Dawn L. Hershman, MD, MS, professor of medicine and epidemiology and leader of the Breast Cancer Program at the Herbert Irving Comprehensive Cancer Center of Columbia University, discusses the design of the phase III TAILORx trial in hormone receptor (HR)—positive, HER2-negative breast cancer.

The TAILORx trial had an incredible impact on this space, says Hershman. This trial enrolled patients with HR-positive, HER2-negative, and axillary lymph node—negative breast cancer. Upon enrollment, the patients’ tumors were analyzed using the Oncotype Dx assay and they were assigned a risk score. Patients determined to be low risk (0-10), received hormone therapy only, while those considered to be high risk (≥26) were given hormone therapy and chemotherapy. Those with intermediate scores (11-25) were randomly assigned to receive either hormone therapy alone or hormone therapy with adjuvant chemotherapy.

The goal of the trial was to determine whether hormone therapy alone could yield outcomes that are just as favorable as those achieved with chemotherapy plus hormone therapy; the results from this trial can be confusing to some patients, says Hershman.

Sometimes patients with a lower risk score glean more benefit from hormone therapy. All the patients included in the TAILORx trial received hormonal therapy and were supposed to receive that therapy. Some patients believe that if they are low risk, they do not need chemotherapy and they might not need hormone therapy either; that is not what the results from the study indicated, stresses Hershman.

Physicians must be very careful in their messaging to patients, says Hershman. Just because a patient is determined to be low or intermediate risk, patients should not interpret that to mean that they do not require any hormone therapy or any treatment at all, concludes Hershman.

Videos

Dawn L. Hershman, MD, MS, discusses the design of the phase III TAILORx trial in hormone receptor (HR)–positive, HER2-negative breast cancer.

Dr. Hershman on Misconceptions With the TAILORx Trial in HR+/HER2- Breast Cancer

Dawn L. Hershman, MD, MS, professor of Medicine and Epidemiology, leader of the breast cancer program at NewYork-Presbyterian/Columbia University Irving Medical Center, discusses the equivalency of biosimilars and biologics.

The data that have been published or presented suggest the similarity between biosimilar and biologic agents, says Hershman. Although biosimilars could establish a substantial cost differential, and lower the overall cost of cancer care, there is still a lot of hesitance regarding their use in oncology.

The development of biologic agents is not sustainable. The field needs to figure out ways to save money so that patients can afford these life-saving medications, says Hershman. Biosimilars are an effective means of ensuring patients can complete their therapy. For example, if a patient with breast cancer requires a multiregimen treatment course, using a trastuzumab (Herceptin) biosimilar could lower the total cost of care. Ultimately, the field needs to be more accepting of the potential gains biosimilars have to offer following a demonstration of clinical equivalence, concludes Hershman.

Dawn L. Hershman, MD, MS, professor of Medicine and Epidemiology, Columbia University Medical Center, leader of the breast cancer program at NewYork-Presbyterian/Columbia University Irving Medical Center, discusses the equivalency of biosimilars and biologics.

Dawn L. Hershman, MD, MS

Articles

Dr. Hershman on Misconceptions With the TAILORx Trial in HR+/HER2- Breast Cancer

Dr. Hershman on the Equivalency of Biosimilars and Biologics