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Recently, the FDA approved subcutaneous trastuzumab/hyaluronidase-oysk injection (Herceptin HylectaTM, Genentech, Inc.) for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. In this interview with i3 Health, Constance Visovsky, PhD, RN, ACNP, FAAN, Associate Professor at the University of South Florida's College of Nursing, discusses the significance of this approval and shares advice for nurses treating patients with breast cancer.
Can you comment on the significance of the recent FDA approval of subcutaneous trastuzumab for patients with HER2-positive breast cancer?
Constance Visovsky, PhD, RN, ACNP, FAAN: There are several points of significance in the FDA approval of subcutaneous trastuzumab for patients with HER2-positive breast cancer. First is the fact that this approval has the potential to make this treatment available to several distinct patient groups with HER2-positive disease, proving wide applicability. Subcutaneous trastuzumab is indicated in combination with chemotherapy for the treatment of specific patients with early breast cancer or for patients with metastatic cancer, either in combination with paclitaxel as a frontline treatment or alone as a single agent in patients who received at least one prior chemotherapy regimen. In addition, subcutaneous trastuzumab is also indicated for patients on oral endocrine therapy or as single-agent trastuzumab.
Second, the results of the Hannah and SafeHER studies showed comparable safety and efficacy of subcutaneous trastuzumab as compared to the intravenous treatment, making the approval of subcutaneous trastuzumab acceptable for patients and clinicians alike. The recommended dose for subcutaneous trastuzumab is 600 mg/10,000 units subcutaneously every three weeks.
How does subcutaneous trastuzumab stack up against the intravenous delivery method, as well as against other options that exist for HER2-positive breast cancer, in terms of side effects?
Dr. Visovsky: In terms of the delivery method for subcutaneous trastuzumab versus intravenous administration, there is no question that the subcutaneous delivery method offers greater convenience, shorter length of stay for treatment delivery, and, in turn, improved quality of life resulting from fewer visits. Additionally, subcutaneous trastuzumab is a relatively uncomplicated regimen, given over two to five minutes, whereas intravenous trastuzumab is administered over 30 to 90 minutes, not accounting for the preparation and delivery of the intravenous solution for administration.
The side effects of subcutaneous trastuzumab that have been reported in at least 10% of patients include fatigue, arthralgia, myalgia, rash, nausea, diarrhea, injection site reactions, upper respiratory infection, cough, pyrexia, headache, edema, flushing, and pain in the extremities. These side effects are generally similar to the intravenous preparation, except that nausea and vomiting may be more severe with the intravenous route, while the subcutaneous route resulted in an increased risk for infection (unknown clinical significance). Other options for the treatment of metastatic HER2-positive breast cancer involve the administration of chemotherapy, tyrosine kinase inhibitors, or newer monoclonal antibodies, which may result in increased side effect profiles or more complex regimens.
What is important for nurses to keep in mind as patients begin to be treated with subcutaneous trastuzumab?
Dr. Visovsky: The transition to subcutaneous trastuzumab will require patient education regarding efficacy and tolerability. Following the first subcutaneous injection, patients may be monitored for a few hours to assess for potential allergic reactions.
Nurses should keep in mind the increased risk for infection with the subcutaneous preparation and monitor patients accordingly. Instruct patients to report fever or persistent cough, which may be indicative of upper respiratory infection.
Injection site reactions are usually grade 1 and short-lived, resolving without intervention. Patients should report symptoms of grade 2 or higher injection site reactions.
Lastly, subcutaneous trastuzumab can result in cardiomyopathy and pulmonary toxicity (interstitial pneumonitis or acute respiratory distress syndrome). Careful assessment of cardiac function before and during treatment is recommended. Assess the patient for signs and symptoms of cardiac failure and respiratory distress at each visit.
Do you have any final words of advice for community oncology nurses treating patients with breast cancer?
Dr. Visovsky: New agents targeting HER2 are driven by the need to overcome drug resistance in trastuzumab. It is important that nurses understand new drugs in the pipeline in order to better monitor for adverse effects and serve as a source of information to patients with breast cancer.
About Dr. Visovsky
Constance Visovsky, PhD, RN, ACNP, FAAN, is an Associate Professor at the University of South Florida's College of Nursing. Dr. Visovsky's research interests include neurotoxic and myotoxic effects of chemotherapy. In addition, she serves on the editorial board of the Journal of the Advanced Practitioner in Oncology and Oncology Nurse, and she is a reviewer of the European Journal of Cancer Care and the Clinical Journal of Oncology Nursing. As a Fulbright Research Global Scholar, she is currently setting up a collaborative breast cancer registry in Panama to help identify risk factors for racially diverse Panamanian women.
For More Information
To gain additional expert perspectives from Dr. Visovsky and to earn CE credit and ILNA points, complete Dr. Visovsky's complimentary i3 Health Online Strategy Session: Nursing Strategies to Optimize Treatment Experiences in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
Gligorov J, Ataseven B, Verrill M, et al (2017). Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients. Eur J Cancer, 82:237-246. DOI:10.1016/j.ejca.2017.05.010
Jackisch C, Kim SB, Semiglazov V, et al (2015). Subcutaneous versus intravenous formulation of trastuzumab for HER2-positive early breast cancer: updated results from the phase III HannaH study. Ann Oncol, 26(2):320-325. DOI:10.1093/annonc/mdu524
Jung KH, Ataseven B, Verrill M, et al (2018). Adjuvant subcutaneous trastuzumab for HER2-positive early breast cancer: subgroup analyses of safety and active medical conditions by body weight in the SafeHer phase III study. Oncologist, 23(10):1137-1143. DOI:10.1634/theoncologist.2018-0065
Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily represent the views of i3 Health.