Abstract

To assess the prognostic value of the Dutch criteria for patients with early-stage hormone receptor-positive and human epidermal growth factor receptor 2-negative breast cancer from the Taiwan Cancer RegistryDatabase. We included 8295 patients with early-stage node-negative breast cancer who underwent surgery during January 2008-December 2012. Patients were stratified into low- and high-risk groups based on the Dutch criteria. The Kaplan-Meier method and log-rank test were used to estimate the difference in breast cancer-specific survival (BCSS) and overall survival (OS) between groups. Multivariable analysis was used to evaluate the prognostic value of the Dutch criteria. Overall, the low-risk and high-risk groups comprised 5375 and 2920 patients, respectively. In the low- and high-risk groups, the 5-year BCSS rate was 99.6% and 98.2% (P < 0.0001) and the 5-year OS rate was 98.3% and 96.8% (P < 0.0001), respectively. The hazard ratio for BCSS was 4.18 (95% confidence interval [CI] 2.63-6.63, P < 0.0001), and the hazard ratio for OS was 1.94 (95% CI 1.48-2.55); both were significantly poorer in the high-risk group than in the low-risk group. In the low-risk group, the 5-year BCSS and OS of patients who did and did not receive adjuvant chemotherapy were similar (99.5% versus 99.6% [P = 0.927] and 98.8% and 98.1% [P = 0.0683], respectively). The prognosis of low-risk patients as classified using the Dutch criteria is excellent with or without adjuvant chemotherapy. The benefit of multi-gene testing for chemotherapy decision-making might be minimal in these patients.

Highlights

  • Breast cancer is the most common malignant disease in women, causing approximately 630,000 deaths worldwide in 2018 [2]

  • HR + and HER2− breast cancer has a sustained risk of disease recurrence and death for at least 15 years after diagnosis, and most patients are treated with long-term endocrine therapy following adjuvant chemotherapy [6]

  • We retrospectively evaluated patients with lymph node-negative, HR+, and HER2− invasive breast cancer initially treated with primary surgery and registered in the Taiwan Cancer Database (TCDB) between January 2008 and December 2012

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Summary

Introduction

Breast cancer is the most common malignant disease in women, causing approximately 630,000 deaths worldwide in 2018 [2]. One of the biggest challenges in treating patients with early stage HR + and HER2− breast cancer is identifying high-risk patients who could benefit from adjuvant chemotherapy [15]. Numerous commercial multi-gene prediction models have been developed to guide decision-making for adjuvant chemotherapy in low-risk patients without medical concerns [4, 10, 13, 14, 18]. The authoritative guideline endorses the Oncotype DX test to guide adjuvant therapy decision-making for patients with early stage HR + and HER2− breast cancer [8], the clinical criterion to undergo this testing is tumor size greater than 0.5 cm. Using clinical risk scales to identify patients with early-stage HR + and HER2− breast cancer who may have excellent survival after surgery and may not benefit from adjuvant chemotherapy is still worthwhile, especially in resource-constrained areas

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