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

Conclusion.These data support the use of fixed‐dose H SC as an adjuvant therapy in HER2‐positive EBC and confirm the comparable safety profile of H SC in patients with low body weight or of Asian origin versus the overall population in SafeHer. ClinicalTrials.gov: NCT01566721.Implications for Practice.The safety profile of fixed‐dose subcutaneous trastuzumab (H SC) was comparable between patients in the lowest bodyweight subgroup and the overall patient population, and also between patients of Asian origin (of whom a higher proportion often fall within the lower bodyweight quartiles) and the overall population. The safety data from this SafeHer subgroup analysis therefore support the use of fixed‐dose H SC 600 mg administered every 3 weeks as an adjuvant therapy for patients with HER2‐positive early breast cancer across different bodyweight subgroups and in the Asian patient population.

Source: The Oncologist - October 12, 2018 Category: Cancer & Oncology Authors: Kyung Hae Jung, Beyhan Ataseven, Mark Verrill, Xavier Pivot, Michelino De Laurentiis, Nedal Al-Sakaff, Sabine Lauer, Mona Shing, Joseph Gligorov, Hamdy A. Azim Tags: Breast Cancer Source Type: research