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1. Systematically higher Ki67 scores on core biopsy samples compared to corresponding resection specimen in breast cancer: a multi-operator and multi-institutional study

Author

Acs, Balazs, Leung, Samuel C.Y., Kidwell, Kelley M., Arun, Indu, Augulis, Renaldas, Badve, Sunil S., Bai, Yalai, Bane, Anita L., Bartlett, John M.S., Bayani, Jane, Bigras, Gilbert, Blank, Annika, Buikema, Henk, Chang, Martin C., Dietz, Robin L., Dodson, Andrew, Fineberg, Susan, Focke, Cornelia M., Gao, Dongxia, Gown, Allen M., Gutierrez, Carolina, Hartman, Johan, Kos, Zuzana, Lænkholm, Anne-Vibeke, Laurinavicius, Arvydas, Levenson, Richard M., Mahboubi-Ardakani, Rustin, Mastropasqua, Mauro G., Nofech-Mozes, Sharon, Osborne, C. Kent, Penault-Llorca, Frédérique M., Piper, Tammy, Quintayo, Mary Anne, Rau, Tilman T., Reinhard, Stefan, Robertson, Stephanie, Salgado, Roberto, Sugie, Tomoharu, van der Vegt, Bert, Viale, Giuseppe, Zabaglo, Lila A., Hayes, Daniel F., Dowsett, Mitch, Nielsen, Torsten O., Rimm, David L., McShane, Lisa M., Nielsen, Torsten, Leung, Samuel, Borgquist, Signe, Chan, Angela, Denkert, Carsten, Ehinger, Anna, Ellis, Matthew, Flowers, Margaret, Galderisi, Chad, Gholap, Abhi, Hartman, Douglas J., Hugh, Judith C., Jadhav, Anagha, Kornaga, Elizabeth N., Kreipe, Hans, Levenson, Richard, Mastropasqua, Mauro, Moriya, Takuya, Pan, Hongchao, Pantanowitz, Liron, Neri, Ernesta Paola, Polley, Mei-Yin, Ruan, Jason, Sakatani, Takashi, Shepherd, Lois, Smith, Ian, Sparano, Joseph, Spears, Melanie, Srinivasan, Malini, Starczynski, Jane, Todd, Austin, Virk, Shakeel, Wang, Yihong, Yang, Hua, Zhang, Zhiwei, and Zlobec, Inti

Published
2022
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3. An international multicenter study to evaluate reproducibility of automated scoring for assessment of Ki67 in breast cancer

Author

Rimm, David L., Leung, Samuel C.Y., McShane, Lisa M., Bai, Yalai, Bane, Anita L., Bartlett, John M.S., Bayani, Jane, Chang, Martin C., Dean, Michelle, Denkert, Carsten, Enwere, Emeka K., Galderisi, Chad, Gholap, Abhi, Hugh, Judith C., Jadhav, Anagha, Kornaga, Elizabeth N., Laurinavicius, Arvydas, Levenson, Richard, Lima, Joema, Miller, Keith, Pantanowitz, Liron, Piper, Tammy, Ruan, Jason, Srinivasan, Malini, Virk, Shakeel, Wu, Ying, Yang, Hua, Hayes, Daniel F., Nielsen, Torsten O., and Dowsett, Mitch

Published
2019
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4. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update

Author

Wolff, Antonio C., Hammond, M. Elizabeth Hale, Allison, Kimberly H., Harvey, Brittany E., Mangu, Pamela B., Bartlett, John M.S., Bilous, Michael, Ellis, Ian O., Fitzgibbons, Patrick, Hanna, Wedad, Jenkins, Robert B., Press, Michael F., Spears, Patricia A., Vance, Gail H., Viale, Giuseppe, McShane, Lisa M., and Dowsett, Mitchell

Subjects
Practice guidelines (Medicine) -- Evaluation, Molecular diagnostic techniques -- Laws, regulations and rules, Breast cancer -- Genetic aspects -- Diagnosis -- Care and treatment, Government regulation, Health
Abstract

* Purpose.--To update key recommendations of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) human epidermal growth factor receptor 2 (HER2) testing in breast cancer guideline. Methods.--Based on the signals approach, an Expert Panel reviewed published literature and research survey results on the observed frequency of less common in situ hybridization (ISH) patterns to update the recommendations. Recommendations.--Two recommendations addressed via correspondence in 2015 are included. First, immunohistochemistry (IHC) 2+ is defined as invasive breast cancer with weak to moderate complete membrane staining observed in >10% of tumor cells. Second, if the initial HER2 test result in a core needle biopsy specimen of a primary breast cancer is negative, a new HER2 test may (not 'must') be ordered on the excision specimen based on specific clinical criteria. The HER2 testing algorithm for breast cancer is updated to address the recommended workup for less common clinical scenarios (approximately 5% of cases) observed when using a dual-probe ISH assay. These scenarios are described as ISH group 2 (HER2/chromosome enumeration probe 17 [CEP17] ratio [greater than or equal to] 2.0; average HER2 copy number (Arch Pathol Lab Med. 2018;142:1364-1382; doi: 10.5858/arpa.2018-0902-SA), First released in 2007 and updated in 2013, the recommendations by the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) human epidermal growth factor receptor 2 (HER2) testing [...]

Published
2018
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6. Selecting patients with HER2-low breast cancer: Getting out of the tangle

Author

Baez-Navarro, Ximena, Salgado, Roberto, Denkert, Carsten, Lennerz, Jochen K., Penault-Llorca, Frédérique, Viale, Giuseppe, Bartlett, John M.S., van Deurzen, Carolien H.M., and Pathology

Subjects
Cancer Research, Immunoconjugates, Oncology, SDG 3 - Good Health and Well-being, Receptor, ErbB-2, Patient Selection, Humans, Reproducibility of Results, Breast Neoplasms, Female, In Situ Hybridization, Fluorescence
Abstract

The promising effect of antibody–drug conjugates on breast cancer with low expression of HER2 (HER2-low) raises many questions regarding the optimal selection of patients for this treatment. A key question is whether HER2 immunohistochemistry, an assay optimised to detect HER2 amplification, is reliable enough to assess HER2 protein levels to select patients with HER2-low breast cancer in daily pathology practices worldwide. Moreover, whether this assessment can be performed with sufficient reproducibility between pathologists in daily practices is debatable. Herein, we address the historical track record of the CAP-ASCO HER2 Guidelines, the reported limited reproducibility by pathologists of HER2 immunohistochemistry in the non-amplified cases, and the performance variation of different antibodies. Based on this summary, we propose solutions to improve the robustness to enable reliable identification of patients with HER2-low breast cancer.

Published
2022

7. Discordance between Immunohistochemistry and Erb-B2 Receptor Tyrosine Kinase 2 mRNA to Determine Human Epidermal Growth Factor Receptor 2 Low Status for Breast Cancer

Author

Xu, Keying, primary, Bayani, Jane, additional, Mallon, Elizabeth, additional, Pond, Gregory R., additional, Piper, Tammy, additional, Hasenburg, Annette, additional, Markopoulos, Christos J., additional, Dirix, Luc, additional, Seynaeve, Caroline M., additional, van de Velde, Cornelis J.H., additional, Rea, Daniel W., additional, and Bartlett, John M.S., additional

Published
2022
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8. Correction: GATA6 Expression Distinguishes Classical and Basal-like Subtypes in Advanced Pancreatic Cancer

Author

O'Kane, Grainne M., primary, Grünwald, Barbara T., additional, Jang, Gun-Ho, additional, Masoomian, Mehdi, additional, Picardo, Sarah, additional, Grant, Robert C., additional, Denroche, Robert E., additional, Zhang, Amy, additional, Wang, Yifan, additional, Miller, Jessica K., additional, Lam, Bernard, additional, Krzyzanowski, Paul M., additional, Lungu, Ilinca M., additional, Bartlett, John M.S., additional, Peralta, Melanie, additional, Vyas, Foram, additional, Khokha, Rama, additional, Biagi, James, additional, Chadwick, Dianne, additional, Ramotar, Stephanie, additional, Hutchinson, Shawn, additional, Dodd, Anna, additional, Wilson, Julie M., additional, Notta, Faiyaz, additional, Zogopoulos, George, additional, Gallinger, Steven, additional, Knox, Jennifer J., additional, and Fischer, Sandra E., additional

Published
2022
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9. Discordance between Immunohistochemistry and ERBB2 mRNA to Determine HER2 Low Status for Breast Cancer

Author

Xu, Keying, Bayani, Jane, Mallon, Elizabeth, Pond, Gregory R., Piper, Tammy, Hasenburg, Annette, Markopoulos, Christos J., Dirix, Luc, Seynaeve, Caroline M., Van De Velde, Cornelis J.h., Rea, Daniel W., and Bartlett, John M.S.

Abstract

Novel HER2-directed antibody-drug conjugates (ADC) have demonstrated efficacy in HER2-low expressing breast cancers, which are currently defined as those with IHC scores of 1+ or 2+ with a negative ISH assay. However, current HER2 testing methods are designed to identify HER2 amplified tumors with “high” expression levels. The true definition of “HER2-low” expressing breast cancers remains controversial. Using quantitative molecular analysis of breast cancers based on RNA expression, the dynamic range of HER2 expression exceeds that detected by in situ IHC approaches. ERBB2 mRNA expression levels across IHC groups using patient samples derived from the Tamoxifen Exemestane Adjuvant Multicenter (TEAM) Trial were investigated. The standardized mean differences in ERBB2 mRNA scores in log base 2 are 0.47 (95% CI: 0.36,0.57), 0.58 (95% CI: 0.26,0.70), and 0.32 (95% CI: -0.12,0.75) when comparing IHC 0+ without staining vs IHC 0+ with some staining, IHC 0+ with some staining vs IHC 1+, and IHC 1+ vs IHC 2+/FISH-ve, respectively. The results showed that immunohistochemical methods have a comparatively limited dynamic range for measuring HER2 protein expression. The range of expression based on RNA abundance suggest that a molecular method defining HER2-low cancers may better serve the treatment decision needs of this group. Indeed, the validity of RNA abundance to identify HER2-low cancers and predict treatment response need to be further evaluated by prospective clinical trials.

Published
2022

10. Breast Cancer Index Is a Predictive Biomarker of Treatment Benefit and Outcome from Extended Tamoxifen Therapy: Final Analysis of the Trans-aTTom Study

Author

Bartlett, John M.S., primary, Sgroi, Dennis C., additional, Treuner, Kai, additional, Zhang, Yi, additional, Piper, Tammy, additional, Salunga, Ranelle C., additional, Ahmed, Ikhlaaq, additional, Doos, Lucy, additional, Thornber, Sarah, additional, Taylor, Karen J., additional, Brachtel, Elena F., additional, Pirrie, Sarah J., additional, Schnabel, Catherine A., additional, and Rea, Daniel W., additional

Published
2022
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11. Heterogeneity of Circulating Tumor Cell–Associated Genomic Gains in Breast Cancer and Its Association with the Host Immune Response

Author

Kanwar, Nisha, primary, Balde, Zaldy, additional, Nair, Ranju, additional, Dawe, Melanie, additional, Chen, Shiyi, additional, Maganti, Manjula, additional, Atenafu, Eshetu G., additional, Manolescu, Sabrina, additional, Wei, Carrie, additional, Mao, Amanda, additional, Fu, Fred, additional, Wang, Dan, additional, Cheung, Alison, additional, Yerofeyeva, Yulia, additional, Peters, Rachel, additional, Liu, Kela, additional, Desmedt, Christine, additional, Sotiriou, Christos, additional, Szekely, Borbala, additional, Kulka, Janina, additional, McKee, Trevor D., additional, Hirano, Naoto, additional, Bartlett, John M.S., additional, Yaffe, Martin J., additional, Bedard, Philippe L., additional, McCready, David, additional, and Done, Susan J., additional

Published
2021
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12. Interobserver Agreement of PD-L1/SP142 Immunohistochemistry and Tumor-Infiltrating Lymphocytes (TILs) in Distant Metastases of Triple-Negative Breast Cancer: A Proof-of-Concept Study. A Report on Behalf of the International Immuno-Oncology Biomarker Working Group

Author

Van Bockstal, Mieke R., primary, Cooks, Maxine, additional, Nederlof, Iris, additional, Brinkhuis, Mariël, additional, Dutman, Annemiek, additional, Koopmans, Monique, additional, Kooreman, Loes, additional, van der Vegt, Bert, additional, Verhoog, Leon, additional, Vreuls, Celine, additional, Westenend, Pieter, additional, Kok, Marleen, additional, van Diest, Paul J., additional, Nauwelaers, Inne, additional, Laudus, Nele, additional, Denkert, Carsten, additional, Rimm, David, additional, Siziopikou, Kalliopi P., additional, Ely, Scott, additional, Zardavas, Dimitrios, additional, Roberts, Mustimbo, additional, Floris, Giuseppe, additional, Hartman, Johan, additional, Acs, Balazs, additional, Peeters, Dieter, additional, Bartlett, John M.S., additional, Dequeker, Els, additional, Salgado, Roberto, additional, Giudici, Fabiola, additional, Michiels, Stefan, additional, Horlings, Hugo, additional, and van Deurzen, Carolien H. M., additional

Published
2021
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13. An International Ki67 Reproducibility Study

Author

Polley, Mei-Yin C., Leung, Samuel C. Y., McShane, Lisa M., Gao, Dongxia, Hugh, Judith C., Mastropasqua, Mauro G., Viale, Giuseppe, Zabaglo, Lila A., Penault-Llorca, Frédérique, Bartlett, John M.S., Gown, Allen M., Symmans, W. Fraser, Piper, Tammy, Mehl, Erika, Enos, Rebecca A., Hayes, Daniel F., Dowsett, Mitch, and Nielsen, Torsten O.

Published
2013
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15. A Preclinical Trial and Molecularly Annotated Patient Cohort Identify Predictive Biomarkers in Homologous Recombination–deficient Pancreatic Cancer

Author

Wang, Yifan, primary, Park, Jin Yong Patrick, additional, Pacis, Alain, additional, Denroche, Robert E., additional, Jang, Gun Ho, additional, Zhang, Amy, additional, Cuggia, Adeline, additional, Domecq, Celine, additional, Monlong, Jean, additional, Raitses-Gurevich, Maria, additional, Grant, Robert C., additional, Borgida, Ayelet, additional, Holter, Spring, additional, Stossel, Chani, additional, Bu, Simeng, additional, Masoomian, Mehdi, additional, Lungu, Ilinca M., additional, Bartlett, John M.S., additional, Wilson, Julie M., additional, Gao, Zu-Hua, additional, Riazalhosseini, Yasser, additional, Asselah, Jamil, additional, Bouganim, Nathaniel, additional, Cabrera, Tatiana, additional, Boucher, Louis-Martin, additional, Valenti, David, additional, Biagi, James, additional, Greenwood, Celia M.T., additional, Polak, Paz, additional, Foulkes, William D., additional, Golan, Talia, additional, O'Kane, Grainne M., additional, Fischer, Sandra E., additional, Knox, Jennifer J., additional, Gallinger, Steven, additional, and Zogopoulos, George, additional

Published
2020
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16. Design and Development of a Fully Synthetic Multiplex Ligation-Dependent Probe Amplification–Based Probe Mix for Detection of Copy Number Alterations in Prostate Cancer Formalin-Fixed, Paraffin-Embedded Tissue Samples

Author

Ebrahimizadeh, Walead, primary, Guérard, Karl-Philippe, additional, Rouzbeh, Shaghayegh, additional, Bramhecha, Yogesh M., additional, Scarlata, Eleonora, additional, Brimo, Fadi, additional, Patel, Palak G., additional, Jamaspishvili, Tamara, additional, Aprikian, Armen G., additional, Berman, David, additional, Bartlett, John M.S., additional, Chevalier, Simone, additional, and Lapointe, Jacques, additional

Published
2020
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18. A Four-Chemokine Signature Is Associated with a T-cell–Inflamed Phenotype in Primary and Metastatic Pancreatic Cancer

Author

Romero, Joan M., primary, Grünwald, Barbara, additional, Jang, Gun-Ho, additional, Bavi, Prashant P., additional, Jhaveri, Aaditeya, additional, Masoomian, Mehdi, additional, Fischer, Sandra E., additional, Zhang, Amy, additional, Denroche, Robert E., additional, Lungu, Ilinca M., additional, De Luca, Angela, additional, Bartlett, John M.S., additional, Xu, Jing, additional, Li, Niandong, additional, Dhaliwal, Sharon, additional, Liang, Sheng-Ben, additional, Chadwick, Dianne, additional, Vyas, Foram, additional, Bronsert, Peter, additional, Khokha, Rama, additional, McGaha, Tracy L., additional, Notta, Faiyaz, additional, Ohashi, Pamela S., additional, Done, Susan J., additional, O'Kane, Grainne M., additional, Wilson, Julie M., additional, Knox, Jennifer J., additional, Connor, Ashton, additional, Wang, Yifan, additional, Zogopoulos, George, additional, and Gallinger, Steven, additional

Published
2020
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19. GATA6 Expression Distinguishes Classical and Basal-like Subtypes in Advanced Pancreatic Cancer

Author

O’Kane, Grainne M., primary, Grünwald, Barbara T., additional, Jang, Gun-Ho, additional, Masoomian, Mehdi, additional, Picardo, Sarah, additional, Grant, Robert C., additional, Denroche, Robert E., additional, Zhang, Amy, additional, Wang, Yifan, additional, Miller, Jessica K., additional, Lam, Bernard, additional, Krzyzanowski, Paul M., additional, Lungu, Ilinca M., additional, Bartlett, John M.S., additional, Peralta, Melanie, additional, Vyas, Foram, additional, Khokha, Rama, additional, Biagi, James, additional, Chadwick, Dianne, additional, Ramotar, Stephanie, additional, Hutchinson, Shawn, additional, Dodd, Anna, additional, Wilson, Julie M., additional, Notta, Faiyaz, additional, Zogopoulos, George, additional, Gallinger, Steven, additional, Knox, Jennifer J., additional, and Fischer, Sandra E., additional

Published
2020
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20. Validation of the IHC4 Breast Cancer Prognostic Algorithm Using Multiple Approaches on the Multinational TEAM Clinical Trial

Author

Bartlett, John M.S., Christiansen, Jason, Gustavson, Mark, Rimm, David L., Piper, Tammy, van de Velde, Cornelis J.H., Hasenburg, Annette, Kieback, Dirk G., Putter, Hein, Markopoulos, Christos J., Dirix, Luc Y., Seynaeve, Caroline, and Rea, Daniel W.

Subjects
Clinical trials -- Models -- Health aspects, Algorithms -- Models -- Health aspects, Recurrence (Disease) -- Models -- Health aspects, Immunohistochemistry -- Models -- Health aspects, Medical research -- Models -- Health aspects, Tamoxifen -- Models -- Health aspects, Exemestane -- Models -- Health aspects, Breast cancer -- Models -- Health aspects, Algorithm, Health
Abstract

Context.--Hormone receptors HER2/neu and Ki-67 are markers of residual risk in early breast cancer. An algorithm (IHC4) combining these markers may provide additional information on residual risk of recurrence in patients treated with hormone therapy. Objective.--To independently validate the IHC4 algorithm in the multinational Tamoxifen Versus Exemestane Adjuvant Multicenter Trial (TEAM) cohort, originally developed on the trans-ATAC (Arimidex, Tamoxifen, Alone or in Combination Trial) cohort, by comparing 2 methodologies. Design.--The IHC4 biomarker expression was quantified on TEAM cohort samples (n = 2919) by using 2 independent methodologies (conventional 3,30-diaminobezidine [DAB] immunohistochemistry with image analysis and standardized quantitative immunofluorescence [QIF] by AQUA technology). The IHC4 scores were calculated by using the same previously established coefficients and then compared with recurrence-free and distant recurrence-free survival, using multivariate Cox proportional hazards modeling. Results.--The QIF model was highly significant for prediction of residual risk (P < .001), with continuous model scores showing a hazard ratio (HR) of 1.012 (95% confidence interval [95% CI]: 1.010-1.014), which was significantly higher than that for the DAB model (HR: 1.008, 95% CI: 1.006-1.009); P < .001). Each model added significant prognostic value in addition to recognized clinical prognostic factors, including nodal status, in multivariate analyses. Quantitative immunofluorescence, however, showed more accuracy with respect to overall residual risk assessment than the DAB model. Conclusions.--The use of the IHC4 algorithm was validated on the TEAM trial for predicting residual risk in patients with breast cancer. These data support the use of the IHC4 algorithm clinically, but quantitative and standardized approaches need to be used. (Arch Pathol Lab Med. 2016; 140:66-74; doi: 10.5858/arpa.2014-0599-OA), With progressively improving outcomes, particularly for patients with estrogen receptor (ER)-positive early breast cancers, personalized risk stratification to direct appropriate therapy is increasingly important. Multiple approaches to the assessment of [...]

Published
2016
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21. Nottingham Prognostic Index Plus: Validation of a clinical decision making tool in breast cancer in an independent series

Author

Green, Andrew R., Soria, Daniele, Stephen, Jacquelin, Powe, Desmond G., Nolan, Christopher C., Kunkler, Ian, Thomas, Jeremy, Kerr, Gillian R., Jack, Wilma, Cameron, David, Piper, Tammy, Ball, Graham R., Garibaldi, Jonathan M., Rakha, Emad, Bartlett, John M.S., and Ellis, Ian O.

Subjects
Nottingham Breast Cancer Research Centre, breast cancer, classification, outcom, mental disorders, prognostic index, outcome, Original Article, Original Articles, molecular, QA, humanities, clinical
Abstract

The Nottingham Prognostic Index Plus (NPI+) is a clinical decision making tool in breast cancer (BC) that aims to provide improved patient outcome stratification superior to the traditional NPI. This study aimed to validate the NPI+ in an independent series of BC. Eight hundred and eighty five primary early stage BC cases from Edinburgh were semi‐quantitatively assessed for 10 biomarkers [Estrogen Receptor (ER), Progesterone Receptor (PgR), cytokeratin (CK) 5/6, CK7/8, epidermal growth factor receptor (EGFR), HER2, HER3, HER4, p53, and Mucin 1] using immunohistochemistry and classified into biological classes by fuzzy logic‐derived algorithms previously developed in the Nottingham series. Subsequently, NPI+ Prognostic Groups (PGs) were assigned for each class using bespoke NPI‐like formulae, previously developed in each NPI+ biological class of the Nottingham series, utilising clinicopathological parameters: number of positive nodes, pathological tumour size, stage, tubule formation, nuclear pleomorphism and mitotic counts. Biological classes and PGs were compared between the Edinburgh and Nottingham series using Cramer's V and their role in patient outcome prediction using Kaplan–Meier curves and tested using Log Rank. The NPI+ biomarker panel classified the Edinburgh series into seven biological classes similar to the Nottingham series (p > 0.01). The biological classes were significantly associated with patient outcome (p 0.01). The good PGs were similarly validated in Luminal B, Basal p53 normal, HER2+/ER− tumours and the poor PG in the Luminal N class (p > 0.01). Due to small patient numbers assigned to the remaining PGs, Luminal N, Luminal B, Basal p53 normal and HER2+/ER− classes could not be validated. This study demonstrates the reproducibility of NPI+ and confirmed its prognostic value in an independent cohort of primary BC. Further validation in large randomised controlled trial material is warranted.

Published
2016

23. Integration of Genomic and Transcriptional Features in Pancreatic Cancer Reveals Increased Cell Cycle Progression in Metastases

Author

Connor, Ashton A., primary, Denroche, Robert E., additional, Jang, Gun Ho, additional, Lemire, Mathieu, additional, Zhang, Amy, additional, Chan-Seng-Yue, Michelle, additional, Wilson, Gavin, additional, Grant, Robert C., additional, Merico, Daniele, additional, Lungu, Ilinca, additional, Bartlett, John M.S., additional, Chadwick, Dianne, additional, Liang, Sheng-Ben, additional, Eagles, Jenna, additional, Mbabaali, Faridah, additional, Miller, Jessica K., additional, Krzyzanowski, Paul, additional, Armstrong, Heather, additional, Luo, Xuemei, additional, Jorgensen, Lars G.T., additional, Romero, Joan M., additional, Bavi, Prashant, additional, Fischer, Sandra E., additional, Serra, Stefano, additional, Hafezi-Bakhtiari, Sara, additional, Caglar, Derin, additional, Roehrl, Michael H.A., additional, Cleary, Sean, additional, Hollingsworth, Michael A., additional, Petersen, Gloria M., additional, Thayer, Sarah, additional, Law, Calvin H.L., additional, Nanji, Sulaiman, additional, Golan, Talia, additional, Smith, Alyssa L., additional, Borgida, Ayelet, additional, Dodd, Anna, additional, Hedley, David, additional, Wouters, Bradly G., additional, O'Kane, Grainne M., additional, Wilson, Julie M., additional, Zogopoulos, George, additional, Notta, Faiyaz, additional, Knox, Jennifer J., additional, and Gallinger, Steven, additional

Published
2019
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24. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update

Author

Wolff, Antonio C., Hammond, M. Elizabeth H., Hicks, David G., Dowsett, Mitch, McShane, Lisa M., Allison, Kimberly H., Allred, Donald C., Bartlett, John M.S., Bilous, Michael, Fitzgibbons, Patrick, Hanna, Wedad, Jenkins, Robert B., Mangu, Pamela B., Paik, Soonmyung, Perez, Edith A., Press, Michael F., Spears, Patricia A., Vance, Gail H., Viale, Giuseppe, and Hayes, Daniel F.

Subjects
Immunohistochemistry, Practice guidelines (Medicine), Diseases -- Relapse, Medical societies, Breast cancer, Evidence-based medicine, Epidermal growth factor, Health
Abstract

Purpose. To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. Methods. ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. Results. The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. Recommendations. The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing. (Arch Pathol Lab Med. 2014; 138:241-256; doi: 10.5858/arpa.2013-0953-SA), In 2007, a joint Expert Panel convened by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) met to develop guidelines for when and how [...]

Published
2014
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25. Genomics-Driven Precision Medicine for Advanced Pancreatic Cancer: Early Results from the COMPASS Trial

Author

Aung, Kyaw L., primary, Fischer, Sandra E., additional, Denroche, Robert E., additional, Jang, Gun-Ho, additional, Dodd, Anna, additional, Creighton, Sean, additional, Southwood, Bernadette, additional, Liang, Sheng-Ben, additional, Chadwick, Dianne, additional, Zhang, Amy, additional, O'Kane, Grainne M., additional, Albaba, Hamzeh, additional, Moura, Shari, additional, Grant, Robert C., additional, Miller, Jessica K., additional, Mbabaali, Faridah, additional, Pasternack, Danielle, additional, Lungu, Ilinca M., additional, Bartlett, John M.S., additional, Ghai, Sangeet, additional, Lemire, Mathieu, additional, Holter, Spring, additional, Connor, Ashton A., additional, Moffitt, Richard A., additional, Yeh, Jen Jen, additional, Timms, Lee, additional, Krzyzanowski, Paul M., additional, Dhani, Neesha, additional, Hedley, David, additional, Notta, Faiyaz, additional, Wilson, Julie M., additional, Moore, Malcolm J., additional, Gallinger, Steven, additional, and Knox, Jennifer J., additional

Published
2018
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26. Pancreatic cancer ascites xenograft-an expeditious model mirroring advanced therapeutic resistant disease

Author

Golan, Talia, primary, Stossel, Chani, additional, Schvimer, Michael, additional, Atias, Dikla, additional, Halperin, Sharon, additional, Buzhor, Ella, additional, Raitses-Gurevich, Maria, additional, Cohen, Keren, additional, Pri-Chen, Sara, additional, Wilson, Julie, additional, Denroche, Robert E., additional, Lungu, Ilinca, additional, Bartlett, John M.S., additional, Mbabaali, Faridah, additional, Yarden, Yosef, additional, Nataraj, Nishanth Belugali, additional, Gallinger, Steven, additional, and Berger, Raanan, additional

Published
2017
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27. A four gene signature of chromosome instability (CIN4) predicts for benefit from taxanes in the NCIC-CTG MA21 clinical trial

Author

Spears, Melanie, primary, Lyttle, Nicola, additional, D’Costa, Alister, additional, Chen, Bingshu E., additional, Yao, Cindy Q., additional, Boutros, Paul C., additional, Burnell, Margot, additional, Levine, Mark N., additional, O’Brien, Patti, additional, Shepherd, Lois, additional, and Bartlett, John M.S., additional

Published
2016
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28. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update

Author

Wolff, Antonio C., primary, Hammond, M. Elizabeth H., additional, Hicks, David G., additional, Dowsett, Mitch, additional, McShane, Lisa M., additional, Allison, Kimberly H., additional, Allred, Donald C., additional, Bartlett, John M.S., additional, Bilous, Michael, additional, Fitzgibbons, Patrick, additional, Hanna, Wedad, additional, Jenkins, Robert B., additional, Mangu, Pamela B., additional, Paik, Soonmyung, additional, Perez, Edith A., additional, Press, Michael F., additional, Spears, Patricia A., additional, Vance, Gail H., additional, Viale, Giuseppe, additional, and Hayes, Daniel F., additional

Published
2013
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29. Abstract C51: Molecular markers, prognosis, and efficacy of adjuvant anthracyclines in breast cancer.

Author

Ali, Alaa M. G., primary, Provenzano, Elena, additional, Abraham, Jean, additional, Driver, Kristy, additional, Bartlett, John M.S., additional, Munro, Alison, additional, Poole, Christopher John, additional, Hiller, Louise, additional, Dunn, Janet, additional, Twelves, Christopher, additional, Earl, Helena Margaret, additional, Caldas, Carlos, additional, and Pharoah, Paul, additional

Published
2011
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