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
Summary
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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