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

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

“…Patient demographics and tumor characteristics of the safety population according to body weight are shown in Table (patient demographics and tumor characteristics according to chemotherapy usage per bodyweight subgroup are provided in supplemental online Table 1). Median body weight at baseline was 67.0 kg (range, 33.6–150.0 kg) in the overall SafeHer study patient population . There were no notable changes in patients’ body weights from baseline to Cycle 9 ( n = 637; data not shown).…”

“…There were no notable changes in patients’ body weights from baseline to Cycle 9 ( n = 637; data not shown). The median number of cycles of H SC received in the overall safety population was 18.0 (range, 1–19); 90% of patients received 18 cycles of H SC . The proportion of patients who completed treatment according to the study protocol was 90.4% (612/677) in the lowest bodyweight quartile, 88.9% (554/623) in the highest quartile, and 89.9% (340/378) in patients of Asian origin.…”

“…The primary objective of the SafeHer study was to assess the safety and tolerability of H SC using two different methods of administration. Here, we report safety data from the SafeHer study treatment period (from the first H SC dose until 28 ±5 days after the last dose) by bodyweight subgroup . The SafeHer study was carried out in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki, and all patients provided written informed consent.…”

“…Safety outcomes were evaluated in the combined H SC Vial and H SC single‐use injection device cohorts grouped according to body weight. Analyses were conducted in the individual cohorts of the SafeHer study; however, as the general safety profiles were very similar between cohorts , this paper focuses on data from the combined population, which provides greater statistical power to observe differences across bodyweight subgroups. Patient subgroups were defined according to bodyweight quartiles (≤59, >59 to ≤67, >67 to ≤77, and >77 kg) and the lowest weight decile (≤53 kg) at baseline, race (Asian origin), and chemotherapy use (sequential or concurrent).…”

“…The HannaH phase III study investigating the use of SC and intravenous (IV) trastuzumab (Herceptin [H IV]; F. Hoffmann‐La Roche) as neoadjuvant–adjuvant therapy in patients with HER2‐positive early breast cancer (EBC) established the noninferiority of pathological complete response and serum trough concentration for H SC versus H IV and showed that H SC had an overall safety profile consistent with the established safety profile of H IV in EBC . The phase III, nonrandomized, multinational, open‐label SafeHer study (NCT01566721) further confirmed the safety and tolerability of fixed‐dose H SC 600 mg in patients with HER2‐positive EBC . No new safety signals were identified, and the adjuvant safety profile of H SC given with concurrent or sequential chemotherapy was consistent with previous studies of H SC and H IV .…”