EMILIA Trial: T-DM1 in Metastatic Breast Cancer

Panelists: Adam M. Brufsky, MD, PhD, University of Pittsburgh; Sara Hurvitz, MD, UCLA;
Joyce A. O'Shaughnessy, MD, US Oncology; Edith A. Perez, MD, Mayo Clinic; Hope S. Rugo, MD, UCSF;
Andrew D. Seidman, MD, MSKCC
Published Online: Monday, June 24, 2013
For High-Definition, Click
In February 2013, the FDA approved T-DM1 (ado-trastuzumab emtansine; Kadcyla) for the treatment of patients with HER2-positive metastatic breast cancer. T-DM1 was the first antibody drug conjugate (ADC) to show activity in breast cancer, explains Edith A. Perez, MD. Furthermore, this novel drug design allows for the delivery of a potent chemotherapy agent directly to HER2-positive cells, effectively combining the efficacy of both agents while minimizing toxicity.

The approval of T-DM1 was based on data from the phase III EMILIA trial that compared the agent to lapatinib plus capecitabine, Perez continues. This trial globally enrolled 991 patients with advanced breast cancer, although only 978 received treatment. All accrued patients had been previously treated with trastuzumab and a taxane.

The trial had coprimary endpoints of progression-free survival (PFS) and overall survival (OS). T-DM1 demonstrated superiority over the doublet by significantly extending PFS by 3.2 months and OS by 5.8 months. Moreover, treatment with T-DM1 was associated with fewer side effects. These findings effectively shifted the global standard of care for these patients, Perez states.

Moderator, Adam M. Brufsky, MD, PhD, believes that several questions accompany the EMILIA trial, particularly since it is the first ADC to be approved in breast cancer. One of the lead questions, Brufsky suggests, involves future combinations and sequences for the agent. Furthermore, Brufsky believes, it remains unclear whether T-DM1 acts as a chemotherapy or an antibody. To address this, Andrew D. Seidman, MD, explains that, by itself, emtansine is very active but extremely toxic. Conjugating emtansine to trastuzumab preserves this efficacy and controls toxicity. However, treatment with T-DM1 seems to affect cells similarly to chemotherapy, Seidman believes.

The lingering question facing many breast oncologists is where to utilize this agent in the sequence. To help answer this question, the phase III MARIANNE trial is currently examining T-DM1 in combination with pertuzumab as a frontline treatment for patients with metastatic breast cancer.

View More From This Discussion
Episode 1 Introduction and Exploration of Fulvestrant in Breast Cancer
Episode 2 Combination of Anastrozole and Fulvestrant in MBC
Episode 3 BOLERO-2 Trial: Everolimus in Metastatic Breast Cancer
Episode 4 Management of mTOR Inhibitor Side Effects in Breast Cancer
Episode 5 EMILIA Trial: T-DM1 in Metastatic Breast Cancer
Episode 6 Frontline T-DM1 in HER2+ Metastatic Breast Cancer
Episode 7 CLEOPATRA Trial: Frontline Pertuzumab for HER2+ MBC
Episode 8 MA.31 Trial: Taxane With Lapatinib or Trastuzumab
Episode 9 Treatment With Eribulin in Metastatic Breast Cancer
Episode 10 Case Study: Treating HER2-Positive MBC, Part I
Episode 11 Case Study: Treating HER2-Positive MBC, Part II
Episode 12 Paclitaxel With Pertuzumab Plus Trastuzumab in MBC
Episode 13 Case Study: Treating HR+ and HER2- Breast Cancer
Episode 14 Managing Bone Health in Metastatic Breast Cancer
Episode 15 Surgical Removal of Primary Tumors in Stage IV MBC
Episode 16 Case Study: Metastatic Triple-Negative Breast Cancer
Episode 17 Personalized Medicine in Triple-Negative Breast Cancer
Episode 18 Conclusion and Final Thoughts on Managing Breast Cancer
Expert Panelists
Dr Adam Brufsky

Adam M. Brufsky, MD, PhD

Professor of Medicine, University of Pittsburgh
Medical Director of the Women’s Cancer Center
at Magee-Womens Hospital of UPMC
and the University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania

Sara Hurvitz, MD

Assistant Professor & Director,
Hematology/Oncology Breast Cancer Program, UCLA's Jonsson Comprehensive Cancer Center, Los Angeles, California

Joyce A. O’Shaughnessy, MD

Co-Director, Breast Cancer Research
Baylor Charles A. Sammons Cancer Center
Texas Oncology, PA/US Oncology,
Dallas, Texas

Edith A. Perez, MD

Deputy Director of the Mayo Clinic Cancer Center, Director of the Breast Cancer Translational Genomics Program and the Breast Program at Mayo Clinic,
Jacksonville, Florida

Hope S. Rugo, MD

Professor of Medicine and Director of the Breast Oncology, Clinical Trials, and Education Program, University of California San Francisco Comprehensive Cancer Center, San Francisco, California

Andrew D. Seidman, MD

Professor of Medicine, Weill Cornell Cancer Center, Attending Physician at Memorial Sloan Kettering Cancer Center,
New York, New York
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