At home administration of trastuzumab subcutaneous has a safety profile comparable with prior studies and is positively assessed by patients and healthcare professionals

The results of a study evaluating the overall safety and tolerability of subcutaneous (SC) trastuzumab administered at home for the treatment of patients with HER2-positive early breast cancer indicated that trastuzumab SC was not associated with any new safety signals. Moreover, trastuzumab SC was considered beneficial by the patients and health care professionals.¹

Results from the phase II HannaH study showed that neoadjuvant-adjuvant SC trastuzumab was non-inferior to intravenous (IV) trastuzumab in terms of pathological complete response (pCR) for patients with HER2-positive early breast cancer, and its safety profile was comparable to that of IV trastuzumab.^2,3 In addition, results from the phase II PrefHer study demonstrated that the majority of patients (88.9%) preferred SC trastuzumab due to reduced administration time and less pain, discomfort and side effects.⁴

The main advantage of SC administration is the shorter administration time. Administration at home for selected patients will allow greater independence and may lead to an improved quality of life. In the current study, the safety and tolerability of trastuzumab SC administered at home by a healthcare professional in patients with HER2-positive early breast cancer was assessed. Secondary endpoint included patient experience, patient reporting of quality of life, healthcare professional overall satisfaction, and perceived time savings at the hospital.

A total of 102 patients were enrolled in the study of which 101 patients received study medication. Only patients who previously completed 6 cycles of trastuzumab IV could be included in the study to receive 12 additional cycles. The 12 additional 3-week cycles consisted of 3 cycles of IV trastuzumab in the hospital, 3 cycles of SC trastuzumab in the hospital, and 6 cycles of SC trastuzumab administered at home by a healthcare professional. Overall, 75 patients (73.5%) were estrogen receptor positive and 52 patients (51%) were progesterone receptor positive. All patients had completed the safety follow-up visit 4 weeks after last study drug administration. At that time, 549 adverse events were reported in 91 patients (90.1%): 535 (97%) of these were grade 1 or 2 and 194 (35%) were considered treatment related. The proportion of patients with at least one adverse event of any grade were 56.4% for trastuzumab IV period 1, 60.6% for SC trastuzumab period 2, and 84.9% for SC trastuzumab period 3. The most common adverse events of any grade were SOC general disorders and administration site conditions (41.6% of patients), and musculoskeletal and connective tissue disorders (11.9% of patients). A total of 8 serious adverse events were reported in 8 patients (2 each in periods 1 and 2, 4 in period 3).

Prior to the first at-home administration, 99% of patients were satisfied with to a large or very large extent with the IV and SC administration at the hospital. At cycle 17, 100% of patients were satisfied to a large or very large extent with the SC administration at home. Moreover, 100% of patients considered treatment at home beneficial to a large or very large extent. All healthcare professionals, eventually, considered both administration routes to be fairly easy or very easy, and SC administration to be quicker and require fewer preparation resources.

The investigators concluded that no new safety signals were revealed when trastuzumab was administered SC both in the hospital and at home. The safety profile of SC trastuzumab is consistent with what was observed in previous studies. The patient reported outcomes and the healthcare professional outcome assessments indicated that SC trastuzumab administered at home by a healthcare professional was considered beneficial over SC administration of the drug in the hospital.

References

1. Cocquyt V, Martinez-Mena CL, Martens MT, et al. BELIS: safety and tolerability of at home administration of trastuzumab (Herceptin©) subcutaneous for the treatment of patients with HER2-positive early breast cancer. San Antonio Breast Cancer Symposium 2016, abstract P4-21-17.
2. Ismael G, Hegg R, Muehlbauer S, et al. Subcutaneous versus intravenous administration of (neo)adjuvant trastuzumab in patients with HER2-positive, clinical stage I–III breast cancer (HannaH study): a phase 3, open-label, multicentre, randomised trial. Lancet Oncol 2012;13:869-78.
3. Jackisch C, Hegg R, Stroyakovskiy D, et al. HannaH phase III randomised study: Association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up. Eur J Cancer 2016;62:62-75.
4. Pivot X, Gligorov J, Müller V, et al. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol 2014;25:1979-87.