Canadian Anaplastic Lymphoma Kinase Study A Model for Multicenter Standardization and Optimization of ALK Testing in Lung Cancer

被引：68

作者：

Cutz, Jean-Claude ^{[1
,2
]}

Craddock, Kenneth J. ^{[3
,4
]}

Torlakovic, Emina ^{[3
,4
]}

Brandao, Guilherme ^{[5
,6
]}

Carter, Ronald F. ^{[1
,2
]}

Bigras, Gilbert ^{[7
,8
]}

Deschenes, Jean ^{[7
,8
]}

Izevbaye, Iyare ^{[9
]}

Xu, Zhaolin ^{[10
,11
]}

Greer, Wenda ^{[10
,11
]}

Yatabe, Yasushi ^{[12
]}

Ionescu, Diana ^{[13
,14
]}

Karsan, Aly ^{[13
,14
]}

Jung, Sungmi ^{[15
]}

Fraser, Richard S. ^{[15
]}

Blumenkrantz, Miriam ^{[15
]}

Lavoie, Josee ^{[15
]}

Fortin, Flechere ^{[16
]}

Bojarski, Anna ^{[17
]}

Cote, Gilbert B. ^{[17
]}

van den Berghe, Janette A. ^{[18
]}

Rashid-Kolvear, Fariborz ^{[18
]}

Trotter, Martin ^{[18
]}

Sekhon, Harmanjatinder S. ^{[19
,20
]}

Albadine, Roula ^{[21
]}

Danh Tran-Thanh ^{[21
]}

Gorska, Isabelle ^{[21
]}

Knoll, Joan H. M. ^{[22
]}

Xu, Jie ^{[7
,8
]}

Blencowe, Ben ^{[23
]}

Iafrate, A. John ^{[24
]}

Hwang, David M. ^{[3
,4
]}

Pintilie, Melania ^{[3
,4
]}

Gaspo, Rania ^{[25
]}

Couture, Christian ^{[26
]}

Tsao, Ming-Sound ^{[3
,4
]}

机构：

[1] McMaster Univ, Hlth Sci Ctr, Dept Pathol & Mol Med, Hamilton, ON, Canada

[2] McMaster Univ, Hamilton, ON, Canada

[3] Princess Margaret Canc Ctr, Univ Hlth Network, Dept Pathol, Toronto, ON, Canada

[4] Univ Toronto, Toronto, ON, Canada

[5] McGill Univ, Jewish Gen Hosp, Dept Pathol, Montreal, PQ H3T 1E2, Canada

[6] McGill Univ, Lady David Inst, Montreal, PQ, Canada

[7] Univ Alberta, Cross Canc Inst, Edmonton, AB, Canada

[8] Univ Alberta, Dept Lab Med & Pathol, Edmonton, AB, Canada

[9] Univ Alberta Hosp, Dept Mol Pathol, Edmonton, AB T6G 2B7, Canada

[10] Queen Elizabeth 2 Hlth Sci Ctr, Dept Pathol, Halifax, NS, Canada

[11] Dalhousie Univ, Halifax, NS, Canada

[12] Aichi Canc Ctr Hosp, Dept Pathol, Nagoya, Aichi 464, Japan

[13] British Columbia Canc Agcy, Dept Pathol, Vancouver, BC V5Z 4E6, Canada

[14] Univ British Columbia, Vancouver, BC V5Z 1M9, Canada

[15] McGill Univ, Ctr Hlth, Dept Pathol, Montreal, PQ, Canada

[16] McGill Univ, Dept Human Genet, Montreal, PQ, Canada

[17] Hlth Sci North, Dept Pathol, Sudbury, ON, Canada

[18] Univ Calgary, Dept Pathol & Lab Med, Calgary, AB, Canada

[19] Ottawa Hosp, Dept Pathol, Ottawa, ON, Canada

[20] Univ Ottawa, Ottawa, ON, Canada

[21] Univ Montreal, Ctr Hosp, Montreal, PQ, Canada

[22] London Hlth Sci Ctr, Dept Pathol, London, ON, Canada

[23] Univ Toronto, Dept Mol Genet, Toronto, ON, Canada

[24] Harvard Univ, Sch Med, Dept Genet, Massachusetts Gen Hosp, Boston, MA USA

[25] Pfizer Oncol Canada, Kirkland, PQ, Canada

[26] Univ Laval, Inst Univ Cardiol & Pneumol Quebec Hop Laval, Quebec City, PQ, Canada

来源：

JOURNAL OF THORACIC ONCOLOGY | 2014年 / 9卷 / 09期

关键词：

ALK testing; Immunohistochemistry; Standardization; Fluorescence in situ hybridization; reverse-transcriptase polymerase chain reaction; CANCER PATIENTS; IMMUNOHISTOCHEMISTRY; ADENOCARCINOMAS; REARRANGEMENTS; FISH; GENE; CRIZOTINIB; EGFR; IHC;

D O I：

10.1097/JTO.0000000000000239

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

Introduction: Fluorescence in situ hybridization (FISH) is currently the standard for diagnosing anaplastic lymphoma kinase (ALK)-rearranged (ALK+) lung cancers for ALK inhibitor therapies. ALK immunohistochemistry (IHC) may serve as a screening and alternative diagnostic method. The Canadian ALK (CALK) study was initiated to implement a multicenter optimization and standardization of laboratory developed ALK IHC and FISH tests across 14 hospitals. Methods: Twenty-eight lung adenocarcinomas with known ALK status were used as blinded study samples. Thirteen laboratories performed IHC using locally developed staining protocols for 5A4, ALK1, or D5F3 antibodies; results were assessed by H-score. Twelve centers conducted FISH using protocols based on Vysis' ALK break-apart FISH kit. Initial IHC results were used to -optimize local IHC protocols, followed by a repeat IHC study to assess the results of standardization. Three laboratories conducted a prospective parallel IHC and FISH analysis on 411 consecutive clinical samples using post-validation optimized assays. Results: Among study samples, FISH demonstrated 22 consensus ALK+ and six ALK wild type tumors. Preoptimization IHC scores from 12 centers with 5A4 and the percent abnormal cells by FISH from 12 centers showed intraclass correlation coefficients of 0.83 and 0.68, respectively. IHC optimization improved the intraclass correlation coefficients to 0.94. Factors affecting FISH scoring and outliers were identified. Post-optimization concurrent IHC/FISH testing in 373 informative cases revealed 100% sensitivity and specificity for IHC versus FISH. Conclusions: Multicenter standardization study may accelerate the implementation of ALK testing protocols across a country/region. Our data support the use of an appropriately validated IHC assay to screen for ALK+ lung cancers.

引用

页码：1255 / 1263

页数：9

共 23 条

[1]

Camidge DR, 2013, J CLIN ONCOL, V31

[2]

Native and Rearranged ALK Copy Number and Rearranged Cell Count in Non-Small Cell Lung Cancer Implications for ALK Inhibitor Therapy [J].

Camidge, D. Ross ;

Skokan, Margaret ;

Kiatsimkul, Porntip ;

Helfrich, Barbara ;

Lu, Xian ;

Baron, Anna E. ;

Schulte, Nathan ;

Maxson, DeLee ;

Aisner, Dara L. ;

Franklin, Wilbur A. ;

Doebele, Robert C. ;

Varella-Garcia, Marileila .

CANCER, 2013, 119 (22) :3968-3975

[3]

Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase 1 study [J].

Camidge, D. Ross ;

Bang, Yung-Jue ;

Kwak, Eunice L. ;

Iafrate, A. John ;

Varella-Garcia, Marileila ;

Fox, Stephen B. ;

Riely, Gregory J. ;

Solomon, Benjamin ;

Ou, Sai-Hong I. ;

Kim, Dong-Wan ;

Salgia, Ravi ;

Fidias, Panagiotis ;

Engelman, Jeffrey A. ;

Gandhi, Leena ;

Jaenne, Pasi A. ;

Costa, Daniel B. ;

Shapiro, Geoffrey I. ;

LoRusso, Patricia ;

Ruffner, Katherine ;

Stephenson, Patricia ;

Tang, Yiyun ;

Wilner, Keith ;

Clark, Jeffrey W. ;

Shaw, Alice T. .

LANCET ONCOLOGY, 2012, 13 (10) :1011-1019

[4]

Optimizing the Detection of Lung Cancer Patients Harboring Anaplastic Lymphoma Kinase (ALK) Gene Rearrangements Potentially Suitable for ALK Inhibitor Treatment [J].

Camidge, D. Ross ;

Kono, Scott A. ;

Flacco, Antonella ;

Tan, Aik-Choon ;

Doebele, Robert C. ;

Zhou, Qing ;

Crino, Lucio ;

Franklin, Wilbur A. ;

Varella-Garcia, Marileila .

CLINICAL CANCER RESEARCH, 2010, 16 (22) :5581-5590

[5]

ALK Rearrangements Are Mutually Exclusive with Mutations in EGFR or KRAS: An Analysis of 1,683 Patients with Non-Small Cell Lung Cancer [J].

Gainor, Justin F. ;

Varghese, Anna M. ;

Ou, Sai-Hong Ignatius ;

Kabraji, Sheheryar ;

Awad, Mark M. ;

Katayama, Ryohei ;

Pawlak, Amanda ;

Mino-Kenudson, Mari ;

Yeap, Beow Y. ;

Riely, Gregory J. ;

Iafrate, A. John ;

Arcila, Maria E. ;

Ladanyi, Marc ;

Engelman, Jeffrey A. ;

Dias-Santagata, Dora ;

Shaw, Alice T. .

CLINICAL CANCER RESEARCH, 2013, 19 (15) :4273-4281

[6]

Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology [J].

Lindeman, Neal I. ;

Cagle, Philip T. ;

Beasley, Mary Beth ;

Chitale, Dhananjay Arun ;

Dacic, Sanja ;

Giaccone, Giuseppe ;

Jenkins, Robert Brian ;

Kwiatkowski, David J. ;

Saldivar, Juan-Sebastian ;

Squire, Jeremy ;

Thunnissen, Erik ;

Ladanyi, Marc .

JOURNAL OF THORACIC ONCOLOGY, 2013, 8 (07) :823-859

[7]

Fluorescence In Situ Hybridization and Immunohistochemistry as Diagnostic Methods for ALK Positive Non-Small Cell Lung Cancer Patients [J].

Martinez, Pablo ;

Hernandez-Losa, Javier ;

Angeles Montero, M. ;

Cedres, Susana ;

Castellvi, Josep ;

Martinez-Marti, Alex ;

Tallada, Natalia ;

Murtra-Garrell, Nuria ;

Navarro-Mendivill, Alejandro ;

Rodriguez-Freixinos, Victor ;

Canela, Mercedes ;

Ramon y Cajal, Santiago ;

Felip, Enriqueta .

PLOS ONE, 2013, 8 (01)

[8]

Dual IHC and FISH Testing for ALK Gene Rearrangement in Lung Adenocarcinomas in a Routine Practice A French Study [J].

McLeer-Florin, Anne ;

Moro-Sibilot, Denis ;

Melis, Adrien ;

Salameire, Dimitri ;

Lefebvre, Christine ;

Ceccaldi, Francoise ;

de Fraipont, Florence ;

Brambilla, Elisabeth ;

Lantuejoul, Sylvie .

JOURNAL OF THORACIC ONCOLOGY, 2012, 7 (02) :348-354

[9]

ALK Status Testing in Non-Small Cell Lung Carcinoma Correlation Between Ultrasensitive IHC and FISH [J].

Minca, Eugen C. ;

Portier, Bryce P. ;

Wang, Zhen ;

Lanigan, Christopher ;

Farver, Carol F. ;

Feng, Yan ;

Ma, Patrick C. ;

Arrossi, Valeria A. ;

Pennell, Nathan A. ;

Tubbs, Raymond R. .

JOURNAL OF MOLECULAR DIAGNOSTICS, 2013, 15 (03) :341-346

[10]

A Novel, Highly Sensitive Antibody Allows for the Routine Detection of ALK-Rearranged Lung Adenocarcinomas by Standard Immunohistochemistry [J].

Mino-Kenudson, Mari ;

Chirieac, Lucian R. ;

Law, Kenny ;

Hornick, Jason L. ;

Lindeman, Neal ;

Mark, Eugene J. ;

Cohen, David W. ;

Johnson, Bruce E. ;

Jaenne, Pasi A. ;

Iafrate, A. John ;

Rodig, Scott J. .

CLINICAL CANCER RESEARCH, 2010, 16 (05) :1561-1571

← 1 2 3 →