Nichole Tucker, MA, is the Web Editor for Targeted Oncology. Tucker received her Bachelor of Arts in Mass Communications from Virginia State University and her Master of Arts in Media & International Conflict from University College Dublin.
In an interview with Targeted Oncology at the 2019 San Antonio Breast Cancer Conference, Antionette Tan, MD, shared the results of the FeDEriCa study and explained how the results can impact the treatment of patients with HER2-positive breast cancer in the clinical setting.
Antoinette Tan, MD
In patients with HER2-positive breast cancer, the subcutaneous injection of pertuzumab (Perjeta) plus trastuzumab (Herceptin) resulted in non-inferior levels of pertuzumab in the blood, meeting the primary endpoint of the phase III FeDeriCa study. This development is exciting for the breast cancer paradigm, said Antoinette Tan, MD, because it makes the treatment process more efficient for patients.
When compared with intravenous (IV) pertuzumab/trastuzumab, the subcutaneous fixed-dose pertuzumab/trastuzumab also had comparable efficacy and safety in patients with HER2-positive breast cancer who were eligible for chemotherapy. Specifically, subcutaneous administration of the drug combination demonstrated a pathologic complete response (pCR) rate of 60%, and only 13% of patients had infusion site reactions, which were predominantly pain, burning, and erythema.
Tan explained that when designing the FeDeriCa study, researchers addressed both the needs and preferences of patients in this disease population who prefer subcutaneous injection over the long infusion times associated with IV treatment.
“Studies are showing that patients have a preference to receive drugs by subcutaneous administration, and there's also an impact on the utilization of resources in a facility, such as nursing and pharmacy. There is a new formulation that we evaluated that combines trastuzumab and pertuzumab in one vile. The compound is delivered subcutaneously in the thigh over 5 to 8 minutes,” said Tan.
In an interview withTargeted Oncologyat the 2019 San Antonio Breast Cancer Conference (SABCS), Tan, chief of breast medical oncology at the Levine Cancer Institute, Atrium Health, shared the results of the FeDEriCa study and explained how the results can impact the treatment of patients with HER2-positive breast cancer in the clinical setting.
TARGETED ONCOLOGY: Can you give an overview of the FeDERiCa study?
Tan: The current treatment of early-stage HER2-positive breast cancer in the neoadjuvant and adjuvant setting involves the administration of IV trastuzumab and IV pertuzumab. For many patients, the long infusion times and IV access can be undesirable. The ability to give a drug by a subcutaneous root has benefits. Namely, [the benefit] would be reducing the treatment burden for patients.
Studies are showing that patients have a preference to receive drugs by subcutaneous administration, and there's also an impact on the utilization of resources in a facility, such as nursing and pharmacy. There is a new formulation we evaluated that combines trastuzumab and pertuzumab in 1 vile. The compound is delivered subcutaneously in the thigh over 5 to 8 minutes.
The FeDEriCa study was designed to evaluate the pharmacokinetics, safety, and the activity of the fixed-dose combination of trastuzumab and pertuzumab subcutaneously, compared to the IV formulation of trastuzumab and pertuzumab in a population of patients with early-stage HER2-positive breast cancer.
TARGETED ONCOLOGY:Can you discuss the study design?
Tan: In terms of the trial design, it enrolled about 500 patients with early-stage HER2 positive breast cancer. Patients were randomized to receive chemotherapy with IV trastuzumab and pertuzumab or chemotherapy with the subcutaneous fixed-dose combination. Then, post-surgery, they would continue onto their anti-HER2 targeted treatment.
The patients that were eligible for the trial were patients that had HER2-positive tumors that were greater than 2 centimeters or were node-positive. The patients that we enrolled were mainly stage II and III patients.
The results of our study showed that there were non-inferior levels of pertuzumab that were achieved with pertuzumab/trastuzumab when we gave the fixed-dose combination subcutaneously compared to the IV trastuzumab and pertuzumab. We also demonstrated that the pCR rate was nearly identical in the groups at 60%. The cardiac safety was also comparable. In terms of infusion site reactions, they were very low at 13% and involved some pain, burning, and erythema.
TARGETED ONCOLOGY:What impact are these data expected to have on the breast cancer paradigm?
Tan: This development is exciting to me because it does provide our patients with a simpler, faster, and easier treatment experience. I think there are several benefits, which includes less time in the chair. It also increases the capacity of a facility in terms of giving IV drugs because it opens up the availability of chairs for those patients who need to get IV drugs. It also impacts drug healthcare delivery costs. With giving a drug subcutaneously, administration time and preparation times are shortened.
TARGETED ONCOLOGY: What key point should community oncologists take away from this research?
Tan: This latest development in drug delivery offers patients a [more efficient] treatment experience. That's the main benefit.
TARGETED ONCOLOGY:In your opinion, how can physicians apply what they have seen at the 2019 SABCS to clinical practice?
Tan: Attendance at SABCS is important, especially for those of us whose expertise is in breast cancer. There have been several exciting presentations, but what stands out in my mind that I would advise physicians to watch out for is that new drugs are being developed in the treatment of HER2 positive metastatic breast cancer. The 2 drugs that got a lot of attention are trastuzumab deruxtecan DS-8201, an antibody-drug conjugate, and tucatinib, small molecule tyrosine kinase inhibitor, which is shown to penetrate the blood-brain barrier.
Roche Holding: Phase III FeDeriCa Study Meets Primary Endpoint - Quick Facts [news release]. Basel, Switzerland: Roche Holding Corporation; December 12, 2019. https://bit.ly/2utipOL. Accessed January 7, 2020.