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T-DM1 Now Standard for Heavily Pretreated HER2+ Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Mar 28, 2016

Dr. Hans Wildiers

Hans Wildiers, MD, PhD

Although T-DM1 (ado-trastuzumab emtansine; Kadcyla) is already approved by the FDA as a treatment for patients with HER2-positive breast cancer previously treated with trastuzumab (Herceptin) and a taxane, findings from the TH3RESA study1 also support the regimen as a standard of care for heavily pretreated patients, explains Hans Wildiers, MD.

, Wildiers, lead author on the TH3RESA study and a professor of Medical Oncology at KU Leuven in Belgium, provides an overview of TH3RESA and discusses the trial’s significance in the field of HER2-positive breast cancer.

OncLive: What was the design of the phase III TH3RESA study?

Wildiers: The TH3RESA study is a randomized study comparing T-DM1 versus a treatment of physician’s choice in patients with HER2-positive metastatic breast cancer. T-DM1 is an antibody-drug conjugate composed of trastuzumab, stably linked to a DM1 cytotoxic microtubule inhibitor. T-DM1 is already approved in HER2-positive metastatic breast cancer.

After a median follow-up of 30 months, OS improved by 6.9 months. It went from 15.8 months for patients in the control arm to 22.7 months for those in the T-DM1 arm, which was highly significant. Because of that effect, at least 50% of patients in the control arm crossed over to T-DM1 at progression.

What are the clinical implications of these findings?

The TH3RESA study confirms the EMILIA study. Both trials show that, if you use T-DM1 in patients with HER2-positive metastatic breast cancer who received a taxane and trastuzumab, T-DM1 is the preferred regimen in that setting.
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