Anaplastic Lymphoma Kinase Inhibition in Non–Small-Cell Lung Cancer

Kwak, Eunice L.; Bang, Yung‐Jue; Camidge, D. Ross; Shaw, Alice T.; Solomon, Benjamin; Maki, Robert G.; Ou, Sai‐Hong Ignatius; Dezube, Bruce J.; Jänne, Pasi A.; Costa, Daniel B.; Varella‐Garcia, Marileila; Kim, Woo Ho; Lynch, Thomas J.; Fidias, Panos; Stubbs, Hannah; Engelman, Jeffrey A.; Sequist, Lecia V.; Tan, Weiwei; Gandhi, Leena; Mino‐Kenudson, Mari; Gao, Wei; Shreeve, S. Martin; Ratain, Mark J.; Settleman, Jeffrey; Christensen, James G.; Haber, Daniel A.; Wilner, Keith D.; Salgia, Ravi; Shapiro, Geoffrey I.; Clark, Jeffrey W.; Iafrate, A. John

doi:10.1056/nejmoa1006448

Cited by 4,078 publications

(3,113 citation statements)

References 28 publications

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“…In agreement with Albarracin et al, 3 we think that an analytical report completed with a critical evaluation of the results about HER-2 genetic heterogeneity (GH) should be worldwide promoted.…”

supporting

confidence: 89%

“…1,2 These reports coincided with the successful results of the clinical trial that tested targeted therapy with crizotinib in ALK-positive lung cancer. 3 Consequently, two recently published large series of adult RCCs cumulatively identified four new ALK-rearranged tumors. 4,5 Current data, combined from four independent studies during 2010-2012, include six ALKrearranged tumors in a representative cohort of 884 RCCs of main morphologies arising in pediatric and adult patients of diverse ethnicities ( Table 1).…”

mentioning

confidence: 99%

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Reply to ‘Distinct ALK-rearranged and VCL-negative papillary renal cell carcinoma variants in two adults without sickle cell trait'

Debelenko

2013

Modern Pathology

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supporting

confidence: 89%

mentioning

confidence: 99%

Reply to ‘Distinct ALK-rearranged and VCL-negative papillary renal cell carcinoma variants in two adults without sickle cell trait'

Debelenko

2013

Modern Pathology

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“…30,35,181,215,216 Although other studies have indicated that these findings may reflect testing bias, 217 the documentation of an association between younger patient age and an actionable biomarker is another consideration in selecting patients for testing. The boundary between young and not young is not well defined, however, and a clear evidence-based cutoff for this guideline cannot be established.…”

Section: Expert Consensus Opinionmentioning

confidence: 99%

Analytical Validation of BRAF Mutation Testing from Circulating Free DNA Using the Amplification Refractory Mutation Testing System

Aung

Donald

Ellison

et al. 2014

The Journal of Molecular Diagnostics

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Context: In 2013, an evidence-based guideline was published by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology to set standards for the molecular analysis of lung cancers to guide treatment decisions with targeted inhibitors. New evidence has prompted an evaluation of additional laboratory technologies, targetable genes, patient populations, and tumor types for testing. Objective: To systematically review and update the 2013 guideline to affirm its validity; to assess the evidence of new genetic discoveries, technologies, and therapies; and to issue an evidence-based update. Design: The College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology convened an expert panel to develop an evidence-based guideline to help define the key questions and literature search terms, review abstracts and full articles, and draft recommendations. Results: Eighteen new recommendations were drafted. The panel also updated 3 recommendations from the 2013 guideline. Conclusions: The 2013 guideline was largely reaffirmed with updated recommendations to allow testing of cytology samples, require improved assay sensitivity, and recommend against the use of

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“…The initial phase I trial of crizotinib, a potent ALK and MET inhibitor, was designed to enroll a series of expanded cohorts at the recommended phase II dose based not on histology per se, but on tumors with proven evidence of ALK or MET activation 64 . Following the discovery of ALK in lung cancer that occurred after the phase I study had begun accrual, the protocol was amended to allow an ALK+ NSCLC cohort to be added.…”

Section: Issues In Specific Tumor Typesmentioning

confidence: 99%

NCCN Working Group Report: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies

Venook¹,

Arcila²,

Benson³

et al. 2014

J Natl Compr Canc Netw

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Defining treatment susceptible or resistant populations of cancer patients through the use of genetically defined biomarkers has revolutionized cancer care in recent years for some disease/patient groups. Research continues to show that histologically defined diseases are diverse in their expression of unique mutations or other genetic alterations, however, which presents both opportunities for the development of personalized cancer treatments, but increased difficulty in testing these therapies because potential patient populations are divided into ever-smaller numbers. To address some of the growing challenges in biomarker development and clinical trial design, NCCN assembled a group of experts across specialties and solid tumor disease types to begin to define the problems and to consider alternate ways of designing clinical trials in the era of multiple biomarkers and targeted therapies. Results from that discussion are presented, focusing on issues of clinical trial design from the perspective of statisticians, clinical researchers, regulators, pathologists and information developers.

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Anaplastic Lymphoma Kinase Inhibition in Non–Small-Cell Lung Cancer

Cited by 4,078 publications

References 28 publications

Reply to ‘Distinct ALK-rearranged and VCL-negative papillary renal cell carcinoma variants in two adults without sickle cell trait'

Reply to ‘Distinct ALK-rearranged and VCL-negative papillary renal cell carcinoma variants in two adults without sickle cell trait'

Analytical Validation of BRAF Mutation Testing from Circulating Free DNA Using the Amplification Refractory Mutation Testing System

NCCN Working Group Report: Designing Clinical Trials in the Era of Multiple Biomarkers and Targeted Therapies

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