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Multigene tests for breast cancer: the physician's perspective.

Francesco Cognetti1, Laura Biganzoli2, Sabino De Placido3

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|May 6, 2021
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Summary

The Oncotype DX Breast Recurrence Score is the only multigene test with Level IA evidence to guide adjuvant therapy decisions in early breast cancer, optimizing chemotherapy use and preserving quality of life.

Keywords:
adjuvant chemotherapyadjuvant hormone therapybreast cancergenomic tests

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Area of Science:

  • Oncology
  • Genomics
  • Clinical Diagnostics

Background:

  • Breast cancer is a leading cause of cancer death in women, emphasizing the need to balance treatment benefits against adverse effects.
  • Adjuvant chemotherapy decisions in HR+ HER2- early breast cancer require careful patient selection for optimal clinical benefit.
  • Multigene tests offer a way to personalize adjuvant therapy decisions.

Purpose of the Study:

  • To review four multigene tests for early breast cancer available in Italy: Oncotype DX, EndoPredict, MammaPrint, and Prosigna.
  • To evaluate their clinical utility, economic impact, and guideline inclusion.
  • To highlight the evidence supporting Oncotype DX for guiding adjuvant therapy decisions.

Main Methods:

  • Review of existing literature on four specific multigene diagnostic tests for early breast cancer.
  • Evaluation of clinical utility studies, economic impact assessments, and guideline recommendations.
  • Focus on the evidence level and clinical validation of each test.

Main Results:

  • The Oncotype DX Breast Recurrence Score (RS) is the sole multigene test with Level IA evidence for guiding adjuvant therapy.
  • Oncotype DX effectively stratifies patients: RS 0-25 for hormone therapy alone, RS 26-100 for considering chemotherapy.
  • Clinical data show Oncotype DX reduces chemotherapy use by up to 49% and identifies under-treated patients for chemotherapy (up to 12%).

Conclusions:

  • The Oncotype DX test has demonstrated significant clinical utility in personalizing adjuvant therapy for early breast cancer.
  • Its inclusion in international guidelines, with strong to moderate recommendations, underscores its value.
  • Multigene tests, particularly Oncotype DX, are crucial for optimizing treatment and improving patient quality of life.