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1.
Lab Invest ; 104(1): 100284, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37949357

RESUMO

Claudin 18.2 (CLDN18.2), the dominant isoform of CLDN18 in gastric tissues, is a highly specific tight junction protein of the gastric mucosa with variably retained expressions in gastric and gastroesophageal junction cancers. Additionally, CLDN18.2-targeted treatment with zolbetuximab, in combination with chemotherapy, has recently been assessed in 2 phase-III studies of patients with HER2-negative, locally advanced, unresectable, or metastatic gastric or gastroesophageal junction adenocarcinoma. These trials used the investigational VENTANA CLDN18 (43-14A) RxDx immunohistochemistry (IHC) assay on the Ventana BenchMark platform to identify patients eligible for CLDN18.2-targeted treatment. We report the findings of a global ring study evaluating the analytical comparability of concordance of the results of 3 CLDN18 antibodies (Ventana, LSBio, and Novus) stained on 3 IHC-staining platforms (Ventana, Dako, and Leica). A tissue microarray (TMA), comprising 15 gastric cancer cases, was stained by 27 laboratories across 11 countries. Each laboratory stained the TMAs using at least 2 of the 3 evaluated CLDN18 antibodies. Stained TMAs were assessed and scored using an agreed IHC-scoring algorithm, and the results were collated for statistical analysis. The data confirmed a high level of concordance for the VENTANA CLDN18 (43-14A; Ventana platform only) and LSBio antibodies on both the Dako and Leica platforms, with accuracy, precision, sensitivity, and specificity rates all reaching a minimum acceptable ≥85% threshold and good-to-excellent levels of concordance as measured by Cohen's kappa coefficient. The Novus antibody showed the highest level of variability against the reference central laboratory results for the same antibody/platform combinations. It also failed to meet the threshold for accuracy and sensitivity when used on either the Dako or Leica platform. These results demonstrated the reliability of IHC testing for CLDN18 expression in gastric tumor samples when using commercially available platforms with an appropriate methodology and primary antibody selection.


Assuntos
Compostos Organofosforados , Polímeros , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/diagnóstico , Neoplasias Gástricas/metabolismo , Reprodutibilidade dos Testes , Junção Esofagogástrica/patologia , Claudinas
2.
Gastroenterol Clin Biol ; 26(4): 405-8, 2002 Apr.
Artigo em Francês | MEDLINE | ID: mdl-12070414

RESUMO

Pulmonary complications of alpha interferon are rare. We report two cases of lung complications in liver transplantation patients for HCV related cirrhosis. After switching from interferon alpha to pegylated interferon alpha 2b, one patient developed a BOOP (Bronchiolitis Obliterans Organizing Pneumonia) and the other severe interstitial pneumonitis. We discuss the causes of these rare pulmonary alpha-interferon induced complications and the different way to suggest that the pegylated interferon alpha 2b could be related to the risk of pulmonary toxicity of this treatment.


Assuntos
Interferon-alfa/efeitos adversos , Doenças Pulmonares Intersticiais/induzido quimicamente , Polietilenoglicóis , Adulto , Hepatite C/patologia , Humanos , Interferon alfa-2 , Cirrose Hepática/cirurgia , Transplante de Fígado , Pulmão/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes
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