi Jain, and Crystal S. Denlinger
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Brief Report ,MEDLINE ,Microsatellite instability ,Cancer ,Immunotherapy ,medicine.disease ,Stomach Neoplasms ,Internal medicine ,medicine ,Humans ,Immunologic Factors ,Microsatellite Instability ,business - Abstract
IMPORTANCE: Immunotherapy has been associated with improved outcomes among patients who have received previous treatment for microsatellite instability–high (MSI-H) tumors. OBJECTIVE: To evaluate the antitumor activity of pembrolizumab therapy vs chemotherapy among patients with MSI-H advanced gastric or gastroesophageal junction (G/GEJ) cancer regardless of the line of therapy in which it was received. DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis of the phase 2 KEYNOTE-059 (third-line treatment or higher) single-arm trial and the phase 3 KEYNOTE-061 (second-line treatment) and KEYNOTE-062 (first-line treatment) randomized trials included patients with advanced G/GEJ cancer from 52 sites in 16 countries enrolled in KEYNOTE-059, 148 sites in 30 countries enrolled in KEYNOTE-061, and 200 sites in 29 countries enrolled in KEYNOTE-062. Patients were enrolled from March 2, 2015, to March 26, 2016, in KEYNOTE-059; from June 4, 2015, to July 26, 2016, in KEYNOTE-061; and from September 18, 2015, to May 26, 2017, in KEYNOTE-062, with data cutoff dates of August 8, 2018; October 26, 2017; and March 26, 2019; respectively. INTERVENTIONS: Pembrolizumab monotherapy in KEYNOTE-059, pembrolizumab monotherapy or chemotherapy (paclitaxel) in KEYNOTE-061, and pembrolizumab monotherapy, pembrolizumab plus chemotherapy (cisplatin and 5-fluorouracil or capecitabine), or chemotherapy alone in KEYNOTE-062. MAIN OUTCOMES AND MEASURES: Response was assessed centrally using Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1; MSI-H status was determined centrally by polymerase chain reaction testing. RESULTS: At data cutoff, 7 of 174 patients (4.0%) in KEYNOTE-059, 27 of 514 patients (5.3%) in KEYNOTE-061, and 50 of 682 patients (7.3%) in KEYNOTE-062 had MSI-H tumors. Among those with MSI-H tumors, the median overall survival was not reached (NR) for pembrolizumab in KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 or for pembrolizumab plus chemotherapy in KEYNOTE-062. The median progression-free survival (PFS) for pembrolizumab was NR (95% CI, 1.1 months to NR) in KEYNOTE-059 and 17.8 months (95% CI, 2.7 months to NR) in KEYNOTE-061 (vs 3.5 months [95% CI, 2.0-9.8 months] for chemotherapy). In KEYNOTE-062, the median PFS was 11.2 months (95% CI, 1.5 months to NR) for pembrolizumab, NR (95% CI, 3.6 months to NR) for pembrolizumab plus chemotherapy, and 6.6 months (95% CI, 4.4-8.3 months) for chemotherapy. The objective response rate (ORR) for pembrolizumab was 57.1% in KEYNOTE-059 and 46.7% (vs 16.7% for chemotherapy) in KEYNOTE-061. In KEYNOTE-062, the ORR was 57.1% for pembrolizumab , 64.7% for pembrolizumab plus chemotherapy, and 36.8% for chemotherapy. CONCLUSIONS AND RELEVANCE: Findings from this study indicate that MSI-H status may be a biomarker for pembrolizumab therapy among patients with advanced G/GEJ cancer regardless of the line of therapy in which it was received. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT02335411, NCT02370498, and NCT02494583 more...
- Published
- 2021
11. Impact of Clinical Markers of Nutritional Status and Feeding Jejunostomy Use on Outcomes in Esophageal Cancer Patients Undergoing Neoadjuvant Chemoradiotherapy
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Joshua E. Meyer, Efrat Dotan, Cherry Au, Talha Shaikh, Crystal S. Denlinger, Elizabeth Handorf, Rishi Jain, and Jia-Llon Yee
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Adult ,Male ,medicine.medical_specialty ,Esophageal Neoplasms ,medicine.medical_treatment ,Jejunostomy ,Nutritional Status ,lcsh:TX341-641 ,Enteral administration ,Gastroenterology ,Article ,03 medical and health sciences ,0302 clinical medicine ,Weight loss ,Internal medicine ,Weight Loss ,medicine ,Humans ,enteral nutrition ,Hypoalbuminemia ,esophageal cancer ,neoadjuvant chemoradiation ,Aged ,Retrospective Studies ,Aged, 80 and over ,Nutrition and Dietetics ,business.industry ,Malnutrition ,Middle Aged ,Esophageal cancer ,Prognosis ,medicine.disease ,Chemotherapy regimen ,Neoadjuvant Therapy ,Esophagectomy ,Survival Rate ,Parenteral nutrition ,nutrition ,030220 oncology & carcinogenesis ,Toxicity ,Female ,030211 gastroenterology & hepatology ,medicine.symptom ,business ,lcsh:Nutrition. Foods and food supply ,Food Science - Abstract
Background: Patients with esophageal cancer (EC) have high rates of malnutrition due to tumor location and treatment-related toxicity. Various strategies are used to improve nutritional status in patients with EC including oral and enteral support. Methods: We conducted a retrospective analysis to determine the impact of malnutrition and prophylactic feeding jejunostomy tube (FJT) placement on toxicity and outcomes in patients with localized EC who were treated with neoadjuvant chemoradiation therapy (nCRT) followed by esophagectomy. Results: We identified 125 patients who were treated with nCRT between 2002 and 2014. Weight loss and hypoalbuminemia occurred frequently during nCRT and were associated with multiple adverse toxicity outcomes including hematologic toxicity, nonhematologic toxicity, grade &ge, 3 toxicity, and hospitalizations. After adjusting for relevant covariates including the specific nCRT chemotherapy regimen received and the onset of toxicity, there were no significant associations between hypoalbuminemia, weight loss, or FJT placement and relapse-free survival (RFS) or overall survival (OS). FJT placement was associated with less weight loss during nCRT (p = 0.003) but was not associated with reduced toxicity or improved survival. Conclusions: Weight and albumin loss during nCRT for EC are important factors relating to treatment toxicity but not RFS or OS. While pretreatment FJT placement may reduce weight loss, it may not impact treatment tolerance or survival. more...
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- 2020
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12. The Role of Malnutrition and Muscle Wasting in Advanced Lung Cancer
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Dwight H. Owen, Rishi Jain, Peter Whooley, Christopher C. Coss, and Mitch A. Phelps
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0301 basic medicine ,Oncology ,medicine.medical_specialty ,Cachexia ,Lung Neoplasms ,medicine.medical_treatment ,Article ,Body Mass Index ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Animals ,Humans ,Obesity ,Lung cancer ,Wasting ,Chemotherapy ,business.industry ,Malnutrition ,Immunotherapy ,medicine.disease ,Ghrelin ,Clinical trial ,030104 developmental biology ,Nutrition Assessment ,030220 oncology & carcinogenesis ,Sarcopenia ,medicine.symptom ,business - Abstract
PURPOSE OF REVIEW: Malnutrition, cancer cachexia, and sarcopenia often co-occur in patients with advanced cancer and are associated with poorer response to chemotherapy and reduced survival. Here, we evaluate the current literature regarding the role of nutrition and these associated conditions in patients with advanced lung cancer. RECENT FINDINGS: While rates of malnutrition are high, nutritional intervention studies have generally been limited by small sample sizes. Novel strategies such as home-based meal delivery may have promise. While no therapy is approved for cancer cachexia, ghrelin agonists and other targeted therapies have yielded promising data in clinical trials. Recent data also suggest that obesity may improve immunotherapy responsiveness. SUMMARY: Malnutrition and associated muscle wasting are clearly negative prognostic markers in advanced lung cancer. Patients with malnutrition should be urgently referred for dietary counseling and guidelines for nutritional support should be followed. Optimal treatment of these syndromes will likely include nutrition and anti-cachexia interventions used in combination. more...
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- 2020
13. Methicillin-Resistant Staphylococcus aureus Infections in Patients With Renal Disorders: A Review
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Venkata Raju, Ravindra Nikalji, Sunil Jawale, Jaishid Ahdal, Haresh Patel, Rishi Jain, and Kailash N Singh
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medicine.medical_specialty ,Teicoplanin ,business.industry ,medicine.drug_class ,Antibiotics ,Tigecycline ,biochemical phenomena, metabolism, and nutrition ,bacterial infections and mycoses ,medicine.disease_cause ,Methicillin-resistant Staphylococcus aureus ,chemistry.chemical_compound ,chemistry ,Internal medicine ,Linezolid ,medicine ,Vancomycin ,Daptomycin ,business ,medicine.drug ,Antibacterial agent - Abstract
Methicillin-resistant Staphylococcus aureus (MRSA) infection is a rapidly escalating global health burden. It is not only restricted to patients in the hospital settings but has also rooted deeply in the community settings. With increasing prevalence of life style and kidney diseases, the prevalence of MRSA infections is also expected to rise. MRSA infection plays a major role in renal disorders due to its direct vascular access (VA) thereby making patients undergoing dialysis and renal transplant more vulnerable to infections. Prolonged hospital stay, close proximity to MRSA-infected individual, exposure to broad-spectrum antibiotics, surgery and presence of foreign bodies such as central venous catheters predispose an individual to MRSA infection. Current panel of antibiotic treatment includes vancomycin, teicoplanin, linezolid, daptomycin, tigecycline and ceftaroline. However, emergence of resistant strains and several undesirable features pertaining to safety and tolerability of these drugs have led to limited options available for the management of multidrug-resistant MRSA infection in patients with renal disorders. Therefore, there is an increasing need for developing a new potent antibacterial agent with established renal safety that decreases the mortality and morbidity rates in MRSA-infected renal patients. World J Nephrol Urol. 2019;8(1):8-13 doi: https://doi.org/10.14740/wjnu384 more...
- Published
- 2019
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14. Immunogenicity, Safety and Efficacy Comparison of Wockhardt’s Biosimilar Insulin Glargine—Glaritus® with Reference Product— Lantus®: Study Protocol & Early Data Trends
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G. Chhaya, V. Pavithran, S. K. Sharma, Agam Shah, Rishi Jain, P. D. Supe, S. Ingole, P. Khosla, A. K. Ajmani, H. Bora, P. Mukhopadhyay, K. G. Prakash, and G. Bhatia
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medicine.medical_specialty ,Insulin glargine ,business.industry ,Insulin ,medicine.medical_treatment ,Immunogenicity ,Type 2 Diabetes Mellitus ,Interim analysis ,Phase IV Trial ,Internal medicine ,medicine ,business ,Body mass index ,medicine.drug ,Glycemic - Abstract
Objective: Present Phase IV Trial is aimed at evaluating the immunogenicity, safety, and efficacy of Wockhardt’s insulin glargine, Glaritus® in comparison with reference insulin glargine, Lantus® in subjects with type 2 diabetes mellitus (T2DM), inadequately controlled on oral hypoglycaemics. Setting: A head-to-head, prospective, open-label, parallel group, randomized, Phase IV, non-inferiority study over 6 months treatment conducted in 10 centres in India. Participants: Considering 20% drop-out rate, 180 subjects of either sex, age 18 - 55 years, diagnosed with T2DM with body mass index (BMI) 18 - 38 kg/m2 and HbA1c levels 8.0% - 10.0% inadequately controlled by 1 or more oral hypoglycaemics and according to investigator needed glargine treatment were enrolled in the study. Interventions: Subjects self-administered insulin glargine (Glaritus® or Lantus®) subcutaneously once daily for 6 months. Treatment in Glaritus® arm was continued till 12 months. Percentage change in anti-insulin antibody (AIA) titre and HbA1C was ascertained at every 3 months interval. The tests were performed at accredited central laboratory. Treat-to-target dose titration: Starting doses of Glaritus® and Lantus® was 10 units (or 0.2 units/kg) once daily. The target fasting blood glucose was 70 to 130 mg/dL. Daily glargine dose was titrated by ±10% based on average of last 3 FBG values being out of target range and presence of nocturnal hypoglycemia. Early data trends: First interim analysis was planned once 100 subjects complete visit 8 (6 months treatment). By then, 119 subjects (78 males and 41 females) with mean age 46.3 years were enrolled, of which 90 (75.6%) subjects had evaluable data. The results of analysis indicated trend of comparability between Glaritus® and Lantus® at the end of 6 months in terms of immunogenicity (% change in AIA titre from baseline, −10.52 ± 23.06 vs. 0.48 ± 63.95), glycemic control (change in HbA1c from baseline, −1.09% ± 1.29% vs. 0.63% ± 1.19%) and hypoglycemic events (reported by 1 vs. 2 patients), respectively. Conclusion: The present study represents a robust design in line with international guidelines on biosimilar insulin development and the early data trends presents expected similarity of Glaritus® in immunogenicity, efficacy and safety to that of Lantus® in treatment of T2DM. more...
- Published
- 2018
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15. Salt sensitivity and its implication in clinical practice
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Sundeep Mishra, Rishi Jain, and Shahu Ingole
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0301 basic medicine ,Epithelial sodium channel ,medicine.medical_specialty ,RD1-811 ,Azilsartan ,Inflammation ,Blood Pressure ,Disease ,Review Article ,030204 cardiovascular system & hematology ,Kidney ,Renin-Angiotensin System ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Diseases of the circulatory (Cardiovascular) system ,Humans ,Sodium Chloride, Dietary ,Stroke ,business.industry ,medicine.disease ,Patho-physiological mechanisms ,Pathophysiology ,030104 developmental biology ,Blood pressure ,Endocrinology ,Salt sensitivity ,RC666-701 ,Heart failure ,Hypertension ,Surgery ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
Hypertension (HTN) is a complex multi-factorial disease and is considered one of the foremost modifiable risk factors for stroke, heart failure, ischemic heart disease and renal dysfunction. Over the past century, salt and its linkage to HTN and cardiovascular (CV) mortality has been the subject of intense scientific scrutiny. There is now consensus that different individuals have different susceptibilities to blood pressure (BP)-raising effects of salt and this susceptiveness is called as salt sensitivity. Several renal and extra-renal mechanisms are believed to play a role. Blunted activity of the renin–angiotensin–aldosterone system (RAAS), adrenal Rac1-MR-Sgk1-NCC/ENaC pathway, renal SNS-GR-WNK4-NCC pathway, defect of membrane ion transportation, inflammation and abnormalities of Na+/Ca2+ exchange have all been implicated as pathophysiological basis for salt sensitive HTN. While salt restriction is definitely beneficial recent observation suggests that treatment with Azilsartan may improve salt sensitivity by selectively reducing renal proximal tubule Na+/H+ exchange. This encourages the future potential benefits of recognizing and therapeutically addressing the salt sensitive phenotype in humans. Keywords: Hypertension, Salt sensitivity, Patho-physiological mechanisms, Azilsartan more...
- Published
- 2017
16. Pharmacokinetics-directed Intravenous Busulfan Combined With High-dose Melphalan and Bortezomib as a Conditioning Regimen for Patients With Multiple Myeloma
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Rishi Jain, Noah Kornblum, Richard Elkind, Amithaba Mazumder, Ramakrishna Battini, David Kaminetzky, Samira Shahnaz, Roy Browne, Jason Carter, Ira Braunschweig, Olga Derman, Amit Verma, Lawrence Almanzar, and Stefan K. Barta more...
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Adult ,Male ,Melphalan ,Cancer Research ,medicine.medical_specialty ,Transplantation Conditioning ,medicine.medical_treatment ,Phases of clinical research ,Kaplan-Meier Estimate ,Transplantation, Autologous ,Gastroenterology ,Maintenance Chemotherapy ,Bortezomib ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Busulfan ,Survival rate ,Aged ,Preparative Regimen ,Chemotherapy ,business.industry ,Graft Survival ,Hematopoietic Stem Cell Transplantation ,Area under the curve ,Hematology ,Middle Aged ,medicine.disease ,Survival Analysis ,Surgery ,Consolidation Chemotherapy ,Regimen ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,Retreatment ,Female ,Multiple Myeloma ,business ,Febrile neutropenia ,030215 immunology ,medicine.drug - Abstract
Background High-dose chemotherapy followed by autologous stem cell transplantation (ASCT) has a well-established role in the treatment of patients with multiple myeloma. Melphalan 200 mg/m 2 (Mel200) is the most commonly used preparative regimen. Several studies have provided evidence for potential synergism and safety when combining bortezomib (Btz) or busulfan (Bu) with melphalan (Mel). Patients and Methods We conducted a prospective phase II study to investigate the safety and efficacy of conditioning with pharmacokinetics (PK)-directed intravenous (IV) Bu with Btz and Mel. Bu dosing was adjusted to target a total area under the curve (AUC) of 20,000 μM × min. Patients received Btz (1 mg/m 2 × 4 doses) and Mel (140 mg/m 2 ). Results A total of 19 subjects were enrolled. Their median age was 55 years, and the median follow-up period was 23.7 months. PK testing resulted in 86% of patients achieving an estimated total AUC of 20,000 ± 2500 μM × min. The overall response rate (ORR) at day +100 after ASCT was 100% in the evaluable patients, with 11% of patients achieving a complete response. The 2-year progression-free survival rate was 57.9% (95% confidence interval [CI], 38%-89%), and the 2-year overall survival rate was 88.5% (95% CI, 76%-100%). The most common grade 3 and 4 toxicities were febrile neutropenia, dysphagia/odynophagia, and oral mucositis. No case of hepatic sinusoidal obstruction syndrome developed. One treatment-related mortality occurred before day +100. Conclusion A preparative regimen of PK-directed IV Bu with Btz and Mel led to an ORR of 100% with acceptable toxicity and should be considered for direct comparison with the Mel200 regimen in future trials. more...
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- 2017
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17. 2322-PUB: Consistency and Predictability of Control of Glycemic Variability with U200 (Concentrated r-DNA Human Insulin Premix 30/70 - 200 IU/mL) in Type 2 Diabetes Mellitus Patients
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Jothydev Kesavadev, Agam Shah, Rishi Jain, Shahu Ingole, and Hemant Thacker
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medicine.medical_specialty ,business.industry ,Endocrinology, Diabetes and Metabolism ,Type 2 Diabetes Mellitus ,Subgroup analysis ,Hypoglycemic episodes ,Insulin dose ,Consistency (statistics) ,Internal medicine ,Internal Medicine ,medicine ,Human insulin ,business ,Body mass index ,Glycemic - Abstract
Introduction: In type 2 diabetes mellitus (T2DM) patients, U200 (concentrated r-DNA Human Insulin Premix 30/70 - 200IU/mL) provides good control of glycemic variability with minimal glycemic excursions and substantial time spent in euglycemia. Objective of this subgroup analysis was to assess consistency and predictability of control of glycemic variability with U200 by gender, body mass index (BMI) and daily insulin dose. Methods: Sixty adult patients with T2DM on treatment with human insulin (regular/NPH/Premix) on stable insulin dose were treated with U200 for 7 days. Variability in 24-hour blood glucose profile measured by CGMS device was compared between various subgroups. Results: There was no statistically significant difference between male and female, patients with BMI 150 mg/dL), mean number and duration of hypoglycemic episodes ( Conclusion: Mean blood glucose, frequency-duration of excursions and time spent in euglycemic range with U200 were unaffected by gender, BMI and daily insulin dose thereby emphasizing consistency and predictability of control of glycemic variability across a wide range of patients. Disclosure H. Thacker: None. J. Kesavadev: None. S.A. Ingole: Employee; Self; Wockhardt. A. Shah: Employee; Self; Wockhardt. R. Jain: Employee; Self; Wockhardt. Funding Wockhardt Pharmaceuticals Ltd. more...
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- 2019
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18. 1113-P: Six Months Comparative Evaluation of Efficacy and Safety of Wockhardt’s Biosimilar Insulin Glargine (Glaritus®) with Reference Insulin Glargine (Lantus®) in Type 2 Diabetes Mellitus in India
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Hrishikesh Bora, Vinodkumar Pavithran, Girish Bhatia, Pravin Supe, Agam Shah, Gaurav Chhaya, Rishi Jain, Pradip Mukhopadhayay, Keerthi Prakash, Surendra K. Sharma, Pooja Khosla, Ajay Kumar Ajmani, and Shahu Ingole more...
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medicine.medical_specialty ,Type 1 diabetes ,Insulin glargine ,business.industry ,Endocrinology, Diabetes and Metabolism ,Type 2 Diabetes Mellitus ,Biosimilar ,medicine.disease ,Treatment period ,Comparative evaluation ,Internal medicine ,Internal Medicine ,medicine ,In patient ,business ,Body mass index ,medicine.drug - Abstract
Introduction: Glaritus® has been found comparable to reference insulin glargine in physico-chemical characteristics, pre-clinical studies and treatment of type 1 diabetes mellitus (DM). Objective: To compare the immunogenicity, HbA1c reduction and safety of Glaritus® to Lantus® over 6 months treatment in type 2 DM. Methods: This is an ongoing prospective, open-label, randomized, multicentre Phase IV study. Total 180 patients of type 2 DM, who were inadequately controlled on oral antidiabetic drugs, were randomized in 1:1 ratio to Glaritus® and reference insulin glargine treatment. Analysis of 144 patients, who completed 6 month comparative phase, is presented herewith. Results: Baseline characteristics of both the treatment arms were comparable in terms of age, gender distribution and body mass index. Over the treatment period, mean anti-insulin antibody titre increased marginally, mean HbA1c reduced significantly and substantial percentage of patients attained HbA1c value 0.05) in terms of these changes. Both glargine treatments were found to be safe in terms of hypoglycemic events. Conclusion: Glaritus® was found to be equally effective and safe in patients with inadequately controlled T2DM compared to reference insulin glargine. Disclosure S. Sharma: None. A. Ajmani: None. P. Khosla: None. P. Mukhopadhayay: None. G. Bhatia: None. P. Kg: None. G. Chhaya: None. P. Supe: None. V. Pavithran: None. H. Bora: None. A. Shah: Employee; Self; Wockhardt. S.A. Ingole: Employee; Self; Wockhardt. R. Jain: Employee; Self; Wockhardt. Funding Wockhardt Pharmaceuticals Ltd. more...
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- 2019
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19. Impact of Baseline Nutrition and Exercise Status on Toxicity and Outcomes in Phase I and II Oncology Clinical Trial Participants
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Elizabeth Handorf, Yana Chertock, Rishi Jain, Vipin Khare, Michael J. Hall, and Matthew Blau
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0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Sarcopenia ,Nutritional Status ,Cachexia ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Neoplasms ,medicine ,Humans ,Adverse effect ,Exercise ,Sedentary lifestyle ,business.industry ,Malnutrition ,Cancer ,medicine.disease ,Clinical trial ,030104 developmental biology ,Tolerability ,Symptom Management and Supportive Care ,030220 oncology & carcinogenesis ,business - Abstract
Background Malnutrition and physical inactivity are common in patients with advanced cancer and are associated with poor outcomes. There are increasing data that altered body composition is related to the pharmacokinetic properties of cancer therapies. These adverse conditions may impact outcomes in early-phase oncology clinical trials. Materials and methods We aimed to understand the relationships between baseline nutrition and exercise status with important trial endpoints including treatment-related toxicity and survival. Baseline assessments of nutrition and exercise status were conducted in patients prior to initiation of phase I and II oncology clinical trials. Patients were followed prospectively for the onset of adverse events. Tumor response and survival data were also obtained. Fisher's exact test and chi-square analysis were used to determine statistical significance. Kaplan-Meier curves were used to compare patient duration on study and survival. Results One hundred patients were recruited, of whom 87 were initiating a phase I trial. Sixty percent were initiating trials studying immunotherapeutic agents. Critical malnutrition was found in 39% of patients, and 52% were sedentary. Patients who were malnourished had significantly increased rates of grade ≥ 3 toxicity (p = .001), hospitalizations (p = .001), and inferior disease control rate (p = .019). Six-month overall survival was significantly reduced in malnourished patients versus nonmalnourished patients (47% vs. 84%; p = .0003), as was median duration on study (48 days vs. 105 days; p = .047). Being sedentary at baseline was associated with decreased duration on study (57 days vs. 105 days; p = .019). Conclusion Malnutrition and sedentary lifestyle are highly prevalent in patients enrolling on early-phase oncology clinical trials and are associated with poor outcomes. The quality of data from these studies may be compromised as a result of these pre-existing conditions. Implications for practice Phase I and II trials are critical steps in the development of effective cancer therapeutics, yet only a small percentage of agents are ultimately approved for human cancer care. Despite increasing awareness of the interactions between malnutrition, sarcopenia, and treatment-related outcomes such as toxicity and response, these factors are not commonly incorporated into therapeutic decision making at the time of clinical trial consideration. Nutritional status and physical performance may be key biomarkers of mechanisms mediating treatment-related toxicity, dose modifications, risk of hospitalizations, and success of novel agents. This study advocates that a baseline nutritional assessment and early nutritional support may improve tolerability and response to experimental therapies. more...
- Published
- 2019
20. Feasibility of using a computerized food frequency questionnaire (FFQ) to assess dietary patterns in patients with advanced gastrointestinal (GI) malignancies
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Alexandra Hunt, Namrata Vijayvergia, Carolyn Y. Fang, Efrat Dotan, Rishi Jain, Elizabeth Handorf, Crystal S. Denlinger, Igor Astsaturov, Roshan George, Michael J. Hall, Bianca Lewis, and Kara Stromberg more...
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High rate ,Cancer Research ,medicine.medical_specialty ,business.industry ,food and beverages ,Food frequency questionnaire ,medicine.disease ,Optimal management ,Malnutrition ,Oncology ,Sarcopenia ,Internal medicine ,medicine ,In patient ,business - Abstract
465 Background: Identification of poor dietary patterns is important for the optimal management of patients with metastatic GI malignancies who suffer from high rates of malnutrition and sarcopenia which are associated with increased rates of treatment-related toxicity and worsened survival. Dietary records or recall methods and FFQs are available but have high patient burden and are seldom utilized in oncology settings outside of formal nutritional consultations. Thus, we evaluated the feasibility of conducting serial assessments of dietary patterns using a novel computerized FFQ technology. Methods: Assessments of diet using the computerized FFQ, nutritional status (NUTRISCORE), QOL and anorexia/cachexia burden (FAACT), anxiety/depression (HADS) and taste burden were done at the time of initiation of first-line chemotherapy (baseline) and 3 months later. The FFQ was done independently either at home on personal computer after visit or via iPad in infusion room. Dietary quality was defined by the Healthy Eating Index 2010 (HEI) score, which was automatically calculated by the computerized FFQ software. Feasibility was defined as at least 70% of patients completing baseline and 3-month assessments. Spearman’s correlations were used to determine associations between measures. Results: 29 patients with advanced (metastatic or unresectable) GI cancers were enrolled and 23 completed the baseline FFQ (8 colorectal, 5 pancreas, 5 gastroesophageal, 5 other). Median age was 58 (20-78) with M:F ratio of 10:13. The overall completion rate of baseline and 3-month assessments was 81.8%, meeting the pre-defined feasibility criteria. The mean baseline HEI score was 65 (range 38-88). Of patients who completed both baseline and 3-month assessments, the mean HEI score remained stable at 58 with changes in specific HEI components including a 20% decline in the seafood and plant protein score and a 13% decline in the whole grain score and small improvements in other areas (e.g. empty calories, dairy). There were no significant correlations between baseline HEI score and other assessments. Conclusions: It is feasible to use a computerized FFQ to assess for longitudinal changes in eating patterns and dietary quality in patients with advanced GI cancers, particularly when patients can complete the assessments during chemotherapy infusions. Preliminary findings also suggest that the FFQ can be helpful for highlighting areas in which diet quality could be improved. Additional analysis of other computerized FFQ data (e.g. macro/micronutrient consumption) is ongoing. more...
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- 2021
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21. Associations between psoas muscle area (PMA) and density (PMD) with phase I oncology clinical trial outcomes
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Rishi Jain, Elizabeth Handorf, Yana Chertock, Michael J. Hall, Peter D. Whooley, Laura Levin, Matthew Blau, and Pritish Iyer
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Oncology ,Cancer Research ,medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Cancer cachexia ,Computed tomography ,Muscle mass ,medicine.disease ,Clinical trial ,Malnutrition ,Internal medicine ,Sarcopenia ,Medicine ,business - Abstract
7007 Background: Malnutrition and cancer cachexia can lead to loss of muscle mass (sarcopenia) and are associated with poor outcomes. Muscle status can be evaluated by computed tomography (CT)-based radiographic measures, specifically at the L3 vertebrae where the psoas and other core muscles reside. We previously found that baseline malnutrition was associated with worse phase 1 clinical trial outcomes including increased toxicity and reduced survival (Jain et al. Oncologist, 2019). We sought to evaluate the relationship between muscle status and phase 1 trial outcomes. Methods: CT-based psoas muscle area (PMA) and psoas muscle density (PMD) were evaluated in 83 patients who enrolled in a phase 1 trial. We localized the L3 vertebral body on axial imaging and manually outlined the psoas muscle to calculate PMA (standardized to height) and PMD. Two reviewers independently conducted the analyses. We stratified patients by having a PMA or PMD above or below the group’s median. We evaluated for associations between PMA/PMD and the following clinical trial outcomes: rates of grade ≥ 3 toxicity, frequency of dose reductions/interruptions, hospitalizations, tumor response, duration on study (DOS), and overall survival (OS). We also evaluated for correlations between PMA/PMD and a validated measure of nutritional status, the PG-SGA. Chi-square analysis was used to determine statistical significance between groups. Kaplan-Meier curves were used to compare DOS and OS. Results: 83 patients were included (38 male, 45 female), with a median age of 60 (range 28-85). The most common cancer type was gastrointestinal (33%). Mean PMA was 2.89 cm2/m2 (range 1.41-5.72) and mean PMD 37.77 Hounsfield units (range 13.27-56.18). PMA above the median was associated with a reduced risk of grade ≥ 3 toxicity (32.5% vs 67.4%, p = 0.001). There was no association between PMD and grade ≥ 3 toxicity, or between PMA/PMD and other phase 1 trial outcomes. There was a significant correlation between nutritional status and PMA (r = -0.278, p = 0.01) but not PMD. Conclusions: PMA and PMD are readily available CT-based measures of muscle status. In oncology phase 1 clinical trial participants, lower baseline PMA was associated with a two-fold increased risk of grade ≥ 3 toxicity. Baseline PMA was moderately correlated with nutritional status which was previously shown to be associated with poor trial outcomes. More research is necessary to further understand the specific mechanisms by which nutritional status and muscle mass may influence toxicity risk in this population. more...
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- 2020
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22. Assessing real-world biomarker testing rates in metastatic colon cancer
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Elizabeth Handorf, Rishi Jain, Shazia Nakhoda, Pritish Iyer, Neal J. Meropol, Mengying Deng, and Efrat Dotan
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Oncology ,Neuroblastoma RAS viral oncogene homolog ,Cancer Research ,medicine.medical_specialty ,business.industry ,Microsatellite instability ,medicine.disease ,medicine.disease_cause ,National guideline ,digestive system diseases ,Internal medicine ,medicine ,Biomarker (medicine) ,DNA mismatch repair ,KRAS ,business ,Metastatic colon cancer - Abstract
209 Background: Despite national guideline recommendations for universal biomarker testing (KRAS, NRAS, BRAF, and mismatch repair/microsatellite instability [MMR/MSI]) in all patients with metastatic colorectal cancer (mCRC), little is known regarding adherence to these recommendations in the community. Methods: We evaluated 20,333 patients aged >18 years with mCRC diagnosed between 1/1/2013-12/27/18 from the nationwide de-identified Flatiron Health electronic health record-derived database. Changes in rates of biomarker testing based upon chart abstraction according to date of mCRC diagnosis were assessed in patients with ≥ 6 months of follow-up using Cochran-Armitage trend tests. We also assessed whether testing differed by patient characteristics using chi-square tests. Results: Biomarker testing rates increased between 2013 and 2018 (15.3 to 65.7% for NRAS, 23.9 to 56.6% for BRAF, and 34 to 76.6% for MMR, all p < 0.0001). There was no change in rate of KRAS testing (63.8 to 68.3% p= 0.1695) over this period of time. Univariate analysis showed that patients with, worse performance status, and Medicare/Medicaid insurance were less likely to be tested (for all variables, p more...
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- 2020
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23. Nutrition and Aging: a Practicing Oncologist's Perspective
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Efrat Dotan and Rishi Jain
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Gerontology ,Oncology ,medicine.medical_specialty ,Aging ,Cachexia ,Psychological intervention ,Nutritional Status ,Risk Assessment ,03 medical and health sciences ,0302 clinical medicine ,Overnutrition ,Weight loss ,Survivorship curve ,Internal medicine ,Intervention (counseling) ,Neoplasms ,Medicine ,Humans ,030212 general & internal medicine ,Aged ,business.industry ,Cancer ,medicine.disease ,Diet ,Malnutrition ,030220 oncology & carcinogenesis ,Body Composition ,medicine.symptom ,business ,Psychosocial - Abstract
Malnutrition is common in patients with cancer and is associated with a variety of negative outcomes. These can include reduced treatment tolerance and worsened cancer prognosis. Various aspects of aging, including sensory, physical, or psychosocial changes, place older patients at a particularly high risk for malnutrition, and these geriatric factors must be identified early and addressed. Despite the lack of available evidence on the optimal nutritional interventions for older adults with cancer, the oncologist must be prepared to address the common nutritional concerns that arise in both advanced cancer and survivorship settings. While BMI, weight loss, and serum albumin are commonly used as surrogates of malnutrition, the use of a comprehensive screening tool may promote early identification of disrupted eating patterns and allow for prompt intervention. New digital technologies have also demonstrated promise to improve nutritional assessment capabilities. Use of conventional nutritional support in conjunction with novel nutraceutical and anti-cachexia approaches may enhance the effectiveness of interventions and improve our ability to reverse malnutrition-associated alterations in body composition. Future geriatric-focused nutrition research will be crucial in helping guide our patients and effectively addressing their dietary and lifestyle concerns. more...
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- 2017
24. A non-interventional, prospective, multicentric real life Indian study to assess safety and effectiveness of un-denatured type 2 collagen in management of osteoarthritis
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Kapil Dev Mehta, Mangesh Borate, Amit Qamra, Agam Shah, Rishi Jain, Apurv Mehra, Prasenjit Paul, Pankaj Anand, and Sanjay Kamble
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medicine.medical_specialty ,education.field_of_study ,WOMAC ,business.industry ,Visual analogue scale ,Nausea ,Incidence (epidemiology) ,Population ,Osteoarthritis ,medicine.disease ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,Non interventional ,Medicine ,030212 general & internal medicine ,medicine.symptom ,business ,Adverse effect ,education - Abstract
Background: Osteoarthritis (OA) is the most common musculoskeletal conditions affecting the quality of life. Undenatured collagen type II has emerged as one of the promising treatment options in treatment of OA. Despite being available in India, clinical safety and efficacy have not been evaluated. We performed a non-interventional, real-life study to determine its safety and efficacy in Indian population.Methods: A non-interventional, real-life study was performed in patients with OA of knee by 18 orthopaedicians in India. Patients enrolled were followed-up at day 30 (visit 2), day 60 (visit 3) and day 90 (visit 4). Efficacy was assessed by Western Ontario McMaster Osteoarthritis Index (WOMAC) and Visual Analogue scale (VAS) on each visit. Safety was assessed by incidence of suspected adverse events (AEs), and abnormal laboratory parameters.Results: Among 291 enrolled patients 226 patients completed the study. Mean age of the population was 56.2±8.7 years and 53.3% of them were females. In 291 patients included in safety analysis, at least one treatment emergent adverse event (TEAE) was seen in 4.47% patients. None of the AEs were serious or resulted in termination of patient from the study. Nausea (1.37%) and headache (1.03%) were the common AEs. Treatment with undenatured collagen type II was associated with significant reduction in WOMC score (pConclusions: Undenatured collagen type II is safe and efficacious in Indian patients with OA. This can be considered early in the initial management of OA. more...
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- 2019
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25. Nutrition and exercise patterns in survivors of esophageal and gastroesophageal junction (EGEJ) cancers
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Rishi Jain, Evgenia Granina, Daohai Yu, Abbas E. Abbas, Xiaoning Lu, Crystal S. Denlinger, Joshua E. Meyer, Carolyn Y. Fang, Chethan Ramamurthy, Efrat Dotan, and Jennifer Y. Sheng
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Gastroesophageal Junction ,medicine.disease ,Obesity ,Malnutrition ,Esophagectomy ,Internal medicine ,medicine ,Risk factor ,business ,Neoadjuvant therapy - Abstract
89 Background: While obesity is a risk factor for EGEJ, malnutrition is common at diagnosis (dx) and can be exacerbated by neoadjuvant therapy (NAT) and esophagectomy. Little is known regarding nutrition and exercise patterns of EGEJ cancer survivors. Methods: A survey of EGEJ survivors > 12 months from esophagectomy was conducted. Pts were identified using institutional tumor registry. The Dillman mailed survey method was used. Questionnaires regarding health behaviors were employed: Godin Leisure-Time Exercise [GLTQ], Cancer Appetite and Symptom [CASQ], Nutritional Self-Efficacy (NSEQ). Chart review included demographics, pt characteristics and therapy received. Spearman correlation, Wilcoxon and Fisher’s tests assessed relationships between groups or variables. Results: Forty one of 140 eligible pts (29%) returned questionnaires and had surgery between 1991-2014. Median age was 69 and 78% were male. Most (83%) had adenocarcinoma. On presentation, 73% had clinical stage II or III disease and 76% received NAT. Median time from dx was 5 years (range 2-25). Mean weight loss from dx to current was 38 lbs. Mean BMI (kg/m2) was 29.52 at dx and 24.15 at most recent clinic visit. Obesity was present in 37% of pts at dx, but only 7% of survivors. Mean health behavior scores (SD): GLTQ 22.10 (22.93), CASQ 31.74 (6.66), and NSEQ 11.39 (4.03). Age, marital status, gender, education, and income were not associated with GLTQ, CASQ or NSEQ. Sedentary lifestyle (SL) with GTLQ score < 14 was present in 46% of survivors and associated with overweight BMI (mean 26.7 for SL vs 23.7 for non-SL; p = 0.04). There was a significant positive correlation between current BMI and NSEQ score (r = 0.68; p = 0.03). Conclusions: Many EGEJ cancer pts present with obesity but subsequently lose weight after curative therapy. The mean CASQ score in our population is similar to other GI cancer populations, suggesting that residual symptoms persist years after treatment ends. There is a high prevalence of SL in survivors which is associated with being overweight. Higher levels of nutrition self-efficacy were also associated with a higher current BMI. Future studies should define strategies to optimize nutrition and exercise habits in EGEJ cancer survivors. more...
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- 2019
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26. Clinical Studies Examining the Impact of Obesity on Breast Cancer Risk and Prognosis
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Howard D. Strickler, Joseph A. Sparano, Eugene J. Fine, and Rishi Jain
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Oncology ,Cancer Research ,medicine.medical_specialty ,Breast Neoplasms ,Breast cancer ,Risk Factors ,Internal medicine ,medicine ,Hyperinsulinemia ,Humans ,Obesity ,Aromatase ,Triple-negative breast cancer ,Clinical Trials as Topic ,biology ,business.industry ,Prognosis ,medicine.disease ,Metformin ,Postmenopause ,Clinical trial ,biology.protein ,Female ,business ,Body mass index ,medicine.drug - Abstract
Obesity is associated with an increased risk of breast cancer, and increased risk of recurrence in women who develop breast cancer. Evidence suggests that the risk of estrogen-receptor (ER)-positive breast cancer is increased in obese postmenopausal women, whereas in premenopausal women the risk of triple negative breast cancer is increased. Nonetheless, the presence of obesity at diagnosis, and possibly weight gain after diagnosis, may independently contribute to an individual's risk of recurrence of both pre- and postmenopausal breast cancer. Factors associated with adiposity that are likely contributing factors include hyperinsulinemia, inflammation, and relative hyperestrogenemia. Some studies suggest that some aromatase inhibitors may be less effective in obese women than lean women. Clinical trials have evaluated pharmacologic (eg, metformin) and dietary/lifestyle interventions to reduce breast cancer recurrence, although these interventions have not been tested in obese women who may be most likely to benefit from them. Further research is required in order to identify adiposity-associated factors driving recurrence, and design clinical trials to specifically test interventions in obese women at highest risk of recurrence. more...
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- 2013
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27. Prevalence and correlates of critical malnutrition (CMN) among gastrointestinal (GI) and non-GI participants in phase I/II (P1/2) clinical trials
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Steven K. Clinton, Rishi Jain, Michael J. Hall, Vipin Khare, Matthew Blau, Yana Chertock, and Elizabeth Handorf
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Cancer Research ,medicine.medical_specialty ,business.industry ,Cancer ,medicine.disease ,Gastroenterology ,Clinical trial ,Malnutrition ,Phase i ii ,Oncology ,Internal medicine ,Toxicity ,medicine ,business - Abstract
770 Background: Patients (pts) with cancer, in particular GI malignancies, are vulnerable to CMN from both tumor-related digestive symptoms and treatment-related toxicity (TRT). CMN is associated with poor cancer outcomes, including reduced quality of life, poor treatment tolerance and decreased survival. P1/2 trial participants are not routinely screened for CMN or potentially associated psychological and physical activity impairments. Methods: Baseline assessments of nutrition (PG-SGA), distress (NCCN-DT), anxiety (HADS-A), depression (HADS-D), and sedentary lifestyle (SL, Godin-LTQ) were conducted in pts beginning a P1/2 trial. CMN was defined as a PG-SGA score of ≥9. Statistical significance was determined by Fisher’s exact test. A regression model was used to identify a composite predictor of CMN. Results: 100 pts (87% P1, 13% P2) were enrolled. Results of assessments are shown in Table 1. 39% of pts had CMN and 52% had a SL. CMN was more common in non-whites (p = 0.05) and those on P1 trials (p = 0.073). No differences were noted by age, gender, or prior lines of therapy. CMN was strongly associated with depression (p < 0.001) and SL (p < 0.001). 31 pts had GI malignancies [CRC (15), pancreas (8), and other (8)]. CMN was more prevalent in GI pts than non-GI (61% vs 29%, p = 0.004). When evaluating the predictive value of commonly used clinical indicators for CMN such as BMI ( < 25), weight loss (WL) past 2 weeks, or WL past month, having 2/3 of these indicators was the optimal cut-point predictor of CMN (76% sensitivity, 85% specificity). TRT data collection is ongoing. Conclusions: CMN and SL are highly prevalent in P1/2 trial pts, particularly in those with GI cancers and minorities. CMN is strongly associated with depression and SL. A composite clinical indicator (BMI + WL) may be most useful in screening for CMN. Urgent nutritional interventions in these participants may be warranted in light of magnified mortality and toxicity risks. [Table: see text] more...
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- 2018
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28. Muscle-invasive urothelial bladder cancer: an update on systemic therapy
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Elizabeth R. Plimack, Rishi Jain, Hayley Knollman, Daniel M. Geynisman, J. Luke Godwin, and Yu-Ning Wong
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Oncology ,Cisplatin ,medicine.medical_specialty ,Pathology ,Chemotherapy ,Metastatic Urothelial Carcinoma ,Bladder cancer ,business.industry ,Urology ,medicine.medical_treatment ,Reviews ,Disease ,Immunotherapy ,lcsh:Diseases of the genitourinary system. Urology ,lcsh:RC870-923 ,medicine.disease ,Malignancy ,Targeted therapy ,Internal medicine ,medicine ,business ,medicine.drug - Abstract
Urothelial carcinoma is a common malignancy that carries a poor prognosis when the disease includes muscle invasion. Metastatic urothelial carcinoma is almost uniformly fatal. The evidence behind treatment options in the neoadjuvant, adjuvant and metastatic settings are discussed in this manuscript, with a focused review of standard and investigational cytotoxic, targeted, and immunotherapy approaches. We have focused especially on neoadjuvant cisplatin-based therapy (supported by level one evidence) and on novel immunotherapy agents such as checkpoint inhibitors, which have shown great promise in early clinical studies. more...
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- 2015
29. Short Term Safety and Tolerability of a Fixed Dose Combination of Olmesartan, Amlodipine and Hydrochlorothiazide
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Rishi Jain, Vijay Chamle, Amit Bhargava, and Jagdish C. Mohan
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medicine.medical_specialty ,hypertension ,Clinical Biochemistry ,Population ,Fixed-dose combination ,adverse event ,lcsh:Medicine ,Pharmacology ,Hydrochlorothiazide ,Internal medicine ,medicine ,observational ,Amlodipine ,education ,Adverse effect ,prescription event monitoring ,education.field_of_study ,Internal Medicine Section ,business.industry ,lcsh:R ,General Medicine ,Tolerability ,Concomitant ,business ,Olmesartan ,medicine.drug - Abstract
OBJECTIVE: To assess the short term safety and tolerability of a fixed dose combination (FDC) of olmesartan, amlodipine and hydrochlorothiazide (OAH) in real-world clinical setting in India. MATERIALS AND METHODS: Physicians were requested to provide eight weeks observational clinical event data of the patients prescribed with FDC of Olmesartan (20/40mg), Amlodipine (5mg) and hydrochlorothiazide (12.5mg) in the prescription event monitoring (PEM) forms. Data on patients' demographics, indication for FDC, concomitant medication and other relevant history was also collected and was analysed with descriptive statistics. RESULTS: Two hundred thirty eight physicians provided data of 4763 patients. Mean age of the population was 55±7 years and males were 59.3%. The commonest indication for the FDC was uncontrolled hypertension (60.7%). Diabetes and dyslipidemia were present in 37.9% and 35.1% respectively. Concomitant medications included statins (42.3%), oral anti-diabetic (33.7%) and antiplatelet agents (24.7%). Pedal oedema (0.29%) was the most common adverse event (AE) reported followed by headache (0.16%), giddiness (0.15%), light headedness (0.15) and stroke (0.15%). Other less common (0.04%) reported AEs were tiredness, dizziness, gastritis, hypersomnia, hypoglycaemia, lower respiratory tract infection (LRTI), weakness, diarrhea, labyrinthitis, urinary tract infection, hyponatremia and hypotension. Occurrence of AEs was more common in patients with uncontrolled hypertension (60.74%). CONCLUSION: The FDC of olmesartan, amlodipine and hydrochlorothiazide prescribed most frequently for patients with uncontrolled hypertension and co-morbidities was found to be safe and well tolerated over a short period of observation. more...
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- 2015
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30. Prevalence of critical malnutrition (CMN) in patients enrolling on phase I/II (P1/2) clinical trials
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Vipin Khare, Rishi Jain, Michael J. Hall, Elizabeth Handorf, and Yana Chertock
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Cancer Research ,medicine.medical_specialty ,business.industry ,Cancer ,medicine.disease ,Caloric intake ,Clinical trial ,Malnutrition ,Phase i ii ,Oncology ,Weight loss ,Internal medicine ,medicine ,In patient ,medicine.symptom ,Adverse effect ,business - Abstract
e21700 Background: Cancer therapies undergo evaluation in P1/2 trials, frequently in patients (pts) with disrupted caloric intake, weight loss, and other adverse effects of cancer on physical and psychological functioning. CMN and sarcopenia may increase treatment related toxicity (TRT) due to acquired pharmacokinetic variability and altered drug metabolism. Little is known about the prevalence of CMN among pts enrolling on P1/2 trials, its association with abnormal physical and psychological functioning, and its role in mediating TRT. Methods: Pts initiating a P1/2 trial were recruited. Study acceptance rate was > 95%. Pts had a comprehensive nutritional assessment using the validated PG-SGA, a short, 3-5 minute tool that evaluates multiple nutritional domains [symptom burden, functional status, metabolic stress and physical exam (muscle/fat status)]. CMN is defined as a PG-SGA score of ≥ 9. Distress, anxiety, depression and physical activity were also measured. BMI and albumin were extracted from the chart. Statistical significance was determined by Fisher’s exact test. Results: 54 pts (85% P1) were enrolled. CMN was identified in 39%. Pts with gastrointestinal (GI) cancers were more likely to have CMN than non-GI cancers (75% vs 24%, p = 0.001); otherwise, CMN rates were not different by age ( < 60 vs 60+), gender, race, or trial phase (1 vs 2). CMN was also associated with number of lines of therapy, but was surprisingly less common among patients with > 2 therapies compared to those with 0-2 (29% vs 57%, p = 0.051). Strong associations of CMN to distress (p = 0.028), depression (p = 0.020) and sedentary lifestyle (p = 0.012) were also seen. Clinical “red flags” of MN such as low BMI ( < 25) and low albumin ( < 3.5) had poor sensitivity (66.7% and 33.3%) and specificity (57.6% and 78.8%) for CMN. Correlation of CMN to TRT is underway. Conclusions: CMN is prevalent among P1/2 trial pts, notably in those with GI cancers and with fewer lines of therapy, and is associated with physical inactivity, distress and depression. BMI and albumin are poorly predictive of CMN. Undiagnosed CMN may, through multiple pathways, increase the vulnerability of pts on P1/2 studies to TRT. Comprehensive nutritional assessment of P1/2 pts should be considered. more...
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- 2017
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31. Management of type 2 diabetes mellitus: insights into prescribing trends
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K M Prasanna Kumar, Shahu Ingole, Rishi Jain, and Tushar Tamboli
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medicine.medical_specialty ,endocrine system diseases ,medicine.drug_class ,business.industry ,nutritional and metabolic diseases ,Type 2 Diabetes Mellitus ,030209 endocrinology & metabolism ,Clinical settings ,030204 cardiovascular system & hematology ,Sulfonylurea ,Metformin ,03 medical and health sciences ,0302 clinical medicine ,Endocrinology ,Novel agents ,Internal medicine ,Family medicine ,Sitagliptin ,medicine ,Vildagliptin ,Teneligliptin ,business ,medicine.drug - Abstract
Background: Recently, management of type 2 diabetes mellitus (T2DM) has changed with advent of novel agents like DPP4i, SGLT2i and GLP-1 agonist. Of these, DPP4i have emerged as promising agents as monotherapy and as an add-on to metformin for improved glycaemic control. This survey was planned to explore current prescribing trends of physicians of India for the management of T2DM.Methods: This was a prospective, cross sectional, questionnaire-based survey of physicians and endocrinologist across different geographic areas in India. A survey questionnaire consisting of 10 questions related to management of T2DM in real-world clinical settings was prepared, validated in a small group of physicians and then administered to physicians and endocrinologists.Results: Responses from 502 physicians were received. About 60% physicians prefer DPP4i as first add-on to metformin followed by sulfonylurea (SU) (30%). Amongst DPP4i, vildagliptin and sitagliptin were preferred by 48% and 28% physicians respectively as first add-on to metformin. For patients uncontrolled on metformin + SU therapy, 54 % physicians prefer DPP4i as second add-on. Vildagliptin is perceived to have the better efficacy and safety data, as suggested by 40% and 43% physicians respectively. Large number of physicians (48%) were hesitant to prescribe teneligliptin due to insufficient data. SGLT2 inhibitors are preferred as third add-on by 44% physicians.Conclusions: DPP4i are being increasingly preferred by physician as an add-on to metformin. Among DPP4i, the survey revealed that vildagliptin is the most preferred DPP4i as an add-on to metformin possibly owing to its established safety and efficacy data. more...
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- 2017
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32. Renal safety profile of di-peptidyl-peptidase inhibitors: a review of available literature
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A G Unnikrishanan, Rishi Jain, Gaurav Saxena, and Arindam Dey
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medicine.medical_specialty ,business.industry ,Type 2 Diabetes Mellitus ,Dipeptidyl peptidase-4 inhibitor ,Pharmacology ,Saxagliptin ,medicine.disease ,Nephropathy ,End stage renal disease ,Diabetic nephropathy ,chemistry.chemical_compound ,chemistry ,Sitagliptin ,Internal medicine ,medicine ,business ,medicine.drug ,Glycemic - Abstract
Diabetic Nephropathy has become the single most import cause of End Stage Renal Disease (ESRD). Various strategies to limit or slow the progress the Diabetic nephropathy are suggested by the guidelines and evidences. By maintaining strict glycemic control the progression of diabetic nephropathy can be altered. Glycemic control in diabetic patients with nephropathy is complex as falling eGFR renders many ant diabetic medications contraindicated while others are needed to be done in low dose. The intent of this review article is to collate the available evidences for renal safety with one such anti diabetic class of medication, dipeptidyl peptidase 4 inhibitor and evaluate the guideline based antidiabetic treatment in Type 2 Diabetes Mellitus patients with renal insufficiency. more...
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- 2017
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33. Toxicity and survival in older versus younger esophageal cancer (EC) patients (pts) treated with neoadjuvant chemoradiotherapy (nCRT)
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Jia-Llon Yee, Cherry Au, Efrat Dotan, Rishi Jain, Joshua E. Meyer, Elizabeth Handorf, and Talha Shaikh
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Oncology ,Cancer Research ,medicine.medical_specialty ,Retrospective review ,Chemotherapy ,business.industry ,medicine.medical_treatment ,Cancer ,Esophageal cancer ,medicine.disease ,Surgery ,Internal medicine ,Toxicity ,Overall survival ,Medicine ,Dose reduction ,business ,Neoadjuvant chemoradiotherapy - Abstract
204 Background: Trimodality therapy (TMT) for EC is associated with significant toxicity. Limited data are available on the safety of nCRT in vulnerable populations such as older pts. We evaluated the associations between age and toxicity as well as survival in pts treated with nCRT as part of TMT. Methods: A retrospective review of pts with EC treated with nCRT as part of TMT at an academic cancer center between 2002-2014 was conducted. We assessed the impact of age ( more...
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- 2017
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34. Association between markers of malnutrition (MN) and toxicity (T) during neoadjuvant chemoradiotherapy (nCRT) for esophageal cancer (EC)
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Joshua E. Meyer, Cherry Au, Jia-Llon Yee, Elizabeth Handorf, Rishi Jain, Efrat Dotan, and Talha Shaikh
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Cancer Research ,medicine.medical_specialty ,Pathology ,business.industry ,Esophageal cancer ,medicine.disease ,Gastroenterology ,Malnutrition ,Oncology ,Weight loss ,Internal medicine ,Toxicity ,Medicine ,medicine.symptom ,business ,Neoadjuvant chemoradiotherapy - Abstract
191 Background: EC is associated with significant MN. Resultant weight loss (WL) can be further exacerbated by toxicity of nCRT. We evaluated the association of surrogates of MN and T during nCRT for EC. Methods: A retrospective analysis of EC patients (pts) treated with nCRT as part of tri-modality therapy between 2002-2014 was performed. The following pre and post-CRT factors were assessed: presence of jejunostomy tube (J-tube), weight change (gain, loss of < 5%, 5-10%, ≥ 10%) and albumin change (decrease by < 0.5 or ≥ 0.5). We recorded rates of chemotherapy (ctx) dose reduction/interruption (DRI), hospitalizations (H), grade 3/4 T (G3+T), any grade non-hematologic (NHT) or hematologic T (HT). Multivariate regression analyses (MVA) were used to determine associations between MN and T, adjusting for age, gender, smoking status, stage, CRT regimen, performance status, and co-morbidities. Results: 125 patients were identified. Median age was 63 (range 35-80). Pre-CRT body mass index ranged from 17-45 kg/m2, with 74% overweight or obese. Mean WL during nCRT was 10 lbs (5%). Increased WL was noted in pts who received cisplatin/5-FU as compared to other ctx (p < 0.001) or ≥ 50 Gy (p = 0.025). In MVA, increased NHT was noted in pts with ≥ 5% WL (p < 0.05) and more G3+T was noted in pts with ≥ 10% WL (p = 0.002). A decrease in albumin by ≥ 0.5 was associated with increased DRI (p = 0.043), NHT (p = 0.004), HT (p = 0.002), and G3+T (p = 0.004). Sixty-three pts (50%) had a J-tube prior to nCRT. Pts with a J-tube had reduced mean WL (8 lbs vs 13 lbs) during nCRT. No differences in T were noted based on J-tube status. No associations between MN and H rates were observed. Conclusions: Hypoalbuminemia and WL during nCRT were associated with multiple T endpoints. The presence of a prophylactic J-tube did not reduce T rates. Other methods to prevent MN and reduce T during nCRT should be studied. more...
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- 2017
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35. Management of hypertension: Insights into prescribing behavior with focus on angiotensin receptor blockers
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Sivasubramanian Ramakrishnan, Shahu Ingole, Rishi Jain, and Arindam Dey
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lcsh:Diseases of the circulatory (Cardiovascular) system ,medicine.medical_specialty ,hypertension ,medicine.drug_class ,lcsh:Surgery ,lcsh:Medicine ,Calcium channel blocker ,030204 cardiovascular system & hematology ,Pharmacology ,telmisartan ,Nephropathy ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,cardiovascular diseases ,030212 general & internal medicine ,business.industry ,lcsh:R ,lcsh:RD1-811 ,Guideline ,Angiotensin receptor blockers ,medicine.disease ,Losartan ,Blood pressure ,lcsh:RC666-701 ,Microalbuminuria ,Telmisartan ,business ,Olmesartan ,medicine.drug - Abstract
Introduction: Angiotensin receptor blockers (ARBs) are emerging as an attractive first choice antihypertensive as recommended by various guidelines. However, choice among the first-line antihypertensive classes and among ARBs differs between practicing physicians. Aims: This survey aimed to understand the usage preferences of ARBs and its place in for treating hypertension (HTN) among physicians from various clinical settings in India. Methods: A cross-sectional survey was conducted with a prevalidated survey questionnaire consisting of 25 questions for HTN management. Practicing general physicians and cardiologists were approached for seeking their perception, opinions, and prescribing behavior. Results: Responses of 594 physicians and cardiologists were received. As opined by 90.1% of physicians, newly diagnosed HTN represented more than 10% of their overall patient load. As a monotherapy, 59.9% of the physicians preferred ARB as the first choice in newly diagnosed HTN patients, followed by calcium channel blocker (12.3%) and angiotensin-converting-enzyme inhibitor (8.1%). Of all ARBs, telmisartan is preferred by 73% of physicians. Most physicians prefer telmisartan among all ARBs for 24 h blood pressure (BP) control, including morning BP surge (76.4%) and for prevention of cardiovascular morbidity and mortality (78.8%) followed by olmesartan and losartan. Predominantly, majority of physicians (89.1%) agreed for the beneficial role of telmisartan in preventing onset of microalbuminuria and nephropathy. Conclusion: Indian physicians prefer ARBs as the first choice in most hypertensive patients, which shows agreement with the guideline recommendations followed globally. Telmisartan has emerged as the most preferred ARB among all, for most of the HTN patients including those with comorbidities. more...
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- 2017
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36. Changing patterns of metastatic pancreatic cancer (mPC) care in the combination therapy era: A geriatric perspective
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Karthik Devarajan, Bianca Lewis, Rishi Jain, Steven J. Cohen, Raji Shameem, Crystal S. Denlinger, Efrat Dotan, and Namrata Vijayvergia
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Oncology ,Cancer Research ,medicine.medical_specialty ,Combination therapy ,FOLFIRINOX ,business.industry ,Perspective (graphical) ,Combination chemotherapy ,03 medical and health sciences ,0302 clinical medicine ,030220 oncology & carcinogenesis ,Internal medicine ,Data presentation ,Metastatic pancreatic cancer ,medicine ,Treatment strategy ,030212 general & internal medicine ,business - Abstract
10048Background: Front-line treatment strategies in mPC have evolved since the FOLFIRINOX data presentation at ASCO 2010 (Conroy et al.) showed improved outcomes with a combination chemotherapy reg... more...
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- 2016
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37. The risk of second primary cancers in clear cell and papillary renal cancer
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Raji Shameem, Muhammad Saad Hamid, Rishi Jain, and Kevin M. Sullivan
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Oncology ,Cancer Research ,Pathology ,medicine.medical_specialty ,education.field_of_study ,business.industry ,Population ,Cancer ,Malignancy ,medicine.disease ,Standardized mortality ratio ,Renal cell carcinoma ,Latency stage ,Internal medicine ,medicine ,Surveillance, Epidemiology, and End Results ,education ,business ,Clear cell - Abstract
446 Background: Renal cell carcinoma (RCC) survivors have an increased risk of developing second primary cancers. We sought to determine the role of RCC tumor histology for the risk of developing second primary solid tumors. Methods: The Surveillance Epidemiology and End Results (SEER) database was used to detect RCC cases diagnosed up to 12/31/2011. The Standardized Incidence Ratio (SIR) was calculated as the ratio of observed to expected cases of second primary malignancy based on incidence data in the general United States population. The two most common RCC histological subtypes were included; clear cell and papillary. The latency exclusion period from the date of diagnosis was 60 months. We investigated for the effect of latency period after initial diagnosis (5-10 years and >10 years) that may increase the risk for a second primary cancer. Results: A total of 2,669 patients with an initial diagnosis of RCC (clear cell: 2,368, papillary: 301) that developed second primary cancers were included in our analysis. There was a significantly increased risk of thyroid cancer (SIR: 2.30, p10 years latency period. Overall, in patients diagnosed with papillary RCC, tumors of the prostate (SIR: 1.30, p more...
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- 2015
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38. Anisocytosis Is Associated With Decreased Survival In Patients With Newly Diagnosed Myelodysplastic Syndromes: A Single Center Experience
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Ashwin Sridharan, Rishi Jain, Marcus Bachhuber, Anthony P. Lam, Yiting Yu, Ellen W. Friedman, and Amit Verma
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medicine.medical_specialty ,business.industry ,Proportional hazards model ,Immunology ,Hazard ratio ,Red blood cell distribution width ,Cell Biology ,Hematology ,Neutropenia ,medicine.disease ,Biochemistry ,Surgery ,Log-rank test ,Internal medicine ,Absolute neutrophil count ,Medicine ,Anisocytosis ,business ,Survival analysis - Abstract
Introduction Anisocytosis is defined as excessive variation in the size of red cells. It can be quantified by measuring the red cell distribution width (RDW) and is routinely included in peripheral blood count reports. Anisocytosis has previously been associated with poorer prognosis in patients with coronary artery disease, congestive heart failure, pulmonary hypertension, pulmonary embolism, stroke, and sepsis, among other conditions. While anisocytosis is frequently present in patients with myelodysplastic syndromes (MDS), its prognostic significance is not well established. To address this, we conducted a survival analysis of patients with MDS evaluated at our clinical center. Methods To determine the association between anisocytosis and survival in patients with MDS, we conducted a retrospective cohort study. Patients with MDS evaluated at our institution between 1997 and 2011 were identified by searching medical records for ICD-9 diagnosis codes for MDS using the Clinical Looking Glass software. Patient records containing an MDS code were then examined for bone marrow biopsy results, and were included if consistent with MDS. Patient age, peripheral blood counts, cytogenetics findings, and bone marrow blast percentages at diagnosis, as well as the date of diagnosis, were abstracted from the medical record. Date of death was recorded from the medical record or by querying the Social Security Death Index. Anisocytosis was defined as an RDW ≥ 16.6%. Peripheral neutropenia was defined as an absolute neutrophil count < 800 cells/uL and a high bone marrow blast percentage as >5%. Low-risk cytogenetics was defined as either “Very Good” or “Good” by IPSS-R criteria; high-risk was either “Intermediate”, “Poor”, or “Very Poor.” We constructed Kaplan-Meier survival curves comparing those with anisocytosis to others. Survival was compared using the log-rank test. Next, we developed a Cox proportional hazards model to examine the association between anisocytosis and survival, after adjusting for age at diagnosis, hemoglobin concentration, platelet count, neutropenia, bone marrow blast percentage, and cytogenetics (values at diagnosis). Results are presented as the hazard ratio [HR] with 95% confidence interval [95% CI]. The study protocol was approved by the Montefiore Institutional Review Board. Results Of 543 patients initially identified, 30% (164/543) had bone marrow biopsies available. Of these, 84% (137/164) had cytogenetics data available. Anisocytosis at diagnosis was found in 57% (78/137). Median survival of patients with anisocytosis was 3.1 years compared to 8.5 years for those patients without anisocytosis (p = 0.02). In Cox regression analyses, anisocytosis was associated with worse prognosis (HR: 1.86 [95% CI: 1.06-3.35]). High-risk cytogenetics was significantly associated with decreased survival (HR: 3.47 [95% CI: 1.99- 5.94]). There was a trend toward a significant association between high bone marrow blast percentage and decreased survival (HR: 2.02 [95% CI: 0.96-4.01]). Age, hemoglobin concentration, platelet count, and presence of neutropenia were not significantly associated with survival. Conclusions In a single center retrospective chart review of patients with MDS, anisocytosis was associated with decreased survival when compared to patients with a normal or low RDW. This association remained in multivariable analysis adjusting for other well established prognostic variables. Our analysis was limited by a small sample size, potentially explaining the lack of significant associations found between survival and patient age, hemoglobin concentration, platelet count, and presence of neutropenia. However, it could also be possible that the effect of RDW supersedes the impact of peripheral cytopenias and even blast %, as reflected by the multivariate analysis. In conclusion, anisocytosis was significantly associated with patient prognosis and should be evaluated for for inclusion into future risk stratification systems. Disclosures: No relevant conflicts of interest to declare. more...
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- 2013
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39. Epidemiologic study of myelodysplastic syndromes in a racially diverse inner-city population
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Ashwin Sridharan, Ellen W. Friedman, Krishna Gundabolu, Amit Verma, Yiting Yu, K. H. Ramesh, and Rishi Jain
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Cancer Research ,medicine.medical_specialty ,education.field_of_study ,Epidemiologic study ,business.industry ,Myelodysplastic syndromes ,Population ,urologic and male genital diseases ,medicine.disease ,Oncology ,Inner city ,International Prognostic Scoring System ,Internal medicine ,medicine ,business ,education - Abstract
7125 Background: The International Prognostic Scoring System (IPSS) and the revised IPSS (IPSS-R) are used to assess prognosis after diagnosis of myelodysplastic syndromes (MDS). They are based on cytogenetics, bone marrow (BM) blasts, and number and degree of cytopenias. This retrospective analysis examined racial disparities in the presentation and survival of MDS patients (pts) in Bronx, NY. Methods: MDS pts treated at the Einstein/Montefiore system between 1997-2011 were included. Diagnosis was confirmed by review of BM biopsy. Demographics, cytogenetics (for 135/161 pts), blood counts, and BM blasts at diagnosis were collected. The Kaplan-Meier method was used for median survival estimates. The two-sample t-test and chi-square analysis were used to compare clinical variables between groups. Results: 161 pts with MDS were identified. Mean length of follow-up was 3.66 years (yrs). There were significant differences between mean age at diagnosis between Hispanics and African-Americans (66.5 vs 72.3 yrs, p more...
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- 2013
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40. Multiplicative Interaction Between Mean Corpuscular Volume and Red Cell Distribution Width in Predicting Mortality of Elderly Patients with and without Anemia
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Ellen W. Friedman, Pavlos Msaouel, Rishi Jain, Elizabeth A. Price, Ashwin Sridharan, Krishna Gundabolu, Stanley L. Schrier, Yiting Yu, Grigorios Chrysofakis, Amit Verma, and Anthony P. Lam
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Erythrocyte Indices ,Male ,Aging ,medicine.medical_specialty ,Pediatrics ,Outpatient Clinics, Hospital ,Anemia ,Immunology ,Erythrocytes, Abnormal ,Macrocytosis ,Gastroenterology ,Biochemistry ,Article ,Cohort Studies ,Internal medicine ,medicine ,Outpatient clinic ,Humans ,Mortality ,Hospitals, Teaching ,Mean corpuscular volume ,Survival analysis ,Aged ,Aged, 80 and over ,medicine.diagnostic_test ,business.industry ,Microcytosis ,Complete blood count ,Reproducibility of Results ,Red blood cell distribution width ,Cell Biology ,Hematology ,Prognosis ,medicine.disease ,Survival Analysis ,Cohort ,Erythrocyte Count ,Anisocytosis ,Female ,New York City ,business ,Biomarkers ,Follow-Up Studies ,circulatory and respiratory physiology - Abstract
Abstract 5150 Recent studies have shown that an elevated red cell distribution width (RDW) is an important predictor of adverse outcomes in a variety of clinical settings. The etiologies of an elevated RDW are different depending on mean corpuscular volume (MCV). If the effect of RDW on mortality differs by MCV (i. e., presence of interaction between RDW and MCV), studies of RDW using MCV as a simple covariate may result in spurious findings. In this study, we set out to confirm the importance of RDW in predicting mortality in a large outpatient cohort of elderly patients and to assess potential interaction between RDW and MCV by anemia status. Our cohort consisted of 36, 292 elderly (>=65yo) patients seen at an outpatient facility within the Einstein/Montefiore system from January 1st 1997 to May 1st 2008 who also had a complete blood count performed within 3 months of the initial visit. Using multivariate regression analyses, we examined the effect of RDW and MCV by anemia status in predicting overall mortality. With a maximum follow-up of 10 years, we found that an elevated RDW (>16. 6) increased risk of mortality in both non-anemic (adjusted HR=3. 55, p96 fL; HR=5. 22, p To assess the predictive value of using both RDW and MCV for risk stratification, we constructed Kaplan-Meier survival curves for each RDW and MCV category by anemia status. In both non-anemic (Fig 1a) and anemic patients (Fig 1b), survival was worse for those with macrocytosis and an elevated RDW. The median survival for this group of patients was 2. 7 years in non-anemics and 2. 2 years in anemics (vs. >10 years and 7. 1 years, respectively, in patients with normal RDW and MCV). For both non-anemic and anemic patients, stratifying by RDW and MCV allowed us to create subgroups with clear survival differences. Patients with an elevated RDW had worse survival than those without. Among both groups, survival was worst in patients with macrocytosis, followed by normocytosis then microcytosis. This pattern remained consistent regardless of anemia status. In conclusion, our results suggest a strong interaction between RDW and MCV in predicting overall mortality in non-anemic patients. Stratification by MCV or the addition of an interaction term to account for multiplicative effect between RDW and MCV is needed in future studies of RDW to avoid spurious results. Anemia status must also be taken into account when assessing RDW as a predictor of adverse outcomes as it affects the strength of the interaction. For both non-anemic and anemic patients, the addition of MCV appears to improve the prognostic value of RDW as a predictor of overall survival in elderly patients. Further studies are needed to better understand the mechanisms in which anisocytosis, especially in the setting of macrocytosis, predicts increased mortality. Figure 1a Figure 1a. Figure 1b Figure 1b. Disclosures: No relevant conflicts of interest to declare. more...
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- 2012
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