Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016
Prospective and clinical validation of ALK immunohistochemistry: results from the phase I/II study of alectinib for ALK-positive lung cancer (AF-001JP study).
Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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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.
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Who cites it
22 citing papers in PubMed.
- Three-Year Follow-Up of an Alectinib Phase I/II Study in ALK-Positive Non-Small-Cell Lung Cancer: AF-001JP.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2017Trial
- Pharmacologic study (JP28927) of alectinib in Japanese patients with ALK+ non-small-cell lung cancer with or without prior crizotinib therapy.Cancer science · 2016Trial
- Companion Diagnostics in Clinical Therapy: Current Applications and Future Directions.MedComm · 2026Review
- Lung adenocarcinoma withTranslational lung cancer research · 2025Article
- Spectrum of Resistance Mechanisms to ALK TKIs in NSCLC: Largest Single-Center Experience from India.South Asian journal of cancer · 2025Article
- Concordance of ALK fusion gene-rearrangement between immunohistochemistry and next-generation sequencing.International journal of clinical oncology · 2024Article
- Optimal Treatment Strategy for Oligo-Recurrence Lung Cancer Patients with Driver Mutations.Cancers · 2024Article
- A NovelOncoTargets and therapy · 2022Article
- Status quo of ALK testing in lung cancer: results of an EQA scheme based on in-situ hybridization, immunohistochemistry, and RNA/DNA sequencing.Virchows Archiv : an international journal of pathology · 2021Article
- The Resistance Mechanisms and Treatment Strategies for ALK-Rearranged Non-Small Cell Lung Cancer.Frontiers in oncology · 2021Review
- The role of plasma genotyping in ALK- and ROS1-rearranged lung cancer.Translational lung cancer research · 2020Review
- Genome analysis of peeling archival cytology samples detects driver mutations in lung cancer.Cancer medicine · 2020Article
- Clinicopathological Features of ALK Expression in 9889 Cases of Non-small-Cell Lung Cancer and Genomic Rearrangements Identified by Capture-Based Next-Generation Sequencing: A Chinese Retrospective Analysis.Molecular diagnosis & therapy · 2019Article
- Expression of C-terminal ALK, RET, or ROS1 in lung cancer cells with or without fusion.BMC cancer · 2019Article
- Discovery Stories of RET Fusions in Lung Cancer: A Mini-Review.Frontiers in physiology · 2019Review
- The correlation between crizotinib efficacy and molecular heterogeneity by next-generation sequencing in non-small cell lung cancer.Journal of thoracic disease · 2018Article
- Novel method for rapid fluorescence in-situ hybridization of ALK rearrangement using non-contact alternating current electric field mixing.Scientific reports · 2017Article
- Anaplastic large cell lymphoma: pathology, genetics, and clinical aspects.Journal of clinical and experimental hematopathology : JCEH · 2017Review
- Inconsistent results in the analysis of ALK rearrangements in non-small cell lung cancer.BMC cancer · 2016Article
- Targeted therapies and immunotherapy in non-small-cell lung cancer.Ecancermedicalscience · 2016Review
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAnaplastic lymphoma kinase (ALK) fusions need to be accurately and efficiently detected for ALK inhibitor therapy. Fluorescence in situ hybridization (FISH) remains the reference test. Although increasing data are supporting that ALK immunohistochemistry (IHC) is highly concordant with FISH, IHC screening needed to be clinically and prospectively validated. PATIENTS AND
methodsIn the AF-001JP trial for alectinib, 436 patients were screened for ALK fusions through IHC (n = 384) confirmed with FISH (n = 181), multiplex RT-PCR (n = 68), or both (n = 16). IHC results were scored with iScore.
resultALK fusion was positive in 137 patients and negative in 250 patients. Since the presence of cancer cells in the samples for RT-PCR was not confirmed, ALK fusion negativity could not be ascertained in 49 patients. IHC interpreted with iScore showed a 99.4% (173/174) concordance with FISH. All 41 patients who had iScore 3 and were enrolled in phase II showed at least 30% tumor reduction with 92.7% overall response rate. Two IHC-positive patients with an atypical FISH pattern responded to ALK inhibitor therapy. The reduction rate was not correlated with IHC staining intensity.
conclusionsOur study showed (i) that when sufficiently sensitive and appropriately interpreted, IHC can be a stand-alone diagnostic for ALK inhibitor therapies; (ii) that when atypical FISH patterns are accompanied by IHC positivity, the patients should be considered as candidates for ALK inhibitor therapies, and (iii) that the expression level of ALK fusion is not related to the level of response to ALK inhibitors and is thus not required for patient selection. REGISTRATION NUMBER: JapicCTI-101264 (This study is registered with the Japan Pharmaceutical Information Center).
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