Journal Article
. 2017 Sep;3().
doi: 10.1038/s41523-017-0034-6.

Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry

Salomon M Stemmer 1 Mariana Steiner 2 Shulamith Rizel 1 Lior Soussan-Gutman 3 Noa Ben-Baruch 4 Avital Bareket-Samish 5 David B Geffen 6 Bella Nisenbaum 7 Kevin Isaacs 8 Georgeta Fried 9 Ora Rosengarten 10 Beatrice Uziely 11 Christer Svedman 12 Debbie McCullough 12 Tara Maddala 12 Shmuel H Klang 13 Jamal Zidan 14 Larisa Ryvo 15 Bella Kaufman 16 Ella Evron 16 Natalya Karminsky 17 Hadassah Goldberg 18 Steven Shak 12 Nicky Liebermann 13 
Affiliations
  • PMID: 28900633
  •     27 References
  •     20 citations

Abstract

The 21-gene Recurrence Score® (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RS-testing through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18-30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan-Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18-30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan-Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 (n = 304) and 11-25 (n = 1037) (TAILORx categorization) had 5-year Kaplan-Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan-Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11-25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.

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