Estrogen- and progesterone-receptor status in ECOG 2197

Comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory

Sunil Badve, Frederick L. Baehner, Robert P. Gray, Barrett H. Childs, Tara Maddala, Mei Lan Liu, Steve C. Rowley, Steven Shak, Edith D. Perez, Lawrence J. Shulman, Silvana Martino, Nancy E. Davidson, George W. Sledge, Lori J. Goldstein, Joseph A. Sparano

Research output: Contribution to journalArticle

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Abstract

Purpose: Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay. Patients and Methods: A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay. Results: For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P <.0001). Conclusion: There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.

Original languageEnglish (US)
Pages (from-to)2473-2481
Number of pages9
JournalJournal of Clinical Oncology
Volume26
Issue number15
DOIs
StatePublished - 2008
Externally publishedYes

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Progesterone Receptors
Estrogen Receptors
Reverse Transcription
Immunohistochemistry
Reverse Transcriptase Polymerase Chain Reaction
Polymerase Chain Reaction
Recurrence
Genes
Antibodies

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Estrogen- and progesterone-receptor status in ECOG 2197 : Comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory. / Badve, Sunil; Baehner, Frederick L.; Gray, Robert P.; Childs, Barrett H.; Maddala, Tara; Liu, Mei Lan; Rowley, Steve C.; Shak, Steven; Perez, Edith D.; Shulman, Lawrence J.; Martino, Silvana; Davidson, Nancy E.; Sledge, George W.; Goldstein, Lori J.; Sparano, Joseph A.

In: Journal of Clinical Oncology, Vol. 26, No. 15, 2008, p. 2473-2481.

Research output: Contribution to journalArticle

Badve, S, Baehner, FL, Gray, RP, Childs, BH, Maddala, T, Liu, ML, Rowley, SC, Shak, S, Perez, ED, Shulman, LJ, Martino, S, Davidson, NE, Sledge, GW, Goldstein, LJ & Sparano, JA 2008, 'Estrogen- and progesterone-receptor status in ECOG 2197: Comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory', Journal of Clinical Oncology, vol. 26, no. 15, pp. 2473-2481. https://doi.org/10.1200/JCO.2007.13.6424
Badve, Sunil ; Baehner, Frederick L. ; Gray, Robert P. ; Childs, Barrett H. ; Maddala, Tara ; Liu, Mei Lan ; Rowley, Steve C. ; Shak, Steven ; Perez, Edith D. ; Shulman, Lawrence J. ; Martino, Silvana ; Davidson, Nancy E. ; Sledge, George W. ; Goldstein, Lori J. ; Sparano, Joseph A. / Estrogen- and progesterone-receptor status in ECOG 2197 : Comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory. In: Journal of Clinical Oncology. 2008 ; Vol. 26, No. 15. pp. 2473-2481.
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title = "Estrogen- and progesterone-receptor status in ECOG 2197: Comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory",
abstract = "Purpose: Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay. Patients and Methods: A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay. Results: For ER, the concordance between local and central IHC was 90{\%} (95{\%} CI, 88{\%} to 92{\%}), between local IHC and central RT-PCR was 91{\%} (95{\%} CI, 89{\%} to 93{\%}), and between central IHC and central RT-PCR was 93{\%} (95{\%} CI, 91{\%} to 95{\%}). For PR, the concordance between local IHC and central IHC was 84{\%} (95{\%} CI, 82{\%} to 87{\%}), between local IHC and central RT-PCR was 88{\%} (95{\%} CI, 85{\%} to 90{\%}), and between central IHC and central RT-PCR was 90{\%} (95{\%} CI, 88{\%} to 92{\%}). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P <.0001). Conclusion: There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.",
author = "Sunil Badve and Baehner, {Frederick L.} and Gray, {Robert P.} and Childs, {Barrett H.} and Tara Maddala and Liu, {Mei Lan} and Rowley, {Steve C.} and Steven Shak and Perez, {Edith D.} and Shulman, {Lawrence J.} and Silvana Martino and Davidson, {Nancy E.} and Sledge, {George W.} and Goldstein, {Lori J.} and Sparano, {Joseph A.}",
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language = "English (US)",
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TY - JOUR

T1 - Estrogen- and progesterone-receptor status in ECOG 2197

T2 - Comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory

AU - Badve, Sunil

AU - Baehner, Frederick L.

AU - Gray, Robert P.

AU - Childs, Barrett H.

AU - Maddala, Tara

AU - Liu, Mei Lan

AU - Rowley, Steve C.

AU - Shak, Steven

AU - Perez, Edith D.

AU - Shulman, Lawrence J.

AU - Martino, Silvana

AU - Davidson, Nancy E.

AU - Sledge, George W.

AU - Goldstein, Lori J.

AU - Sparano, Joseph A.

PY - 2008

Y1 - 2008

N2 - Purpose: Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay. Patients and Methods: A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay. Results: For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P <.0001). Conclusion: There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.

AB - Purpose: Central and local laboratory concordance for hormone receptor measurement is therapeutically important. This study compares estrogen receptor (ER) and progesterone receptor (PR) measured by local laboratory immunohistochemistry (IHC), central IHC, and central reverse-transcriptase polymerase chain reaction (RT-PCR) using a proprietary 21-gene assay. Patients and Methods: A case-control sample of 776 breast cancer patients from Eastern Cooperative Oncology Group (ECOG) study E2197 was evaluated. Central IHC Allred score for ER and PR was obtained using tissue microarrays and 1D5 ER antibody and 636 PR antibody. Quantitative RT-PCR for ER and PR in whole sections was performed using the 21-gene assay. Results: For ER, the concordance between local and central IHC was 90% (95% CI, 88% to 92%), between local IHC and central RT-PCR was 91% (95% CI, 89% to 93%), and between central IHC and central RT-PCR was 93% (95% CI, 91% to 95%). For PR, the concordance between local IHC and central IHC was 84% (95% CI, 82% to 87%), between local IHC and central RT-PCR was 88% (95% CI, 85% to 90%), and between central IHC and central RT-PCR was 90% (95% CI, 88% to 92%). Although concordance was high, IHC ER-negative cases that were RT-PCR positive were more common than IHC ER-positive cases that were RT-PCR negative. In ER-positive patients, ER expression by central IHC Allred score was marginally associated with recurrence (P = .091), and ER expression by central RT-PCR was significantly associated with recurrence (P = .014). However, recurrence score, which incorporates additional genes/pathways, was a highly significant predictor of recurrence (P <.0001). Conclusion: There is a high degree of concordance among local IHC, central IHC, and central RT-PCR by the proprietary gene assay for ER and PR status. Although ER expression is marginally associated with relapse in ER-positive patients treated with chemohormonal therapy, recurrence score is a highly significant predictor of recurrence.

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