Trial reportPloS one2014
Accurate and economical detection of ALK positive lung adenocarcinoma with semiquantitative immunohistochemical screening.
Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy of D5F3 IHC for detecting ALK gene rearrangement in NSCLC patients: a systematic review and meta-analysis.Oncotarget · 2016Pooled it
- Targeting ALK in Neuroendocrine Tumors of the Lung.Frontiers in oncology · 2022Article
- Article
- Chinese perspectives on clinical efficacy and safety of alectinib in patients withOncoTargets and therapy · 2019Article
- [Current Status for Anaplastic Lymphoma Kinase in Non-small Cell Lung Cancer].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2018Review
- ALK (D5F3) CDx: an immunohistochemistry assay to identify ALK-positive NSCLC patients.Pharmacogenomics and personalized medicine · 2018Review
- Anaplastic Lymphoma Kinase Testing: IHC vs. FISH vs. NGS.Current treatment options in oncology · 2017Review
- Worse disease-free, tumor-specific, and overall survival in surgically-resected lung adenocarcinoma patients withOncotarget · 2017Article
- Immunohistochemistry for predictive biomarkers in non-small cell lung cancer.Translational lung cancer research · 2017Review
- Neuroendocrine carcinoma of the lung expressing anaplastic lymphoma kinase on high-sensitivity immunohistochemistry: A case report.Molecular and clinical oncology · 2017Article
- Nonsmall cell lung carcinoma: diagnostic difficulties in small biopsies and cytological specimens: Number 2 in the Series "Pathology for the clinician" Edited by Peter Dorfmüller and Alberto Cavazza.European respiratory review : an official journal of the European Respiratory Society · 2017Review
- [Clinical Advanced in Early-stage ALK-positive Non-small Cell Lung Cancer Patients].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2017Review
- Advanced lung adenocarcinomas with ROS1-rearrangement frequently show hepatoid cell.Oncotarget · 2016Article
- Inconsistent results in the analysis of ALK rearrangements in non-small cell lung cancer.BMC cancer · 2016Article
- Economic Analysis of Alternative Strategies for Detection of ALK Rearrangements in Non Small Cell Lung Cancer.Diagnostics (Basel, Switzerland) · 2016Article
- Clinicopathological features and relation between anaplastic lymphoma kinase (ALK) mutation and histological subtype of lung adenocarcinoma in Eastern European Caucasian population.Journal of Cancer · 2016Article
- A Prediction Model for ROS1-Rearranged Lung Adenocarcinomas based on Histologic Features.PloS one · 2016Article
- [Influence of Immunohistochemistry Scoring Criteria in Detecting EGFR Mutations].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2015Article
- Poor response to gefitinib in lung adenocarcinoma with concomitant epidermal growth factor receptor mutation and anaplastic lymphoma kinase rearrangement.Thoracic cancer · 2015Article
- Different histopathology but the same clonality: ALK rearrangement in a patient with metastatic non-small-cell lung cancer.International journal of clinical and experimental pathology · 2015Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Right detection of anaplastic lymphoma kinase (ALK) gene rearrangement is pivotal to selection of patients with lung adenocarcinoma for ALK-targeted therapy. We explored the potential of combination of immunohistochemistry (IHC) screening and fluorescence in situ hybridization (FISH) as an affordable practice. We analyzed 410 unselected lung adenocarcinomas by ALK IHC (D5F3 clone) and FISH. Some equivocal cases were further analyzed by RT-PCR. The EGFR mutation was detected by pyrosequencing assay. In total 368 cases which got all IHC, FISH, EGFR mutation results were eligible for analysis. Cases were evaluated as IHC score 3+ (n = 26), score 2+ (n = 9), score 1+ (n = 51), and score 0 (n = 282), respectively. 23 of 26 IHC 3+ and 5 of 9 IHC 2+ cases were FISH positive, whereas 3 of 26 IHC 3+, 4 of 9 IHC 2+ and all 333 IHC 1+/0 cases were FISH negative. If considering FISH as the standard, the sensitivity and specificity of ALK IHC 3+/2+ as ALK positive were 100% and 97.9%, respectively. Three IHC 3+ cases reported as FISH "negative" were actually ALK positive confirmed by ALK RT-PCR or re-detected. Based on the final classify, ALK IHC 3+/2+ was 100% sensitive and 98.8% specific. However, FISH was 90.3% sensitive and 100% specific. IHC 2+ was regarded as equivocal and need to be confirmed by FISH or RT-PCR. In the 368 cases, 8.4% cases had ALK positive, 52.2% cases had EGFR mutation, and only one case had a coexisting. Manually semiquantitative ALK IHC (primary antibody D5F3 coupled with secondary DAKO Envision system) used as the initial screening combined with auxiliary FISH confirmation is a reliable, economical approach to identify ALK positive lung adenocarcinoma. The IHC can find some ALK positive cases which would be missed by FISH only.
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