Abstract P4-21-17: BELIS: Safety and tolerability of at home administration of trastuzumab (Herceptin®) subcutaneous for the treatment of patients with HER2-positive early breast cancer
Authors: Cocquyt VF , Martinez-Mena CL , Martens MT , D'Hondt RG , Graas M-PL , Evron E , Fried G , Ben-Baruch NE , Dijkstra AC , Van De Walle EI 
Published: March 2017

Abstract
Background: Trastuzumab (Herceptin®; H) is a standard component of adjuvant treatment in patients with HER2+ early breast cancer (eBC) and is supported by all major treatment guidelines. The efficacy and safety of Herceptin intravenous (H IV) and Herceptin subcutaneous (H SC) have been shown to be comparable. The main advantage of SC administration is its shorter administration time. Administration at home for selected patients will allow greater independence and may lead to an improved quality of life. In this study, we assessed the safety and tolerability of H SC administered at home by a healthcare professional (HCP) in patients with HER2+ eBC.
Methods: Patients with HER2+ eBC who previously completed 6 cycles of H IV could be included in the study to receive 12 additional cycles of H for a total of 18 cycles. The 12 additional 3-week cycles consisted of 3 cycles of H IV in the hospital (6 mg/kg; cycles 7 to 9; period 1); 3 cycles of H SC in the hospital (600 mg; cycles 10 to 12; period 2); and 6 cycles of H SC administered in the home by a HCP (600 mg; cycles 13 to 18; period 3). Patients are being followed for a total of 24 months after their last treatment. Safety is being assessed from the adverse events (AEs) reported during the study. Patient-reported outcomes were obtained from validated questionnaires for: the satisfaction and quality of the treatments and care, and for symptom severity (0 [absent] to 10 [worst]). HCPs also reported on their experiences with both treatments.
Results: A total of 102 patients were treated in the study between November 2013 and July 2015 and will be followed for safety and efficacy through July 2017. The primary analysis reported here was done after the last 4-week post-treatment follow-up was completed (September 2015). Patient mean age at baseline was 54.4±12.3 (SD) years. A total of 91 (89%) patients reported 549 AEs: 535 (97%) of these were grade 1 or 2 and 194 (35%) were considered treatment related. The proportions of patients with at least one related AE were 7% for H IV period 1, 32% for H SC period 2, and 47% for H SC period 3, which was twice as long as periods 1 or 2. A total of 8 serious AEs were reported in 8 patients (2 each in periods 1 and 2; 4 in period 3). Prior to the first at-home SC administration (cycle 13), 99% of patients were satisfied to a large or very large extent with the IV and SC treatments at the hospital. At cycle 17, 100% of patients were satisfied to a large or very large extent with the SC treatment at home, and 100% of patients thought treatment at home was beneficial to a large or very large extent. In all 3 treatment periods, maximum mean scores were 3.0−3.8 for the most severe symptoms (fatigue, disturbed sleep, and numbness or tingling). All HCPs considered both administration routes to be fairly easy or very easy, and SC administration to be quicker and require fewer preparation resources.
Conclusions: The safety analyses and patient-reported outcomes recorded in this study indicate that H SC administered by a HCP at home instead of at the hospital was not associated with any new safety signals and was considered beneficial by the patients and HCPs.
Citation Format: Cocquyt VF, Martinez-Mena CL, Martens MT, D'Hondt RG, Graas M-PL, Evron E, Fried G, Ben-Baruch NE, Dijkstra AC, Van De Walle EI. BELIS: Safety and tolerability of at home administration of trastuzumab (Herceptin®) subcutaneous for the treatment of patients with HER2-positive early breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-21-17.