Publications by authors named "Ihab Abdulkader"

71 Publications

Molecular diagnosis in non-small-cell lung cancer: expert opinion on and testing.

J Clin Pathol 2021 Apr 19. Epub 2021 Apr 19.

Department of Pathology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.

The effectiveness of targeted therapies with tyrosine kinase inhibitors in non-small-cell lung cancer (NSCLC) depends on the accurate determination of the genomic status of the tumour. For this reason, molecular analyses to detect genetic rearrangements in some genes (ie, , , ) have become standard in patients with advanced disease. Since immunohistochemistry is easier to implement and interpret, it is normally used as the screening procedure, while fluorescence in situ hybridisation (FISH) is used to confirm the rearrangement and decide on ambiguous immunostainings. Although FISH is considered the most sensitive method for the detection of and rearrangements, the interpretation of results requires detailed guidelines. In this review, we discuss the various technologies available to evaluate and genomic rearrangements using these techniques. Other techniques such as real-time PCR and next-generation sequencing have been developed recently to evaluate and gene rearrangements, but some limitations prevent their full implementation in the clinical setting. Similarly, liquid biopsies have the potential to change the treatment of patients with advanced lung cancer, but further research is required before this technology can be applied in routine clinical practice. We discuss the technical requirements of laboratories in the light of quality assurance programmes. Finally, we review the recent updates made to the guidelines for the determination of molecular biomarkers in patients with NSCLC.
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http://dx.doi.org/10.1136/jclinpath-2021-207490DOI Listing
April 2021

Time-Course Changes of Serum Keratin Concentrations after Liver Transplantation: Contrasting Results of Keratin-18 and Keratin-19 Fragments.

Case Reports Hepatol 2020 30;2020:8895435. Epub 2020 Nov 30.

Department of Internal Medicine and Hepatology, Complejo Hospitalario Universitario de Santiago, Santiago, Spain.

Objective: Under normal conditions, adult hepatocytes express only keratin-8 (K8) and keratin-18 (K18), whereas cholangiocytes also express K19. In this study, we delineate the pattern of normal time-course changes in serum K19 and K18 levels after liver transplantation. Serum levels of the K19 fragment CYFRA 21-1 and the K18 fragments tissue polypeptide specific antigen (TPS) and M30 (a neoepitope that is generated after caspase cleavage during apoptosis) were measured at baseline and at regular intervals (up to 6 months) after liver transplantation in 11 adult patients.

Results: There was a gradual decrease in serum K19 concentrations from baseline values after transplantation, following a time-course pattern similar to that of serum bilirubin. In contrast, serum concentrations of K18 fragments increased markedly shortly after transplantation and gradually decreased thereafter, following a time-course pattern similar to that of serum transaminases. The increase in TPS tended to occur earlier than that in M30, suggesting an initial predominance of hepatocyte necrosis followed by a predominance of apoptosis in the first days after transplantation. Five patients presented posttransplant complications (acute rejection in three cases and HCV recurrence in two cases). An early increase in serum K19 concentrations was observed in all cases. An increase in serum concentrations of K18 fragments (M30 and TPS) was observed in the two cases with HCV recurrence and was more variable in the three cases with acute rejection.

Conclusions: Serum concentrations of K19 and K18 fragments follow a dissimilar pattern of time-course changes after liver transplantation. The diagnostic value of variations in these normal patterns should be addressed in future studies.
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http://dx.doi.org/10.1155/2020/8895435DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7723486PMC
November 2020

Corrigendum to "Lung cancer survival in never-smokers and exposure to residential radon: Results of the LCRINS study" [Canc. Lett. 487 (2020) 21-26].

Cancer Lett 2020 Nov 15;493:10. Epub 2020 Aug 15.

Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain; Consortium for Biomedical Research in Epidemiology & Public Health (CIBER en Epidemiología and Salud Pública - CIBERESP), Spain.

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http://dx.doi.org/10.1016/j.canlet.2020.07.020DOI Listing
November 2020

Lung cancer survival in never-smokers and exposure to residential radon: Results of the LCRINS study.

Cancer Lett 2020 09 24;487:21-26. Epub 2020 May 24.

Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain; Consortium for Biomedical Research in Epidemiology & Public Health (CIBER en Epidemiología and Salud Pública - CIBERESP), Spain.

We aimed to evaluate lung cancer survival in never-smokers, both overall and specifically by sex, exposure to residential-radon, age, histological type, and diagnostic stage. We included lung cancer cases diagnosed in a multicentre, hospital-based, case-control-study of never-smoker patients, diagnosed from January-2011 to March-2015 (Lung Cancer Research In Never Smokers study). 369 never-smokers (79% women; median age 71 years; 80% adenocarcinoma; 66% stage IV) were included. Median overall survival, and at one, 3 and 5 years of diagnosis was 18.3 months, 61%, 32% and 22%, respectively. Higher median survival rates were obtained for: younger age, adenocarcinoma, actionable mutations, and earlier-stage at diagnosis. Higher indoor radon showed a higher risk of death in multivariate analysis. Median lung cancer survival in never-smokers seems higher than that in ever-smokers. Patients with actionable mutations have a significantly higher survival. Higher indoor-radon exposure has a negative effect on survival.
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http://dx.doi.org/10.1016/j.canlet.2020.05.022DOI Listing
September 2020

Detection of MET Alterations Using Cell Free DNA and Circulating Tumor Cells from Cancer Patients.

Cells 2020 02 24;9(2). Epub 2020 Feb 24.

Liquid Biopsy Analysis Unit, Translational Medical Oncology (Oncomet), Health Research Institute of Santiago (IDIS), 15706 Santiago de Compostela, Spain.

MET alterations may provide a potential biomarker to evaluate patients who will benefit from treatment with MET inhibitors. Therefore, the purpose of the present study is to investigate the utility of a liquid biopsy-based strategy to assess MET alterations in cancer patients. We analyzed amplification in circulating free DNA (cfDNA) from 174 patients with cancer and 49 healthy controls and demonstrated the accuracy of the analysis to detect its alteration in patients. Importantly, a significant correlation between cfDNA concentration and copy number (CN) in cancer patients ( = 0.57, <10) was determined. Furthermore, we evaluated two approaches to detect the presence of MET on circulating tumor cells (CTCs), using the CellSearch and Parsortix systems and monitored patients under anti-EGFR treatment ( = 30) combining both cfDNA and CTCs analyses. This follow-up provides evidence for the potential of CN assessment when patients develop resistance to anti-EGFR therapy and a significant association between the presence of CTCs MET and the Overall Survival (OS) in head and neck cancer patients (P = 0.05; HR = 6.66). In conclusion, we develop specific and noninvasive assays to monitor MET status in cfDNA/CTCs and demonstrate the utility of plasma CN determination as a biomarker for monitoring the appearance of resistance to anti-EGFR therapy.
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http://dx.doi.org/10.3390/cells9020522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7072825PMC
February 2020

[Tumors of the thyroid gland. Proposal for the management and study of samples from patients with thyroid neoplasms].

Rev Esp Patol 2020 Jan - Mar;53(1):27-36. Epub 2019 May 7.

IPATIMUP-Institute of Molecular Pathology and Immunology, University of Porto, Porto, Portugal; Department of Pathology, Hospital de S. João, Porto, Portugal.

The recent changes in the classification and staging of thyroid tumors have arisen from the need to provide an adequate response to the exponential increase of thyroid cancer, which, however, has not been accompanied by an increase in mortality. These changes pretend to reduce overdiagnoses of malignancy, unnecessary treatment, side effects as well as cost for the health system. To this end, this article reviews recommendations for the management of thyroid surgical pathology samples with emphasis on the new terminology of the WHO classification. The basic criteria for the diagnosis of malignancy in well-differentiated thyroid carcinomas are reviewed and the criteria for NIFTP (non-invasive follicular tumor with papillary-like nuclear features) diagnosis are updated. Recommendations for the elaboration of the pathological report are also included.
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http://dx.doi.org/10.1016/j.patol.2019.03.003DOI Listing
March 2021

Dramatic Response of Leptomeningeal Carcinomatosis to Nivolumab in PD-L1 Highly Expressive Non-small Cell Lung Cancer: A Case Report.

Front Oncol 2019 6;9:819. Epub 2019 Sep 6.

Medical Oncology Department, University Hospital Complex of Ourense, Ourense, Spain.

In a patient who had been diagnosed of located squamous cell lung carcinoma, pneumonectomy, and adjuvant chemotherapy were performed. Brain recurrence and subsequent lung metastatic disease were uncontrolled by neurosurgery, holocranial radiotherapy, and first-line chemotherapy. In August 2015, appearance of leptomeningeal carcinomatosis triggered severe clinical deterioration and threatened the patient's life. Anti-PD1 immune checkpoint inhibitor was initiated in an attempt to stop tumor growth, achieving a spectacular brain and pulmonary complete response and clinical improvement, without serious adverse effects. High expression PD-L1 level (100%) was found in the pathological tissue sample. Nivolumab was maintained for more than 2 years and stopped in December 2017 after 28 months of treatment, with no disease evidence. More than 3 years after its onset, the patient maintains an outstanding PS with complete tumor response and no evidence of disease in last surveillance CT scan and brain MRI.
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http://dx.doi.org/10.3389/fonc.2019.00819DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6743439PMC
September 2019

Assessment of a New ROS1 Immunohistochemistry Clone (SP384) for the Identification of ROS1 Rearrangements in Patients with Non-Small Cell Lung Carcinoma: the ROSING Study.

J Thorac Oncol 2019 12 23;14(12):2120-2132. Epub 2019 Jul 23.

Alvaro Cunqueiro Hospital, Vigo, Spain.

Introduction: The ROS1 gene rearrangement has become an important biomarker in NSCLC. The College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology testing guidelines support the use of ROS1 immunohistochemistry (IHC) as a screening test, followed by confirmation with fluorescence in situ hybridization (FISH) or a molecular test in all positive results. We have evaluated a novel anti-ROS1 IHC antibody (SP384) in a large multicenter series to obtain real-world data.

Methods: A total of 43 ROS1 FISH-positive and 193 ROS1 FISH-negative NSCLC samples were studied. All specimens were screened by using two antibodies (clone D4D6 from Cell Signaling Technology and clone SP384 from Ventana Medical Systems), and the different interpretation criteria were compared with break-apart FISH (Vysis). FISH-positive samples were also analyzed with next-generation sequencing (Oncomine Dx Target Test Panel, Thermo Fisher Scientific).

Results: An H-score of 150 or higher or the presence of at least 70% of tumor cells with an intensity of staining of 2+ or higher by the SP384 clone was the optimal cutoff value (both with 93% sensitivity and 100% specificity). The D4D6 clone showed similar results, with an H-score of at least 100 (91% sensitivity and 100% specificity). ROS1 expression in normal lung was more frequent with use of the SP384 clone (p < 0.0001). The ezrin gene (EZR)-ROS1 variant was associated with membranous staining and an isolated green signal FISH pattern (p = 0.001 and p = 0.017, respectively).

Conclusions: The new SP384 ROS1 IHC clone showed excellent sensitivity without compromising specificity, so it is another excellent analytical option for the proposed testing algorithm.
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http://dx.doi.org/10.1016/j.jtho.2019.07.005DOI Listing
December 2019

Agreement on endoscopic ultrasonography-guided tissue specimens: Comparing a 20-G fine-needle biopsy to a 25-G fine-needle aspiration needle among academic and non-academic pathologists.

Dig Endosc 2019 Nov 10;31(6):690-697. Epub 2019 Jul 10.

Stony Brook University Hospital, New York, USA.

Background And Aim: A recently carried out randomized controlled trial showed the benefit of a novel 20-G fine-needle biopsy (FNB) over a 25-G fine-needle aspiration (FNA) needle. The current study evaluated the reproducibility of these findings among expert academic and non-academic pathologists.

Methods: This study was a side-study of the ASPRO (ASpiration versus PROcore) study. Five centers retrieved 74 (59%) consecutive FNB and 51 (41%) FNA samples from the ASPRO study according to randomization; 64 (51%) pancreatic and 61 (49%) lymph node specimens. Samples were re-reviewed by five expert academic and five non-academic pathologists and rated in terms of sample quality and diagnosis. Ratings were compared between needles, expert academic and non-academic pathologists, target lesions, and cytology versus histological specimens.

Results: Besides a higher diagnostic accuracy, FNB also provided for a better agreement on diagnosing malignancy (ĸ = 0.59 vs ĸ = 0.76, P < 0.001) and classification according to Bethesda (ĸ = 0.45 vs ĸ = 0.61, P < 0.001). This equally applied for expert academic and non-academic pathologists and for pancreatic and lymph node specimens. Sample quality was also rated higher for FNB, but agreement ranged from poor (ĸ = 0.04) to fair (ĸ = 0.55). Histology provided better agreement than cytology, but only when a core specimen was obtained with FNB (P = 0.004 vs P = 0.432).

Conclusion: This study shows that the 20-G FNB outperforms the 25-G FNA needle in terms of diagnostic agreement, independent of the background and experience of the pathologist. This endorses use of the 20-G FNB needle in both expert and lower volume EUS centers.
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http://dx.doi.org/10.1111/den.13424DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900144PMC
November 2019

Chylothorax as a debut form of Gorham-Stout disease.

Pulmonology 2019 May - Jun;25(3):195-197. Epub 2019 Apr 15.

Department of Pulmonology, University Clinical Hospital of Santiago, Santiago de Compostela, Spain; Interdisciplinary Group of Research in Pulmonology, Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.

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http://dx.doi.org/10.1016/j.pulmoe.2019.01.008DOI Listing
April 2020

Analysis of expression of the PD-1/PD-L1 immune checkpoint system and its prognostic impact in gastroenteropancreatic neuroendocrine tumors.

Sci Rep 2018 12 13;8(1):17812. Epub 2018 Dec 13.

Services of Endocrinology, Immunology and Molecular Biology Unit, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Instituto Princesa, 28006, Madrid, Spain.

The immune checkpoint based therapy targeting the programmed death-1 (PD-1) receptor and its PD-L1 ligand has recently been approved for the therapy of different malignant conditions, but not yet for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In this context, we evaluated the expression of PD-1 and PD-L1 in GEP-NETs and its potential correlations with clinical outcomes. Expression of PD-1/PD-L1 was analyzed by immunohistochemistry in 116 GEP-NETs and 48 samples of peritumoral tissue. In addition, the expression of these molecules was assessed by flow cytometry in peripheral blood mononuclear cells (PBMC) from patients with GEP-NETs (n = 32) and healthy controls (n = 32) and in intratumoral mononuclear cells (TMCs) (n = 3). Expression of PD-L1 and PD-1 was detected by immunohistochemistry in 6% and 1% of tumor tissue samples, respectively, and in 8% of peritumoral tissue samples, for both markers. We also observed that PD-1 expression by TMCs was associated with metastatic disease at diagnosis, and the levels of circulating PD-1+ PBMCs were associated with progressive disease upon follow-ups. In addition, circulating PD-1+ PBMCs were significantly correlated with PD-L1 expression by tumor cells. Our data suggest that PD-1/PD-L1 is expressed in 1 to 8% of GEP-NETs, and that this feature is significantly associated with disease evolution (p < 0.01).
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http://dx.doi.org/10.1038/s41598-018-36129-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6292913PMC
December 2018

CTCs-derived xenograft development in a triple negative breast cancer case.

Int J Cancer 2019 05 16;144(9):2254-2265. Epub 2018 Dec 16.

Roche-Chus Joint Unit. Oncomet, Health Research Institute of Santiago (IDIS), Spain.

Triple-negative breast cancer (TNBC) is characterized by high rates of metastasis and no available molecular targets. CTCs derived xenografts (CDX) have demonstrated to be a promising tool for understanding cancer biology. In our study, a CDX from a TNBC patient was developed for the first time. After CDX characterization, WNT signaling was found as the main mechanism related with this tumor biology and potential CTCs markers were identified and subsequently validated in TNBC patients. In this cohort high levels of MELK expression were associated with poorer survival rates. Overall, our study demonstrates that CTCs from TNBC are tumorigenic and CDXs are a useful model to obtain valuable information about the tumor.
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http://dx.doi.org/10.1002/ijc.32001DOI Listing
May 2019

A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device.

Gastrointest Endosc 2019 02 24;89(2):329-339. Epub 2018 Oct 24.

Department of Endoscopy, Stony Brook University Hospital, Stony Brook, New York, USA.

Background And Aims: Several studies have compared EUS-guided FNA with fine-needle biopsy (FNB), but none have proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle.

Methods: Consecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). The primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders.

Results: A total of 608 patients were allocated to FNA (n = 306) or FNB (n = 302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (P = .043), with no differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histologic yield (77% vs 44%, P < .001), accuracy for malignancy (87% vs 78%, P = .002) and Bethesda classification (82% vs 72%, P = .002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (odds ratio, 3.53; 95% confidence interval, 1.55-8.56; P = .004), and did not differ among centers (P = .836).

Conclusion: The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histologic yield and diagnostic accuracy. This benefit was irrespective of the indication and was consistent among participating centers, supporting the general applicability of our findings. (Clinical trial registration number: NCT02167074.).
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http://dx.doi.org/10.1016/j.gie.2018.10.026DOI Listing
February 2019

Cribriform-morular variant of thyroid carcinoma: a neoplasm with distinctive phenotype associated with the activation of the WNT/β-catenin pathway.

Mod Pathol 2018 08 21;31(8):1168-1179. Epub 2018 May 21.

i3S Instituto de Investigação e Inovação em Saúde, Porto, Portugal.

Cribriform-morular variant of thyroid carcinoma is classically associated with familial adenomatous polyposis but, it can also occur as a sporadic neoplasm. This neoplasm is much more frequently observed in women than in men (ratio of 61:1). In familial adenomatous polyposis patients, tumors are generally multifocal and/or bilateral (multinodular appearance), whereas in the sporadic cases tumors tend to occur as single nodules. The tumors are well delimited, and characteristically show a blending of follicular, cribriform, papillary, trabecular, solid, and morular patterns. Neoplastic cells are tall or cuboidal with the occasional nuclear features of classic papillary thyroid carcinoma. The morules include cells with peculiar nuclear clearing and show positivity for CDX2 and CD10. Angioinvasion and capsular invasion have been described in about 30 and 40% of cases, respectively, with lymph node metastases in less than 10% of patients and distant metastases in 6%. Although this tumor has good prognosis, neuroendocrine and/or poor differentiation have been associated with aggressive behavior. Tumor cells can be focally positive or negative for thyroglobulin, but are always positive for TTF-1, estrogen and progesterone receptors, and negative for calcitonin and cytokeratin 20. Nuclear and cytoplasmic staining for β-catenin is the hallmark of this tumor type; this feature plays a role in fine needle aspiration biopsy. Cribriform-morular variant of thyroid carcinoma has a peculiar endodermal (intestinal-like) type phenotype, activation of the WNT/β-catenin signaling pathway, and belongs to the non-BRAF-non-RAS subtype of the molecular classification of thyroid tumors. Elevated expression of estrogen and progesterone receptors and activation of the WNT/β-catenin pathway may prove useful as putative therapeutic targets in cases that do not respond to conventional therapy. Clinicians should be alerted to the possibility of familial adenomatous polyposis when a diagnosis of cribriform-morular variant of thyroid carcinoma is made. Instead of being considered as a variant of papillary thyroid carcinoma its designation as cribriform-morular thyroid carcinoma seems more appropriate.
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http://dx.doi.org/10.1038/s41379-018-0070-2DOI Listing
August 2018

Impact of the treatment of pancreatic exocrine insufficiency on survival of patients with unresectable pancreatic cancer: a retrospective analysis.

BMC Cancer 2018 May 5;18(1):534. Epub 2018 May 5.

Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, C/ Choupana s/n, 15706, Santiago de Compostela, Spain.

Background: Malnutrition and weight loss are commonly observed in patients with pancreatic cancer and contribute to poor survival. Pancreatic exocrine insufficiency (PEI), which can be caused by ductal obstruction by a tumor, causes maldigestion and malabsorption of nutrients, thus contributing to malnutrition in these patients. In this study, we evaluated the effects of pancreatic enzyme replacement therapy (PERT) on survival in patients with unresectable pancreatic cancer.

Methods: A retrospective analysis was conducted on a database of patients with unresectable, pathologically confirmed pancreatic cancer. All patients were evaluated for palliative chemotherapy and received the optimal palliative care. Patients were divided into two groups: Group 1 received standard therapy; Group 2 underwent additional evaluation of the pancreatic function and therapy with PERT, if needed. Survival (median and 95% confidence interval [CI]) was analyzed using Kaplan-Meier and Cox regression; groups were compared using the log-rank test.

Results: Overall, 160 patients with unresectable pancreatic cancer were included in the analysis (mean age: 70.5 years [range 28-100]; gender: 57.5% male; tumor stage: 78.7% Stage IV). Eighty-six patients (53.75%) were in Group 1 and 74 (46.25%) were in Group 2. Age, gender, tumor size, location and stage, weight loss, and serum CA 19-9 were similar between groups. Ninety-three (58.1%) patients received palliative chemotherapy; 46.5% in Group 1 and 71.6% in Group 2 (P < 0.001). Forty-nine (66.2%) patients in Group 2 and none in Group 1 received PERT. Survival in Group 2 (189 days, 95% CI 167.0-211.0 days) was significantly longer than in Group 1 (95.0 days, 95% CI 75.4-114.6 days) (HR 2.117, 95% CI 1.493-3.002; P < 0.001). Chemotherapy and PERT were significantly and independently associated with longer survival in a model controlled by age and tumor stage. In patients with significant weight loss at diagnosis (> 10% bodyweight within 6 months), PERT was associated with longer survival (HR 2.52, 95% CI 1.55-4.11; P < 0.001).

Conclusions: In patients with unresectable pancreatic cancer, PERT in patients with PEI was associated with longer survival compared with those not receiving PERT, especially in those experiencing significant weight loss. This finding should guide future prospective clinical trials of similar interventions.
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http://dx.doi.org/10.1186/s12885-018-4439-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5935964PMC
May 2018

Endoscopic ultrasound cytologic brushing vs endoscopic ultrasound - fine needle aspiration for cytological diagnosis of cystic pancreatic lesions. A multicenter, randomized open-label trial.

Rev Esp Enferm Dig 2018 Aug;110(8):478-484

Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Spain.

Introduction: the incidence of cystic pancreatic lesions (CPL) in the asymptomatic population is increasing. Achieving a preoperative diagnosis of CPL still remains a challenge.

Objectives: to evaluate the diagnostic accuracy of the cytological diagnosis of CPL from samples obtained by cytology brush versus standard endoscopic ultrasound fine needle aspiration (EUS-FNA).

Methods: a multicenter, randomized, open-label trial was performed of EUS-cytology brush (EUS-EB) versus EUS-FNA for the cytological diagnosis of CPL. Patients that underwent EUS-FNA with a CPL > 15 mm were included and randomized into two groups: group I, EUS-EB; group II, EUS-FNA. The final diagnosis was based on the histological evaluation of surgical specimens and clinical parameters, imaging and a five year follow-up in non-operated patients. The main outcome was the diagnostic accuracy of both methods. Secondary outcomes were the diagnostic adequacy of specimens and the rate of adverse events. Data were compared using the Chi-squared test. An intention to treat (ITT) and per-protocol (PP) analysis were performed.

Results: sixty-five patients were included in the study, 31 in group I and 34 in group II. Three patients initially randomized to group I were changed to group II as it was impossible to obtain a sample using the brush. The mean size of the CPL was 28.2 mm (range 16-60 mm). The diagnostic accuracy of EUS-EB was not superior to EUS-FNA, neither in the ITT nor the PP analysis (44.8% vs 41.1%, p = 0.77 and 38.4% vs 45.9%, p = 0.55).

Conclusions: EUS-EB does not improve the diagnostic accuracy of CPL in comparison with EUS-FNA.
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http://dx.doi.org/10.17235/reed.2018.5449/2017DOI Listing
August 2018

A rare cause of obstructive jaundice: diagnosis by EUS and single-operator per-oral cholangioscopy.

VideoGIE 2019 Aug 26;4(8):375-378. Epub 2017 Dec 26.

Gastroenterology Department, Hospital Clinico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.

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http://dx.doi.org/10.1016/j.vgie.2017.09.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6669262PMC
August 2019

Comparison of pancreatic histology specimens obtained by EUS 19G versus 22G core biopsy needles: A prospective multicentre study among experienced pathologists.

United European Gastroenterol J 2017 Oct 11;5(6):854-858. Epub 2017 Jan 11.

Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational & Clinical Research Center, Vita Salute San Raffaele University, San Raffaele Scientific Institute, Milan, Italy.

Background And Aim: Scanty data about inter-observer agreement (IOA) among pathologists in the evaluation of pancreatic samples acquired with EUS histology needle are available. The aim of this study was to determine IOA on adequacy of pancreatic histology specimens obtained with a 22G needle by a panel of experienced pathologist, in comparison with the 19G needle.

Methods: This multicentre prospective study involved 73 pancreatic specimens prepared using histology needles of different calibres. Five pathologists independently reviewed all the samples, assessing the presence of a core, specimen adequacy and the possibility to perform additional analyses. IOA determined by Fleiss' Kappa statistic was used as the primary outcome measure. Secondary outcome was to compare 22G versus 19G needle results.

Results: A core was present in 57% of pancreatic specimens obtained by 22G needle. The specimens were considered adequate in 72% of cases, with poor agreement among pathologists ( = 0.02, Fleiss' κ = 0.26). The possibility to perform further analyses was rated as 'positive' in 66% of cases without significant difference among observers ( = 0.80). When comparing the results, the presence of a core and the adequacy of tissue slides were significantly better for the 19G needle (57% vs. 84%  = 0.002; 72% vs. 83%  = 0.004, respectively). Reproducibility in the assessment of pancreatic sample adequacy was significantly better with the 19G needle (κ = 0.26 for 22G samples vs. κ = 0.81 for 19G samples).

Conclusions: Our results suggest that histology sampling of pancreatic masses should be performed with a 19G histology needle, since is able to provide a core in the majority of cases, with 83% of adequate specimens and excellent results in term of reproducibility among pathologists.
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http://dx.doi.org/10.1177/2050640616687231DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5625872PMC
October 2017

Environmental tobacco smoke exposure and EGFR and ALK alterations in never smokers' lung cancer. Results from the LCRINS study.

Cancer Lett 2017 12 5;411:130-135. Epub 2017 Oct 5.

Department of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain; CIBER de Epidemiología y Salud Pública, CIBERESP, Spain; Service of Preventive Medicine, University Hospital Complex of Santiago de Compostela, Spain.

Environmental tobacco smoke (ETS) exposure is a main risk factor of lung cancer in never smokers. Epidermal Growth Factor Receptor (EGFR) mutations and ALK translocations are more frequent in never smokers' lung cancer than in ever-smokers. We performed a multicenter case-control study to assess if ETS exposure is associated with the presence of EGFR mutations and its types and if ALK translocations were related with ETS exposure. All patients were never smokers and had confirmed lung cancer diagnosis. ETS exposure during childhood showed a negative association on the probability of EGRF mutation though not significant. Exposure during adulthood, at home or at workplace, did not show any association with EGFR mutation. The mutation type L858R seemed the most associated with a lower probability of EGFR alterations for ETS exposure at home in adult life. There is no apparent association between ETS exposure and ALK translocation. These results might suggest that ETS exposure during childhood or at home in adult life could influence the EGFR mutations profile in lung cancer in never smokers, reducing the probability of presenting EFGR mutation.
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http://dx.doi.org/10.1016/j.canlet.2017.09.042DOI Listing
December 2017

Small Cell Lung Cancer. Methodology and Preliminary Results of the SMALL CELL Study.

Arch Bronconeumol 2017 Dec 15;53(12):675-681. Epub 2017 Jun 15.

Área de Medicina Preventiva y Salud Pública, Universidad de Santiago de Compostela, Santiago de Compostela, España; CIBER de Epidemiología y Salud Pública (CIBERESP), España.

Introduction: Small cell lung cancer (SCLC) is the most aggressive histologic type of lung cancer, and accounts for approximately 10%-15% of all cases. Few studies have analyzed the effect of residential radon. Our aim is to determine the risk factors of SCLC.

Methods: We designed a multicenter, hospital-based case-control study with the participation of 11 hospitals in 4 autonomous communities.

Results: Results of the first 113 cases have been analyzed, 63 of which included residential radon measurements. Median age at diagnosis was 63 years; 11% of cases were younger than 50 years of age; 22% were women; 57% had extended disease; and 95% were smokers or former smokers. Median residential radon concentration was 128Bq/m. Concentrations higher than 400Bq/m were found in 8% of cases. The only remarkable difference by gender was the percentage of never smokers, which was higher in women compared to men (P<.001). Radon concentration was higher in patients with stageIV disease (non-significant difference) and in individuals diagnosed at 63 years of age or older (P=.032).

Conclusions: A high percentage of SCLC cases are diagnosed early and there is a predominance of disseminated disease at diagnosis. Residential radon seems to play an important role on the onset of this disease, with some cases having very high indoor radon concentrations.
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http://dx.doi.org/10.1016/j.arbres.2017.04.016DOI Listing
December 2017

Development of de novo psoriasis during nivolumab therapy for metastatic renal cell carcinoma: immunohistochemical analyses and clinical outcome.

APMIS 2017 03;125(3):259-263

Servizo de Oncoloxía Médica & Grupo de Oncoloxía Médica Traslacional, Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.

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http://dx.doi.org/10.1111/apm.12658DOI Listing
March 2017

Long-term Response to Nivolumab and Acute Renal Failure in a Patient with Metastatic Papillary Renal Cell Carcinoma and a PD-L1 Tumor Expression Increased with Sunitinib Therapy: A Case Report.

Front Oncol 2016 22;6:250. Epub 2016 Nov 22.

Servizo de Oncoloxía Médica & Grupo de Oncoloxía Médica Traslacional, Instituto de Investigación Sanitaria de Santiago de Compostela (IDIS), Complexo Hospitalario Universitario de Santiago de Compostela , A Coruña , Spain.

Introduction: Papillary renal cell carcinoma (PRCC), which represents around 20% of renal cell carcinomas, is a heterogeneous disease that includes different tumor types with several clinical and molecular phenotypes. Nivolumab, a fully human IgG4 programed cell death protein 1 immune checkpoint inhibitor antibody, has shown not only an overall survival advantage when compared to everolimus but also a relatively good side-effect profile among patients with previously treated advanced or metastatic renal cell carcinoma.

Case Report: We describe a case of a young man diagnosed with PRCC that achieved a durable response to nivolumab despite a temporary suspension of the treatment due to a renal function side effect. To the best of our knowledge, it is the first renal failure secondary to nivolumab in a metastatic renal cell carcinoma patient.

Concluding Remarks: Nivolumab is a promising drug in patients with metastatic PRCC and long-term responses can be achieved. In case of acute renal failure secondary to this treatment, temporary therapy suspension and a low dose of systemic corticosteroids can recover renal function without a negative impact on treatment efficacy.
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http://dx.doi.org/10.3389/fonc.2016.00250DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5118772PMC
November 2016

Residential radon, EGFR mutations and ALK alterations in never-smoking lung cancer cases.

Eur Respir J 2016 11 6;48(5):1462-1470. Epub 2016 Oct 6.

Dept of Preventive Medicine and Public Health, University of Santiago de Compostela, Santiago de Compostela, Spain.

The aim of this study was to assess if residential radon exposure might cause EGFR mutations or ALK rearrangements in never-smokers.We designed a multicentre case-control study in a radon-prone area (Galicia, Spain); only lung cancer cases were included in the study. We obtained residential radon measurements and clinical information for all the participants. We compared the median values of residential radon between patients with EGFR mutations or ALK rearrangements versus those without them.323 patients were included. Median age was 70 years and 19.5% were males. 42 and 15% of patients were EGFR- and ALK-positive, respectively. The most frequent EGFR alterations were exon 19 deletions and exon 21 (L858R) single-point substitution mutations. ALK-positive patients were 10 years younger than ALK-negative patients. Residential radon levels were two-fold higher in patients with exon 19 deletions compared with patients with exon 21 (L858R) single-point substitution mutations (216 versus 118 Bq·m; p=0.057). There were no differences in residential radon levels by EGFR mutation status. ALK-positive patients (n=12) essentially had two-fold residential radon levels compared with ALK-negative patients (290 versus 164 Bq·m, respectively).Residential radon may have a role in the molecular signature of lung cancer in never-smokers, although more studies with larger sample sizes are needed to support this hypothesis.
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http://dx.doi.org/10.1183/13993003.00407-2016DOI Listing
November 2016

Fluorescence hybridization analysis of the gene in 2,045 non-small cell lung cancer patients from North-Western Spain (Galicia).

Oncol Lett 2016 Aug 28;12(2):1403-1407. Epub 2016 Jun 28.

Department of Anatomic Pathology, Clinical University Hospital, Galician Healthcare Service (SERGAS), 15706 Santiago de Compostela, Spain.

Identification of anaplastic lymphoma receptor tyrosine kinase () gene rearrangements is a standard diagnostic test in patients with advanced non-small cell lung cancer (NSCLC). The current study describes the experience of rearrangement detection of a referral center in the public health care system of Galicia in North-Western Spain. The fluorescence hybridization (FISH) patterns of the gene and the clinical and pathological features of these patients are reported. This study is also of interest for comparative purposes due to the relative geographical isolation of the area, which could have contributed to particular genetic features. A total of 2,045 tissue samples from NSCLC patients were collected between October 2010 and July 2015 and tested for rearrangements by FISH. Examination of 1,686 paraffin-embedded tissue specimens and 395 cytological samples (306 cell block preparations and 53 cytological smears) was conducted, and any associations between the FISH results and clinicopathological features were assessed. The rate of successful evaluation was marginally higher in tissue samples than in cytological samples (92.9% vs. 84.1%); this difference was not significant. rearrangements were identified in 82 patients(4%): 65 (79.3%) in tissue specimens, 15 (18.3%) in cell block samples and 2 (2.4%) in cytological smears. This genetic translocation appeared to be associated with a non-smoking history, younger age, female gender, stage IV and adenocarcinoma histological type. The findings demonstrate that evaluation by FISH is feasible in tissue and cytological samples. The clinical and pathological features of the -positive series of patients are similar to those previously reported in the literature.
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http://dx.doi.org/10.3892/ol.2016.4788DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4950728PMC
August 2016

EGFR testing and clinical management of advanced NSCLC: a Galician Lung Cancer Group study (GGCP 048-10).

Cancer Manag Res 2016 4;8:11-20. Epub 2016 Feb 4.

Galician Public Foundation of Genomic Medicine-SERGAS, Santiago de Compostela Clinic Hospital, Santiago de Compostela, Spain.

Purpose: This study aimed to assess the incidence of mutations in the epidermal growth factor receptor (EGFR) gene in non-small-cell lung cancer (NSCLC) patients in the Galician region of Spain and the clinical management and outcome of patients carrying EGFR mutations.

Patients And Methods: All newly diagnosed advanced or metastatic NSCLC patients were screened for EGFR mutations in matched tumor samples (tissue or cytology specimens) and serum samples.

Results: Of 198 patients screened for EGFR mutations in tumor samples, 184 had evaluable data and, of these, 25 (13.6%) had EGFR mutations (84% sensitizing mutations). EGFR mutation was found in serum in 14 (8.1%) patients (of 174 evaluable). Compared to matched tumor tissue, serum EGFR mutation testing specificity and sensitivity were 99% and 52%, respectively. All but two patients received gefitinib. Median progression-free survival and overall survival were 10 (95% confidence interval: 4.8-15.3) months and 17.8 (95% confidence interval: 13.9-21.6) months, respectively, in patients carrying sensitizing mutations.

Conclusion: The incidence of EGFR mutations in Galicia is consistent with previous data in Spain. Our results also support the feasibility of EGFR testing to guide treatment decision making using tumor tissue or cytology samples, or serum samples if tumor specimens are unavailable. These findings also confirm that first-line gefitinib is an active treatment option in Caucasians with EGFR mutation-positive NSCLC.
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http://dx.doi.org/10.2147/CMAR.S85173DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4745839PMC
February 2016

Spontaneous bilateral haemothorax as presentation of primary pleural epithelioid haemangioendothelioma.

Clin Respir J 2017 Nov 24;11(6):1079-1085. Epub 2016 Jan 24.

Department of Pulmonology, University of Santiago Hospital Complex, Santiago de Compostela, Spain.

Pleural epithelioid haemangioendothelioma (EHE) is a rare tumour that originates in the vascular endothelium with an intermediate degree of malignancy between haemangioma and angiosarcoma. Smoking and asbestos exposure are unproven risk factors and diagnosis is usually confirmed by thoracoscopy, since pleural fluid (PF) cytology is often not conclusive. Immunohistochemistry can also help to confirm the diagnosis. We report an 85-year-old patient with bilateral pleural EHE diagnosed by thoracoscopy, who debuted with a spontaneous bilateral haemothorax, the second described so far, and we conducted a thorough review of the literature to describe the clinical, radiological and prognostic features, as well as the PF, of this rare tumour.
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http://dx.doi.org/10.1111/crj.12421DOI Listing
November 2017

Accuracy and inter-observer agreement of the Procore™ 25 gauge needle for endoscopic ultrasound-guided tissue core biopsy.

Dig Liver Dis 2015 Nov 13;47(11):943-9. Epub 2015 Jul 13.

Digestive Endoscopy Unit, Catholic University, Rome, Italy. Electronic address:

Background: Scanty data on the performance of the new 25-gauge Procore™ biopsy needle are available.

Methods: Consecutive patients who underwent endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) using the 25G Procore™ were retrospectively retrieved. All samples were independently reviewed by 3 pathologists for the following: histological, cytological or no specimen, neoplasia, diagnostic or non-diagnostic. Diagnostic accuracy and inter-rater concordance among pathologists were calculated.

Results: 94 patients underwent EUS-FNB of 101 sites (69 solid masses, 25 lymph nodes, 5 wall thickening). Forty-one biopsies (40.5%) were classified as histological samples by at least two pathologists, 29 as cytological (28.7%), 31 had no sample (30.7%). Good and almost perfect agreements among pathologists in defining cytological vs. histological samples (k 0.82; 95% CI: 0.74-0.90), diagnostic vs. non-diagnostic (k 0.95; 95% CI: 0.85-1.00) and neoplastic vs. non-neoplastic (k 0.94; 95% CI: 0.83-1.00). According to consensus rating, 61 cases were diagnostic samples (60.4%). Histological samples were more likely to lead to a correct diagnosis (OR, 4.1; 95% P=0.027), while neoplastic lesions were less likely to be correctly classified than benign (OR, 0.11; P=0.04).

Conclusions: EUS-FNB with the Procore™ 25G needle provided samples for histological examination in only 40% of the cases, with 31% of inadequate specimens, despite excellent results in term of inter-observer variability.
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http://dx.doi.org/10.1016/j.dld.2015.07.003DOI Listing
November 2015

Thyroid Pathology Findings in Cowden Syndrome: A Clue for the Diagnosis of the PTEN Hamartoma Tumor Syndrome.

Am J Clin Pathol 2015 Aug;144(2):322-8

Gastroenterology, Hospital do Meixoeiro, SERGAS, Vigo, Spain; and.

Objectives: PTEN hamartoma tumor syndrome (PHTS) is a hereditary disorder caused by germline inactivating mutations of the PTEN gene. PHTS includes Cowden syndrome and Bannayan-Riley-Ruvalcaba syndrome. We describe how the peculiar pathologic and immunohistochemical thyroid features lead pathologists to suggest PHTS.

Methods: A 28-year-old white Spanish woman had a multinodular goiter. Total thyroidectomy was performed after fine-needle aspiration biopsy. Microscopic, immunohistochemical, and molecular analyses of the thyroid lesions were realized.

Results: The thyroid was multinodular, showing one papillary microcarcinoma, five follicular adenomas, three adenolipomas, 46 tiny adenomatous nodules (microadenomas), scattered foci of adipose tissue, and lymphocytic thyroiditis. Tumors were positive for thyroglobulin, thyroperoxidase, pendrin, cyclin D1, and p27 but negative for calcitonin and PTEN. A germline heterozygous deletion of one adenine at nucleotide 827 in exon 8 of the PTEN gene was confirmed. No BRAF, NRAS, or KRAS somatic mutations were detected in the papillary microcarcinoma, follicular adenoma, adenolipomas, or microadenomas. Negativity for PTEN was also found in the colonic tubulovillous adenoma and the storiform collagenoma.

Conclusions: Pathologists play a crucial role in recognizing pathologic thyroid findings associated with PHTS for selecting patients for genetic testing.
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http://dx.doi.org/10.1309/AJCP84INGJUVTBMEDOI Listing
August 2015

A clinical model for predicting lymph node metastasis in submucosal invasive (T1) colorectal cancer.

Int J Colorectal Dis 2015 Jun 21;30(6):761-8. Epub 2015 Feb 21.

Gastroenterology Department, University Hospital of Santiago de Compostela, c/Choupana s/n, 15706, Santiago de Compostela, Spain,

Background: No single histopathological feature of submucosal invasive colorectal cancer (T1-CRC) can reliably predict the risk for lymph node metastasis (LNM).

Aim: The purpose of the study was to develop a prediction model of LNM in T1-CRC.

Methods: Ninety-seven surgically resected T1-CRC at our institution were retrospectively evaluated. Morphology, localization, grading, mode of growth, presence of background adenoma, lymphoid infiltration, angiolymphatic invasion, budding, and depth of invasion were assessed. Mortality and morbidity related to surgery were also evaluated. Benefit-risk balance was assessed according to the presence of severe complications and to the presence of LNM.

Results: Fourteen cases had LNM (14%). Eight patients (8%) presented severe surgical complications and there were two deaths (2 %). Infiltrative growth pattern (OR 31.91, 95% CI 2.37-428.36; p = 0.009) and the absence of lymphoid infiltrate (OR 28.75; 95% CI 2.13-388.37; p = 0.011) were the only variables independently associated with LNM in the multivariate analysis. Both variables were included in the prediction model together with sessile morphology (OR 4.88; 95% CI 0.81-29.3; p = 0.083) and poorly differentiated carcinoma (OR 11.77; 95% CI 0.77-179.83; p = 0.076). A 0-100 score was developed (infiltrative growth pattern: no = 0, yes = 33; lymphoid infiltrate: no = 29, yes = 0; sessile morphology: no = 0, yes = 15; poorly differentiated: no = 0, yes = 23). Cutoff point to indicate additional surgery was set in 35 points (i.e., 10% risk LNM). Discrimination of the prediction model was excellent (AUC 0.90; 95% CI 0.81-0.99).

Conclusion: Combined evaluation of infiltrative growth pattern, lymphoid infiltration, poorly differentiated carcinoma, and sessile appearance showed good performance for discriminating T1-CRC patients with LNM. The benefit-risk balance was in favor of surgery when at least two of these criteria were present.
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http://dx.doi.org/10.1007/s00384-015-2164-3DOI Listing
June 2015

Interobserver agreement and accuracy of preoperative endoscopic ultrasound-guided biopsy for histological grading of pancreatic cancer.

Endoscopy 2015 Apr 18;47(4):308-14. Epub 2014 Dec 18.

Department of Pathology, Università Cattolica del Sacro Cuore, Rome, Italy.

Background And Study Aim: Poorly differentiated/high grade pancreatic ductal adenocarcinoma (PDAC) is associated with an early unfavorable outcome, and patients with these tumors may be candidates for neo-adjuvant treatment. Endoscopic ultrasound-guided pancreatic fine-needle biopsy (EUS-FNB) may, in theory, allow preoperative assessment of PDAC histological grading. The aim of the current study was to assess the interobserver agreement and accuracy of preoperative PDAC grading from EUS-FNB specimens.

Methods: Data from 42 postsurgical PDAC patients who had undergone preoperative EUS-FNB were retrieved. Four experienced pathologists independently reviewed the EUS-FNB slides and reported tumor grading (well, moderately, or poorly differentiated). Agreement among pathologists for grading of preoperative EUS-FNB samples was expressed by using Cohen's or Fleiss' kappa statistic, as appropriate. Postsurgical PDAC grading was used as the gold standard to assess the cumulative accuracy of EUS-FNB for the preoperative prediction of PDAC grading.

Results: The kappa values for PDAC grading on EUS-FNB specimens ranged from 0.09 to 0.41. The total agreement among the four pathologists was only fair (κ = 0.27; 95 % confidence interval [CI] 0.14 - 0.38). When tumor grades were grouped as well or moderately differentiated vs. poorly differentiated, kappa values ranged from 0.19 to 0.50, with only a fair overall agreement (κ = 0.27; 95 %CI 0.21 - 0.49). The accuracy of preoperative grading from EUS-FNB was 56 % (75/134 readings; 95 %CI 40 % - 65 %), with mean sensitivity and specificity to detect a high grade, poorly differentiated tumor of 41 % (95 %CI 19 % - 54 %) and 78 % (53/68 readings; 95 %CI 60 % - 99 %), respectively.

Conclusions: Preoperative EUS-FNB-based histological grading of PDAC is unreliable, and current results do not support the use of this information in clinical practice. This appears to be due to suboptimal interobserver agreement among pathologists and an overall low accuracy in predicting postsurgical grading.
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http://dx.doi.org/10.1055/s-0034-1390912DOI Listing
April 2015