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"2013-06", "numChildren": 1 }, "data": { "key": "7PH7KBME", "version": 42, "itemType": "journalArticle", "title": "Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors", "creators": [ { "creatorType": "author", "firstName": "Neal I.", "lastName": "Lindeman" }, { "creatorType": "author", "firstName": "Philip T.", "lastName": "Cagle" }, { "creatorType": "author", "firstName": "Mary Beth", "lastName": "Beasley" }, { "creatorType": "author", "firstName": "Dhananjay Arun", "lastName": "Chitale" }, { "creatorType": "author", "firstName": "Sanja", "lastName": "Dacic" }, { "creatorType": "author", "firstName": "Giuseppe", "lastName": "Giaccone" }, { "creatorType": "author", "firstName": "Robert Brain", "lastName": "Jenkins" }, { "creatorType": "author", "firstName": "David J", "lastName": "Kwiatkowski" }, { "creatorType": "author", "firstName": "Juan-Sebastian", "lastName": "Saldivar" }, { "creatorType": "author", "firstName": "Jeremy", "lastName": "Squire" }, { "creatorType": "author", "firstName": "Erik", "lastName": "Thunnissen" }, { "creatorType": "author", "firstName": "Marc", "lastName": "Ladanyi" } ], "abstractNote": "⬚⬚ Objective.—To establish evidence-based recommenda- tions for the molecular analysis of lung cancers that are required to guide EGFR- and ALK-directed therapies, addressing which patients and samples should be tested, and when and how testing should be performed.\nParticipants.—Three cochairs without conflicts of interest were selected, one from each of the 3 sponsoring professional societies: College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Writing and advisory panels were constituted from additional experts from these societies.\nEvidence.—Three unbiased literature searches of elec- tronic databases were performed to capture articles published from January 2004 through February 2012, yielding 1533 articles whose abstracts were screened to identify 521 pertinent articles that were then reviewed in detail for their relevance to the recommendations. Evidence was formally graded for each recommendation.\nConsensus Process.—Initial recommendations were for- mulated by the cochairs and panel members at a public meeting. Each guideline section was assigned to at least 2 panelists. Drafts were circulated to the writing panel (version 1), advisory panel (version 2), and the public (version 3) before submission (version 4).\nConclusions.—The 37 guideline items address 14 sub- jects, including 15 recommendations (evidence grade A/ B). The major recommendations are to use testing for EGFR mutations and ALK fusions to guide patient selection for therapy with an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) inhibitor, respective- ly, in all patients with advanced-stage adenocarcinoma, regardless of sex, race, smoking history, or other clinical risk factors, and to prioritize EGFR and ALK testing over other molecular predictive tests. As scientific discoveries and clinical practice outpace the completion of random- ized clinical trials, evidence-based guidelines developed by expert practitioners are vital for communicating emerging clinical standards. Already, new treatments targeting genetic alterations in other, less common driver oncogenes are being evaluated in lung cancer, and testing for these may be addressed in future versions of these guidelines.\n(Arch Pathol Lab Med. 2013;137:828–860; doi: 10.5858/ arpa.2012-0720-OA)", "publicationTitle": "Arch Pathol Lab Med", "publisher": "", "place": "", "date": "June 2013", "volume": "137", "issue": "", "section": "", "partNumber": "", "partTitle": "", "pages": "828-860", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "", "accessDate": "", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2014-12-17T23:43:32Z", "dateModified": "2014-12-17T23:49:19Z" } }, { "key": "SP9JN39K", "version": 35, "library": { "type": "group", "id": 312108, 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"charset": "", "tags": [], "relations": {}, "dateAdded": "2014-12-17T23:06:58Z", "dateModified": "2014-12-17T23:06:58Z" } }, { "key": "8E6JMAKI", "version": 31, "library": { "type": "group", "id": 312108, "name": "ALS 359 Project", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_359_project", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/312108/items/8E6JMAKI", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_359_project/items/8E6JMAKI", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2095283, "username": "yshi14", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/yshi14", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "8E6JMAKI", "version": 31, "itemType": "webpage", "title": "European multicenter harmonization study shows anaplastic lymphoma kinase immunohistochemistry testing comparable to, if not better than, fluorescence in situ hybridization testing. | International Association for the Study of Lung Cancer", "creators": [], "abstractNote": "", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "https://www.iaslc.org/articles/european-multicenter-harmonization-study-shows-anaplastic-lymphoma-kinase", "accessDate": "2014-12-17T21:50:22Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2014-12-17T23:06:58Z", "dateModified": "2014-12-17T23:06:58Z" } }, { "key": "74MHC5ZX", "version": 31, "library": { "type": "group", "id": 312108, "name": "ALS 359 Project", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_359_project", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/312108/items/74MHC5ZX", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_359_project/items/74MHC5ZX", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2095283, "username": "yshi14", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/yshi14", "type": "text/html" } } }, "creatorSummary": "Selinger et al.", "parsedDate": "2013-12", "numChildren": 0 }, "data": { "key": "74MHC5ZX", "version": 31, "itemType": "journalArticle", "title": "Testing for ALK rearrangement in lung adenocarcinoma: a multicenter comparison of immunohistochemistry and fluorescent in situ hybridization", "creators": [ { "creatorType": "author", "firstName": "Christina I.", "lastName": "Selinger" }, { "creatorType": "author", "firstName": "Toni-Maree", "lastName": "Rogers" }, { "creatorType": "author", "firstName": "Prudence A.", "lastName": "Russell" }, { "creatorType": "author", "firstName": "Sandra", "lastName": "O'Toole" }, { "creatorType": "author", "firstName": "PoYee", "lastName": "Yip" }, { "creatorType": "author", "firstName": "Gavin M.", "lastName": "Wright" }, { "creatorType": "author", "firstName": "Zoe", "lastName": "Wainer" }, { "creatorType": "author", "firstName": "Lisa G.", "lastName": "Horvath" }, { "creatorType": "author", "firstName": "Michael", "lastName": "Boyer" }, { "creatorType": "author", "firstName": "Brian", "lastName": "McCaughan" }, { "creatorType": "author", "firstName": "Maija RJ", "lastName": "Kohonen-Corish" }, { "creatorType": "author", "firstName": "Stephen", "lastName": "Fox" }, { "creatorType": "author", "firstName": "Wendy A.", "lastName": "Cooper" }, { "creatorType": "author", "firstName": "Benjamin", "lastName": "Solomon" } ], "abstractNote": "Rearrangements of anaplastic lymphoma kinase (ALK) gene in non-small cell lung cancer (NSCLC) define a molecular subgroup of tumors characterized clinically by sensitivity to ALK tyrosine kinase inhibitors such as crizotinib. Although ALK rearrangements may be detected by reverse transcriptase-PCR, immunohistochemistry or fluorescence in situ hybridization (FISH), the optimal clinical strategy for identifying ALK rearrangements in clinical samples remains to be determined. We evaluated immunohistochemistry using three different antibodies (ALK1, 5A4 and D5F3 clones) to detect ALK rearrangements and compared those with FISH. We report the frequency and clinicopathologic features of lung cancers harboring ALK translocations in 594 resected NSCLCs (470 adenocarcinomas; 83 squamous carcinomas, 26 large cell carcinomas and 15 other histological subtypes) using a tissue microarray approach. We identified an ALK gene rearrangement in 7/594 cases (1%) by FISH and all anti-ALK antibodies correctly identified the seven ALK-positive cases (100% sensitivity), although the intensity of staining was weak in some cases. These data indicate that the use of antibodies with high sensitivity and avidity to ALK may provide an effective pre-screening technique to complement the more expensive and labor-intensive approach of ALK FISH testing.", "publicationTitle": "Modern Pathology", "publisher": "", "place": "", "date": "December 2013", "volume": "26", "issue": "12", "section": "", "partNumber": "", "partTitle": "", "pages": "1545-1553", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Mod Pathol", "DOI": "10.1038/modpathol.2013.87", "citationKey": "", "url": "http://www.nature.com/modpathol/journal/v26/n12/full/modpathol201387a.html", "accessDate": "2014-12-06T20:01:14Z", "PMID": "", "PMCID": "", "ISSN": "0893-3952", "archive": "", "archiveLocation": "", "shortTitle": "Testing for ALK rearrangement in lung adenocarcinoma", "language": "en", "libraryCatalog": "www.nature.com", "callNumber": "", "rights": "© 2013 Nature Publishing Group", "extra": "", "tags": [ { "tag": "NSCLC", "type": 1 }, { "tag": "anaplastic lymphoma kinase", "type": 1 }, { "tag": "non-small cell lung cancer", "type": 1 } ], "collections": [], "relations": {}, "dateAdded": "2014-12-17T23:06:58Z", "dateModified": "2014-12-17T23:06:58Z" } }, { "key": "XVNQCPHM", "version": 31, "library": { "type": "group", "id": 312108, "name": "ALS 359 Project", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_359_project", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/312108/items/XVNQCPHM", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_359_project/items/XVNQCPHM", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2095283, "username": "yshi14", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/yshi14", "type": "text/html" } } }, "creatorSummary": "Lee et al.", "parsedDate": "2013-05-01", "numChildren": 0 }, "data": { "key": "XVNQCPHM", "version": 31, "itemType": "journalArticle", "title": "Testing for anaplastic lymphoma kinase rearrangement to target crizotinib therapy: oncology, pathology and health economic perspectives", "creators": [ { "creatorType": "author", "firstName": "James A", "lastName": "Lee" }, { "creatorType": "author", "firstName": "Lukas", "lastName": "Bubendorf" }, { "creatorType": "author", "firstName": "Rolf", "lastName": "Stahel" }, { "creatorType": "author", "firstName": "Solange", "lastName": "Peters" } ], "abstractNote": "Crizotinib is a first-in-class oral anaplastic lymphoma kinase (ALK) inhibitor targeting ALK-rearranged non-small-cell lung cancer. The therapy was approved by the US FDA in August 2011 and received conditional marketing approval by the European Commission in October 2012 for advanced non-small-cell lung cancer. A break-apart FISH-based assay was jointly approved with crizotinib by the FDA. This assay and an immunohistochemistry assay that uses a D5F3 rabbit monoclonal primary antibody were also approved for marketing in Europe in October 2012. While ALK rearrangement has relatively low prevalence, a clinical benefit is exhibited in more than 85% of patients with median progression-free survival of 8–10 months. In this article, the authors summarize the therapy and alternative test strategies for identifying patients who are likely to respond to therapy, including key issues for effective and efficient testing. The key economic considerations regarding the joint companion diagnostic and therapy are also presented. Given the observed clinical benefit and relatively high cost of crizotinib therapy, companion diagnostics should be evaluated relative to response to therapy versus correlation alone whenever possible, and both high inter-rater reliability and external quality assessment programs are warranted.", "publicationTitle": "Expert Review of Anticancer Therapy", "publisher": "", "place": "", "date": "May 1, 2013", "volume": "13", "issue": "5", "section": "", "partNumber": "", "partTitle": "", "pages": "625-636", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "Expert Review of Anticancer Therapy", "DOI": "10.1586/era.13.42", "citationKey": "", "url": "http://informahealthcare.com/doi/abs/10.1586/era.13.42", "accessDate": "2014-11-09T09:13:07Z", "PMID": "", "PMCID": "", "ISSN": "1473-7140", "archive": "", "archiveLocation": "", "shortTitle": "Testing for anaplastic lymphoma kinase rearrangement to target crizotinib therapy", "language": "", "libraryCatalog": "informahealthcare.com (Atypon)", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2014-12-17T23:06:58Z", "dateModified": "2014-12-17T23:06:58Z" } }, { "key": "RJ698F9C", "version": 31, "library": { "type": "group", "id": 312108, "name": "ALS 359 Project", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_359_project", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/312108/items/RJ698F9C", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_359_project/items/RJ698F9C", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2095283, "username": "yshi14", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/yshi14", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "RJ698F9C", "version": 31, "itemType": "webpage", "title": "Media Release", "creators": [], "abstractNote": "", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "http://www.ventana.com/site/page?view=press-release-sep11-2013", "accessDate": "2014-12-17T21:52:57Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2014-12-17T23:06:58Z", "dateModified": "2014-12-17T23:06:58Z" } }, { "key": "D6KSDHJT", "version": 31, "library": { "type": "group", "id": 312108, "name": "ALS 359 Project", "links": { "alternate": { "href": "https://www.zotero.org/groups/als_359_project", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/312108/items/D6KSDHJT", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/als_359_project/items/D6KSDHJT", "type": "text/html" } }, "meta": { "createdByUser": { "id": 2095283, "username": "yshi14", "name": "", "links": { "alternate": { "href": "https://www.zotero.org/yshi14", "type": "text/html" } } }, "creatorSummary": "Wynes et al.", "parsedDate": "2014-05", "numChildren": 1 }, "data": { "key": "D6KSDHJT", "version": 31, "itemType": "journalArticle", "title": "An International Interpretation Study Using the ALK IHC Antibody D5F3 and a Sensitive Detection Kit Demonstrates High Concordance between ALK IHC and ALK FISH and between Evaluators", "creators": [ { "creatorType": "author", "firstName": "Murry W.", "lastName": "Wynes" }, { "creatorType": "author", "firstName": "Lynette M.", "lastName": "Sholl" }, { "creatorType": "author", "firstName": "Manfred", "lastName": "Dietel" }, { "creatorType": "author", "firstName": "Ed", "lastName": "Schuuring" }, { "creatorType": "author", "firstName": "Ming S.", "lastName": "Tsao" }, { "creatorType": "author", "firstName": "Yasushi", "lastName": "Yatabe" }, { "creatorType": "author", "firstName": "Raymond R.", "lastName": "Tubbs" }, { "creatorType": "author", "firstName": "Fred R.", "lastName": "Hirsch" } ], "abstractNote": "Introduction\nThe goal of personalized medicine is to treat patients with a therapy predicted to be efficacious based on the molecular characteristics of the tumor, thereby sparing the patient futile or toxic therapy. Anaplastic lymphoma kinase (ALK) inhibitors are effective against ALK-positive non–small-cell lung cancer (NSCLC) tumors, but to date the only approved companion diagnostic is a break-apart fluorescence in situ hybridization (FISH) assay. Immunohistochemistry (IHC) is a clinically applicable cost-effective test that is sensitive and specific for ALK protein expression. The purpose of this study was to assemble an international team of expert pathologists to evaluate a new automated standardized ALK IHC assay.\n\nMethods\nArchival NSCLC tumor specimens (n =103) previously tested for ALK rearrangement by FISH were provided by the international collaborators. These specimens were stained by IHC with the anti-ALK (D5F3) primary antibody combined with OptiView DAB IHC detection and OptiView amplification (Ventana Medical Systems, Inc., Tucson, AZ). Specimens were scored binarily as positive if strong granular cytoplasmic brown staining was present in tumor cells. IHC results were compared with the FISH results and interevaluator comparisons made.\n\nResults\nOverall for the 100 evaluable cases the ALK IHC assay was highly sensitive (90%), specific (95%), and accurate relative (93%) to the ALK FISH results. Similar results were observed using a majority score. IHC negativity was scored by seven of seven and six of seven evaluators on three and two FISH-positive cases, respectively. IHC positivity was scored on two FISH-negative cases by seven of seven readers. There was agreement among seven of seven and six of seven readers on 88% and 96% of the cases before review, respectively, and after review there was agreement among seven of seven and six of seven on 95% and 97% of the cases, respectively.\n\nConclusions\nOn the basis of expert evaluation the ALK IHC test is sensitive, specific, and accurate, and a majority score of multiple readers does not improve these results over an individual reader’s score. Excellent inter-reader agreement was observed. 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