Publications by authors named "Manoj Panigrahi"

57 Publications

Lymphomas morphologically, immunohistochemically, and ISH compatible with BL: A single-center experience.

Indian J Pathol Microbiol 2021 Oct-Dec;64(4):870-872

Department of Pathology and Lab Services, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India.

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http://dx.doi.org/10.4103/IJPM.IJPM_715_20DOI Listing
October 2021

Seroprevalence of SARS-CoV-2 antibodies among healthcare workers in a teaching hospital in Eastern India.

J Family Med Prim Care 2021 Aug 27;10(8):2974-2979. Epub 2021 Aug 27.

Director, AIIMS, Bhubaneswar, Odisha, India.

Statement Of The Problem: Healthcare workers (HCW) are the most vulnerable group for contracting SARS-CoV-2. Assessment of seroprevalence of SARS-CoV-2 antibodies among HCW, thus can provide important data on pathogen exposure, infectivity, and adherence to personal protective equipment (PPE). The present study aimed at assessing SARS-CoV-2 seroprevalence among HCW and exploring associations with demographics, category of exposure to COVID-19 patients, preventive measures taken and relation with COVID-19 symptoms.

Method Of Study: HCWs with a minimum gap 2 weeks from last duty were eligible to participate in the study. The enrolled HCW were categorized into high-risk and low-risk category based on work in COVID-19 areas. HCWs SARS-CoV-2 specific IgG and IgM antibodies were detected using rapid immunochromatography test.

Results: Out of 821 randomly selected HCWs, either IgM or IgG antibody was detected in 32 HCWs (32/821, 3.9%). Only IgM antibodies were detected in 14 (1.7%), only IgG was detected in 9 (1.0%), and both IgM and IgG antibodies were present in 9 HCWs. Seropositivity was significantly higher in high-risk category (5.7% vs. 2.2.%), HCWs who ever had COVID-19 related symptoms in last 3 months (5.6% vs. 2.8%), and those who had earlier tested positive for SARS-CoV-2 with real-time reverse transcriptase PCR (36.6% vs. 3.5%). Seroprevalence was highest (6.9%) among housekeeping and sanitation staff.

Conclusions: Overall, low seroprevalence of SARS-CoV-2 antibodies in our HCWs is an indicator of effective infection control practice. HCW posted in dedicated COVID ward need more stringent implementation of infection prevention measures.
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http://dx.doi.org/10.4103/jfmpc.jfmpc_2486_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483124PMC
August 2021

Comparison of endobronchial ultrasound-guided transbronchial needle aspiration cytology versus cell blocks in adults with undiagnosed mediastinal lymphadenopathy.

Lung India 2021 Sep-Oct;38(5):425-430

Department of Pulmonary Medicine and Critical care, All India Institute of Medical Science, Bhubaneswar, Odisha, India.

Introduction: Retrospective studies have shown improved diagnostic yield of combined cytology and cell blocks specimens from endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) with variable additional yields in cell blocks. In this prospective study, we assessed the diagnostic performance of cytology and cell blocks in patients undergoing EBUS-TBNA.

Methods: This was a single-center, cross-sectional study conducted between December 2017 and November 2019 including patients aged ≥18 years with mediastinal lymphadenopathy. EBUS-TBNA was performed under conscious sedation using 22G needles. Both cytology smears and cell blocks by the tissue coagulum clot technique were prepared for each patient without rapid on-site evaluation.

Results: Data were analyzed for 93 patients (mean age 54.25 ± 13.7 years, 73 males) where both cytology and cell blocks were available. Sample adequacy was 100%. Overall diagnostic yield either by cytology or cell block was 83%. Cytology yield was 79.6%, whereas cell block was diagnostic in 73% of patients (P < 0.001). The overall additional yield of cell blocks was 3.2%. Cell blocks had additional yields of 1.8%, 0%, and 14.3% in malignancy, tuberculosis, and sarcoidosis, respectively. Tumor histology was better identified in 76% of positive cell blocks, and accurate histological subtyping was possible in 32.6% cases. Immunohistochemistry was feasible in 82.5% of all positive cell blocks, and these were judged to be adequate for the mutational analysis.

Conclusions: Compared to cytology, EBUS-TBNA cell blocks did not significantly increase the overall diagnostic yield in unselected patients. However, cell blocks are beneficial in the characterization of tumor morphology and histological subtyping of lung cancer.
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http://dx.doi.org/10.4103/lungindia.lungindia_836_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509166PMC
September 2021

Robust home brew fragment sizing assay for detection of MET exon 14 skipping mutation in non-small cell lung cancer patients in resource constrained community hospitals.

J Pathol Transl Med 2021 Sep 2;55(5):324-329. Epub 2021 Sep 2.

Section of Molecular Diagnostics, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.

Background: A mutation/deletion involving donor or acceptor sites for exon 14 results in splicing out of exon 14 of the mesenchymal epithelial transition (MET) gene and is known as "MET exon 14 skipping" (ΔMET14). The two recent approvals with substantial objective responses and improved progression-free survival to MET inhibitors namely capmatinib and tepotinib necessitate the identification of this alteration upfront. We herein describe our experience of ΔMET14 detection by an mRNA-based assay using polymerase chain reaction followed by fragment sizing.

Methods: This is a home brew assay which was developed with the concept that the transcripts from true ΔMET14 will be shorter by ~140 bases than their wild type counterparts. The cases which were called MET exon 14 skipping positive on next-generation sequencing (NGS) were subjected to this assay, along with 13 healthy controls in order to establish the validity for true negatives.

Results: Thirteen cases of ΔMET14 mutation were detected on NGS using RNA-based sequencing. Considering NGS as a gold standard, the sizing assay using both gel and capillary electrophoresis that showed 100% specificity for both with concordance rates of 84.6% and 88.2% with NGS, respectively, were obtained.

Conclusions: Owing to the cost-effective nature and easy to use procedures, this assay will prove beneficial for small- and medium-sized laboratories where skilled technical personnel and NGS platforms are unavailable.
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http://dx.doi.org/10.4132/jptm.2021.07.15DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8476318PMC
September 2021

Collateral Impact of the COVID-19 Pandemic on Acute Care of Non-COVID Patients: An Internet-based Survey of Critical Care and Emergency Personnel.

Indian J Crit Care Med 2021 Apr;25(4):374-381

Department of Critical Care, Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.

Purpose: The impact of disruption to the care of non-coronavirus disease (COVID) patients (COVID collateral damage syndrome-CCDS) is largely unknown in resource-limited settings. We investigated CCDS as perceived by healthcare workers (HCWs) providing acute and critical care services in India.

Materials And Methods: A clinician and nurse codesigned and validated an internet-based survey, which was disseminated to HCWs using a multiple frame sampling technique.

Results: Responses were received from 468 HCWs (completion rate 84%); at the time of the survey, 48% were working in critical care, 41% aged 30-40 years, and 53% represented public institutions. Respondents perceived a decrease in service utilization and disruption to time-sensitive acute interventions (60.1% and 40.8%, respectively), with fear of infection (score, 63.0; standard deviation (SD), 31.8) and restrictions due to lockdown (61.4; SD 32.5) being cited as the causes of service disruption. Being overwhelmed or lack of protective equipment was perceived to contribute less to CCDS. Insistence on COVID test results ( = 0.02) and duty-avoidance ( < 0.01) was perceived as significant causes for CCDS by HCWs from private hospitals and those in leadership roles, respectively.

Conclusions: Fear of infection and the effect of lockdown were perceived as important contributors to CCDS resulting in disruption to services and decreased service utilization. Perceptions were influenced by HCWs' role and hospital organizational structure.

How To Cite This Article: Tripathy S, Vijayaraghavan BKT, Panigrahi MK, Shetty AP, Haniffa R, Mishra RC, . Collateral Impact of the COVID-19 Pandemic on Acute Care of Non-COVID Patients: An Internet-based Survey of Critical Care and Emergency Personnel. Indian J Crit Care Med 2021;25(4):374-381.
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http://dx.doi.org/10.5005/jp-journals-10071-23782DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8138627PMC
April 2021

Concomitant echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase rearrangement and epidermal growth factor receptor mutation in non-small cell lung cancer patients from eastern India.

J Cancer Res Ther 2020 Jul-Sep;16(4):850-854

Department of Pathology, AIIMS, Bhubaneswar, Odisha, India.

Background: In non-small cell lung cancer common driver mutations such as epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) are usually mutually exclusive. This study aimed to elucidate the concurrence of EGFR mutation and ALK rearrangement in eastern India patients with primary lung adenocarcinoma and assess the response of EGFR tyrosine kinase inhibitor (TKI) therapy after 6 months in primary lung adenocarcinoma.

Methods: We retrospectively analyzed 198 adenocarcinomas for EGFR and ALK mutations. EGFR and ALK tests were done by real-time polymerase chain reaction and immunohistochemistry (IHC) techniques, respectively. Radiological response was assessed by Response Evaluation Criteria in Solid Tumors (version 1.1).

Results: EGFR/ALK co-alteration was found in 4 adenocarcinoma patients. All were males with advanced disease. Younger patients had exon 19 deletion whereas older ones showed exon 21 mutation. The initial option of ALK-TKI in all four patients was excluded straightaway due to the high-cost burden of ALK-TKI. Two of them showed a partial response while other two had stable disease after 6 months of EGFR TKI therapy.

Conclusion: EGFR/ALK co-alterations in adenocarcinomas albeit rare do exist. The challenge of monetary hurdle in developing countries with ALK TKI therapy can be handled by giving only EGFR TKI in these cases of concomitant mutations. Future perspective in research could be finding an agent with the potential of dual inhibition of ALK and EGFR.
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http://dx.doi.org/10.4103/jcrt.JCRT_678_18DOI Listing
November 2020

ROS1 positive non-small cell lung cancer with pulmonary embolism in a 22-year woman.

Monaldi Arch Chest Dis 2020 Aug 7;90(3). Epub 2020 Aug 7.

Department of Pulmonary Medicine and Critical Care, All India Institute of Medical Sciences, Bhubaneswar.

ROS1-rearrangement occurs in 1-2% of non-small cell lung cancer (NSCLC). This mutation is predominantly seen in relatively young, non-smoker, female with adenocarcinoma. Association of pulmonary embolism with ROS1-rearranged NSCLC has been suggested. We report a case of a 22-year-old woman with ROS1-positive NSCLC and pulmonary embolism. This case possibly represents the youngest patient in the literature.
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http://dx.doi.org/10.4081/monaldi.2020.1435DOI Listing
August 2020

CSF cell-free DNA EGFR testing using DdPCR holds promise over conventional modalities for diagnosing leptomeningeal involvement in patients with non-small cell lung cancer.

Lung Cancer 2020 10 5;148:33-39. Epub 2020 Aug 5.

Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, 110085, India.

Background: EGFR mutant NSCLC patients have leptomeningeal (LM) involvement in more than 9% cases.

Material & Methods: We conducted a study evaluating the diagnostic utility of cfDNA EGFR testing in CSF using DdPCR while comparing it against MRI and CSF cytology. We also looked for known EGFR mutations in the CSF sample. These mutations were also tested in paired plasma samples. We further compared which constituent of CSF (pellet/supernatant) had better yield.

Results: 21 patients comprised the study. Of these 17 patients were diagnosed to have LM involvement based on conventional criteria. All modalities had 100 % specificity and positive predictive value. However, MRI and CSF cytology had a poor negative predictive value. cfDNA had the highest sensitivity (92.3 %), negative predictive value (75 %), accuracy (94.1 %), and net comparative benefit. Paired plasma samples were available for 19 patients. Primary EGFR mutation was detectable in the CSF sample in 16/19 patients; however, the plasma sample was positive only in 7/19 patients. 3 samples were negative for primary EGFR mutation in both CSF and plasma. None of the CSF samples showed positivity for T790M mutation which could however be observed in two patients in plasma samples. Both supernatant and pellet were analysed for cfDNA mutation analysis in 18/21 patients. The intraclass correlation coefficient regarding the percentage fraction tumor-derived DNA of cfDNA observed was 0.83(95 % CI 0.29 to 0.95) between both samples.

Conclusion: EGFR detection in CSF has a potential role in diagnosing LM involvement. T790 M resistance mutations are uncommon in CSF post first and second-generation TKIs. Both supernatant and pellet samples can be used for the extraction of cell-free DNA in CSF.
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http://dx.doi.org/10.1016/j.lungcan.2020.07.034DOI Listing
October 2020

Late manifestation of follicular conjunctivitis in ventilated patient following COVID-19 positive severe pneumonia.

Indian J Ophthalmol 2020 Aug;68(8):1675-1677

Department of Microbiology, AIIMS, Bhubaneshwar, Odisha, India.

A 65-year-old known diabetic, hypertensive, and asthmatic patient was admitted for suspected coronavirus disease 19 (COVID-19) infection following complaints of breathlessness. He tested positive for COVID-19 and was put on ventilation. He developed severe follicular conjunctivitis of the right eye while on a ventilator, which was treated conservatively. The resolution of ocular signs was noted over 2 weeks without any complications. This case highlights the timeline of events and discusses the late ophthalmic manifestations in patients with COVID-19 infection.
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http://dx.doi.org/10.4103/ijo.IJO_1682_20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640827PMC
August 2020

Atypical presentation of hairy cell leukemia: a report and comprehensive review.

Blood Res 2020 Jun;55(2):123-127

Departments of Pathology and Laboratory Medicine, IMS and Sum Hospital, S'O'A Deemed to be University, Bhubaneswar, India.

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http://dx.doi.org/10.5045/br.2020.2020069DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7343552PMC
June 2020

Tuberculous splenic abscess in the immunocompetent host: a report and review of literature.

Monaldi Arch Chest Dis 2020 Feb 18;90(1). Epub 2020 Feb 18.

Department of Pulmonary Medicine and Critical Care, All India Institute of Medical Sciences, Bhubaneswar.

Tubercular splenic abscess is rare, particularly in immunocompetent patients. Diagnostic difficulties usually arise in patients with tubercular splenic abscess because of its non-specific presentation. We report an elderly male who presented with cough and fever and had pulmonary infiltrates suspicious of tuberculosis. Bronchoalveolar lavage microbiology including XpertMTB/Rif assay was non-contributory. Contrast enhanced computed tomography scan of abdomen revealed multiple non-enhancing lesions in the spleen. Ultrasound guided splenic aspirate revealed pus that was positive for Mycobacterium tuberculosis in XpertMTB/Rif assay confirming the diagnosis of tuberculosis.
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http://dx.doi.org/10.4081/monaldi.2020.1167DOI Listing
February 2020

Rasmussen's aneurysm masquerading as mass lesion.

BMJ Case Rep 2020 Feb 16;13(2). Epub 2020 Feb 16.

Pulmonary Medicine and Critical Care, All India Institute of Medical Sciences Bhubaneswar, Bhubaneswar, India

Haemoptysis is an often encountered respiratory symptom. The amount of haemoptysis varies from mild to life-threatening severity and may indicate the underlying pulmonary disorder. Herein, we report a 50-year-old male smoker who presented with occasional streaky to mild haemoptysis for last 1 year. He had pulmonary tuberculosis 10 years ago and had received adequate treatment. Chest radiograph was suspicious of a mass lesion in left upper lung. Contrast-enhanced CT scan of thorax revealed pulmonary artery pseudoaneurysm suggestive of Rasmussen's aneurysm. Unlike this case, Rasmussen's aneurysm usually manifests as life-threatening haemoptysis and portends a high mortality.
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http://dx.doi.org/10.1136/bcr-2019-232669DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7046436PMC
February 2020

Melioidosis in Odisha: A clinico-microbiological and epidemiological description of culture-confirmed cases over a 2-year period.

Indian J Med Microbiol 2019 Jul-Sep;37(3):430-432

Department of Pediatrics, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.

Melioidosis is an emerging infectious disease in India mostly reported from South-western coastal Karnataka and North-eastern Tamil Nadu. We speculate the existence of another major hidden focus in Odisha, one of the eastern coastal states. The clinico-epidemiological features of 47 culture-confirmed melioidosis at a tertiary care teaching hospital over a period of 2 years are reported. Septicaemia was the most common clinical presentation. Diabetes mellitus (DM) was present in 72.3% of our cases. The geo-climatic conditions of Odisha and other coastal states of India and the rise in the incidence of DM demand a nationwide surveillance of melioidosis and creation of melioidosis registry.
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http://dx.doi.org/10.4103/ijmm.IJMM_19_367DOI Listing
June 2020

Isolated persistent left superior vena cava in a young adult without cardiac disease.

Adv Respir Med 2019;87(6):272-273

All India Institute of Medical Sciences, Bhubaneswar, India.

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http://dx.doi.org/10.5603/ARM.2019.0068DOI Listing
July 2020

Predictive biomarkers in nonsmall cell carcinoma and their clinico-pathological association.

South Asian J Cancer 2019 Oct-Dec;8(4):250-254

Department of Molecular Diagnostics and Cell Biology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.

Background: Lung cancer is the leading cause of cancer-related mortality worldwide. Genome-directed therapy is less toxic, prolongs survival and provides a better quality of life. Predictive biomarker testing, therefore, has become a standard of care in advanced lung cancers. The objective of this study was to relate clinical and pathological features, including response to targeted therapy (TT) and progression-free survival (PFS) with positive driver mutation.

Materials And Methods: Archival data of nonsmall cell carcinoma patients with Stage IV disease were retrieved. Those who tested positive for one of the four biomarkers (epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], MET, and ROS) were included. Patient demographics and clinical features were reviewed. Tumor histomorphology was correlated with oncological drivers. Treatment response, PFS, and overall survival were studied in three subcohorts of patients who received computed tomography (CT), CT followed by TT and those who received TT in the first line.

Results: A total of 900 patients underwent biomarker evaluation of which 288 tested positive. Frequency of the four biomarkers observed was 26.6% (229/860), 6.6% (51/775), 6.6% (5/75), and 5.1% (3/59) for EGFR, ALK, MET, and ROS-1, respectively. The median PFS for EGFR-mutated cohort was 12 months, whereas it was 21 months for ALK protein overexpressing cases. Patients treated with first-line tyrosine kinase inhibitors performed better compared to those who were switched from chemotherapy to TT or those who received chemotherapy alone ( < 0.05).

Conclusion: Biomarker testing has improved patient outcome. Genome-directed therapy accords best PFS with an advantage of nearly 10 months over cytotoxic therapy.
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http://dx.doi.org/10.4103/sajc.sajc_373_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6852638PMC
December 2019

Droplet digital polymerase chain reaction offers an improvisation over conventional immunohistochemistry and fluorescent hybridization for ascertaining Her2 status of breast cancer.

South Asian J Cancer 2019 Oct-Dec;8(4):203-210

Amity Institute of Molecular Medicine and Stem Cell Research, Amity University, Noida, Uttar Pradesh, India.

Background: Droplet digital polymerase chain reaction (DDPCR) is a recent modality for detecting Her2 expression which is quantitative, cheaper, easier to standardize, and free from interobserver variation.

Purpose: The purpose of this study is to incorporate DDPCR in the current diagnostic paradigm with clinical benefit.

Materials And Methods: Fifty-four consecutive patients were tested by immunohistochemistry (IHC), fluorescent hybridization (FISH), and DDPCR. With FISH result as gold standard, receiver operating characteristic curves for DDPCR ratio were analyzed to label Her2-negative, equivocal, and positive cases as DDPCR score 1, 2, and 3, respectively. Proportion of patients labeled unequivocally as Her2 positive or negative was defined to have "clinically benefitted" from the test. Drawing parallel to inter-relationships between DDPCR, IHC, and FISH in the test cohort, four diagnostic pathways were defined - (1) initial IHC followed by FISH, (2) initial DDPCR followed by FISH, (3) initial IHC followed by DDPCR followed by FISH, and (4) initial DDPCR followed by IHC followed by FISH.

Results: Clinical benefit of DDPCR as an initial test in the test cohort was 57%, while it was 65% if used as a second-line test among those with an initial inconclusive IHC result. Sensitivity analysis in the simulation cohort revealed that if DDPCR cost was ≤0.6 times the cost of IHC, then a three-step pathway with DDPCR upfront would near certainly prove most cost beneficial. If DDPCR cost was >0.6 but ≤2 times the cost of IHC, then a three-step pathway with DDPCR as second-line test had a higher probability to prove most cost beneficial. If DDPCR cost was >2 times the cost of IHC, then conventional pathway had a higher probability to prove most cost-effective.

Conclusion: Incorporating DDPCR in the current clinical diagnostic paradigm has the potential to improve its cost-effectiveness and benefit.
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http://dx.doi.org/10.4103/sajc.sajc_344_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6852626PMC
December 2019

Diagnostic ability of real-time quantitative polymerase chain reaction versus immunohistochemistry for Ki-67 assessment in breast cancer: An Indian perspective.

Indian J Med Res 2019 09;150(3):254-260

Department of Laboratory & Transfusion Services, Rajiv Gandhi Cancer Institute & Research Centre, Delhi, India.

Background & Objectives: Breast cancer is the most common cancer of women. Inferior prognosis in some patients has been attributed to the higher proliferative capability of the tumour. Immunohistochemistry (IHC) for Ki-67, despite being a simple and cost-effective method, has not become a valid tool to evaluate this biomarker. This is ascribed to variation in pre-analytical and analytical techniques, variable expression, hotspot distribution and inter-and intra-observer inconsistency. This study was aimed at defining the analytical and clinical validity of real-time quantitative polymerase chain reaction (RT-qPCR) as an alternative to IHC evaluation.

Methods: This study included a total of 109 patients with invasive breast cancers. Ki-67 IHC visual assessment was compared with the mRNA value determined by RT-qPCR. Concordance between both the methods was assessed. Receiver operating characteristic (ROC) curve analysis and Cohen's kappa value with intraclass correlation were performed.

Results: The threshold value for Ki-67 by RT-qPCR obtained by ROC curve was 22.23 per cent, which was used to divide breast cancer cases into high proliferative and low proliferative groups. A significant correlation was observed between both the breast cancer groups formed using RT-qPCR threshold as well as median laboratory value of Ki-67 labelling index by IHC.

Interpretation & Conclusions: The study results showed a significant correlation between the two methods. While IHC is subject to technical and interpretative variability, RT-qPCR may offer a more objective alternative.
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http://dx.doi.org/10.4103/ijmr.IJMR_644_18DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886141PMC
September 2019

Corticosteroid as an Adjunct in the Treatment of Endobronchial Tuberculosis: A Systematic Review & Meta-analysis.

Curr Pediatr Rev 2020 ;16(1):53-60

Department of Pediatrics, AIIMS, Bhubaneswar, India.

Background: Corticosteroid exerts anti-inflammatory action and can prevent tissue damage resulting from various causes. Studies have shown that corticosteroids may prevent the damaging effect of tuberculosis (TB) in various organs, but there is no published meta-analysis specifically looking for the effect of corticosteroid in endobronchial TB.

Objective: To synthesize the evidence regarding the usefulness of corticosteroid in endo-bronchial TB.

Methods: A comprehensive search was performed of the major electronic databases till 30th November 2018. Randomized trials comparing treatment with corticosteroid as an adjunct to antitubercular drugs (ATT) versus placebo/no treatment in endobronchial TB were included. Three authors independently applied eligibility criteria, assessed the studies for methodological quality, and extracted data. The review is registered at PROSPERO database [CRD42016047063].

Results: Out of 525 search results, 4 trials including 205 patients (151 children) were eligible for inclusion. Oral prednisolone was used in various dose schedules. Rifampicin containing ATT regimen was used in 3 trials. The bronchoscopy findings showed no significant improvement at 1 month (effect size could not be calculated due to 0 event in the intervention group, p = 0.05), 2 months (RR 1.26, 95% CI 0.89 to 1.8), and at completion of ATT (RR 0.63, 95% CI 0.1 to 4.14) in steroid-treated group compared to the control group. The need for repeat bronchoscopy was significantly decreased in the steroid group (RR 0.13, 95% CI 0.02 to 0.9). Among the adverse events, the infection rate was significantly lesser in the steroid group (RR 0.53, 95% CI 0.29 to 0.97); but other adverse events (mortality, hypertension, and abdominal distension) showed no significant difference between the two groups. The GRADE evidence generated was of very low quality.

Conclusion: The present meta-analysis showed that oral steroid does not help patients with endobronchial tuberculosis. However, the quality of evidence was very low. Future trials with robust design and a larger sample size would be required to provide any firm recommendation regarding the use of oral prednisolone in endobronchial tuberculosis.
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http://dx.doi.org/10.2174/1573396315666191016100615DOI Listing
January 2021

Immunophenotyping of male breast cancer - Experience at a tertiary care centre.

Indian J Pathol Microbiol 2019 Apr-Jun;62(2):226-231

Department of Pathology, Rajiv Gandhi Cancer Institute and Research Centre, Delhi, India.

Background: Male breast cancers (MBCs) are uncommon and account for 1% of all breast cancers. Medical conditions that increase the estrogen to testosterone ratio are implicated as the risk factors. Morphologically similar, but MBCs have biological differences compared with female breast cancer (FBC).

Purpose: The present study was aimed to examine the immunophenotype of MBC, subsequent molecular subtypes, their association with clinicopathological features, and prognosis.

Materials And Methods: We analyzed clinicopathological features of 42 cases of MBC, and classified them according to molecular classification using immunohistochemistry (IHC). This is the second largest study from India.

Results And Conclusion: Median age of patients was 61 years (age range: 41-87 years). Invasive duct carcinoma comprised 95.2% of cases. Tumor grade II and III was seen in 50% and 47.6% of cases, respectively, and advanced stage disease (III/IV) was seen in 45.2% cases (n = 39). Estrogen receptor (ER) was positive in 97.6% cases, progesterone receptor (PR) in 83.3%, androgen receptor (AR) in 76.2%, HER2 in 4.8%, Cyclin-D1 in 92.9%, Bcl2 in 66.7%, GCDFP-15 in 23.8%, p53 in 16.7%, and Ki67 index was low (<14%) in 66.7% cases. Molecular subtyping of these cases revealed 64.3% of luminal A, 35.7% of luminal B, and no HER2 rich/driven category or triple negative case. There was no statistical significance between luminal A and B category pertaining to overall stage of tumor (P = 0.905). Lymph node metastasis was more commonly associated with luminal B category (P = 0.089). p53 positivity showed significant association with luminal A cases (P = 0.002) and nodal metastasis (P = 0.042). GCDFP-15 positivity showed significant association with higher tumor grade (P = 0.042) and stage (P = 0.047). Stage was the most significant prognostic marker (P < 0.0001). On follow-up (n = 27), all the six cases that showed recurrence/persistent disease were high stage (III/IV) on presentation.
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http://dx.doi.org/10.4103/IJPM.IJPM_543_18DOI Listing
August 2019

Germline and deleterious mutations and variants of unknown clinical significance associated with breast/ovarian cancer: a report from North India.

Cancer Manag Res 2018 30;10:6505-6516. Epub 2018 Nov 30.

Department of Research, Rajiv Gandhi Cancer Institute and Research Centre, Rohini, Delhi 110085, India.

Background: The spectrum of BRCA mutations that predispose to development of breast/ovarian cancer in Indian population remains unexplored. We report incidence and various types of pathogenic, likely pathogenic and variants of unknown significance (VUS) mutations in and genes observed at a tertiary cancer center in North India.

Materials And Methods: A total of 206 unrelated breast and/or ovarian cancer patients, who met the National Comprehensive Cancer Network (NCCN) guidelines for genetic testing, were screened for germline / mutations on high-throughput sequencing platform; large genomic rearrangements were assessed by multiple ligation probe assay. Mutations were mined in mutational databases, PubMed, and discerned into classes. Furthermore, the clinicopathological correlation of BRCA mutation status with prognostic markers in breast cancer and tumor histology in ovarian cancer was performed.

Results: In total, 45/206 and 17/206 cases showed positivity for and mutations, respectively, whereas 1/206 was positive for a mutation in both the genes. Altogether, 33 distinct mutations were observed, among which 27 were deleterious (12 frameshifts, 8 nonsense, 1 missense, 3 splice-site variants, 2 big deletions and 1 large duplication) and 6 were VUS. Five novel mutations (c.541G>T, c.1681delT, c.2295delG, c.4915C>T and exon 23 deletion) were identified. Seven mutations (c.2214_2215insT, c.2295delG, c.3607C>T,c.4158_4162delCTCTC, c.4571C>A, splicesite_3 (C>T) and exon 21-23 duplication) occurred more than once, whereas 16 distinct mutations were noted - 9 were lethal (6 frameshifts, 2 nonsense and 1 big deletion) and 7 VUS. One unique pathogenic mutation (c.932_933insT) was recognized. Two mutations (c.9976A>T and c.10089A>G) recurred twice. No significant difference in hormone receptor status was observed among carriers, carriers and noncarriers.

Conclusion: We have documented various pathogenic and VUS mutations in and genes observed in the cohort. Six novel mutations were identified. The knowledge shared would assist genetic testing in enabling more focused site-specific screening for mutations in biological relatives.
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http://dx.doi.org/10.2147/CMAR.S186563DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6280886PMC
November 2018

Clinico-pathological Features of Mutation in HER2-Positive Breast Cancer of Indian Population.

Indian J Surg Oncol 2018 Sep 3;9(3):381-386. Epub 2018 May 3.

1Department of Bioengineering and Technology, Gauhati University, Assam, 781014 India.

pathway is one of the important signaling pathways in cells, which is involved in cell proliferation, cell survival, motility, and growth. Mutation in gene negatively effects to anti-HER2 therapy in breast cancer patients. gene of HER2-positive breast cancers associated with reduced sensitivity to neoadjuvant therapy. In this study, we assessed the frequency of mutations and influence of mutations on patient survival in a series of HER2-positive breast cancer patients. mutations were assessed by pyrosequencing and next generation sequencing in 107 HER2-positive breast cancer patients of a tertiary Cancer Centre of India from Jan 2012 to Jun 2013 with minimum follow-up of 3 years. We found mutations in 26 tumors (24.2%) of which 5 were in exon 9, 20 were in exon 20, and 1 was in both exon 9 and 20. In exon 9, the mutation c.1634A>G was found in 4 cases and mutation c.1636C>A was found in 2 cases. In exon 20, the mutation c.3140A>G was found in 15 cases and c.3140A>T was found in 6 cases. The outcome between mutated versus wild type was significant showing value 0.014. Overall survival of mutation and treatment with herceptin, mutation with other chemotherapy treatment in both early breast cancer (EBC), and locally advanced breast cancer (LABC) showed significant value 0.037 and 0.044 respectively. In conclusion, we identified 24.2% somatic mutation of PIK3CA in HER2-positive breast cancer patients. PIK3CA mutation is significantly associated with ER-positive tumors. The frequency and distribution pattern reported in this study is similar to the global report. Overall survival of PIK3CA mutation is slightly lower but in patients who received herceptin with PIK3CA mutation showed better clinical outcome.
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http://dx.doi.org/10.1007/s13193-018-0749-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6154351PMC
September 2018

The detection of primary and secondary EGFR mutations using droplet digital PCR in patients with nonsmall cell lung cancer.

Lung India 2018 Sep-Oct;35(5):384-389

Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.

Background: We share our experience of using droplet digital polymerase chain reaction (DdPCR) in liquid biopsy specimens for detecting primary and secondary epidermal growth factor receptor (EGFR) mutations among patients with nonsmall-cell lung cancer who had tissue biopsy initially analyzed for del19, L858R and T790M.

Materials And Methods: Three groups of patients were chosen: Group 1: patients positive for EGFR mutation (del 19 or L858R) by conventional tissue biopsy that were treatment naïve, Group 2: patients positive for EGFR mutation (del 19 or L858R) by conventional tissue biopsy with acquired resistance to tyrosine kinase inhibitor (TKI) therapy, documented by radiology, and Group 3: no known EGFR mutation detected on primary tissue biopsy and treatment naive.

Results: One hundred and thirty-three patients were included in the study. Group 1 had 40 cases, of which 21 (52.5%) and 19 (47.5%) were positive for del19 and L858R mutations, respectively, by tissue biopsy. DdPCR detected primary mutation in all but 5 cases. DdPCR additionally found four patients to have T790M mutation. Group 2 had 73 cases and DdPCR detected T790M mutation in 39 (53.4%) cases. Liquid biopsy also picked the original primary mutation in 56/73 cases. Secondary tissue biopsy for T790M mutation status was performed in 11 patients and while it detected mutation in 2 out of 11 cases, DdPCR detected the same in 7 cases, thus providing significantly superior yield (46% difference, McNemar's test, P value 0.063). Tissue biopsy additionally detected c-MET amplification in a patient who had T790M mutation on liquid biopsy. Group 3 had 20 patients and none were falsely positive for EGFR mutation on liquid biopsy. Overall, DdPCR had a Cohen's kappa of 0.82 (standard error 0.074, 95% CI 0.68-0.97) indicating "very good agreement" with conventional tissue biopsy.

Conclusion: DdPCR demonstrated 87.5% sensitivity and 100% specificity in detecting primary EGFR mutations in patients who were treatment naïve with overall positive and negative predictive value of 100% and 80%, respectively. DdPCR demonstrated T790M mutation postprogression on TKI therapy in 53.4% patients.
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http://dx.doi.org/10.4103/lungindia.lungindia_472_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6120312PMC
September 2018

Primary pulmonary synovial sarcoma: A reappraisal.

J Cancer Res Ther 2018 Apr-Jun;14(3):481-489

Department of Pulmonary Medicine, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.

Synovial sarcoma (SS) is a malignant mesenchymal tumor with variable epithelial differentiation that affects mostly young adults and can arise at any anatomic site. Primary intrathoracic SS is very rare accounting for <0.5% of all lung tumors. Most commonly, it arises from the lung followed by pleura and mediastinum. Primary pulmonary SS (PPSS) affects both sexes equally with no preference for any hemithorax. The morphology, immunostaining properties, cytogenetic features, and management strategy of PPSS are similar to that of soft tissue SS. Histologically, there are two main types of SS - monophasic and biphasic with a feature of poor differentiation seen in both types. Most patients present with large intrathoracic masses with or without ipsilateral pleural effusion. Bone invasion or mediastinal adenopathy is very rare. SS is characterized by a specific chromosomal translocation producing SS18-SSX fusion gene in more than 90% of cases. Identification of this fusion gene remains the gold standard for the diagnosis in the presence of consistent histology and immunophenotype. Multimodality treatment including wide excision, chemotherapy, and radiotherapy is the mainstay of therapy. SS is relatively chemosensitive, and ifosfamide-based regimen showed improved survival in metastatic disease. Generally, SS is considered as high-grade tumors with a poor prognosis. Novel therapies targeted at fusion oncogene, SS18-SSX-derived peptide vaccine, epidermal growth factor receptor, and vascular endothelial growth factor are the future hope in SS. We describe a prototype case and present an elaborate review on primary SS of lung.
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http://dx.doi.org/10.4103/0973-1482.204883DOI Listing
October 2018

Clinical utility of RT-PCR in assessing HER 2 gene expression versus traditional IHC and FISH in breast cancer patients.

Breast Cancer 2018 Jul 9;25(4):416-430. Epub 2018 Feb 9.

Amity Institute of Molecular Medicine and Stem Cell Research (AIMMSCR) Amity University, Uttar Pradesh Campus, Sector-125, Noida, 201313, India.

Background: IHC and FISH are used for categorizing HER 2 status in breast cancer at the protein and DNA level, respectively. HER 2 expression at the RNA level is quantitative, cheaper, easier to standardize and free from interobserver variation.

Methods: 115 consecutive patients were tested by IHC, FISH and RT-PCR (test cohort). Assuming FISH result to be the response variable, ROC curves for RT-PCR ratio were analyzed to label HER 2 negative, equivocal and positive cases as RT-PCR score 1, 2 and 3, respectively. Inter-relationships between RT-PCR, IHC and FISH were defined. 'Clinical benefit' of a test was defined as proportion of patients labeled unequivocally as HER 2 positive or negative. Population for 1 year was simulated constraint to previous reports of HER 2 positivity and IHC category distribution by a meta-analysis of previous studies that evaluated concordance between IHC and FISH to determine HER 2 status (simulation cohort). Four diagnostic pathways in the simulation cohort were defined-(1) initial IHC, followed by FISH (conventional pathway); (2) initial RT-PCR, followed by FISH; (3) initial IHC, followed by RT-PCR and then by FISH; (4) initial RT-PCR, followed by IHC and then by FISH. The clinical benefit of IHC and RT-PCR in the four pathways was analyzed and sensitivity analysis for incremental cost-effectiveness ratio and cost-benefit comapring RT-PCR against IHC, both as first-line tests and among those with IHC score 2 as a reflex second-line test was performed by the Monte Carlo technique.

Findings: 115 patients comprised the study population. While none with IHC score of 0 or 1 was FISH positive for HER 2, all cases with IHC score of 3 were FISH positive. 43 cases were assigned IHC score of 2. Thus, 72 patients benefited from the initial IHC testing [clinical benefit 62.6%], with the overall concordance between IHC and FISH being 100% for those with IHC score of 0, 1 and 3 (conclusive IHC categories). For RT-PCR with 100% concordance, 15.7% (115-97 = 18) patients would have benefited from RT-PCR testing if it was used as a first-line test. If RT-PCR would have been used as a second-line test among those with IHC score 2 (n = 43), then only 6 patients would have been assigned a conclusive RT-PCR category (category 1 or 3) translating to a clinical benefit of 14% (6/43) as a second-line test. As a second-line test it had 51% probability to prove more cost-effective than the conventional pathway, provided the cost of RT-PCR was 0.4 times the cost of IHC. Also in a three-step pathway, RT-PCR upfront would have 56% probability of higher cost-benefit provided the cost of RT-PCR was 0.1 times the cost of IHC.

Conclusion: RT-PCR results were found to be suboptimal to IHC in terms of discriminative ability and clinical benefit; thus, it is unlikely to replace IHC as a first-line test in the near future.
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http://dx.doi.org/10.1007/s12282-018-0840-1DOI Listing
July 2018

Actively caseating endobronchial tuberculosis successfully treated with intermittent chemotherapy without corticosteroid: a report of 2 cases.

Adv Respir Med 2017 ;85(6):322-327

All India Institute of Medical Sciences, Bhubaneswar, 751019 Bhubaneswar, India.

Tuberculous infection of the tracheobronchial tree confirmed by microbiological or histopathological evidence with or without parenchymal involvement is known as endobronchial tuberculosis. Chronic cough is the predominant symptom. Expectorated sputum examination for acid fast bacilli is often negative leading to delay in diagnosis. Therefore, bronchoscopy is crucial for early diagnosis and evaluation of the extent of disease. Bronchostenosis is a significant complication of endobronchial tuberculosis that may be present at the time of diagnosis or develops during the course of treatment. Previously, corticosteroids have been used along with antitubercular therapy to prevent or reduce the extent of bronchostenosis; however, their role is debatable as bronchostenosis often develops despite the use of corticosteroids. Furthermore, the duration of treatment varied from 6-9 months of daily therapy in previous series and little is known about efficacy of intermittent antituberculous therapy. Here we report two cases of actively caseating endobronchial tuberculosis successfully managed with six months of intermittent oral antitubercular therapy without corticosteroids.
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http://dx.doi.org/10.5603/ARM.2017.0055DOI Listing
September 2018

Biomodification Strategies for the Development of Antimicrobial Urinary Catheters: Overview and Advances.

Glob Chall 2018 Jan 27;2(1):1700068. Epub 2017 Dec 27.

Bioengineering Laboratory Department of Textile Technology Indian Institute of Technology New Delhi 110016 India.

Microbial burden associated with medical devices poses serious health challenges and is accountable for an increased number of deaths leading to enormous medical costs. Catheter-associated urinary tract infections are the most common hospital-acquired infections with enhanced patient morbidity. Quite often, catheter-associated bacteriuria produces apparent adverse outcomes such as urosepsis and even death. Taking this into account, the methods to modify urinary catheters to control microbial infections with relevance to clinical drug resistance are systematically evaluated in this review. Technologies to restrict biofilm formation at initial stages by using functional nanomaterials are elucidated. The conventional methodology of using single therapeutic intervention for developing an antimicrobial catheter lacks clinically meaningful benefit. Therefore, catheter modification using naturally derived antimicrobials such as essential oils, curcumin, enzymes, and antimicrobial peptides in combination with synthetic antibiotics/nanoantibiotics is likely to exert sufficient inhibitory effect on uropathogens and is extensively discussed. Futuristic efforts in this area are projected here that demand clinical studies to address areas of uncertainty to avoid development of bacterial resistance to the new generation therapy with minimum discomfort to the patients.
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http://dx.doi.org/10.1002/gch2.201700068DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6607219PMC
January 2018

Mutation Analysis in Acute Myeloid Leukemia: Comparison of Three Techniques - Sanger Sequencing, Pyrosequencing, and Real-Time Polymerase Chain Reaction.

Turk J Haematol 2018 Mar 13;35(1):49-53. Epub 2017 Nov 13.

Gauhati University Faculty of Medicine, Department of Bioengineering and Technology, Guwahati, India.

Objective: Nucleophosmin-1 (NPM1) mutations have prognostic importance in acute myeloid leukemia (AML) patients with intermediate-risk karyotype at diagnosis. Approximately 30% of newly diagnosed cytogenetically normal AML (CN-AML) patients harbor the NPM1 mutation in India. In this study we compared the efficiency of three molecular techniques in detecting NPM1 mutation in peripheral blood and bone marrow samples.

Materials And Methods: In a single-center cohort we analyzed 165 CN-AML bone marrow/peripheral blood samples for NPM1 mutation analysis. About 30% of the CN-AML samples revealed NPM1 mutations. For the detection, three methods were compared: Sanger sequencing, pyrosequencing, and real-time polymerase chain reaction (PCR).

Results: NPM1 exon 12 mutations were observed in 52 (31.51%) of all CN-AML cases. The sensitivity of Sanger sequencing, pyrosequencing, and real-time PCR was 80%, 90%, and 95%, whereas specificity was 95%, 100%, and 100%, respectively. The minimum limit of mutation detection was 20%-30% for Sanger sequencing, 1%-5% for pyrosequencing, and 0.1%-1% for real-time PCR.

Conclusion: The sequencing method, which is the reference method, has the lowest sensitivity and is sometimes difficult to interpret. Real-time PCR is a highly sensitive method for mutation detection but is limited for specific mutation types. In our study, pyrosequencing emerged as the most suitable technique for the detection of NPM1 mutations on the basis of its easy interpretation and less time-consuming processes than Sanger sequencing.
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http://dx.doi.org/10.4274/tjh.2017.0095DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5843774PMC
March 2018

DNMT3A (R882) mutation features and prognostic effect in acute myeloid leukemia in Coexistent with NPM1 and FLT3 mutations.

Hematol Oncol Stem Cell Ther 2018 Jun 18;11(2):82-89. Epub 2017 Oct 18.

Dept of Bioengineering & Technology, Gauhati University, Guwahati 781014, India. Electronic address:

Objective/background: In the absence of high-risk cytogenetic, DNMT3A (DNA Methyltransferase 3a) mutation status has an impact on outcome in the presence of FLT3 (FMS-like Tyrosine Kinase3) and/or NPM1 (Nucleophosmin). In this study, we focus on the features and effect of DNMT3A (R882) mutation in acute myeloid leukemia (AML) in the presence or absence of NPM1 and FLT3 mutations.

Methods: A total of 174 cytogenetically normal (CN)-AML cases were analyzed for NPM1, FLT3, and DNMT3A mutations. For NPM1 mutation detection, we used the pyrosequencing technique; for FLT3 mutations, polymerase chain reaction and RFLP with ECO-RV techniques were used, and for DNMT3A mutation analysis, we used Sanger sequencing and RFLP (Restriction Fragment Length Polymorphism) techniques.

Results: NPM1 mutation was found in 40.80%, DNMT3A in 12.06%, and FLT3 mutation was found in 16.66% of 174 CN-AML patients. We also found seven cases which were (NPM1+, FLT3+), 10 cases which were (NPM1+, DNMT3A+), and two cases were found positive for (DNMT3A+, FLT3+) mutations. Adult patients had significantly higher frequency of NPM1 mutation than children (72.22% vs. 16.66%; p = .020), whereas FLT3/ITD and DNMT3A mutation was associated with higher white blood count (p = .081). Immunophenotypically, NPM1 and DNMT3A mutations were significantly associated with the lack of CD34, whereas FLT3/ITD mutation was positively associated with the expression of CD7. We also assessed the overall survival and progression-free survival of DNMT3A mutation status among patients with CN-AML. Indeed, DNMT3A mutations within the CN-AML subset were associated with significantly shorter overall survival and progression-free survival compared to NPM1 and FLT3 mutated patients (p = .067 and p = .065, respectively).

Conclusion: DNMT3A R882 mutation plays an important role in CN-AML patients' prognosis and clinical outcomes in the presence and absence of NPM1 and FLT3 mutations.
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http://dx.doi.org/10.1016/j.hemonc.2017.09.004DOI Listing
June 2018

Unusual cause of opaque hemithorax.

Thorax 2018 04 13;73(4):395-396. Epub 2017 Oct 13.

Department of Pulmonary Medicine, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.

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http://dx.doi.org/10.1136/thoraxjnl-2017-210418DOI Listing
April 2018

rearrangement and response to crizotinib in Stage IV non-small cell lung cancer.

Lung India 2017 Sep-Oct;34(5):411-414

Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.

Background: The frequency of ROS1 rearrangement in non-small cell lung cancers has been reported from 1.6% to 2.3%.

Materials And Methods: We examined 105 lung adenocarcinoma patients for ROS1 rearrangement which were negative for EGFR and anaplastic lymphoma kinase. Clinical characteristics of ROS1 rearranged patients and their responses to crizotinib therapy were studied.

Results: Of the 105 patients, three cases were positive for ROS1 rearrangement by fluorescence in situ hybridization analysis. All of them showed heterogeneous pattern. All the 3 ROS1-positive patients were females in their forties and started on crizotinib. All of them responded to treatment. One of them developed resistance after 3 months. Another one showed marked systemic response but central nervous system lesions progressed. The third case is doing well till date with inactive lesions on positron emission tomography scan.

Conclusions: The frequency of ROS1 rearrangement is low in non-small cell lung carcinoma, but their diagnosis offers patients an opportunity to receive highly effective targeted therapies.
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http://dx.doi.org/10.4103/lungindia.lungindia_116_17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5592750PMC
September 2017
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