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Purpose <p>Statistically standardized estrogen receptor (ER) and progesterone receptor (PgR) differentiated prognosis. Here we examined statistically standardized human epidermal growth receptor 2 (HER2).</p> Methods <p>CCTG MA.27 (NCT00066573) was an adjuvant phase III trial of exemestane versus anastrozole in postmenopausal women with ER + and/or PgR + tumors. We centrally quantitated machine-image immunohistochemical HER2, defined American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) dual-probe FISH HER2/CEP17 categories, determined ultra-low HER2 (IHC 0 with (0,10%] 1 + stain), and standardized HER2 to mean 0, standard deviation 1. Univariate distant disease-free survival (DDFS) was described with Kaplan–Meier plots and examined with Wilcoxon (Peto-Prentice) test statistic. Adjusted Cox multivariable regressions 2-sided Wald tests had nominal significance <i>p</i> &lt; 0.05.</p> Results <p>Of 7576 women, 2900 had ER results; 2726, PgR; 2680, HER2; and 2325, ER/PgR/HER2 for multivariable investigations. ASCO/CAP categorization significantly differentiated univariate DDFS (<i>p</i> = 0.01), although not values of IHC 0 (<i>N</i> = 864) and ultra-low HER2 (<i>N</i> = 1143). Statistical standardization did not differentiate univariate DDFS (<i>p</i> = 0.08–0.27); however, (natural logarithm-) standardized values ≤ −&#xa0;1.0 (ultra-low 1 + /2 + /3 + HSCORE, or % + , &lt; 0.1) were similar to &gt; 1.0 (HSCORE &gt; 19; % +  &gt; 14). Neither ASCO/CAP, nor statistically standardized, ER (<i>p</i> = 0.65–0.94) or HER2 (<i>p</i> = 0.20–0.97) were associated with DDFS in models with PgR; higher PgR had better DDFS (<i>p</i> ≤ .003).</p> Conclusions <p>ASCO/CAP categories significantly differentiated DDFS, while statistical standardization did not. Patients with ultra-low HER2 and IHC 0 without stain had similar 5-year DDFS, while standardization indicated similar prognosis for very low 1 + /2 + /3 + and highest HER2 stain. We caution about assessment of ultra-low, or very low, HER2 due to HER2 assay dynamic range.</p>

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Adjunctive statistical standardization of quantitated adjuvant HER2 and ultra-low HER2 in Canadian Cancer Trials Group MA.27 trial of exemestane versus anastrozole

  • 期刊论文

  • 发表日期：

    2025年6月23日

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  • Judith-Anne W. Chapman,
  • Jane Bayani,
  • Sandip SenGupta,
  • John M. S. Bartlett,
  • Tammy Piper,
  • Mary Anne Quintayo,
  • Shakeel Virk,
  • Paul E. Goss,
  • James N. Ingle,
  • Matthew J. Ellis,
  • George W. Sledge,
  • G. Thomas Budd,
  • Manuela Rabaglio,
  • Rafat H. Ansari,
  • Richard Tozer,
  • David P. D’Souza,
  • Haji Chalchal,
  • Silvana Spadafora,
  • Vered Stearns,
  • Edith A. Perez,
  • Karen A. Gelmon,
  • Timothy J. Whelan,
  • Catherine Elliott,
  • Lois E. Shepherd,
  • Bingshu E. Chen,
  • Karen J. Taylor

摘要

Purpose

Statistically standardized estrogen receptor (ER) and progesterone receptor (PgR) differentiated prognosis. Here we examined statistically standardized human epidermal growth receptor 2 (HER2).

Methods

CCTG MA.27 (NCT00066573) was an adjuvant phase III trial of exemestane versus anastrozole in postmenopausal women with ER + and/or PgR + tumors. We centrally quantitated machine-image immunohistochemical HER2, defined American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) dual-probe FISH HER2/CEP17 categories, determined ultra-low HER2 (IHC 0 with (0,10%] 1 + stain), and standardized HER2 to mean 0, standard deviation 1. Univariate distant disease-free survival (DDFS) was described with Kaplan–Meier plots and examined with Wilcoxon (Peto-Prentice) test statistic. Adjusted Cox multivariable regressions 2-sided Wald tests had nominal significance p < 0.05.

Results

Of 7576 women, 2900 had ER results; 2726, PgR; 2680, HER2; and 2325, ER/PgR/HER2 for multivariable investigations. ASCO/CAP categorization significantly differentiated univariate DDFS (p = 0.01), although not values of IHC 0 (N = 864) and ultra-low HER2 (N = 1143). Statistical standardization did not differentiate univariate DDFS (p = 0.08–0.27); however, (natural logarithm-) standardized values ≤ − 1.0 (ultra-low 1 + /2 + /3 + HSCORE, or % + , < 0.1) were similar to > 1.0 (HSCORE > 19; % +  > 14). Neither ASCO/CAP, nor statistically standardized, ER (p = 0.65–0.94) or HER2 (p = 0.20–0.97) were associated with DDFS in models with PgR; higher PgR had better DDFS (p ≤ .003).

Conclusions

ASCO/CAP categories significantly differentiated DDFS, while statistical standardization did not. Patients with ultra-low HER2 and IHC 0 without stain had similar 5-year DDFS, while standardization indicated similar prognosis for very low 1 + /2 + /3 + and highest HER2 stain. We caution about assessment of ultra-low, or very low, HER2 due to HER2 assay dynamic range.