The HERMIONE study was conducted to assess, in HER2-positive early breast cancer, the safety profile of subcutaneous formulation of trastuzumab (SC T) in real life in France.
This prospective, multicenter, noninterventional study included 511 patients planned to be treated in both neoadjuvant and adjuvant settings with a follow-up (FU) of 12 months maximum. The safety analyses concerned 505 patients, either naïve (40.4%) or non-naïve (59.6%) of intravenous trastuzumab (IV T). According to routine practice, patients received concomitant locoregional radiotherapy (68.7%), endocrine therapy (59.9%) and chemotherapy (37.8%). Primary endpoint was the description of systemic and local Adverse Events (AEs) of SC T assessed by NCI-CTCAE. Congestive Heart Failure (CHF), hepatobiliary toxicity and suspected transmission of an infectious agent by SC T were AEs of Special Interest (AESIs). Secondary endpoints included description of patients, disease characteristics and modalities of SC T administration. Quality of life (QoL) was assessed by QLQ-C30.
Patients were included in 101 sites between January and November 2015. The median age was 58 years. Over the FU period, AEs occurred in 422 patients (83.6%): 92 AEs (3.8%) were grade ≥ 3, 76 (3.1%) were serious, 87 (3.6%) were AESIs and 336 (13.7%) were related to SC T. Most frequent AEs (> 10% of patients) were asthenia, arthralgia, radiation skin injury, myalgia, hot flush and diarrhea. Main grade ≥3 events were radiation skin injury (1.8% of patients) and febrile neutropenia (1.4%). Serious AEs (SAEs) included febrile neutropenia (9.2% of SAEs) and pulmonary embolism (6.6%). Main AESI was CHF in 11.5% of patients and was related to SC T only in 4.5%. Injection site pain was the main SC Trelated AE (9.1% of patients). Few AEs (1.4%) led to permanent SC T discontinuation. Only 1 death assessed as not related to SC T (pulmonary thromboembolism) was reported. QoL analyses showed no deterioration of global health status.
The Hermione study showed that the safety of SC T (HERCEPTIN®) in a real-life setting is consistent with the known profile, without new safety concerns or QoL deterioration.
Clinical trial identification
Legal entity responsible for the study
Stéphanie Mohsen, Aixial.
H. Attar-Rabia, S. Deblay, S. Pibre: Roche employee. Y. Belkacemi: Honoraria and consulting: Astellas, Roche, Genomic Health. All other authors have declared no conflicts of interest.