by Gunter von
Minckwitz, Marco Colleoni, Hans-Christian Kolberg, Serafin Morales, Patricia
Santi, Zorica Tomasevic, Nan Zhang, Vladimir Hanes
The Lancet Oncology, Vol 19, No. 7, p987-998, July
2018
Although the lower
bounds of the 90% CIs for RR and risk difference showed non-inferiority, the
upper bounds exceeded the predefined equivalence margins when based on local
laboratory review of tumour samples, meaning that non-superiority was
non-conclusive. In our sensitivity analyses based on central laboratory
evaluation of tumour samples, estimates for the two drugs were contained within
the predefined equivalence margins, indicating similar efficacy. ABP 980 and
trastuzumab had similar safety outcomes in both the neoadjuvant and adjuvant
phases of the study.
