Change in therapeutic management after the EndoPredict assay in a prospective decision impact study of Mexican premenopausal breast cancer patients

PLoS One. 2020 Mar 11;15(3):e0228884. doi: 10.1371/journal.pone.0228884. eCollection 2020.

Abstract

Objective: To evaluate the change in adjuvant therapeutic decision in a cohort of young women with breast cancer discussed by a multidisciplinary team, before and after EndoPredict testing.

Patients and methods: 99 premenopausal women with hormone receptor-positive, HER2-negative, T1-T2, and N0-N1 breast cancer were included. Clinicopathological characteristics were recorded and cases were presented in a multidisciplinary tumor board. Consensual therapeutic decisions before and after EndoPredict results were registered. Medical records were reviewed at six-month follow-up to determine physicians' adherence to therapeutic recommendations. Pearson chi-square and McNemar's tests were used to analyze differences between groups and changes in treatment recommendations, respectively.

Results: Median age at diagnosis was 43 years. The most frequent tumor size was pT2 (53.5%) and 27% of patients had 1-3 positive lymph nodes. 46% of patients had a low-risk EPclin result. Nodal status and tumor grade were significantly associated with EPclin result (p < .00001 and p = .0110, respectively), while Ki67 levels and age ≤40 years were not. A change in chemotherapy decision was registered in 19.2% of patients (p = .066), with the greatest impact in de-escalation (9% net reduction). A change in chemotherapy or endocrine therapy regimen was suggested in 19% and 20% of cases, respectively, after EPclin results were available. A significant difference was found in the median EPclin score between patients with a low- vs. high-intensity chemotherapy and endocrine therapy regimen recommendation (p = 0.049 and p = 0.0001, respectively). Tumor board treatment recommendation adherence with the EndoPredict result was 95% and final treatment adherence to EPclin result was 93%.

Conclusions: The EndoPredict test successfully assisted the clinical decision-making process in premenopausal patients, with a clinically significant change in overall decision-making, with the greatest impact seen in chemotherapy reduction, and a high rate of therapeutic adherence.

MeSH terms

  • Adult
  • Antineoplastic Agents, Hormonal / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / metabolism
  • Chemotherapy, Adjuvant / methods*
  • Clinical Decision-Making*
  • Cohort Studies
  • Decision Making
  • Female
  • Humans
  • Mexico
  • Middle Aged
  • Neoplasm Grading
  • Premenopause*
  • Transcriptome*

Substances

  • Antineoplastic Agents, Hormonal

Grants and funding

The author(s) received no specific funding for this work. EndoPredict tests were donated by Myriad Genetics. Myriad Genetics did not play any role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.