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In genomic research, identifying the exon regions in eukaryotes is the most cumbersome task. This article introduces a new promising model-independent method based on short-time discrete Fourier transform (ST-DFT) and fine-tuned variational mode decomposition (FTVMD) for identifying exon regions. The proposed method uses the N/3 periodicity property of the eukaryotic genes to detect the exon regions using the ST-DFT. However, background noise is present in the spectrum of ST-DFT since the sliding rectangular window produces spectral leakage. To overcome this, FTVMD is proposed in this work. VMD is more resilient to noise and sampling errors than other decomposition techniques because it utilizes the generalization of the Wiener filter into several adaptive bands. The performance of VMD is affected due to the improper selection of the penalty factor (α), and the number of modes (K). Therefore, in fine-tuned VMD, the parameters of VMD (K and α) are optimized by maximum kurtosis value. The main objective of this article is to enhance the accuracy in the identification of exon regions in a DNA sequence. At last, a comparative study demonstrates that the proposed technique is superior to its counterparts.
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BACKGROUND AND AIMS: Angiosarcoma (AS) is a rare malignant vascular tumor that phenotypically and functionally recapitulate normal endothelium. They constitute approximately 2-4% of soft tissue sarcomas. We present 36 cases of head and neck AS diagnosed for 11 years at a tertiary care hospital in South India to analyze the clinical, pathological, and immunophenotypic profiles with special emphasis on their differential diagnoses and diagnostic pitfalls. MATERIALS AND METHODS: Head and neck AS diagnosed from January 2006 to December 2017 were included. Clinical characteristics, treatment received, and follow-up data were obtained from electronic medical records. Hematoxylin and eosin (H&E)-stained slides and immunohistochemistry (IHC) slides were reviewed, and the histomorphological features, immunohistochemical staining, and their utility in resolving differential diagnosis were assessed. RESULTS: Twenty-two females and 14 males were diagnosed with head and neck AS in the study period. Histomorphological patterns observed were mixed vasoformative and solid ( n = 22), pure vasoformative ( n = 13), and pure solid ( n = 1). Neoplastic cells showed epithelioid, spindly, signet cell-like, clear cell, and rhabdoid morphology. CD31 was positive in 100% of cases, and CD34 was positive in 40% of cases. Differential diagnoses included melanoma, rhabdomyosarcoma, and large-cell lymphoma. Surgery, radiotherapy, and chemotherapy were the treatment modalities used. Twelve patients developed local recurrence, and 12 patients developed metastasis on follow-up. Twenty-five patients died of disease, on an average of 24 months after diagnosis. CONCLUSION: Head and neck AS pose a significant diagnostic challenge due to their broad morphologic spectrum. Proper clinicopathologic correlation is necessary to avoid misdiagnosis.
Subject(s)
Head and Neck Neoplasms , Hemangiosarcoma , Humans , Hemangiosarcoma/diagnosis , Hemangiosarcoma/pathology , Female , Male , Head and Neck Neoplasms/diagnosis , Head and Neck Neoplasms/pathology , Middle Aged , Adult , Diagnosis, Differential , Aged , India , Young Adult , Immunohistochemistry , Adolescent , Child , Biomarkers, Tumor , Retrospective StudiesABSTRACT
SMARCB1 deficient sinonasal carcinomas are rare neoplasms, classified under sinonasal undifferentiated carcinomas by the fourth edition of the World Health Organization (WHO) classification of head and neck tumors. It is characterized immunohistochemically by loss of SMARCB1(INI1) expression. We are reporting the case of a 63-year-old man who was evaluated for nasal stuffiness of 3 months duration in another hospital where a radiological evaluation showed a polypoidal soft tissue lesion in the right maxillary sinus extending to the right nasal cavity and spheno-ethmoidal sinus. He underwent excision biopsy which was reported as non- keratinizing nasopharyngeal carcinoma. He was referred to our center with residual disease in spheno-ethmoidal recess for which radiotherapy was given. After completion of radiotherapy, the primary site had no residual disease, but while on follow-up he developed left sided neck nodes within 4 months of completion of treatment. Excision of the lesion was done and histopathological and immunohistochemical analysis revealed it to be metastasis from SMARCB1 deficient sinonasal carcinoma and not nasopharyngeal carcinoma as diagnosed from the other center. This case is being reported to highlight the diagnostic challenge associated with this rare entity.
Subject(s)
Carcinoma , Maxillary Sinus Neoplasms , Nasopharyngeal Neoplasms , Male , Humans , Middle Aged , SMARCB1 Protein/genetics , SMARCB1 Protein/analysis , Maxillary Sinus Neoplasms/diagnosis , Maxillary Sinus Neoplasms/genetics , Maxillary Sinus Neoplasms/metabolism , Carcinoma/diagnosis , Carcinoma/genetics , Carcinoma/metabolism , Biopsy , Nasopharyngeal Carcinoma/diagnosis , Nasopharyngeal Carcinoma/genetics , Biomarkers, Tumor/genetics , Biomarkers, Tumor/analysisABSTRACT
Background: The eighth edition of the American Joint Committee on Cancer (AJCC) for oral cancer has incorporated additional pathological features like depth of invasion (DOI) and extranodal extension (ENE) into T and N staging. The incorporation of these two factors will impact the staging and, hence, the treatment decisions. The aim of the study was to clinically validate the new staging system in predicting the outcome in patients treated for carcinoma oral tongue. The study also examined the correlation of pathological risk factors with survival. Methods: We studied 70 patients with squamous cell carcinoma of the oral tongue who underwent primary surgical treatment at a tertiary care center in the year 2012. All these patients were restaged pathologically according to the new AJCC eighth staging system. The 5-year overall survival (OS) and disease-free survival (DFS) were calculated using the Kaplan-Meier method. Akaike information criterion and concordance index were calculated between both staging systems to identify a better predictive model. Log-rank test and univariate Cox regression analysis were conducted to find out the significance of different pathological factors on outcome. Results: Incorporation of DOI and ENE resulted in 47.2% and 12.8% stage migration, respectively. DOI less than 5 mm was associated with a 5-year OS and DFS of 100% and 92.9%, respectively, compared to 88.7% and 85.1%, respectively, when the DOI was more than 5 mm. Presence of lymph node involvement, ENE, and perineural invasion (PNI) were associated with inferior survival. The eighth edition had lower Akaike information criterion and improved concordance index values compared with the seventh edition. Conclusion: The eighth edition of AJCC allows better risk stratification. Restaging of cases based on the eighth edition AJCC staging manual resulted in significant upstaging with difference in survival.
Subject(s)
Carcinoma, Squamous Cell , Tongue Neoplasms , Humans , Treatment Outcome , Tongue Neoplasms/surgery , Disease-Free Survival , Tongue , Carcinoma, Squamous Cell/surgeryABSTRACT
CONTEXT: Differentiating NSCLC as either adeno or squamous type and identification of Epidermal Growth Factor Receptor (EGFR) mutations is clinically relevant for lung cancer patients for selecting treatment. Thyroid transcription factor-1 (TTF-1) and p63 were demonstrated as useful markers for histologic typing of lung cancer. Mutation and overexpression of EGFR has been reported in a subset of non-small cell lung cancers. If these markers can be validated for the differential diagnosis of adenocarcinoma in a sputum sample itself, it will be highly beneficial for lung cancer patients. AIMS: To evaluate whether immunocytochemical expression of TTF-1, p63, and EGFR proteins in sputum samples can be used for differential diagnosis of lung adenocarcinoma by comparing with that of the corresponding tissue samples. SETTINGS AND DESIGN: Ninety sputum samples and matched tissue samples were used for the study. SUBJECTS AND METHODS: Monolayered smears and cell blocks of sputum and the corresponding tissue samples were immunostained with the standard ABC method. The expression patterns of these markers were analyzed statistically and compared with clinic-pathological parameters. STATISTICAL ANALYSIS USED: Chi-square test and paired t-test. RESULTS: The p63 protein had a positive expression in 73.9% of SCC whereas TTF1 had positive expression in 75.8% of ADC. The EGFR expression was positive in 27 cases of adenocarcinoma, 21 cases of SCC and 19 cases of NSCLC. CONCLUSIONS: Immunocytochemistry of the aforementioned antibodies in sputum samples can be used as supplementary evidence for the subtyping of NSCLC.
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The grossing of radical surgery specimens of the head and neck region is extremely challenging due to the complicated anatomy with the inclusion of various tissues such as mucosa, soft-tissue, bone, skin, etc., in the specimen. Also, essential/core data provided in the histopathology report significantly influence further treatment decisions taken. The eighth edition of the cancer staging manual of the American Joint Committee on Cancer has brought about major changes in reporting of squamous cell carcinoma of the oral cavity. Though pathologists in oncology centers who routinely handle such specimens are aware of these updates and the impact of their report on patient management, this may not be true for other peripheral centers that may be handling these specimens. Lack of awareness can lead to a compromised report which will adversely affect patient management. This article attempts to discuss the salient features to be noted in grossing and reporting of squamous cell carcinoma of the oral cavity and the rationale behind this.
Subject(s)
Carcinoma, Squamous Cell/pathology , Disease Notification/methods , Evidence-Based Medicine/methods , Mouth Neoplasms/pathology , Humans , Neoplasm StagingABSTRACT
A 36-year-old female presented with lump in the left breast of 2 months duration. Fine-needle aspiration cytology (FNAC) and trucut biopsy confirmed the diagnosis of carcinoma. Clinically, it was T3N1Mx disease. Computed tomography (CT) of the chest detected bilateral lung metastasis. CT head and neck detected a nodule in the thyroid which on FNAC was suspicious of papillary carcinoma. The patient was started on chemotherapy for breast disease with a good initial response; however, while on-follow up, there was progression of disease at primary site. The patient was taken up for surgery. Radical mastectomy along with total thyroidectomy was performed. Histopathological examination showed infiltrating duct carcinoma, not otherwise specified type and papillary carcinoma thyroid. There was a 0.4 cm × 0.4 cm metastatic focus, from breast carcinoma within the papillary carcinoma thyroid. The metastasis was confirmed by immunohistochemistry. Metastasis to thyroid is rare. However, tumor-to-tumor metastasis with papillary carcinoma serving as recipient to breast carcinoma is exceedingly rare with very few case reports in the literature. We report this case for its rarity and also for highlighting the fact that pathologists should keep in mind the possibility of metastasis also when coming across unusual morphology in thyroid lesions.
Subject(s)
Breast Neoplasms/diagnostic imaging , Neoplasm Metastasis/diagnosis , Thyroid Cancer, Papillary/diagnosis , Thyroid Gland/pathology , Adult , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Female , Humans , Immunohistochemistry , Lymphatic Metastasis , Mastectomy, Radical , Thorax/diagnostic imaging , Thyroid Cancer, Papillary/pathology , Thyroid Gland/surgery , Thyroidectomy , Tomography, X-Ray ComputedABSTRACT
CONTEXT: Despite sputum cytology being accepted as a simple and noninvasive diagnostic method for lung cancer, the clinical usefulness of sputum for evaluation of prognosis is yet to be explored. Validation of some of the markers in sputum for prognosis prediction will be highly useful for selective therapy. AIMS: This study was aimed to evaluate a reliable panel of immunocytochemical markers for their significance to predict survival. MATERIALS AND METHODS: We have analyzed the expression of p53, p16, galectin-3, and epidermal growth factor receptor (EGFR) proteins in sputum samples processed in a mucolytic agent/cellblock and compared the same with that of the corresponding tissue samples. RESULTS: Overexpression of p16 and EGFR was found to have a better survival benefit, whereas positive p53 and galectin-3 expressions had shorter period of survival. Expression patterns of all these four proteins were more or less similar in smears, cellblocks of sputum, and tissue samples except for slight changes in staining intensity which was not found to be statistically significant. No significant difference was found in the association of these proteins with survival pattern between sputum and tissue samples. CONCLUSION: This is the first report of immunocytochemistry of a panel of markers on cells exfoliated in sputum samples which suggests that analysis of immunocytochemical markers in sputum samples can be attempted as a cost-effective and reliable predictor of prognosis and survival. Accumulation of mutated p53, overexpression of galectin-3, and lower expression of p16 and EGFR proteins were found to predict poor prognosis for lung cancer.
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OBJECTIVE: To prospectively investigate the value of rapid on-site evaluation (ROSE) in transthoracic fine needle aspiration cytology (FNAC) of patients with pulmonary nodules. Computed tomography (CT)-guided FNA is commonly employed for the diagnosis of lung lesions and the most common reason for not being able to provide a diagnosis in FNA is inadequacy of samples. MATERIALS AND METHODS: This was a prospective study conducted in the departments of pathology and radiology of our cancer centre. This study had approval from the institutional review board and ethical committee of our institute. Fifty consecutive cases undergoing CT-guided transthoracic FNAC in our centre were included in the study. The smear submitted for ROSE was stained using toluidine blue stain. The specimen adequacy and diagnosis in ROSE was compared with that of the final cytology report, and the concordance regarding adequacy and diagnosis were noted. RESULTS: Smears were adequate in 34 cases (68%) and inadequate in 16 cases (32%) Out of the 16 inadequate cases, 5 (31%) were converted to adequate due to the application of ROSE, thus increasing the adequate number of cases to 39 (78%). A diagnosis of malignancy was made in all 39 adequate cases. Sensitivity of ROSE in determining adequacy was 92% and specificity was 100%. The most common malignancy was adenocarcinoma in 26 cases. Pnemothorax occurred in 2 cases. No significant complications occurred in other cases. CONCLUSION: CT-guided FNA with ROSE is a safe and useful tool in the diagnostic work-up of lung cancer patients. A multidisciplinary approach along with onsite evaluation of adequacy will increase the diagnostic utility of cytology in lung lesions.
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The effect of morphology of Platinum (Pt) nanoparticles supported on alumina (γ-Al2O3) for complete catalytic oxidation of volatile organic compounds (VOCs) was investigated. Pt nanoparticles were synthesized through a simple method comprising of reduction followed by calcination of metal precursor coated chitosan templates using three different reducing agents: sodium borohydride (NaBH4), hydrazine (N2H4) and hydrogen (H2). The morphology and facet orientation of Pt nanoparticles were influenced by the reducing agents. The catalytic oxidation performance studies of these Pt nanoparticles loaded on γ-Al2O3 for VOCs showed strong dependence of their activities on their morphologies. High indexed facet (220) Pt nanosheets synthesized through NaBH4 reduction showed superior catalytic oxidation activity compared to the catalysts prepared using other reducing agents. Cyclic performance studies on these catalysts showed stable benzene oxidation performance implying their thermal stability. The absence of any shape directing agents in the synthesis of Pt nanoparticles with homogeneous morphologies and preferential orientation is an aspect that can be extended to other catalytic applications.
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A 58-year-old female, a known diabetic and hypertensive, presented with left-sided swelling on the anterior aspect of the neck of 1-year duration, which was rapidly increasing in size for the past 6 months. She was on Eltroxin for hypothyroidism for the past 1 year. Computed tomography study of the neck showed a nodule in the left lobe of thyroid which on fine-needle aspiration was suspicious for malignancy. Total thyroidectomy with left posterolateral lymph node dissection was done. Histopathological examination showed sclerosing mucoepidermoid carcinoma with eosinophilia (SMECE) of the thyroid gland with lymph node metastasis. SMECE of the thyroid was initially thought to be a low-grade malignancy with indolent clinical behavior. However, our case showed extra thyroidal spread with lymph node metastasis, necessitating adjuvant therapy for our patient. Such aggressive behavior has been noted in few earlier case reports also.
Subject(s)
Carcinoma, Mucoepidermoid/pathology , Eosinophilia/pathology , Thyroid Gland/pathology , Carcinoma, Mucoepidermoid/diagnosis , Carcinoma, Mucoepidermoid/diagnostic imaging , Female , Humans , Lymphatic Metastasis/pathology , Middle Aged , Thyroid Gland/surgery , Thyroidectomy , Tomography, X-Ray ComputedABSTRACT
INTRODUCTION: Lesions of the thyroid gland composed of Hurthle cells constitute a wide spectrum of pathological entities ranging from benign hyperplastic nodules with Hurthle cell metaplasia at one end to malignancies like Hurthle cell carcinomas. The cytological distinction of these entities is not only diagnostically challenging but are also critical since they influence treatment decisions. AIM: To critically analyze the cytomorphology of cases of Hurthle cell lesions in FNACs and to characterize cytological features shown to be statistically signific ant in predicting Hurthle cell neoplasm (HCN). METHODS: During the period from January 2014 to August 2015, 1667 cases of thyroid FNAs were done at our centre, of which 54cases,showed a predominance of hurthle cells, i.e. more than or equal to 50% hurthle cells (≥=50%).These cases were included in the study and were critically reviewed for 9 cytomorphologic features which included cellularity, architecture, and percentage of Hurthle cells, background colloid, chronic inflammation, nucleoli, intranuclear cytoplasmic inclusions (INCI), nuclear grooves and transgressing blood vessels (TBV). The results were evaluated by using univariate and stepwise logistic regression (SLR) analysis; statistical significance was achieved at P-value < 0.05. RESULTS: Out of the 9 parameters studied, the cytological features shown to be statistically significant in predicting HCN and distinguishing them from benign hurthle cell lesions(BHCLs) were increased cellularity, non-macro follicular architecture, >90% Hurthle cells, absence of background colloid and absence of chronic inflammation.
Subject(s)
Adenoma, Oxyphilic/pathology , Cytodiagnosis/methods , Thyroid Neoplasms/pathology , HumansABSTRACT
OBJECTIVES: Cervical cancer is the second most common cancer in women in developing countries, including India. Recently, microRNAs (miRNAs) are gaining importance in cancer biology because of their involvement in various cellular processes. The present study aimed to profile miRNA expression pattern in cervical cancer, identify their target genes, and understand their role in carcinogenesis. METHODS: Human papillomavirus (HPV) infection statuses in samples were assessed by heminested polymerase chain reaction followed by direct DNA sequencing. Next-generation sequencing and miRNA microarray were used for miRNA profiling in cervical cancer cell lines and tissue samples, respectively. MicroRNA signature was validated by quantitative real-time PCR, and biological significance was elucidated using various in silico analyses. RESULTS: Cervical cancer tissues samples were mostly infected by HPV type 16 (93%). MicroRNA profiling showed that the pattern of miRNA expression differed with respect to HPV positivity in cervical cancer cell lines. However, target and pathway analyses indicated identical involvement of these significantly deregulated miRNAs in HPV-positive cervical cancer cell lines irrespective of type of HPV infected. Microarray profiling identified a set of miRNAs that are differentially deregulated in cervical cancer tissue samples which were validated using quantitative real-time PCR. In silico analyses revealed that the signature miRNAs are mainly involved in PI3K-Akt and mTOR pathways. CONCLUSIONS: The study identified that high-risk HPV induces similar carcinogenic mechanism irrespective of HPV type. The miRNA signature of cervical cancer and their target genes were also elucidated, thereby providing a better insight into the molecular mechanism underlying cervical cancer development.
Subject(s)
MicroRNAs/biosynthesis , Papillomaviridae/genetics , Uterine Cervical Neoplasms/genetics , Uterine Cervical Neoplasms/virology , Adult , Aged , Carcinogenesis/genetics , Cell Line, Tumor , DNA, Viral/genetics , Down-Regulation , Female , HeLa Cells , Human papillomavirus 16/genetics , Humans , MicroRNAs/genetics , Middle Aged , Papillomavirus Infections/genetics , Papillomavirus Infections/virology , Up-Regulation , Uterine Cervical Neoplasms/metabolismABSTRACT
Rare cancers account for about 22 per cent of all cancers diagnosed worldwide, disproportionately affecting some demographic groups, with an occurrence of less than 6 per 100,000 individuals annually. Many rare cancers in adults, adolescents and children are not curable, and patients and care providers have little option to take therapeutic decisions. The epidemiology of rare cancers is a challenging area of study but is inadequately addressed. Despite efforts mainly in some European nations, a few improvements have been observed in the management of rare cancers. Reasons for this obvious stagnation are multifactorial and are mainly inherent to logistical difficulties in carrying out clinical trials in very small patient populations, hesitation of the pharmaceutical industry to spend in small markets and complexity in creating adequate information for the development of cost-effective drugs. Rare cancers also face specific challenges that include late and incorrect diagnosis, lack of clinical expertise and lack of research interest and development of new therapies. The utilization of nationally representative study findings for the patients' evaluation may possibly offer chances to find out pathogenesis and prevalence, and this will eventually lead to control and prevention. Currently, advancing targeted therapies offer a great opportunity for the better management of rare cancers. Conducting clinical trials with small patient population, innovative clinical trial approach, prevailing controlling obstacles for international cooperation and financial support for research are the present challenges for rare cancers. The International Rare Cancers Initiative functions as a main platform for achieving new international clinical trials in rare tumours. This review delineates the current challenges and issues in the interpretation, management and research scenarios of rare cancers.
Subject(s)
Disease Management , Neoplasms/epidemiology , Rare Diseases/epidemiology , Cost-Benefit Analysis , Humans , Molecular Targeted Therapy , Neoplasms/drug therapy , Neoplasms/pathology , Rare Diseases/drug therapy , Rare Diseases/pathologyABSTRACT
INTRODUCTION: Chronic lymphocytic thyroiditis [Hashimoto thyroiditis (HT)] is a common thyroid lesion diagnosed on fine-needle aspiration cytology (FNAC). Apart from FNAC, various other parameters, such as clinical features, ultrasonographic findings, antithyroid antibody levels, hormone profiles, and radionuclide thyroid scan, are also taken into consideration in making a diagnosis of HT. AIMS: To grade lymphocytic thyroiditis based on the cytomorphology and to correlate the cytological grades with the levels of antithyroid peroxidase antibody (ATPO), antithyroglobulin antibody (ATG), and thyroid stimulating hormone (TSH). MATERIALS AND METHODS: During a period of one and half years, 1,667 cases underwent FNAC of thyroid at our tertiary care center. Of these, 128 cases had cytological evidence of lymphocytic thyroiditis. Out of these, in 60 cases the levels of ATPO, ATG, and TSH were known. The cytological grades of lymphocytic thyroiditis in these cases were correlated with these parameters. RESULTS: Out of the 60 cases, 55 were females. Age ranged from 5 years to 70 years, with majority of patients in third decade. Diffuse enlargement of thyroid was the commonest presentation. However, 14 cases presented with nodular disease. Majority of the patients had grade 1 thyroiditis (27 cases), followed by grade 2 thyroiditis (22 cases). Cytomorphology was diagnostic of thyroiditis in all 60 cases. ATPO was elevated in 57 cases and ATG was elevated in 40 cases. Elevated level of TSH was seen in only 18 cases. In 39 cases, TSH value was normal. There was no correlation between the cytological grades of thyroiditis and the levels of antithyroid antibodies and TSH. CONCLUSION: Lymphocytic infiltration of thyroid follicles is pathognomonic of lymphocytic thyroiditis. Positivity for antithyroid antibodies is strongly associated with HT but no correlation was observed between the grades of thyroiditis and the levels of ATPO, ATG, and TSH.
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BACKGROUND: Breast conserving surgery (BCS) is increasingly done for early breast cancers in many countries since it has been demonstrated by randomized trials that survival rates after BCS followed by adjuvant therapy are equivalent to those obtained after mastectomy. Frozen section analyses (FSA) is a technique used for intra-operative assessment of margin status in BCS. The aim of this study was to assess the concordance of margin status assessment by FSA and permanent sections and to assess correlation with local recurrence. MATERIALS AND METHODS: A total of 162 patients underwent BCS for in situ or invasive carcinoma with FSA of margins during the year 2008 at our center. The inclusion criteria in this study were patients with intact tumor at the time of surgery. After application of the inclusion criteria, 60 patients could be included in this study. RESULTS: After frozen section, 20 patients had an initial negative margin. 40 subjects underwent additional excisions at the time of initial surgery because of close or positive margins. Of these 40 patients, in 32 patients a negative margin could be achieved with re-excisions. Pathological analyses of frozen section showed concordance to permanent sections in all cases. At a median follow-up of 40 months, there were no local recurrences. CONCLUSION: Intra-operative FSA allows resection of suspicious margins at the time of primary conservative surgery and results in low rates of local recurrence and second surgeries. There is good concordance between results of FSA and the final paraffin section in assessing margin status.
Subject(s)
Breast Neoplasms/surgery , Frozen Sections/methods , Mastectomy, Segmental/methods , Adult , Aged , Breast Neoplasms/pathology , Female , Humans , Middle Aged , Young AdultABSTRACT
Hepatitis C is a global epidemic. Worldwide, 185 million people are estimated to be infected, most of whom live in low- and middle-income countries. Recent advances in the development of antiviral drugs have produced therapies that are more effective, safer and better tolerated than existing treatments for the disease. These therapies present an opportunity to curb the epidemic, provided that they are affordable, that generic production of these medicines is scaled up and that awareness and screening programmes are strengthened. Pharmaceutical companies have a central role to play. We examined the marketed products, pipelines and access to medicine strategies of 20 of the world's largest pharmaceutical companies. Six of these companies are developing medicines for hepatitis C: AbbVie, Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck & Co. and Roche. These companies employ a range of approaches to supporting hepatitis C treatment, including pricing strategies, voluntary licensing, capacity building and drug donations. We give an overview of the engagement of these companies in addressing access to hepatitis C products. We suggest actions companies can take to play a greater role in curbing this epidemic: (i) prioritizing affordability assessments; (ii) developing access strategies early in the product lifecycle; and (iii) licensing to manufacturers of generic medicines.
L'hépatite C est une épidémie mondiale. On estime à 185 millions le nombre d'individus infectés par ce virus dans le monde, la plupart vivant dans des pays à revenu faible ou intermédiaire. Les récents progrès dans la mise au point de médicaments antiviraux ont conduit à des traitements plus efficaces, plus surs et mieux tolérés que les traitements existants pour soigner cette maladie. Ces traitements permettraient de freiner l'épidémie, à condition que leur coût soit abordable, que la production de médicaments génériques soit intensifiée et que les programmes de sensibilisation et de dépistage soient renforcés. Les sociétés pharmaceutiques ont, à cet égard, un rôle central à jouer. Nous avons examiné les produits commercialisés, les produits à l'étude et les stratégies d'accès aux médicaments de 20 des plus importantes sociétés pharmaceutiques mondiales. Six de ces sociétés développent des médicaments pour soigner l'hépatite C: AbbVie, Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck & Co. et Roche. Ces sociétés adoptent diverses approches pour faciliter le traitement de l'hépatite C, qui reposent notamment sur des stratégies de fixation des prix, l'octroi volontaire de licences, un renforcement des capacités et des dons de médicaments. Nous donnons un aperçu des efforts déployés par ces sociétés pour faciliter l'accès aux médicaments permettant de soigner l'hépatite C, et proposons des actions que peuvent mener ces sociétés afin de jouer un plus grand rôle dans l'enraiement de cette épidémie: (i) donner un degré de priorité élevé aux évaluations de l'accessibilité économique; (ii) développer des stratégies d'accès au début du cycle de vie du produit; et (iii) octroyer des licences aux fabricants de médicaments génériques.
La hepatitis C es una epidemia global. Se estima que, en todo el mundo, hay 185 millones de personas infectadas, la mayoría de las cuales viven en países de ingresos bajos y medios. Los recientes avances en el desarrollo de antivirales han producido terapias más efectivas, seguras y de mejor tolerancia que los tratamientos para la enfermedad existentes. Estas terapias presentan una oportunidad para poner freno a la epidemia, siempre y cuando sean asequibles, aumentar la producción genérica de dichos medicamentos y reforzar los programas de sensibilización y detección. Las empresas farmacéuticas juegan un papel central. Se examinaron los productos comercializados, tuberías y estrategias de acceso a los medicamentos de veinte de las mayores empresas farmacéuticas del mundo. Seis de estas empresas están desarrollando medicamentos para tratar la hepatitis C: AbbVie, Bristol-Myers Squibb, Gilead, Johnson & Johnson, Merck & Co. y Roche. Estas empresas emplean una gama de enfoques para apoyar el tratamiento para la hepatitis C, incluyendo las estrategias de fijación de precios, la concesión voluntaria de licencias, la creación de capacidad y las donaciones de medicamentos. Ofrecemos una visión general del compromiso de estas empresas a la hora de ofrecer acceso a los productos para tratar la hepatitis C. Sugerimos acciones que las empresas pueden llevar a cabo para tener un papel más importante a la hora de frenar esta epidemia: (i) dar prioridad a los criterios de asequibilidad; (ii) desarrollar estrategias de acceso al principio del ciclo de vida del producto; y (iii) ofrecer licencias a los fabricantes de medicamentos genéricos.