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HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials

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HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. / Press, Michael F; Sauter, Guido; Buyse, Marc; Fourmanoir, Hélène; Quinaux, Emmanuel; Tsao-Wei, Denice D; Eiermann, Wolfgang; Robert, Nicholas; Pienkowski, Tadeusz; Crown, John; Martin, Miguel; Valero, Vicente; Mackey, John R; Bee, Valerie; Ma, Yanling; Villalobos, Ivonne; Campeau, Anaamika; Mirlacher, Martina; Lindsay, Mary-Ann; Slamon, Dennis J.

In: J CLIN ONCOL, Vol. 34, No. 29, 10.10.2016, p. 3518-3528.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Press, MF, Sauter, G, Buyse, M, Fourmanoir, H, Quinaux, E, Tsao-Wei, DD, Eiermann, W, Robert, N, Pienkowski, T, Crown, J, Martin, M, Valero, V, Mackey, JR, Bee, V, Ma, Y, Villalobos, I, Campeau, A, Mirlacher, M, Lindsay, M-A & Slamon, DJ 2016, 'HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials', J CLIN ONCOL, vol. 34, no. 29, pp. 3518-3528. https://doi.org/10.1200/JCO.2016.66.6693

APA

Press, M. F., Sauter, G., Buyse, M., Fourmanoir, H., Quinaux, E., Tsao-Wei, D. D., Eiermann, W., Robert, N., Pienkowski, T., Crown, J., Martin, M., Valero, V., Mackey, J. R., Bee, V., Ma, Y., Villalobos, I., Campeau, A., Mirlacher, M., Lindsay, M-A., & Slamon, D. J. (2016). HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J CLIN ONCOL, 34(29), 3518-3528. https://doi.org/10.1200/JCO.2016.66.6693

Vancouver

Press MF, Sauter G, Buyse M, Fourmanoir H, Quinaux E, Tsao-Wei DD et al. HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J CLIN ONCOL. 2016 Oct 10;34(29):3518-3528. https://doi.org/10.1200/JCO.2016.66.6693

Bibtex

@article{45c2043c82d645e2849600123c354ef3,
title = "HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials",
abstract = "PURPOSE: ASCO and the College of American Pathologists (ASCO-CAP) recently recommended further changes to the evaluation of human epidermal growth factor receptor 2 gene (HER2) amplification by fluorescent in situ hybridization (FISH). We retrospectively assessed the impact of these new guidelines by using annotated Breast Cancer International Research Group (BCIRG) -005, BCIRG-006, and BCIRG-007 clinical trials data for which we have detailed outcomes.PATIENTS AND METHODS: The HER2 FISH status of BCIRG-005/006/007 patients with breast cancers was re-evaluated according to current ASCO-CAP guidelines, which designates five different groups according to HER2 FISH ratio and average HER2 gene copy number per tumor cell: group 1 (in situ hybridization [ISH]-positive): HER2-to-chromosome 17 centromere ratio ≥ 2.0, average HER2 copies ≥ 4.0; group 2 (ISH-positive): ratio ≥ 2.0, copies < 4.0; group 3 (ISH-positive): ratio < 2.0, copies ≥ 6.0; group 4 (ISH-equivocal): ratio < 2.0, copies ≥ 4.0 and < 6.0; and group 5 (ISH-negative): ratio < 2.0, copies < 4.0. We assessed correlations with HER2 protein, clinical outcomes by disease-free survival (DFS) and overall survival (OS) and benefit from trastuzumab therapy (hazard ratio [HR]).RESULTS: Among 10,468 patients with breast cancers who were successfully screened for trial entry, 40.8% were in ASCO-CAP ISH group 1, 0.7% in group 2; 0.5% in group 3, 4.1% in group 4, and 53.9% in group 5. Distributions were similar in screened compared with accrued subpopulations. Among accrued patients, FISH group 1 breast cancers were strongly correlated with immunohistochemistry 3+ status (P < .0001), whereas groups 2, 3, 4, and 5 were not; however, groups 2, 4 and, 5 were strongly correlated with immunohistochemistry 0/1+ status (all P < .0001), whereas group 3 was not. Among patients accrued to BCIRG-005, group 4 was not associated with significantly worse DFS or OS compared with group 5. Among patients accrued to BCIRG-006, only group 1 showed a significant benefit from trastuzumab therapy (DFS HR, 0.71; 95% CI, 0.60 to 0.83; P < .0001; OS HR, 0.69; 95% CI, 0.55 to 0.85; P = .0006), whereas group 2 did not.CONCLUSION: Our findings support the original categorizations of HER2 by FISH status in BCIRG/Translational Research in Oncology trials.",
author = "Press, {Michael F} and Guido Sauter and Marc Buyse and H{\'e}l{\`e}ne Fourmanoir and Emmanuel Quinaux and Tsao-Wei, {Denice D} and Wolfgang Eiermann and Nicholas Robert and Tadeusz Pienkowski and John Crown and Miguel Martin and Vicente Valero and Mackey, {John R} and Valerie Bee and Yanling Ma and Ivonne Villalobos and Anaamika Campeau and Martina Mirlacher and Mary-Ann Lindsay and Slamon, {Dennis J}",
note = "{\textcopyright} 2016 by American Society of Clinical Oncology.",
year = "2016",
month = oct,
day = "10",
doi = "10.1200/JCO.2016.66.6693",
language = "English",
volume = "34",
pages = "3518--3528",
journal = "J CLIN ONCOL",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "29",

}

RIS

TY - JOUR

T1 - HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials

AU - Press, Michael F

AU - Sauter, Guido

AU - Buyse, Marc

AU - Fourmanoir, Hélène

AU - Quinaux, Emmanuel

AU - Tsao-Wei, Denice D

AU - Eiermann, Wolfgang

AU - Robert, Nicholas

AU - Pienkowski, Tadeusz

AU - Crown, John

AU - Martin, Miguel

AU - Valero, Vicente

AU - Mackey, John R

AU - Bee, Valerie

AU - Ma, Yanling

AU - Villalobos, Ivonne

AU - Campeau, Anaamika

AU - Mirlacher, Martina

AU - Lindsay, Mary-Ann

AU - Slamon, Dennis J

N1 - © 2016 by American Society of Clinical Oncology.

PY - 2016/10/10

Y1 - 2016/10/10

N2 - PURPOSE: ASCO and the College of American Pathologists (ASCO-CAP) recently recommended further changes to the evaluation of human epidermal growth factor receptor 2 gene (HER2) amplification by fluorescent in situ hybridization (FISH). We retrospectively assessed the impact of these new guidelines by using annotated Breast Cancer International Research Group (BCIRG) -005, BCIRG-006, and BCIRG-007 clinical trials data for which we have detailed outcomes.PATIENTS AND METHODS: The HER2 FISH status of BCIRG-005/006/007 patients with breast cancers was re-evaluated according to current ASCO-CAP guidelines, which designates five different groups according to HER2 FISH ratio and average HER2 gene copy number per tumor cell: group 1 (in situ hybridization [ISH]-positive): HER2-to-chromosome 17 centromere ratio ≥ 2.0, average HER2 copies ≥ 4.0; group 2 (ISH-positive): ratio ≥ 2.0, copies < 4.0; group 3 (ISH-positive): ratio < 2.0, copies ≥ 6.0; group 4 (ISH-equivocal): ratio < 2.0, copies ≥ 4.0 and < 6.0; and group 5 (ISH-negative): ratio < 2.0, copies < 4.0. We assessed correlations with HER2 protein, clinical outcomes by disease-free survival (DFS) and overall survival (OS) and benefit from trastuzumab therapy (hazard ratio [HR]).RESULTS: Among 10,468 patients with breast cancers who were successfully screened for trial entry, 40.8% were in ASCO-CAP ISH group 1, 0.7% in group 2; 0.5% in group 3, 4.1% in group 4, and 53.9% in group 5. Distributions were similar in screened compared with accrued subpopulations. Among accrued patients, FISH group 1 breast cancers were strongly correlated with immunohistochemistry 3+ status (P < .0001), whereas groups 2, 3, 4, and 5 were not; however, groups 2, 4 and, 5 were strongly correlated with immunohistochemistry 0/1+ status (all P < .0001), whereas group 3 was not. Among patients accrued to BCIRG-005, group 4 was not associated with significantly worse DFS or OS compared with group 5. Among patients accrued to BCIRG-006, only group 1 showed a significant benefit from trastuzumab therapy (DFS HR, 0.71; 95% CI, 0.60 to 0.83; P < .0001; OS HR, 0.69; 95% CI, 0.55 to 0.85; P = .0006), whereas group 2 did not.CONCLUSION: Our findings support the original categorizations of HER2 by FISH status in BCIRG/Translational Research in Oncology trials.

AB - PURPOSE: ASCO and the College of American Pathologists (ASCO-CAP) recently recommended further changes to the evaluation of human epidermal growth factor receptor 2 gene (HER2) amplification by fluorescent in situ hybridization (FISH). We retrospectively assessed the impact of these new guidelines by using annotated Breast Cancer International Research Group (BCIRG) -005, BCIRG-006, and BCIRG-007 clinical trials data for which we have detailed outcomes.PATIENTS AND METHODS: The HER2 FISH status of BCIRG-005/006/007 patients with breast cancers was re-evaluated according to current ASCO-CAP guidelines, which designates five different groups according to HER2 FISH ratio and average HER2 gene copy number per tumor cell: group 1 (in situ hybridization [ISH]-positive): HER2-to-chromosome 17 centromere ratio ≥ 2.0, average HER2 copies ≥ 4.0; group 2 (ISH-positive): ratio ≥ 2.0, copies < 4.0; group 3 (ISH-positive): ratio < 2.0, copies ≥ 6.0; group 4 (ISH-equivocal): ratio < 2.0, copies ≥ 4.0 and < 6.0; and group 5 (ISH-negative): ratio < 2.0, copies < 4.0. We assessed correlations with HER2 protein, clinical outcomes by disease-free survival (DFS) and overall survival (OS) and benefit from trastuzumab therapy (hazard ratio [HR]).RESULTS: Among 10,468 patients with breast cancers who were successfully screened for trial entry, 40.8% were in ASCO-CAP ISH group 1, 0.7% in group 2; 0.5% in group 3, 4.1% in group 4, and 53.9% in group 5. Distributions were similar in screened compared with accrued subpopulations. Among accrued patients, FISH group 1 breast cancers were strongly correlated with immunohistochemistry 3+ status (P < .0001), whereas groups 2, 3, 4, and 5 were not; however, groups 2, 4 and, 5 were strongly correlated with immunohistochemistry 0/1+ status (all P < .0001), whereas group 3 was not. Among patients accrued to BCIRG-005, group 4 was not associated with significantly worse DFS or OS compared with group 5. Among patients accrued to BCIRG-006, only group 1 showed a significant benefit from trastuzumab therapy (DFS HR, 0.71; 95% CI, 0.60 to 0.83; P < .0001; OS HR, 0.69; 95% CI, 0.55 to 0.85; P = .0006), whereas group 2 did not.CONCLUSION: Our findings support the original categorizations of HER2 by FISH status in BCIRG/Translational Research in Oncology trials.

U2 - 10.1200/JCO.2016.66.6693

DO - 10.1200/JCO.2016.66.6693

M3 - SCORING: Journal article

C2 - 27573653

VL - 34

SP - 3518

EP - 3528

JO - J CLIN ONCOL

JF - J CLIN ONCOL

SN - 0732-183X

IS - 29

ER -