Comparison of the Modified IHC4 Score and 21-Gene Recurrence Score Assay in Patients with Estrogen Receptor-Positive Breast Cancer

Oncology ◽  
2021 ◽  
Author(s):  
Kei Yamaguchi ◽  
Ryoichi Matsunuma ◽  
Ryosuke Hayami ◽  
Michiko Tsuneizumi

Introduction: Not only the 21-gene recurrence score (RS) assay but also online prognostic tools and immunohistochemical prognostic models predict chemotherapy benefits for women with early breast cancer. Multi-gene assays, including Oncotype DX, are expensive and not covered by insurance in some countries. Methods: In this study, we retrospectively analyzed a series of 155 patients with estrogen receptor-positive primary breast cancer for whom an Oncotype DX assay was performed between January 2016 and August 2021. The patients’ modified immunohistochemical marker (mIHC4) scores were calculated on the basis of their pathological reports. The correlations of the RS with the online tool PREDICT and mIHC4 scores were evaluated. Results: Of the patients, 43.9% were premenopausal, 147 (94.8%) had T1 or T2 tumor, and 55.5% had no positive lymph nodes. Low (0–10), intermediate (11–25), and high RSs (26–100) were obtained in 16.1%, 61.9%, and 21.9% of the patients, respectively. The RS showed no correlation with the PREDICT score (r = 0.2720) but correlated with the mIHC4 score (r = 0.6356). In addition, a stronger correlation was observed in the patients with no node involvement and in the postmenopausal patients (r = 0.6609 and r = 0.7277, respectively). Conclusions: A relatively strong correlation was observed between the RS and the mIHC4 score. The mIHC4 score is a potentially easy and useful tool to guide adjuvant chemotherapy decision making especially for postmenopausal patients with no node involvement if a genomic test could not be performed for some reason.

2007 ◽  
Vol 53 (6) ◽  
pp. 1084-1091 ◽  
Author(s):  
Maureen Cronin ◽  
Chithra Sangli ◽  
Mei-Lan Liu ◽  
Mylan Pho ◽  
Debjani Dutta ◽  
...  

Abstract Background: Oncotype DX™ is a clinically validated, high-complexity, multianalyte reverse transcription–PCR genomic test that predicts the likelihood of breast cancer recurrence in early-stage, node-negative, estrogen receptor–positive breast cancer. The Recurrence Score™ (RS) provides a more accurate, reproducible measure of breast cancer aggressiveness and therapeutic responsiveness than standard measures. Individualized patient management requires strict performance criteria for clinical laboratory tests. We therefore investigated the analytical performance of the assay. Methods: Assays used a pooled RNA sample from fixed paraffin-embedded tissues to evaluate the analytical performance of a 21-gene panel with respect to amplification efficiency, precision, linearity, and dynamic range, as well as limits of detection and quantification. Performance variables were estimated from assays carried out with sample dilutions. In addition, individual patient samples were used to test the optimized assay for reproducibility and sources of imprecision. Results: Assay results defined acceptable operational performance ranges, including an estimated maximum deviation from linearity of <1 cycle threshold (CT) units over a ≥2000-fold range of RNA concentrations, with a mean quantification bias of 0.3% and CVs of 3.2%–5.7%. An analysis of study design showed that assay imprecision contributed by instrument, operator, reagent, and day-to-day baseline variation was low, with SDs of <0.5 CT. Conclusion: The analytical and operational performance specifications defined for the Oncotype DX assay allow the reporting of quantitative RS values for individual patients with an SD within 2 RS units on a 100-unit scale.


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