676 results on '"Pankaj Malhotra"'
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2. Noncommunicable disease incidence and mortality in Chandigarh Union Territory, 2018–2019: Findings from the Chandigarh Noncommunicable Disease Registry
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J. S. Thakur, Rajbir Kaur, Ronika Paika, Pankaj Malhotra, Sanjay Kumar Bhadada, Rakesh Kapoor, Rajesh Vijayvergiya, and Dheeraj Khurana
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age-adjusted rate ,incidence ,integrated disease registry ,mortality ,noncommunicable diseases ,Specialties of internal medicine ,RC581-951 - Abstract
Context: The Chandigarh Noncommunicable Disease (NCD) Registry was set up in 2018 to assess the burden of major NCDs and inform the planning of public health and clinical interventions. Aim: The aim of the present study was to assess the burden of NCDs in Chandigarh. Settings and Design: The cross-sectional study design includes data from government and private facilities, pathology laboratories, birth, and death registrar offices catering to urban and rural Chandigarh. Subjects and Methods: It collects data of young diabetes, stroke, acute cardiac events, aplastic anemia, and cancer patients using a structured questionnaire. Statistical Analysis Used: The study reports a descriptive analysis of case distribution, done using SPSS version 23. MS Excel 2016 was used to produce graphical illustrations and calculate age-adjusted rates using the world standard population. Results: During July 2018–December 2019, 3721 (incident and death) cases were recorded for cancer (n = 2414, 64.9%), acute cardiac events (n = 1034, 27.8%), stroke (n = 231, 6.2%), young diabetes (n = 28, 0.8%), and aplastic anemia (n = 14, 0.4%). The age-adjusted incidence and mortality rates (per 100,000 population) were calculated for cancer (males: 102.6 and 62.0; females: 100.8 and 52.9), acute cardiac events (males: 47.1; females: 21.7 and 28.8), and stroke (males: 7.5 and 8.5; females: 13.1 and 21.8). Study participants were exposed to tobacco and alcohol consumption. Positive family history was reported by 40% of the registered patients. Conclusions: An integrated model of the NCD registry is feasible and can yield evidence in low-resource settings for secondary prevention to achieve global targets for reducing risk factors and premature mortality due to NCDs.
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- 2024
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3. A systematic review on the epidemiology and treatment options of multiple Myeloma in Asia
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Wee-Joo Chng, Chandramouli Nagarajan, Shang-Yi Huang, Pankaj Malhotra, Yu-Yan Hwang, Vivian Blunk, Manmohan Singh, and Lin Wang
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Newly diagnosed multiple myeloma ,Relapsed/refractory multiple myeloma ,Autologous stem cell transplant ,Proteasome inhibitors ,B-cell maturation antigen targeted chimeric antigen receptor T-cell therapy ,Science (General) ,Q1-390 ,Social sciences (General) ,H1-99 - Abstract
Multiple myeloma (MM) accounts for almost 15 % of all neoplastic malignancies around the globe. This systematic review intends to analyse data on the treatment and management of MM in selected regions in Asia to identify and prioritize areas that need attention. A comprehensive review of original articles, published in English from 2005 to 2022, derived from the PubMed/MEDLINE database was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. There were 98 studies from select regions of Asia (China, India, Taiwan, Hong Kong, and Singapore) on newly diagnosed MM and relapsed/refractory MM. This review evaluated the trends in disease outcomes with the gradual shift in treatment regimens from doublet to triplet. Additionally, this review also explored autologous stem cell transplant outcome and anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy in MM patients. This is the first systematic review attempting to collect data on the utility and comparison of innovative agents and modifications in treatment regimens in the context of the Asian population. This review established that the body of evidence for the management of MM was generally of poor quality and there is a need for more versatile studies in the region. Novel and innovative drug regimens may help in combating the illness but consorted efforts by researchers, industry partners, policymakers, and the government are key factors in the long-term survival of MM patients. In the current systematic review, the authors have tried to give a comprehensive account of the available treatments, trends in MM management and prognosis for MM in Asia.
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- 2024
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4. Health-related quality of life and its determinants among cancer patients: evidence from 12,148 patients of Indian database
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Jyoti Dixit, Nidhi Gupta, Amal Kataki, Partha Roy, Nikita Mehra, Lalit Kumar, Ashish Singh, Pankaj Malhotra, Dharna Gupta, Aarti Goyal, Kavitha Rajsekar, Manjunath Nookala Krishnamurthy, Sudeep Gupta, and Shankar Prinja
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Cancer ,Health-related quality of life ,Utility scores ,Cancer site ,Type of treatment ,Treatment response ,Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
Abstract Background Cancer survivors experience a decrement in health-related quality of life (HRQoL) resulting from the disease as well as adverse effects of therapy. We evaluated the HRQoL of cancer patients, stratified by primary cancer site, stage, treatment response and associated adverse events, along with its determinants. Methods Data were collected from 12,148 patients, sampled from seven purposively chosen leading cancer hospitals in India, to elicit HRQoL using the EuroQol questionnaire comprising of 5-dimensions and 5-levels (EQ-5D-5L). Multiple linear regression was used to determine the association between HRQoL and various socio-demographic as well as clinical characteristics. Results Majority outpatients (78.4%) and inpatients (81.2%) had solid cancers. The disease was found to be more prevalent among outpatients (37.5%) and inpatients (40.5%) aged 45–60 years and females (49.3–58.3%). Most patients were found to be in stage III (40–40.6%) or stage IV (29.4–37.3%) at the time of recruitment. The mean EQ-5D-5 L utility score was significantly higher among outpatients [0.630 (95% CI: 0.623, 0.637)] as compared to inpatients [0.553 (95% CI: 0.539, 0.567)]. The HRQoL decreased with advancing cancer stage among both inpatients and outpatients, respectively [stage IV: (0.516 & 0.557); stage III (0.609 & 0.689); stage II (0.677 & 0.713); stage I (0.638 & 0.748), p value
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- 2024
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5. A multicentre, double-blind, placebo-controlled randomized trial of Mycobacterium w in critically ill patients with COVID-19 (ARMY-2)
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Inderpaul S Sehgal, Ritesh Agarwal, Atul Jindal, Md Sabah Siddiqui, Anant Mohan, Arnab Pal, Randeep Guleria, Ashish Bhalla, Kamal Kajal, Pankaj Malhotra, Goverdhan Dutt Puri, Sagar Khadanga, Rajnish Joshi, Sarman Singh, Saurabh Saigal, Nitin M Nagarkar, Vikas Suri, Sushma Bhatnagar, Pawan Tiwari, Mini P Singh, Laxmi Narayana Yaddanapudi, Saurabh Mittal, Anshika Chauhan, Gaurab Banerjee, Deependra K Rai, and Bikram K Gupta
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coronavirus ,covid ,mycobacterium indicus pranii ,mw ,mycobacterium w ,Diseases of the respiratory system ,RC705-779 - Abstract
Background: Mycobacterium w (Mw), an immunomodulator, resulted in better clinical status in severe coronavirus infectious disease 19 (COVID-19) but no survival benefit in a previous study. Herein, we investigate whether Mw could improve clinical outcomes and survival in COVID-19. Materials and Methods: In a multicentric, randomized, double-blind, parallel-group, placebo-controlled trial, we randomized hospitalized subjects with severe COVID-19 to receive either 0.3 mL/day of Mw intradermally or a matching placebo for three consecutive days. The primary outcome was 28-day mortality. The co-primary outcome was the distribution of clinical status assessed on a seven-point ordinal scale ranging from discharged (category 1) to death (category 7) on study days 14, 21, and 28. The key secondary outcomes were the change in sequential organ failure assessment (SOFA) score on days 7 and 14 compared to the baseline, treatment-emergent adverse events, and others. Results: We included 273 subjects (136 Mw, 137 placebo). The use of Mw did not improve 28-day survival (Mw vs. placebo, 18 [13.2%] vs. 12 [8.8%], P = 0.259) or the clinical status on days 14 (odds ratio [OR], 1.33; 95% confidence intervals [CI], 0.79-2.3), 21 (OR, 1.49; 95% CI, 0.83-2.7) or 28 (OR, 1.49; 95% CI, 0.79-2.8) between the two study arms. There was no difference in the delta SOFA score or other secondary outcomes between the two groups. We observed higher injection site reactions with Mw. Conclusion: Mw did not reduce 28-day mortality or improve clinical status on days 14, 21 and 28 compared to placebo in patients with severe COVID-19. [Trial identifier: CTRI/2020/04/024846]
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- 2024
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6. Understanding the Constraints and Optimization of Serum Immunofixation Electrophoresis and Serum Free Light Chains for Detecting Monoclonal Proteins: A Single-Center Experience
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Malvika Shastri, Pankaj Malhotra, Harvinder Kaur, and Ritu Aggarwal
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serum immunofixation ,serum free light chain ,multiple myeloma ,concordance ,discordance ,Medicine - Abstract
Introduction Serum immunofixation electrophoresis (SIFE) and serum free light chain (SFLC) assay are imperative investigations in diagnosis and follow-up of multiple myeloma (MM). SFLC assays are reported to have higher sensitivity than SIFE. However, discrepancies have been reported between them. The current study was aimed at assessing concordance and discordance between SIFE and SFLC results in MM.
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- 2023
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7. Cost-Effectiveness Analysis of Denosumab in the Prevention of Skeletal-Related Events Among Patients With Breast Cancer With Bone Metastasis in India
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Raina Wadhwa, Nidhi Gupta, Jyoti Dixit, Pankaj Malhotra, PVM Lakshmi, and Shankar Prinja
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
PURPOSEDenosumab is clinically superior to zoledronic acid (ZA) for preventing and delaying time to first and subsequent skeletal-related events (SREs) among patients with breast cancer (BC) with bone metastases. We evaluated the cost and health benefits of denosumab and ZA (once every 4 weeks and once every 12 weeks) among four different molecular subtypes of BC with bone metastases in India.MATERIALS AND METHODSA Markov model was developed in Microsoft Excel to estimate lifetime health consequences and resulting costs among cohort of 1,000 patients with BC with bone metastasis, for three intervention scenarios, namely denosumab (once every 4 weeks), ZA (once every 4 weeks), and ZA (once every 12 weeks). The health outcomes were measured in terms of SREs averted and quality-adjusted life-years (QALYs) gained. The cost of each intervention scenario was measured using both the health system and the patient's perspectives. Indirect costs because of lost productivity were not included. The future costs and outcomes were discounted at the standard rate of 3%.RESULTSOver a lifetime, the incremental number of SREs averted with use of denosumab once every 4 weeks (compared with ZA once every 4 weeks and once every 12 weeks) among patients with luminal A, luminal B, human epidermal growth factor receptor 2–enriched, and triple negative breast cancer were estimated as 0.39, 0.26, 0.25, and 0.19, respectively. The number of QALYs lived were slightly higher in the denosumab arm (1.45-2.80) compared with ZA once every 4 weeks and once every 12 weeks arms (1.44-2.78). However, denosumab once every 4 weeks was not found to be a cost-effective alternative for either of the four molecular subtypes of breast cancer. ZA once every 12 weeks was found to be a cost-effective option with an average cost-effectiveness ratio ranging between ₹68,254 and ₹73,636.CONCLUSIONZA once every 12 weeks is the cost-effective treatment option for BC with bone metastases in India. The present study findings hold significance for standard treatment guidelines under India’s government-funded health insurance program.
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- 2024
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8. Fertility and parenthood in patients with acute promyelocytic leukemia treated with Arsenic Trioxide and All-Trans retinoic acid
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Charanpreet Singh, Manpreet Saini, Arihant Jain, Deepesh Lad, Gaurav Prakash, Alka Khadwal, Shano Naseem, and Pankaj Malhotra
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Published
- 2024
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9. Multipronged strategy for protection and motivation of healthcare workers during the COVID-19 pandemic: a real-life study
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Madhumita Premkumar, Usha Dutta, Anchal Sandhu, Harman Kaur, Mini P Singh, Kapil Goyal, Rashmi Ranjan Guru, PVM Lakshmi, Madhu Gupta, Manisha Biswal, Arnab Ghosh, Anurag Sachan, Shikha Guleria, Swapanjeet Sahoo, Sandeep Grover, Tulika Gupta, Vipin Koushal, Mahesh Devnani, Shweta Talati, Ritin Mohindra, Vikas Suri, RK Ratho, Ashish Bhalla, Sanjay Jain, Pankaj Arora, Navin Pandey, Ashok Kumar, Arun K. Aggarwal, Arunaloke Chakrabarti, Goverdhan Dutt Puri, Jagat Ram, SS Pandav, Rakesh Sehgal, Pankaj Malhotra, Narayana Yaddanapuddi, Surjeet Singh, and PGIMER COVID-19 Healthcare Worker Welfare Taskforce
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Infectious and parasitic diseases ,RC109-216 ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract Objective: We aimed to assess risk of COVID-19 infection & seroprotection status in healthcare workers (HCWs) in both hospital and community settings following an intensive vaccination drive in India. Setting: Tertiary Care Hospital Methods: We surveyed COVID-19 exposure risk, personal protective equipment (PPE) compliance, vaccination status, mental health & COVID-19 infection rate across different HCW cadres. Elecsys® test for COVID-19 spike (Anti-SARS-CoV-2S; ACOVs) and nucleocapsid (Anti-SARS-CoV-2; ACOV) responses following vaccination and/or COVID-19 infection were measured in a stratified sample of 386 HCW. Results: We enrolled 945 HCWs (60.6% male, age 35.9 ± 9.8 years, 352 nurses, 211 doctors, 248 paramedics & 134 support staff). Hospital PPE compliance was 90.8%. Vaccination coverage was 891/945 (94.3%). ACOVs neutralizing antibody was reactive in 381/386 (98.7%). ACOVs titer (U/ml) was higher in the post-COVID-19 infection group (N =269; 242.1 ± 35.7 U/ml) than in the post-vaccine or never infected subgroup (N = 115, 204.1 ± 81.3 U/ml). RT PCR + COVID-19 infections were documented in 224/945 (23.7%) and 6 HCWs had disease of moderate severity, with no deaths. However, 232/386 (60.1%) of HCWs tested positive for nucleocapsid ACOV antibody, suggesting undocumented or subclinical COVID-19 infection. On multivariate logistic regression, only female gender [aOR 1.79, 95% CI 1.07–3.0, P = .025] and COVID-19 family contact [aOR 5.1, 95% CI 3.84–9.5, P < .001] were predictors of risk of developing COVID-19 infection, independent of association with patient-related exposure. Conclusion: Our HCWs were PPE compliant and vaccine motivated, with immunization coverage of 94.3% and seroprotection rate of 98.7%. There was no relationship between HCW COVID-19 infection to exposure characteristics in the hospital. Vaccination reduced disease severity and prevented death in HCW.
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- 2024
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10. Invasive Aspergillosis and Candidiasis in a Patient with Plasma Cell Myeloma
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Alka Khadwal, Kirti Gupta, Nabhajit Mallik, Madhurima Sharma, and Pankaj Malhotra
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multiple myeloma ,light chain deposition disease ,invasive fungal infections ,candidiasis ,aspergillosis ,autopsy ,Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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11. Real-world outcomes of diffuse large B-cell lymphoma in the biosimilar era
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Reena Nair, Gull Mohammad Bhat, Narendra Agrawal, Manju Sengar, Pankaj Malhotra, Soniya Nityanand, Chitra Lele, Pramod Reddy, Suresh Kankanwadi, and Narendra Maharaj
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rituximab ,real world ,DLBCL ,biosimilar ,Reditux™ ,Ristova® Rituximab ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
BackgroundDiffuse large B-cell lymphoma (DLBCL) is an aggressive and the most common type of non-Hodgkin lymphoma (NHL). The clinical use of rituximab has improved the treatment response and survival of patients with DLBCL. The introduction of rituximab biosimilar into healthcare system has helped in providing a cost-effective treatment to B-cell lymphoid malignancies as standard of care and has improved access to patients worldwide. The aim of this study was to observe the real-world effectiveness and safety of Reditux™ and Ristova® in DLBCL patients.MethodsObservational study in adults with DLBCL receiving Reditux™ or Ristova® across 29 centers in India (2015–2022). Effectiveness and safety were assessed up to 2 years after first dose.ResultsOut of 1,365 patients considered for analysis, 1,250 (91.6%) were treated with Reditux™ and 115 (8.42%) with Ristova®. At 2 years, progression-free survival (PFS) 69% [hazard ratio (HR), 1.16; 95% CI, 0.80–1.67], overall survival (OS) 78.7% (HR, 1.20; 95% CI, 0.78–1.86), response rates, quality of life (QoL), and overall safety in both the cohorts were comparable. The best overall response rate (BORR) at 6 months was comparable with no statistically significant differences between the Reditux™ and the Ristova® cohorts (89.2% vs. 94.3%). In multivariate analysis, BCL-2 and VAS were significant prognostic factors for PFS.ConclusionReditux™ and Ristova® were comparable in real-world setting.Clinical Trial RegistrationISRCTN registry, identifier (ISRCTN13301166)
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- 2023
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12. Prevalence and factors affecting cancer medication nonadherence among patients on chemotherapy: A systematic review protocol
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J S Thakur, Rajbir Kaur, Anjali Rana, Samir Malhotra, Rakesh Kapoor, and Pankaj Malhotra
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cancer ,compliance ,medication nonadherence ,Specialties of internal medicine ,RC581-951 - Abstract
Introduction: Adherence to cancer medication varies universally with compliance ranging from 70% to 80%. One of the main reasons cited is the cost of anticancer drugs which many may not be able to bear, and yet the cancer with extensive need of aggressive treatment affects the economic condition of people. Inequitable distribution of disease and service utilization poses the threat of an increase in cancer-related deaths due to poor treatment adherence. The suggested systematic review will assess the cancer medication nonadherence prevalence in cancer patients and identify cost-related, sociodemographic, comorbid conditions, and disease-specific aspects of medication nonadherence. Methodology: Eligibility criteria include any cancer patient on oral or intravenous chemotherapy with or without radiotherapy or surgical intervention. Electronic databases will be searched using predefined search terms to identify relevant studies. Observational, experimental, and qualitative studies (if available) will be included. Methodological quality of included studies will be assessed using the Mixed Methods Assessment Tool by Pace et al. Data synthesis will be done following a predesigned data extraction template, answering the research question. Quality of evidence for an association will be evaluated as per the GRADE system. Meta-analysis will be performed to quantify the association between multiple characteristics and nonadherence, if there is no data heterogeneity (tested using I2 test of heterogeneity). If applicable, meta-regression will be performed to address confounders. Conclusion: The authors have clearly described the methodology and intended outcomes. The findings will help in understanding the potential barriers to successful chemotherapy compliance among cancer patients.
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- 2023
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13. P1364: PHARMACOKINETIC PROFILE OF VARNIMCABTAGENE AUTOLEUCEL (IMN-003A), FIRST-IN-INDIA INDUSTRY CD19-DIRECTED CAR-T CELL THERAPY FOR PATIENTS WITH RELAPSED/ REFRACTORY B CELL MALIGNANCIES (IMAGINE STUDY)
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Pankaj Malhotra, Sunil Bhat, Sharat Damodar, Raja Thirumalairaj, Revathy Raj, Pooja Mallya, Akshatha Nayak, Ravi Joshi, Sudarshan Chougule, Deepak Mb, Sudeshna Dhar, Anne Roshan Joseph, Arun Kumar Mg, Jeetendra Kumar, Melina Soares, Sunil Yadav, Pallavi Arasu, Sri Ramulu Elluru, Mohammed Manzoor Akheel, Rahul Nahar, and Anil Kamat
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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14. P1409: PHASE-2 STUDY OF VARNIMCABTAGENE AUTOLEUCEL (IMN-003A) FIRST-IN-INDIA INDUSTRY CD19-DIRECTED CAR-T WITH FRACTIONATED INFUSIONS FOR PATIENTS WITH RELAPSED REFRACTORY B CELL MALIGNANCIES: IMAGINE STUDY
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Pankaj Malhotra, Sharat Damodar, Sunil Bhat, Raja Thirumalairaj, Revathy Raj, Akshatha Nayak, Pooja Mallya, Ravi Joshi, Deepak Mb, Sudarshan Chougule, Sudeshna Dhar, Arun Kumar Mg, Pallavi Arasu, Sri Ramulu Elluru, Mohammed Manzoor Akheel, and Anil Kamat
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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15. Financial toxicity of cancer treatment in India: towards closing the cancer care gap
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Shankar Prinja, Jyoti Dixit, Nidhi Gupta, Anushikha Dhankhar, Amal Chandra Kataki, Partha Sarathi Roy, Nikita Mehra, Lalit Kumar, Ashish Singh, Pankaj Malhotra, Aarti Goyal, Kavitha Rajsekar, Manjunath Nookala Krishnamurthy, and Sudeep Gupta
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financial toxicity ,catastrophic health expenditure ,impoverishment ,direct out of pocket expenditure ,indirect cost due to loss of productivity ,cancer ,Public aspects of medicine ,RA1-1270 - Abstract
BackgroundThe rising economic burden of cancer on patients is an important determinant of access to treatment initiation and adherence in India. Several publicly financed health insurance (PFHI) schemes have been launched in India, with treatment for cancer as an explicit inclusion in the health benefit packages (HBPs). Although, financial toxicity is widely acknowledged to be a potential consequence of costly cancer treatment, little is known about its prevalence and determinants among the Indian population. There is a need to determine the optimal strategy for clinicians and cancer care centers to address the issue of high costs of care in order to minimize the financial toxicity, promote access to high value care and reduce health disparities.MethodsA total of 12,148 cancer patients were recruited at seven purposively selected cancer centres in India, to assess the out-of-pocket expenditure (OOPE) and financial toxicity among cancer patients. Mean OOPE incurred for outpatient treatment and hospitalization, was estimated by cancer site, stage, type of treatment and socio-demographic characteristics. Economic impact of cancer care on household financial risk protection was assessed using standard indicators of catastrophic health expenditures (CHE) and impoverishment, along with the determinants using logistic regression.ResultsMean direct OOPE per outpatient consultation and per episode of hospitalization was estimated as ₹8,053 (US$ 101) and ₹39,085 (US$ 492) respectively. Per patient annual direct OOPE incurred on cancer treatment was estimated as ₹331,177 (US$ 4,171). Diagnostics (36.4%) and medicines (45%) are major contributors of OOPE for outpatient treatment and hospitalization, respectively. The overall prevalence of CHE and impoverishment was higher among patients seeking outpatient treatment (80.4% and 67%, respectively) than hospitalization (29.8% and 17.2%, respectively). The odds of incurring CHE was 7.4 times higher among poorer patients [Adjusted Odds Ratio (AOR): 7.414] than richest. Enrolment in PM-JAY (CHE AOR = 0.426, and impoverishment AOR = 0.395) or a state sponsored scheme (CHE AOR = 0.304 and impoverishment AOR = 0.371) resulted in a significant reduction in CHE and impoverishment for an episode of hospitalization. The prevalence of CHE and impoverishment was significantly higher with hospitalization in private hospitals and longer duration of hospital stay (p
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- 2023
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16. Cost-effectiveness analysis of different combination therapies for the treatment of chronic lymphocytic leukaemia in IndiaResearch in context
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Prerika Nehra, Akashdeep Singh Chauhan, Pankaj Malhotra, Lalit Kumar, Ashish Singh, Nidhi Gupta, Nikita Mehra, Anisha Mathew, Amal Chandra Kataki, Sudeep Gupta, and Shankar Prinja
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Cost effectiveness ,Leukaemia ,Chemotherapy ,Economic evaluation ,Public aspects of medicine ,RA1-1270 - Abstract
Summary: Background: Over the years, there has been introduction of newer drugs, like bendamustine and ibrutinib, for the management of chronic lymphocytic leukaemia (CLL). Though these drugs lead to better survival, they are also associated with higher cost. The existing evidence on cost effectiveness of these drugs is from high-income countries, which has limited generalisability for low-income and middle-income counties. Therefore, the present study was undertaken to assess the cost-effectiveness of three therapeutic regimens, chlorambucil plus prednisolone (CP), bendamustine plus rituximab (BR) and ibrutinib for CLL treatment in India. Methods: A Markov model was developed for estimating lifetime costs and consequences in a hypothetical cohort of 1000 CLL patients following treatment with different therapeutic regimens. The analysis was performed based on a limited societal perspective, 3% discount rate and lifetime horizon. The clinical effectiveness of each regime in the form of progression-free survival and occurrence of adverse events were assessed from various randomised controlled trials. A structured comprehensive review of literature was undertaken for the identification of relevant trials. The data on utility values and out of pocket expenditure was obtained from primary data collected from 242 CLL patients across six large cancer hospitals in India. Findings: As compared to the most affordable regimen comprising of CP as first-line followed by BR as second-line therapy, none of the other therapeutic regimens were cost-effective at one time per capita gross-domestic product of India. However, if the current price of either combination of BR and ibrutinib or even ibrutinib alone could be reduced by more than 80%, regimen comprising of BR as first-line therapy followed by second-line ibrutinib would become cost-effective. Interpretation: At the current market prices, regimen comprising of CP as first-line followed by BR as second-line therapy is the most cost-effective strategy for CLL treatment in India. Funding: Department of Health Research, Government of India.
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- 2023
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17. Autopsy findings of acute erythroid leukemia
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Mayur Parkhi, Nabhajit Mallik, Deepesh Lad, Man Updesh Singh Sachdeva, Amanjit Bal, Pankaj Malhotra, and Suvradeep Mitra
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Pancytopenia ,Leukemia ,Erythroblastic ,Acute ,Diagnosis ,Differential ,Medicine ,Internal medicine ,RC31-1245 - Abstract
Acute erythroid leukemia (AEL) is an exceedingly uncommon but distinct hematological malignancy that shows neoplastic proliferation of erythroid precursors with maturation arrest and no significant myeloblasts. We describe an autopsy case of this rare entity in a 62-year-old man with co-morbidities. He underwent a bone marrow (BM) examination for pancytopenia during the first outpatient department visit, which revealed an increased number of erythroid precursors with dysmegakaryopoiesis suggesting the possibility of Myelodysplastic syndromes (MDS). Thereafter, his cytopenia got worsened, warranting blood and platelet transfusions. Four weeks later on the second BM examination, AEL was diagnosed based on morphology and immunophenotyping. Targeted resequencing for myeloid mutations revealed TP53 and DNMT3A mutations. He was initially managed along febrile neutropenia with the stepwise escalation of antibiotics. He developed hypoxia attributed to anemic heart failure. Subsequently, he had hypotension and respiratory fatigue pre-terminally and succumbed to his Illness. A complete autopsy showed infiltration of various organs by AEL and leukostasis. Besides, there was extramedullary hematopoiesis, arterionephrosclerosis, diabetic nephropathy (ISN-RPS class II), mixed dust pneumoconiosis, and pulmonary arteriopathy. The histomorphology of AEL was challenging, and the differential diagnoses were many. Thus, this case highlights the autopsy pathology of AEL, an uncommon entity with a strict definition, and its relevant differentials.
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- 2023
18. Management of B-cell lineage acute lymphoblastic leukemia: expert opinion from an Indian panel via Delphi consensus method
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Vikram Mathews, Anu Korula, Anupam Chakrapani, Dinesh Bhurani, Jina Bhattacharyya, Manju Sengar, Pankaj Malhotra, Pavan Kumar Boyella, Pawan Kumar Singh, Prasanth Ganesan, Rishi Dhawan, Sameer Melinkeri, Sharat Damodar, Tuphan Kanti Dolai, and Venkatraman Radhakrishnan
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B-cell acute lymphoblastic leukemia ,relapsed/refractory ,India ,management ,consensus ,Delphi ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
IntroductionCurrently, there are no guidelines for the management of B-cell lineage acute lymphoblastic leukemia (B-ALL) from an Indian perspective. The diagnostic workup, monitoring, and treatment of B-ALL vary among different physicians and institutes.ObjectiveTo develop evidence-based practical consensus recommendations for the management of B-ALL in Indian settings.MethodsModified Delphi consensus methodology was considered to arrive at a consensus. An expert scientific committee of 15 experts from India constituted the panel. Clinically relevant questions belonging to three major domains were drafted for presentation and discussion: (i) diagnosis and risk assignment; (ii) frontline treatment; and (iii) choice of therapy (optimal vs. real-world practice) in relapsed/refractory (R/R) settings. The questionnaire was shared with the panel members through an online survey platform. The level of consensus was categorized into high (≥ 80%), moderate (60%–79%), and no consensus (< 60%). The process involved 2 rounds of discussion and 3 rounds of Delphi survey. The questions that received near or no consensus were discussed during virtual meetings (Delphi rounds 1 and 2). The final draft of the consensus was emailed to the panel for final review.ResultsExperts recommended morphologic assessment of peripheral blood or bone marrow, flow cytometric immunophenotyping, and conventional cytogenetic analysis in the initial diagnostic workup. Berlin–Frankfurt–Münster (BFM)–based protocol is the preferred frontline therapy in pediatric and adolescent and young adult patients with B-ALL. BFM/German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia–based regimen is suggested in adult patients with B-ALL. Immunotherapy (blinatumomab or inotuzumab ozogamicin) followed by allogeneic hematopoietic cell transplantation (allo-HCT) is the optimal choice of therapy that would yield the best outcomes if offered in the first salvage in patients with R/R B-ALL. In patients with financial constraints or prior allo-HCT (real-world practice) at first relapse, standard-intensive chemotherapy followed by allo-HCT may be considered. For subsequent relapses, chimeric antigen receptor T-cell therapy or palliative care was suggested as the optimal choice of therapy.ConclusionThis expert consensus will offer guidance to oncologists/clinicians on the management of B-ALL in Indian settings.
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- 2023
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19. Characterization of Immunophenotypic Aberrancies with Respect to Common Fusion Transcripts in B-Cell Precursor Acute Lymphoblastic Leukemia: A Report of 986 Indian Patients
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Dikshat Gopal Gupta, Neelam Varma, Shano Naseem, Man UpdeshSingh Sachdeva, Parveen Bose, Jogeshwar Binota, Ashish Kumar, Minakshi Gupta, Palak Rana, Preeti Sonam, Pankaj Malhotra, Amita Trehan, Alka Khadwal, and Subhash Varma
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acute leukemia ,acute lymphoblastic leukemias ,molecular biology ,molecular hematology ,neoplasia ,Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
Objective: Based on the immunophenotype, acute lymphoblastic leukemia (ALL) can be categorized into B-cell or T-cell lineages. B-cell precursor ALL (BCP-ALL) cases show various genetic/molecular abnormalities, and varying frequencies of chimeric fusion transcripts in BCP-ALL cases are reported from different parts of the world. We studied the immunophenotypic aberrancy profiles of a large number of BCP-ALL cases with respect to various common chimeric fusion transcripts. Materials and Methods: Flow cytometric immunophenotyping and multiplex reverse-transcription polymerase chain reaction assays were performed for 986 BCP-ALL cases. Results: Among 986 BCP-ALL cases, the incidence of various fusion transcripts was 38.36% in adult cases and 20.68% in pediatric cases. Adult BCP-ALL patients with t(9;22)(BCR-ABL1) fusion transcripts and expression of aberrant myeloid markers were significantly older at presentation (p=0.0218) with male preponderance (p=0.0246) compared to those without aberrant myeloid expression. In pediatric patients with the t(12;21)(ETV6-RUNX1) chimeric fusion transcript, aberrant expression of CD13 was observed in 39.13%, CD33 in 36.95%, and CD117 in 8.69% of patients, respectively. Pediatric BCPALL patients with the ETV6-RUNX1 fusion transcript and expression of aberrant myeloid markers were not significantly different compared to those without with respect to demographic and clinical/hematological characteristics (p=0.5955). Aberrant myeloid markers were rarely or never expressed in pediatric and adult BCP-ALL patients with the t(4;11)(KTM2A-AF4) and t(1;19)(TCF3-PBX1) fusion transcripts. Conclusion: Aberrant myeloid markers were frequently expressed among BCP-ALL patients with the t(9;22)(BCR-ABL1) and t(12;21) (ETV6-RUNX1) fusion transcripts. However, BCP-ALL patients with the t(4;11)(KTM2A-AF4) and t(1;19)(TCF3-PBX1) fusion transcripts rarely or never expressed aberrant myeloid markers. Aberrant myeloid CD markers can be used in predicting chimeric fusion transcripts at baseline so as to plan appropriate tyrosine kinase inhibitor therapy in cases of BCP-ALL with specific chimeric fusion transcripts. This study has delineated the relationship of chimeric fusion transcripts with the aberrant expression of myeloid markers in a large cohort of BCP-ALL cases.
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- 2022
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20. Outcomes of patients with hematologic malignancies and COVID-19 from the Hematologic Cancer Registry of India
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Arihant Jain, Lingaraj Nayak, Uday Prakash Kulkarni, Nikita Mehra, Uday Yanamandra, Smita Kayal, Sharat Damodar, Joseph M. John, Prashant Mehta, Suvir Singh, Pritesh Munot, Sushil Selvarajan, Venkatraman Radhakrishnan, Deepesh Lad, Rajan Kapoor, Biswajit Dubashi, Ram S. Bharath, Hasmukh Jain, P. K. Jayachandran, Jeyaseelan Lakshmanan, Thenmozhi Mani, Jayashree Thorat, Satyaranjan Das, Omprakash Karunamurthy, Biju George, Manju Sengar, and Pankaj Malhotra
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Published
- 2022
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21. Cost-Effectiveness of the First Line Treatment Options For Metastatic Renal Cell Carcinoma in India
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Dharna Gupta, Ashish Singh, Nidhi Gupta, Nikita Mehra, Pankaj Bahuguna, Vipul Aggarwal, Manjunath Nookala Krishnamurthy, Partha Sarathi Roy, Pankaj Malhotra, Sudeep Gupta, Lalit Kumar, Amal Kataki, and Shankar Prinja
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
PURPOSETyrosine kinase inhibitors such as sunitinib and pazopanib are the mainstay of treatment of metastatic renal cell carcinoma (mRCC) in India. However, pembrolizumab and nivolumab have shown significant improvement in the median progression-free survival and overall survival among patients with mRCC. In this study, we aimed to determine the cost-effectiveness of the first-line treatment options for the patients with mRCC in India.METHODSA Markov state-transition model was used to measure the lifetime costs and health outcomes associated with sunitinib, pazopanib, pembrolizumab/lenvatinib, and nivolumab/ipilimumab among patients with first-line mRCC. Incremental cost per quality-adjusted life-year (QALY) gained with a given treatment option was compared against the next best alternative and assessed for cost-effectiveness using a willingness to pay threshold of one-time per capita gross-domestic product of India. The parameter uncertainty was analyzed using the probabilistic sensitivity analysis.RESULTSWe estimated the total lifetime cost per patient of ₹ 0.27 million ($3,706 US dollars [USD]), ₹ 0.35 million ($4,716 USD), ₹ 9.7 million ($131,858 USD), and ₹ 6.7 million ($90,481 USD) for the sunitinib, pazopanib, pembrolizumab/lenvatinib, and nivolumab/ipilimumab arms, respectively. Similarly, the mean QALYs lived per patient were 1.91, 1.86, 2.75, and 1.97, respectively. Sunitinib incurs an average cost of ₹ 143,269 ($1,939 USD) per QALY lived. Therefore, sunitinib at current reimbursement rates (₹ 10,000 per cycle) has a 94.6% probability of being cost-effective at a willingness to pay threshold of 1-time per capita gross-domestic product (₹ 168,300) in the Indian context.CONCLUSIONOur findings support the current inclusion of sunitinib under India's publicly financed health insurance scheme.
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- 2023
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22. Effect of breathing intervention in patients with COVID and healthcare workers
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Manjari Rain, Goverdhan Dutt Puri, Aashish Bhalla, Pramod Avti, Balachundhar Subramaniam, Vipin Kaushal, Vinod Srivastava, Pranay Mahajan, Mini Singh, Navin Pandey, Pankaj Malhotra, Sonu Goel, Krishan Kumar, Naresh Sachdeva, Kalyan Maity, Prashant Verma, Nishant Dixit, Sheetal Jindal Gupta, Priya Mehra, Pooja Nadholta, Radhika Khosla, Shweta Ahuja, and Akshay Anand
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COVID-19 ,breathing technique ,D-dimer ,mindfulness ,yoga ,SpO2 ,Public aspects of medicine ,RA1-1270 - Abstract
BackgroundRegulated breathing facilitates ventilation and reduces breathlessness. However, the effect of Yogic breathing on patients with COVID remains unclear. We aimed to evaluate the efficacy of two breathing protocols, i.e., short breathing technique (SBT) and long duration breathing technique (LBDT).MethodsThree groups including COVID-positive patients, COVID-recovered patients, and healthcare workers (HCWs) were included in the study and segregated into Yoga and control groups. SBT was administered to COVID-positive patients. Both SBT and LBDT were administered to COVID-recovered patients and HCWs. A total of 18 biochemical parameters, a 6-min walk test (6MWT), and a 1-min sit-stand test (1MSST) were assessed on 0th, 7th, and 15th days, where biochemical parameters were the primary outcome. Pre-post estimation of neuropsychological parameters (nine questionnaires) and heart rate variability (HRV) were carried out. The paired t-test or Wilcoxon rank test was applied for pre-post comparison and the Student's t-test or Mann–Whitney U test was used for group comparison. Repeated measures test was applied for data recorded at three time points.ResultsA significant elevation in white blood cell (WBC) count was observed in COVID-positive intervention (p < 0.001) and control groups (p = 0.003), indicating no role of intervention on change in WBC number. WBC count (p = 0.002) and D-dimer (p = 0.002) significantly decreased in the COVID-recovered intervention group. D-dimer was also reduced in HCWs practicing Yogic breathing as compared to controls (p = 0.01). D-dimer was the primary outcome, which remained below 0.50 μg/ml (a cutoff value to define severity) in the COVID-positive yoga group (CYG) and decreased in the COVID-recovered yoga group (RYG) and the HCW yoga group (HYG) after intervention. A 6-min walk test (6MWT) showed an increase in distance covered among the COVID-positive patients (p = 0.01) and HCWs (p = 0.002) after intervention. The high-frequency power (p = 0.01) was found to be reduced in the COVID-positive intervention group. No significant change in neuropsychological parameters was observed.ConclusionYogic breathing lowered D-dimer, which is helpful in reducing thrombosis and venous thromboembolism in patients with COVID-19 besides lowering the chances of vaccine-induced thrombotic thrombocytopenia in vaccinated individuals. The breathing intervention improved exercise capacity in mild to moderate cases of COVID-19. Further studies can show if such breathing techniques can influence immunity-related genes, as reported recently in a study. We suggest that Yogic breathing may be considered an integrative approach for the management of patients with COVID.Trial registrationhttp://ctri.nic.in/Clinicaltrials/login.php, identifier: CTRI/2020/10/028195.
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- 2022
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23. Bisalbuminemia: A Pathologist’s Insight of an Uncommon Phenomenon
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Gargi Kapatia, Monika Wadhwa, Pankaj Malhotra, Gaurav Prakash, and Ritu Aggarwal
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gel electrophoresis ,albumin ,serum protein electrophoresis ,Medicine - Abstract
Background The incidence of a bifid electrophoretic pattern in the albumin region on serum protein electrophoresis is an infrequent phenomenon. The availability of literature from India is scarce and is limited to case reports. Objective The aim of the study is to analyze the frequency of bisalbuminemia in an Indian referral facility. The study delved into their clinical associations. Material and Methods The retrospective case records of the patient from the departmental database were scrutinized. The study subjects were for an 8-year study period. Results There were about 39,900 serum electrophoresis performed in an 8-year study period. A total of 40 cases of bisalbuminemia were detected. The incidence in our cohort was 0.01%. Conclusion Bisalbuminemia, an overtly benign condition, is infrequent in Indian population although not rare. It is associated with several clinical disorders; however, the association seems to be plausibly coincidental.
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- 2021
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24. Cost Effectiveness of Bevacizumab Plus Chemotherapy for the Treatment of Advanced and Metastatic Cervical Cancer in India—A Model-Based Economic Analysis
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Nidhi Gupta, Prerika Nehra, Akashdeep Singh Chauhan, Nikita Mehra, Ashish Singh, Manjunath Nookala Krishnamurthy, Kavitha Rajsekhar, Jayachandran Perumal Kalaiyarasi, Partha Sarathi Roy, Prabhat Singh Malik, Anisha Mathew, Pankaj Malhotra, Amal Chandra Kataki, Jyoti Dixit, Sudeep Gupta, Lalit Kumar, and Shankar Prinja
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
PURPOSEPatients with advanced and metastatic cervical cancer have a poor prognosis with a 1-year survival rate of 10%-15%. Recently, an antiangiogenic humanized monoclonal antibody bevacizumab has shown to improve the survival of these patients. This study was designed to assess the cost effectiveness of incorporating bevacizumab with standard chemotherapy for the treatment of patients with advanced and metastatic cervical cancer in India.METHODSUsing a disaggregated societal perspective and lifetime horizon, a Markov model was developed for estimating the costs and health outcomes in a hypothetical cohort of 1,000 patients with advanced and metastatic cervical cancer treated with either standard chemotherapy alone or in combination with bevacizumab. Effectiveness data for each of the treatment regimen were assessed using estimates from Gynecologic Oncology Group 240 trial. Data on disease-specific mortality in metastatic cervical cancer, health system cost, and out-of-pocket expenditure were derived from Indian literature. Multivariable probabilistic sensitivity analysis was undertaken to account for parameter uncertainty.RESULTSOver the lifetime of one patient with advanced and metastatic cervical cancer, bevacizumab along with standard chemotherapy results in a gain of 0.275 (0.052-0.469) life-years (LY) and 0.129 (0.032-0.218) quality-adjusted life-years (QALY), at an additional cost of $3,816 US dollars (USD; 2,513-5,571) compared with standard chemotherapy alone. This resulted in an incremental cost of $19,080 USD (7,230-52,434) per LY gained and $34,744 USD (15,782-94,914) per QALY gained with the use of bevacizumab plus standard chemotherapy.CONCLUSIONAddition of bevacizumab to the standard chemotherapy is not cost effective for the treatment of advanced and metastatic cervical cancer in India at a threshold of 1-time per-capita gross domestic product.
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- 2022
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25. COVID-19-related dynamic coagulation disturbances and anticoagulation strategies using conventional D-dimer and point-of-care Sonoclot tests: a prospective cohort study
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Pankaj Malhotra, Inderpaul Singh Sehgal, Virendra Singh, Amarjyoti Hazarika, Vikas Suri, Madhumita Premkumar, Sant Ram, Narayana Yaddanapudi, Ashish Bhalla, Goverdhan Dutt Puri, Narender Kumar, Sekar Loganathan, Kamal Kajal, Shiv Soni, Jasmina Ahluwalia, Kushal Kekan, Karan Singla, and Varun Mahajan
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Medicine - Abstract
Objectives Coagulation changes associated with COVID-19 suggest the presence of a hypercoagulable state with pulmonary microthrombosis and thromboembolic complications. We assessed the dynamic association of COVID-19-related coagulation abnormalities with respiratory failure and mortality.Design Single-centre, prospective cohort study with descriptive analysis and logistic regression.Setting Tertiary care hospital, North India.Participants Patients with COVID-19 pneumonia requiring intensive care unit (ICU) admission between August 2020 and November 2020.Primary and secondary outcome measures We compared the coagulation abnormalities using standard coagulation tests like prothrombin time, D-dimer, platelet count, etc and point-of-care global coagulation test, Sonoclot (glass beaded(gb) and heparinase-treated(h)). Incidence of thromboembolic or bleeding events and presence of endogenous heparinoids were assessed. Cox proportional Hazards test was used to assess the predictors of 28-day mortality.Measurement All patients underwent Sonoclot (glass beaded) test at admission apart from the routine investigations. In patients at risk of thromboembolic or bleeding phenomena, paired tests were performed at day 1 and 3 with Sonoclot. Activated clotting time (ACT) 75 units were used as the cut-off for hypercoagulable state. Presence of heparin-like effect (HLE) was defined by a correction of ACT ≥40 s in h-Sonoclot.Results Of 215 patients admitted to ICU, we included 74 treatment naive subjects. A procoagulant profile was seen in 45.5% (n=5), 32.4% (n=11) and 20.7% (n=6) in low-flow, high-flow and invasive ventilation groups. Paired Sonoclot assays in a subgroup of 33 patients demonstrated the presence of HLE in 17 (51.5%) and 20 (62.5%) at day 1 and 3, respectively. HLE (day 1) was noted in 59% of those who bled during the disease course. Mortality was observed only in the invasive ventilation group (16, 55.2%) with overall mortality of 21.6%. HLE predicted the need for mechanical ventilation (HR 1.2 CI 1.04 to 1.4 p=0.00). On multivariate analysis, the presence of HLE (HR 1.01; CI 1.006 to 1.030; p=0.025), increased C reactive protein (HR 1.040; CI 1.020 to 1.090; p=0.014), decreased platelet function (HR 0.901; CI 0.702 to 1.100 p=0.045) predicted mortality at 28days.Conclusion HLE contributed to hypocoagulable effect and associated with the need for invasive ventilation and mortality in patients with severe COVID-19 pneumonia.Trial registration NCT04668404; ClinicalTrials.gov.in. Available from https://clinicaltrials.gov/ct2/show/NCT04668404.
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- 2022
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26. Chronic Lymphocytic Leukemia: Real-World Data From India
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V. Tejaswi, Deepesh P. Lad, Nishant Jindal, Gaurav Prakash, Pankaj Malhotra, Alka Khadwal, Arihant Jain, Sreejesh Sreedharanunni, Manupdesh Singh Sachdeva, Shano Naseem, Neelam Varma, and Subhash Varma
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
PURPOSE Chronic lymphocytic leukemia (CLL) is uncommon in India. There are limited studies on CLL from the Indian subcontinent. METHODS This was a prospective study (2011-2017) of consecutively diagnosed patients with CLL at a single center. The diagnosis, prognosis, treatment indication, response criteria, and adverse events were recorded as per International Workshop on Chronic Lymphocytic Leukemia guidelines. Biosimilar rituximab dosing (375 mg/m2) was fixed for all cycles. Time to next treatment (TTNT) was defined as the time from front-line treatment initiation to next treatment or death from any cause. Overall survival (OS) was defined as the time from treatment initiation until death from any cause. RESULTS A total of 409 patients with CLL were enrolled over the study period. The median follow-up was 32 months (range, 2-135 months). The median age was 61 years, and 31.8% of patients with CLL were ≤ 55 years of age; 43.3% of patients had a cumulative illness rating scale score ≥ 3. Prognostic fluorescence in situ hybridization data were available in 53.3% of patients. Chlorambucil (94/180; 52.2%) and bendamustine + rituximab (BR; 57/180; 31.6%) were the most common regimens used up front. The overall response rates after front-line therapy were 74.4% and 91.2%, respectively. The TTNT was 33 months and not reached, respectively (P = .001). Grade 3/4 neutropenia and infections were seen in 52.6% and 38.5% of patients receiving BR. The median OS was not reached in both regimens (P = .25). CONCLUSION Indian patients with CLL are younger in chronological age but have higher morbidity burden. Treatment outcomes with biosimilar fixed-dose BR are comparable to those reported in the literature. Chlorambucil is still a valid option, given the economic burden of the disease and treatment.
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- 2020
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27. Bariatric surgery to aLleviate OCcurrence of Atrial Fibrillation Hospitalization—BLOC-AF
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Uma N. Srivatsa, MBBS, MAS, FHRS, Pankaj Malhotra, MD, Xin J. Zhang, MD, Neil Beri, MD, Guibo Xing, PhD, Ann Brunson, PhD, Mohamed Ali, MD, Dali Fan, MD, Nayereh Pezeshkian, MD, MPH, FHRS, Nipavan Chiamvimonvat, MD, and Richard H. White, MD
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Atrial fibrillation ,Bariatric surgery ,Heart failure ,Obesity ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background: Obesity is associated with a higher incidence of atrial fibrillation (AF). Weight reduction improves outcomes in patients known to have AF. Objective: The purpose of this study was to compare the incidence of heart failure (HF) or first-time AF hospitalization in obese patients undergoing bariatric surgery (BAS) vs other abdominal surgeries. Methods: A retrospective cohort study was conducted using linked hospital discharge records from 1994–2014. Obese patients without known AF or atrial flutter (AFL) who had undergone abdominal hernia or laparoscopic cholecystectomy surgery were identified for each case that underwent BAS (2:1). Clinical outcomes were HF, first-time hospitalization for AF, AFL, gastrointestinal bleeding (GIB), and ischemic or hemorrhagic stroke. Outcomes were analyzed using conditional proportional hazard modeling accounting for the competing risk of death, adjusting for demographics and comorbidities. Results: There were 1581 BAS cases and 3162 controls (48% age
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- 2020
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28. Prevention and management of carbapenem-resistant Enterobacteriaceae in haematopoietic cell transplantation
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Dangudubiyyam Sri Krishna Sahitya, Aditya Jandiyal, Arihant Jain, Jayastu Senapati, Saumya Nanda, Mukul Aggarwal, Pradeep Kumar, Sarita Mohapatra, Pallab Ray, Pankaj Malhotra, Manoranjan Mahapatra, and Rishi Dhawan
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Infectious and parasitic diseases ,RC109-216 - Abstract
Carbapenem-resistant Enterobacteriaceae (CRE) infections are associated with high morbidity and mortality rates in haematopoietic cell transplantation (HCT) recipients. Factors like mucositis, neutropenia, prolonged hospital stay, and frequent use of prophylactic antimicrobials make HCT recipients especially susceptible to CRE infections. Low culture positivity rates, delay in microbiological diagnosis, and resistance to empirical antimicrobial therapy for febrile neutropenia are responsible for high mortality rates in HCT recipients infected with CRE. In this review we discuss the epidemiology, diagnosis, and management of CRE infections with particular emphasis on patients undergoing HCT. We emphasise the need for preventive strategies like multidisciplinary antimicrobial stewardship, and pre-emptive screening for CRE colonisation in prospective HCT patients as measures to mitigate the adverse impact of CRE on HCT outcomes. Newer diagnostic tests like polymerase chain reaction and matrix-assisted laser desorption ionisation-time of flight (MALDI-TOF) assay that enable earlier and better identification of CRE isolates are discussed. Antimicrobial agents available against CRE, including newer agents like ceftazidime-avibactam and meropenem-vaborbactam, have been reviewed. We also discuss the data on promising experimental treatments against CRE: phage therapy and healthy donor faecal microbiota transplant. Finally, this review puts forth recommendations as per existing literature on diagnosis and management of CRE infections in blood and marrow transplant (BMT) unit.
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- 2021
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29. Factors associated with mortality among moderate and severe patients with COVID-19 in India: a secondary analysis of a randomised controlled trial
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Ashish Sharma, Anand Zachariah, Pankaj Malhotra, Ashish Jain, Priscilla Rupali, Gajanan Sapkal, Aparna Mukherjee, Vivek Kumar, Lakshmanan Jeyaseelan, Neha Singh, John Victor Peter, Anup Agarwal, Gunjan Kumar, Pranab Chatterjee, Tarun Bhatnagar, B Latha, Sunita Bundas, Ravi Dosi, Rosemarie de Souza, Simmi Dube, B Thrilok Chander, Shalini Bahadur, Amit Suri, Aikaj Jindal, Om Shrivastav, Vijay Barge, Archana Bajpayee, Muralidhar Tambe, Nimisha Sharma, Shreepad Bhat, Anil Gurtoo, D Himanshu Reddy, Kamlesh Upadhyay, Tinkal C Patel, Irfan Nagori, Pramod R Jha, C Aparna, Sunil Jodharam Panjwani, Milind Baldi, M Natarajan, Vrushali Khirid Khadke, Seema Dua, Joy John Mammen, Snehil Kumar, Dolly Daniel, Ravindraa Singh, Jayashree Sharma, Yojana A Gokhale, V Saravana Kumar, Himanshu Kaushal, Lovely Thomas, Jess Elizabeth Rasalam, Binila Chacko, Thenmozhi Mani, Melvin Joy, Malathi Murugesan, Janakkumar R Khambholja, Ram S Kaulgud, K V Sreedhar Babu, and Pragya D Yadav
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Medicine - Abstract
Objective Large data on the clinical characteristics and outcome of COVID-19 in the Indian population are scarce. We analysed the factors associated with mortality in a cohort of moderately and severely ill patients with COVID-19 enrolled in a randomised trial on convalescent plasma.Design Secondary analysis of data from a Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease.Setting 39 public and private hospitals across India during the study period from 22 April to 14 July 2020.Participants Of the 464 patients recruited, two were lost to follow-up, nine withdrew consent and two patients did not receive the intervention after randomisation. The cohort of 451 participants with known outcome at 28 days was analysed.Primary outcome measure Factors associated with all-cause mortality at 28 days after enrolment.Results The mean (SD) age was 51±12.4 years; 76.7% were males. Admission Sequential Organ Failure Assessment score was 2.4±1.1. Non-invasive ventilation, invasive ventilation and vasopressor therapy were required in 98.9%, 8.4% and 4.0%, respectively. The 28-day mortality was 14.4%. Median time from symptom onset to hospital admission was similar in survivors (4 days; IQR 3–7) and non-survivors (4 days; IQR 3–6). Patients with two or more comorbidities had 2.25 (95% CI 1.18 to 4.29, p=0.014) times risk of death. When compared with survivors, admission interleukin-6 levels were higher (p10 (9.97, 3.65–27.13, p1.0 mg/L (2.50, 1.14–5.48, p=0.022), ferritin ≥500 ng/mL (2.67, 1.44–4.96, p=0.002) and lactate dehydrogenase ≥450 IU/L (2.96, 1.60–5.45, p=0.001) were significantly associated with death.Conclusion In this cohort of moderately and severely ill patients with COVID-19, severity of illness, underlying comorbidities and elevated levels of inflammatory markers were significantly associated with death.Trial registration number CTRI/2020/04/024775.
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- 2021
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30. Systemic ALK-positive anaplastic large cell lymphoma involving implant site: a fortuitous association
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Mayur Parkhi, Charanpreet Singh, Rajender Kumar, Pankaj Malhotra, and Amanjit Bal
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Femoral Fractures ,Prostheses and Implants ,Lymphoma ,Large-Cell ,Anaplastic ,Anaplastic Lymphoma Kinase ,Medicine ,Internal medicine ,RC31-1245 - Abstract
Anaplastic lymphoma kinase (ALK) positive, anaplastic large cell lymphoma involving the non-mammary implant is an extremely rare presentation. Irrespective of the type or site, the implant-associated primary ALCL is morphologically and immunophenotypically similar to ALK-negative ALCLs. Herein, we present the case of a 42-year-old male who developed a lytic lesion after an implant for a right femur fracture. The lytic lesion biopsy revealed anaplastic large cell lymphoma with ALK protein expression. Imaging findings showed the widespread dissemination of disease all over the body, entrapping the implant too. ALCL involving the bone implant is a very unusual and rare presentation that needs to be documented.
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- 2021
31. Spectrum of Endocrine Dysfunction and Association With Disease Severity in Patients With COVID-19: Insights From a Cross-Sectional, Observational Study
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Liza Das, Pinaki Dutta, Rama Walia, Soham Mukherjee, Vikas Suri, Goverdhan Dutt Puri, Varun Mahajan, Pankaj Malhotra, Shakun Chaudhary, Rahul Gupta, Satyam Singh Jayant, Kanhaiya Agrawal, Vijay Kumar, Naresh Sachdeva, Ashu Rastogi, Sanjay Kumar Bhadada, Sant Ram, and Anil Bhansali
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COVID-19 ,endocrinology ,hormones ,central hypoadrenalism ,mixed thyroid dysfunction ,hypogonadism ,Diseases of the endocrine glands. Clinical endocrinology ,RC648-665 - Abstract
IntroductionEvidence on new-onset endocrine dysfunction and identifying whether the degree of this dysfunction is associated with the severity of disease in patients with COVID-19 is scarce.Patients and MethodsConsecutive patients enrolled at PGIMER Chandigarh were stratified on the basis of disease severity as group I (moderate-to-severe disease including oxygen saturation 94% and without comorbidities) (n=49). Hypothalamo-pituitary-adrenal, thyroid, gonadal axes, and lactotroph function were evaluated. Inflammatory and cell-injury markers were also analysed.ResultsPatients in group I had higher prevalence of hypocortisolism (38.5 vs 6.8%, p=0.012), lower ACTH (16.3 vs 32.1pg/ml, p=0.234) and DHEAS (86.29 vs 117.8µg/dl, p= 0.086) as compared to group II. Low T3 syndrome was a universal finding, irrespective of disease severity. Sick euthyroid syndrome (apart from low T3 syndrome) (80.9 vs 73.1%, p= 0.046) and atypical thyroiditis (low T3, high T4, low or normal TSH) (14.3 vs 2.4%, p= 0.046) were more frequent in group I than group II. Male hypogonadism was also more prevalent in group I (75.6% vs 20.6%, p=0.006) than group II, with higher prevalence of both secondary (56.8 vs 15.3%, p=0.006) and primary (18.8 vs 5.3%, p=0.006) hypogonadism. Hyperprolactinemia was observed in 42.4% of patients without significant difference between both groups.ConclusionCOVID-19 can involve multiple endocrine organs and axes, with a greater prevalence and degree of endocrine dysfunction in those with more severe disease.
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- 2021
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32. Development of National Cancer Database for Cost and Quality of Life (CaDCQoL) in India: a protocol
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Sudeep Gupta, Nidhi Gupta, Pankaj Malhotra, Lalit Kumar, Shankar Prinja, Gurpreet Singh, Kavitha Rajsekar, Jyoti Dixit, Nikita Mehra, Ashish Singh, Manjunath Nookala Krishnamurthy, Dharna Gupta, Jayachandran Perumal Kalaiyarasi, Partha Sarathi Roy, Prabhat Singh Malik, Anisha Mathew, Awadhesh Pandey, and Amal Kataki
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Medicine - Abstract
Introduction The rising economic burden of cancer on healthcare system and patients in India has led to the increased demand for evidence in order to inform policy decisions such as drug price regulation, setting reimbursement package rates under publicly financed health insurance schemes and prioritising available resources to maximise value of investments in health. Economic evaluations are an integral component of this important evidence. Lack of existing evidence on healthcare costs and health-related quality of life (HRQOL) makes conducting economic evaluations a very challenging task. Therefore, it is imperative to develop a national database for health expenditure and HRQOL for cancer.Methods and analysis The present study proposes to develop a National Cancer Database for Cost and Quality of Life (CaDCQoL) in India. The healthcare costs will be estimated using a patient perspective. A cross-sectional study will be conducted to assess the direct out-of-pocket expenditure (OOPE), indirect cost and HRQOL among cancer patients who will be recruited at seven leading cancer centres from six states in India. Mean OOPE and HRQOL scores will be estimated by cancer site, stage of disease and type of treatment. Economic impact of cancer care on household financial risk protection will be assessed by estimating prevalence of catastrophic health expenditures and impoverishment. The national database would serve as a unique open access data repository to derive estimates of cancer-related OOPE and HRQOL. These estimates would be useful in conducting future cost-effectiveness analyses of management strategies for value-based cancer care.Ethics and dissemination Approval was granted by Institutional Ethics Committee vide letter no. PGI/IEC-03/2020-1565 of Post Graduate Institute of Medical Education and Research, Chandigarh, India. The study results will be published in peer-reviewed journals and presented to the policymakers at national level.
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- 2021
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33. Retinal Involvement in COVID-19: Results From a Prospective Retina Screening Program in the Acute and Convalescent Phase
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Reema Bansal, Ashish Markan, Nitin Gautam, Rashmi Ranjan Guru, P. V. M. Lakshmi, Deeksha Katoch, Aniruddha Agarwal, Mini P. Singh, Vikas Suri, Ritin Mohindra, Neeru Sahni, Ashish Bhalla, Pankaj Malhotra, Vishali Gupta, and G. D. Puri
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acute ,convalescent ,coronavirus disease 2019 ,cotton wool spots ,retinopathy ,retina ,Medicine (General) ,R5-920 - Abstract
Objective: To detect retinal involvement in coronavirus disease 2019 (COVID-19) patients in acute and convalescent phase by their fundus screening.Methods: In a prospective, cross-sectional, observational study (July–November 2020), 235 patients (142 acute and 93 convalescent phase) underwent fundus screening in a tertiary care center in North India. For convalescent phase, “hospitalized” patients (73) were screened at least 2 weeks after hospital discharge, and “home-isolated” patients (20) were screened 17 days after symptom onset/COVID-19 testing.Results: None in acute phase showed any retinal lesion that could be attributed exclusively to COVID-19. Five patients (5.38%) in convalescent phase had cotton wool spots (CWSs) with/without retinal hemorrhage, with no other retinal finding, and no visual symptoms, seen at a median of 30 days from COVID-19 diagnosis.Conclusions: CWSs (and retinal hemorrhages) were an incidental finding in COVID-19, detected only in the convalescent phase. These patients were much older (median age = 69 years) than the average age of our sample and had systemic comorbidities (diabetes mellitus, hypertension, etc.). We propose the term “COVID-19 retinopathy” to denote the presence of CWSs at the posterior pole, occasionally associated with intraretinal hemorrhages, in the absence of ocular inflammation in patients with a history of COVID-19 disease.
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- 2021
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34. Safety of an immunomodulator Mycobacterium w in COVID-19
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Inderpaul Singh Sehgal, Ashish Bhalla, Goverdhan Dutt Puri, Laxmi Narayana Yaddanapudi, Mini Singh, Pankaj Malhotra, Sahajal Dhooria, Vikas Suri, and Ritesh Agarwal
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Diseases of the respiratory system ,RC705-779 - Published
- 2020
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35. Bone marrow emboli following bone marrow procedure: A possible complication
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Praveen Sharma, Arambam Gautam, Prashant Kumar, Pankaj Malhotra, Ritambhra Nada, and Jasmina Ahluwalia
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Pathology ,RB1-214 ,Microbiology ,QR1-502 - Published
- 2022
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36. Unique characteristics of leukocyte volume, conductivity and scatter in chronic myeloid leukemia
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Balan Louis Gaspar, Prashant Sharma, Neelam Varma, Dmitry Sukhachev, Ishwar Bihana, Shano Naseem, Pankaj Malhotra, and Subhash Varma
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Medicine (General) ,R5-920 ,Biology (General) ,QH301-705.5 - Abstract
Background: Modern automated hematology analyzers provide quantitative data on leukocyte size and structure that may be useful to distinguish reactive from neoplastic cellular proliferations. We compared leukocyte volume, conductivity and scatter (VCS) characteristics of chronic myeloid leukemia (CML), bcr-abl1-positive patients with those of non-neoplastic neutrophilia. Materials and methods: Complete blood counts and VCS data (LH750 hematology analyzers, Beckman Coulter) from 38 newly-diagnosed CML patients, 65 CML on imatinib mesylate therapy, 58 patients with elevated age-specific neutrophil counts due to varied causes, 100 pregnant women and 99 healthy controls were collated and compared. Receiver-operating-characteristic curves, logistic regression models and classification trees were studied for their abilities to distinguish various groups. Results: Untreated CML had higher mean neutrophil volume and mean monocyte volume (MNV and MMV), mean lymphocyte scatter (MLS) and higher standard deviations of the mean neutrophil volume and conductivity (MNV-SD and MNC-SD) over all other groups (p 163.0 AND MNC-SD>12.69 was 89.5% sensitive and 100% specific for CML. Two algorithmic classification-tree approaches using VCS parameters alone (i.e. without the aid of blood count parameters) correctly separated 100% cases of untreated CML from all others. Conclusion: Successful distinction of untreated but not post-imatinib CML patients from subjects who were either normal, pregnant or had reactive neutrophilia by automated analyzer-derived cell-population data opens possibilities for their applications in diagnosing and understanding the pathogenesis of CML. Keywords: Automated hematology analyzers, Cell population data, Cellular analysis, Chronic myeloid leukemia, Laboratory instrumentation, Neutrophilia
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- 2019
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37. Fluorescence In situ hybridization signal patterns and intrachromosomal breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 amplification analysis in imatinib-resistant chronic myelogenous leukemia patients using tricolor dual fusion probe
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Karthik B K. Bommannan, Shano Naseem, Neelam Varma, Jogeshwar Binota, Pankaj Malhotra, and Subhash Varma
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Breakpoint cluster region/Abelson murine leukemia viral oncogene homolog/arginosuccinate synthetase 1 tricolor dual fusion probe ,chronic myelogenous leukemia ,fluorescence in situ hybridization ,imatinib resistant ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
BACKGROUND: Cytogenetic evaluation is required till a complete cytogenetic remission is achieved in chronic myelogenous leukemia (CML) patients on tyrosine kinase inhibitor (TKI) therapy. The routine dual colour fluorescence in situ hybridization (FISH) probes are less sensitive in identifying der(9) abnormalities. BCR/ABL/ASS1 tri-colour dual fusion (TCDF) probe is highly sensitive and specific in identifying der(9) deletions and random signal overlaps. METHODS: Peripheral blood interphase FISH analysis was performed on imatinib-resistant CML patients using TCDF probe. RESULTS: On analyzing 37 adult patients, all had residual Philadelphia (Ph) chromosome. Classic Ph fusion pattern was seen in 33 (89%), derivative chromosome 9 [der(9)] abnormalities in 25 (67.5%) and supernumerary Ph chromosomes in 11 (30%) patients. Coexistence of classical fusion and der(9) abnormalities was seen in 21 patients (57%); and classical fusion, der(9) abnormalities and supernumerary Ph chromosome in 8 patients (22%). None of the patients had BCR-ABL1 gene amplification. There was significant difference in the der(9) abnormal cell percentages between patients with e13a2 and e14a2 transcripts (P = 0.008) and patients with disease transformation (P = 0.007). CONCLUSION: A high frequency of der(9) abnormalities and absence of BCR-ABL1 gene amplification was seen in imatinib-resistant CML patients analyzed. The use of TCDF probe for cytogenetic follow-up in CML patients was found to be useful in identifying BCR-ABL1 related aberrations. The identified patterns in this study, can serve as a reference material for I-FISH signal interpretation using TCDF probe.
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- 2019
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38. Role of plasma exchange in postpartum microangiopathies: An experience from a tertiary care center
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Rekha Hans, Satya Prakash, Divjot Singh Lamba, Ratti Ram Sharma, Pankaj Malhotra, Vanita Suri, and Neelam Marwaha
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microangiopathy ,plasma exchange ,postpartum ,Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
BACKGROUND: Postpartum microangiopathies are rare but are associated with high maternal and fetal mortality requiring early diagnosis and prompt treatment to improve the outcome. AIMS AND OBJECTIVES: This retrospective study aims to assess the efficacy of plasma exchange (PE) therapy in postpartum thrombotic microangiopathies. MATERIALS AND METHODS: We did retrospective analysis of all plasma exchange procedures performed in patients of postpartum thrombotic microangiopathies over a period of 1 year (2015-2016). Patient's pre- and post-plasma exchange hematological and biochemical parameters were recorded and compared for analyzing the response to the therapy. Patients were followed telephonically even after their discharge from the hospital. RESULTS: Hematological and renal profile improved in 8 out of 9 patients after PE therapy. Survival after PE therapy was 40% in post partum atypical HUS and 75% in patients with HELLP syndrome at 4 months of follow up. CONCLUSION: Early initiation of PE therapy in postpartum thrombotic microangiopathies can reduce morbidity and mortality associated with them.
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- 2019
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39. Plasmablastic lymphoma of bone marrow: Report of a rare case and immunohistochemistry based approach to the diagnosis
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Praveen Sharma, Sreejesh Sreedharanunni, Abin Koshy, Gaurav Prakash, Man Updesh Singh Sachdeva, and Pankaj Malhotra
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Anti-CD30 monoclonal antibody ,immunohistochemistry ,plasmablastic lymphoma ,Pathology ,RB1-214 ,Microbiology ,QR1-502 - Abstract
Plasmablastic lymphoma (PBL) is a distinctly rare neoplasm believed to arise from post-germinal center, terminally differentiated, activated B cells before transformation to plasma cells; and predominantly affecting human immunodeficiency virus (HIV) infected or immunodeficient males. Here, we report a rare case of primary PBL of bone marrow in an immunocompetent male, the diagnosis of which is complicated by the overlapping morphology and immunophenotype with several large cell lymphomas and plasma cell neoplasms; and showing dramatic response to anti-CD30 monoclonal antibody based therapy. We discuss the immunohistochemistry based approach and the possible diagnostic pitfalls in such cases. The inclusion of markers of plasmablastic differentiation in the diagnostic panel of large cell lymphomas is essential to avoid misclassification of these rare lymphomas.
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- 2019
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40. A randomised trial of Mycobacterium w in critically ill patients with COVID-19: ARMY-1
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Inderpaul Singh Sehgal, Randeep Guleria, Sarman Singh, Mohammad Sabah Siddiqui, Ritesh Agarwal, ARMY trial study group:, Anant Mohan, A. Jindal, A. Bhalla, Kamal Kajal, Pankaj Malhotra, Goverdhan Dutt Puri, Sagar Khadanga, Rajnish Joshi, S. Saigal, Nitin M. Nagarkar, Vikas Suri, Sushma Bhatnagar, Pawan Tiwari, Mini P. Singh, Laxmi Narayana Yaddanapudi, and Sourab Mittal
- Subjects
Medicine - Abstract
Purpose We investigated whether Mycobacterium w (Mw), an immunomodulator, would improve clinical outcomes in coronavirus disease 2019 (COVID-19). Methods We conducted an exploratory, randomised, double-blind, placebo-controlled trial of hospitalised subjects with severe COVID-19 (pulmonary infiltrates and oxygen saturation ≤94% on room air) conducted at four tertiary care centres in India. Patients were randomised 1:1 to receive either 0.3 mL·day−1 of Mw intradermally or a matching placebo for three consecutive days. The primary outcome of the study was the distribution of clinical status assessed on a seven-point ordinal scale ranging from discharged (category 1) to death (category 7) on study days 14, 21, and 28. The co-primary outcome was a change in SOFA (sequential organ failure assessment) score on days 7 and 14 compared to the baseline. The secondary outcomes were 28-day mortality, time to clinical recovery, time to reverse transcription PCR negativity, adverse events, and others. Results We included 42 subjects (22 Mw, 20 placebo). On days 14 (OR 30.4 (95% CI 3.3–276.4)) and 21 (OR 14.9 (95% CI 1.8–128.4)), subjects in the Mw arm had a better clinical status distribution than placebo. There was no difference in the SOFA score change on days 7 and 14 between the two groups. We did not find any difference in the mortality, or other secondary outcomes. We observed no adverse events related to the use of Mw. Conclusions The use of Mw results in better clinical status distribution on days 14 and 21 compared to placebo in critically ill patients with COVID-19.
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- 2021
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41. Multidimensional dynamic healthcare personnel (HCP)-centric model from a low-income and middle-income country to support and protect COVID-19 warriors: a large prospective cohort study
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Mini P Singh, Sanjay Jain, Gurmeet Singh, Ashok Kumar, Pankaj Malhotra, Manisha Biswal, Inderpaul Singh Sehgal, Ritesh Agarwal, Swapnajeet Sahoo, Muralidharan Jayashree, J S Thakur, Vipin Koushal, Vikas Suri, Rakesh Kochhar, Usha Dutta, Jayanta Samanta, Madhumita Premkumar, Arnab Ghosh, Narayana Yaddanapudi, Ritin Mohindra, Ashish Bhalla, Anurag Sachan, Tulika Gupta, Sandeep Grover, Sugandhi Sharma, P V M Lakshmi, Shweta Talati, Babita Ghai, Rajesh Chhabra, Bhavneet Bharti, Pankaj Arora, Sunita Malhotra, Rashmi Ranjan Guru, Navin Pandey, Ranjitpal Singh Bhogal, Arun K Aggarwal, Kapil Goel, Pranay Mahajan, Rakesh Sehgal, Arunaloke Chakrabarti, Goverdhan Dutt Puri, and Jagat Ram
- Subjects
Medicine - Abstract
Objectives Healthcare personnel (HCP) are at an increased risk of acquiring COVID-19 infection especially in resource-restricted healthcare settings, and return to homes unfit for self-isolation, making them apprehensive about COVID-19 duty and transmission risk to their families. We aimed at implementing a novel multidimensional HCP-centric evidence-based, dynamic policy with the objectives to reduce risk of HCP infection, ensure welfare and safety of the HCP and to improve willingness to accept and return to duty.Setting Our tertiary care university hospital, with 12 600 HCP, was divided into high-risk, medium-risk and low-risk zones. In the high-risk and medium-risk zones, we organised training, logistic support, postduty HCP welfare and collected feedback, and sent them home after they tested negative for COVID-19. We supervised use of appropriate personal protective equipment (PPE) and kept communication paperless.Participants We recruited willing low-risk HCP, aged
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- 2021
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42. High Prevalence of Hypocalcemia in Non-severe COVID-19 Patients: A Retrospective Case-Control Study
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Rimesh Pal, Sant Ram, Deepy Zohmangaihi, Indranil Biswas, Vikas Suri, Laxmi N. Yaddanapudi, Pankaj Malhotra, Shiv L. Soni, Goverdhan D. Puri, Ashish Bhalla, and Sanjay K. Bhadada
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COVID-19 ,calcium ,hypocalcemia ,hypovitaminosis D ,vitamin D ,Medicine (General) ,R5-920 - Abstract
Purpose: To compare serum total calcium and phosphate levels in patients with non-severe COVID-19 with age, sex, and serum 25-hydroxyvitamin D level matched healthy adult cohort.Methods: In this retrospective case-control study, medical records of patients (≥18 years) diagnosed as non-severe COVID-19 admitted at and discharged from our tertiary care institution during the period from April 10, 2020 and June 20, 2020 were retrieved. Baseline investigations, notably, serum calcium, phosphate, albumin, magnesium, 25-hydroxyvitamin D, and C-reactive protein (CRP), were performed at admission before any form of calcium or vitamin D supplementation were considered. The biochemical parameters were compared with age, sex, and 25-hydroxyvitamin D matched healthy adult controls (1:1 ratio) derived from the Chandigarh Urban Bone Epidemiological Study (CUBES).Results: After exclusion, 72 patients with non-severe COVID-19 (63 mild and 9 moderate disease) and an equal number of healthy controls were included in the final analysis. Age, sex, serum 25-hydroxyvitamin D, and albumin levels were matched between the 2 groups. Hypovitaminosis D and hypocalcemia were seen in 97 and 67% of the patients, respectively. The patients had lower serum calcium (P value
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- 2021
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43. NPM1 and FLT3-ITD/TKD Gene Mutations in Acute Myeloid Leukemia
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Shano Naseem, Jogeshwar Binota, Harpreet Virk, Neelam Varma, Subhash Varma, and Pankaj Malhotra
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Acute myeloid leukemia ,Nucleophosmin 1(NPM1) mutation ,FMS-like tyrosine kinase 3 (FLT3) mutation ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background: A number of mutations have been reported to occur in patients with acute myeloid leukemia (AML), of which NPM1 and FLT3 gene mutations are the commonest and have important diagnostic and therapeutic implications, respectively. Material and Methods: Molecular testing for NPM1 and FLT3 genes was performed in 92 de-novo AML patients. The frequency and characteristics of NPM1 and FLT3 mutations were analyzed. Results: Nucleophosmin 1(NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutations were seen in 22.8% and 16.3% of patients, respectively. Amongst FLT3 mutations, FLT3-ITD mutation was seen in 8.7% cases, FLT3-TKD in 5.4%, and FLT3-ITD+TKD in 2.2% cases. Certain associations between the gene mutations and clinical characteristics were found, including in NPM1 mutated group- female preponderance, the higher incidence in M4/M5 categories and decreased expression of CD34 and HLA-DR; and in FLT3-ITD mutated group- higher age of presentation, higher total leucocyte count and blast percentage. Conclusion- AML patients with NPM1 and FLT3 mutations have differences in clinical and hematological features, which might represent their different molecular mechanisms in leukemogenesis. The frequency of NPM1 and FLT3 mutations in this study was comparable to reports from Asian countries but lower than that reported from western countries. However, as the number of patients in the study was less, a larger number of patients need to be studied to corroborate these findings
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- 2021
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44. Lived Experiences of COVID-19 Intensive Care Unit Survivors
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Swapnajeet Sahoo, Aseem Mehra, Vikas Suri, Pankaj Malhotra, Lakshmi Narayana Yaddanapudi, GD Puri, and Sandeep Grover
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Psychiatry ,RC435-571 - Published
- 2020
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45. Transforming a General Hospital to an Infectious Disease Hospital for COVID-19 Over 2 Weeks
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Navin Pandey, Vipin Kaushal, Goverdhan Dutt Puri, Sunil Taneja, Manisha Biswal, Pranay Mahajan, Rashmi Ranjan Guru, Pankaj Malhotra, Inderpaul Singh Sehgal, Sahajal Dhooria, Valliappan Muthu, and Ritesh Agarwal
- Subjects
hospital management ,infection control ,isolation unit ,infectious disease hospital ,COVID-19 ,Public aspects of medicine ,RA1-1270 - Abstract
Pandemics like the coronavirus disease (COVID)-19 can cause a significant strain on the healthcare system. Healthcare organizations must be ready with their contingency plans for managing many patients with contagious infectious disease. Ideally, every large hospital should have a facility that can function as a high-level isolation unit. An isolation unit ensures that the healthcare staff and the hospital are equipped to deal with infectious disease outbreaks. Unfortunately, such facilities do not exist in several hospitals, especially in resource-limited settings. In such a scenario, healthcare setups need to convert their existing general structure into an infectious disease facility. Herein, we describe our experience in transforming a general hospital into a functional infectious disease isolation unit.
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- 2020
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46. DATA-DRIVEN PROGNOSTICS WITH PREDICTIVE UNCERTAINTY ESTIMATION USING ENSEMBLE OF DEEP ORDINAL REGRESSION MODELS
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Vishnu TV, Diksha, Pankaj Malhotra, Lovekesh Vig, and Gautam Shroff
- Subjects
recurrent neural networks ,remaining useful life estimation ,uncertainty estimation ,deep learning ,ordinal regression ,censored data ,Engineering machinery, tools, and implements ,TA213-215 ,Systems engineering ,TA168 - Abstract
rognostics or Remaining Useful Life (RUL) Estimation from multi-sensor time series data is useful to enable condition-based maintenance and ensure high operational availability of equipment. We propose a novel deep learning based approach for Prognostics with Uncertainty Quantification that is useful in scenarios where: (i) access to labeled failure data is scarce due to rarity of failures (ii) inherent noise ispresent in the sensor readings. The two scenarios mentioned are unavoidable sources of uncertainty in the RUL estimation process, often resulting in unreliable RUL estimates. To address (i), we formulate RUL estimation as an Ordinal Regression (OR) problem and propose LSTM-OR: deep Long Short Term Memory (LSTM) network-based approach to learn the OR function. We show that LSTM-OR naturally allows for the incorporation of censored operational instances in training along with the failed instances, leading to more robust learning. To address (ii), we propose a simple yet effective approach to quantify predictive uncertainty in the RUL estimation models by training an ensemble of LSTM-OR models. Through empirical evaluation on the publicly available turbofan engine benchmark datasets, we demonstrate that LSTMOR is at par with commonly used deep metric regressionbased approaches for RUL estimation when sufficient failed instances are available for training. Importantly, LSTM-OR outperforms these metric regression-based approaches in the practical scenario where failed training instances are scarce, but sufficient operational (censored) instances are additionally available. Furthermore, our uncertainty quantification approach yields high-quality predictive uncertainty estimates while also leading to improved RUL estimates compared to single best LSTM-OR models.
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- 2019
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47. Home-Based yoga program for the patients suffering from malignant lymphoma during chemotherapy: A feasibility study
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Gurpreet Kaur, Gaurav Prakash, Pankaj Malhotra, Sandhya Ghai, Sukhpal Kaur, Mahender Singh, and Kulbeer Kaur
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Acceptability ,adherence ,chemotherapy ,malignant lymphoma ,recruitment rate ,retention rate ,Miscellaneous systems and treatments ,RZ409.7-999 - Abstract
Background: Yoga is proven beneficial in improving quality of life among breast cancer survivors receiving chemotherapy, but its effectiveness in lymphoma patients needs to be explored. As chemotherapy-induced neutropenia is very common among lymphoma patients, they are much prone to infections from the environment. Furthermore, trained yoga instructors are not available in every setting, so there is a need to develop home-based yoga program modules for lymphoma patients receiving chemotherapy. Aim: The aim of the study was to explore the feasibility and safety of yogic exercises among lymphoma patients during chemotherapy. Subjects and Methods: An interventional, single-arm prepost design study was conducted at a tertiary health-care center. Patients suffering from malignant lymphoma (18–65 years) with Eastern Cooperative Oncology Group performance status from 0 to 2, planned to receive chemotherapy were administered a home-based yoga program over a period of 2 months from the start of chemotherapy. The primary outcome variables were retention rate, acceptance rate, safety, and adherence. Health-related quality of life (HRQOL), fatigue level, overall sleep quality, depression, anxiety level, and pain were also assessed. Statistical Analysis: Descriptive statistics was used to see the feasibility and adherence. The paired t-test was used to compare various pre and postintervention outcome measures. Results: Fourteen patients (median age: 36 years, range13–65 years) of malignant lymphoma were enrolled in the study. Male-to-female ratio was 9:5. Non-Hodgkin's lymphoma patients constituted 64%. The recruitment rate was 93%. Favorable retention (100%), acceptability (97%), adherence (78.6%), and no serious adverse events following yoga practice were reported. Improvement was also found in HRQOL, fatigue, sleep, depression, and anxiety. However, it needs further validation in a randomized study. Conclusion: Home-based yoga program is safe and feasible among the patients suffering from malignant lymphoma receiving chemotherapy.
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- 2018
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48. Variation in Adherence Measures to Imatinib Therapy
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Uday Yanamandra, Pankaj Malhotra, K.K. Sahu, Yanamandra Sushma, Neha Saini, Pooja Chauhan, Jasmeen Gill, Deepika Rikhi, Alka Khadwal, Gaurav Prakash, Deepesh Lad, Vikas Suri, Savita Kumari, Neelam Varma, and Subhash Varma
- Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Purpose: The introduction of tyrosine kinase inhibitors has transformed the care of patients with chronic myeloid leukemia, with survival approaching that of healthy individuals. Current-day challenges in chronic myeloid leukemia care include adherence to tyrosine kinase inhibitor therapy. We studied adherence from resource-constrained settings and tried to analyze the factors responsible for nonadherence in these individuals. We also correlated adherence to current molecular status. Patients and Methods: This was a single-center, cross-sectional, observational study from north India. It consisted of a questionnaire-based survey in which a one-to-one interview technique was used by trained nursing staff administering the Modified Morisky Adherence Scale (MMAS-9) questionnaire. Adherence was also measured on the basis of physician’s assessment. JMP 13.0.0 was used for statistical analysis. Results: A total of 333 patients with a median age of 42 years were included in the study. The median BCR-ABL/ABL ratio (IS) was 0.175 (0.0 to 98.0). The mean MMAS-9 score was 11 ± 2. Adherence was seen in 54.95% on the basis of MMAS-9, whereas physician’s assessment reported adherence in 90.39% of patients. Using the χ2 test, no relationship was found between the two assessment techniques. There was a significant relationship between major molecular response status and adherence by physician’s assessment and MMAS-9 (P < .001). Bivariate analysis by logistic fit showed a good relation between the MMAS-9 score and the BCR-ABL/ABL ratio (IS), χ2 (1,220) = 135.45 (P < .001). On multivariate analysis, enrolment in the Novartis Oncology Access program (a patient assistance program) was significantly associated with adherence (P = .012). Conclusion: This study highlights the lack of adherence in real-world settings and the various factors responsible. Such studies are important from a public health services perspective in various settings around the world because they may lead to corrective action being taken at the institutional level.
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- 2017
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49. Urban–rural differences in cancer incidence and pattern in Punjab and Chandigarh: Findings from four new population-based cancer registries in North India
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J S Thakur, Atul Budukh, Rakesh Kapoor, Pankaj Malhotra, Md Abu Bashar, S Kathirvel, Rajesh Dixit, Pankaj Arora, SPS Bhatia, and R A Badwe
- Subjects
Age-standardized incidence rates ,GLOBOCAN ,low- and middle-income countries ,population-based cancer registries ,Specialties of internal medicine ,RC581-951 - Abstract
Background: Establishment of a cancer registry is the first step in cancer control, and population-based cancer registries (PBCRs) are considered the gold standard for providing information on cancer incidence and mortality at population level. Materials and Methods: Earlier surveys reported a high prevalence of cancer in Punjab state. To address this issue and to provide reliable data on cancer incidence and mortality, four PBCRs were set up in Punjab and Chandigarh in year 2013 covering a total population of 4.5 million with PBCR Chandigarh and SAS Nagar, predominantly urban (covering 2.9 million population) and Mansa and Sangrur, predominantly rural (covering 2.6 million population). Results: Among males, Chandigarh and SAS Nagar have the age-standardized incidence rates (ASRs) of 93.5 and 73.5/100,000, respectively, whereas PBCR Mansa and Sangrur have age-standardized incidence rates (ASIRs) of only 45.3 and 43.7/100,000, respectively. Similarly, in females, PBCR Chandigarh and SAS Nagar have the ASIRs of 105.0 and 104.5/100,000, respectively, which was almost 2 times that seen at PBCR Mansa (55.8/100,000) and Sangrur (52.8/100,000). The incidence of breast cancer in females was 4–5 times higher in urban registries as compared to rural ones, whereas incidence of lung cancer was 4–7 times higher in urban registries. The most common cancer was lung cancer among males and breast cancer among females at PBCR Chandigarh and SAS Nagar, whereas it was esophagus among males and cervical cancer among females at PBCR Mansa and Sangrur. Conclusion: There were wider urban–rural differences with respect to incidence and pattern of cancers among the four registries which may be due to urbanization, lifestyle, and environmental factors which need to be explored further. Cancer incidence and pattern of cancer in Punjab are comparable with rest of the country.
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- 2017
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50. THE SPECTRUM OF HYPEREOSINOPHILIA AND ASSOCIATED CLONAL DISORDERS – A REAL WORLD DATA FROM A TROPICAL SETTING.
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Sreejesh Sreedharanunni, Neelam Varma, Man Updesh Singh Sachdeva, Shano Naseem, Pankaj Malhotra, Deepak Bansal, Amita Trehan, and Subhash Varma
- Subjects
Hypereosinophilia ,Hypereosinophilic syndromes ,Flow cytometry ,fluorescent in situ hybridization ,FIP1L1-PDGFRA ,clonal hypereosinophilia ,Imatinib responsive hypereosinophilia ,lymphocytic variant of hypereosinophilia ,Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
Objective: To determine the frequency, etiological spectrum and treatment outcome of hypereosinophilia (HE) and hypereosinophilic syndrome (HES) in a tropical setting. Methods: A retrospective analysis of hospital data of five years and a comprehensive prospective evaluation of patients presenting with HE/HES over a period of 33 months was performed. Results: HE/HES was diagnosed in total of 125 patients during study period with an estimated prevalence of 0.5-1 case per one lakh population in our hospital settings. Infections, especially helminthes were the commonest cause (34%) followed by primary/clonal HE/HES (24%) and reactive HE/HES secondary to various clonal disorders (14.3%). Lymphocytic variant of HES and FIP1L1-PDGFRA positive HES were diagnosed in 3.6% each. Imatinib responsive BCR-ABL1 negative HE/HES constitute 7.1% in our patients. Conclusions: None of the clinical or routine laboratory features including the age of patients, duration of HE, presence or absence of organomegaly, hemoglobin levels, eosinophil %, absolute eosinophil count, total leukocyte count, platelet counts, serum IgE levels or presence of myelofibrosis can be used to predict or exclude malignancy in patients with HE/HES. The absence of blasts in peripheral blood or the absence of >5% blasts in bone marrow does not exclude primary/clonal HES. Clonal disorders (Primary HES and reactive HES secondary to clonal disorders; 38%) are diagnosed with nearly equal frequency compared to infections (34%) in tropical settings necessitating a thorough follow-up and comprehensive work-up in these patients.
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- 2018
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