Maryam Nemati Shafaee, MD, assistant professor, Duncan Cancer Center, Lester & Sue Smith Breast Cancer, Baylor College of Medicine, discusses the value of biosimilars in oncology.

If biosimilars are as effective as their originator biologic, they will be a great facet of oncology, explains Shafaee. They may also lower the costs of medications.

However, ensuring the equivalence of biosimilars to the originator biologic is a difficult assurance to give, says Shafaee. Recommending a biosimilar over a biologic may potentially put the oncologist in a difficult position, says Shafaee. Although biosimilars are put through a rigorous process in order to be FDA approved, they do not necessarily go through the same phases of clinical trials as the originator biologic. Shafaee states that it is this process upon which physicians rely to recommend therapy. To stray from that standard may be the cause for concern, explains Shafaee.

Although this is a difficult question, there have not been difficult questions that have not been answered before in the history of modern medicine, states Shafaee.

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Dr. Shafaee on the Value of Biosimilars

Maryam Nemati Shafaee, MD, assistant professor, Duncan Cancer Center, Lester & Sue Smith Breast Cancer, Baylor College of Medicine, discusses the PERSEPHONE trial in women with early-stage HER2-positive breast cancer.

In the PERSEPHONE trial, the investigators looked at disease-free survival in women with early-stage HER2-positive breast cancer who would need adjuvant trastuzumab (Herceptin). Twelve months of adjuvant trastuzumab was compared with 6 months of adjuvant trastuzumab to assess whether 9 doses was noninferior to 18 doses, says Shafaee.

The trial reported noninferiority with 6 months of adjuvant trastuzumab, which has a very high clinical impact, explains Shafaee. Shafaee recently saw a patient with mild cardiomyopathy who was being treated with adjuvant trastuzumab. The patient’s ejection fraction recovered, following 9 doses of trastuzumab. Following the results of the trial, they considered stopping therapy after 9 doses. Shafaee underscores that this is not yet included in the NCCN guidelines, so more data are needed before straying from the current standard 12 months of therapy.

Maryam Nemati Shafaee, MD

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Dr. Shafaee on the Value of Biosimilars

Dr. Shafaee on the PERSEPHONE Trial in Early-Stage HER2+ Breast Cancer