We are pleased to inform you that a STEPP analysis of the updated data from the APHINITY trial has been published in European Journal of Cancer
The primary analysis of the randomized, phase 3 APHINITY (NCT01358877) trial showed that one year of adjuvant pertuzumab added to trastuzumab and chemotherapy statistically significantly improved invasive disease-free survival (iDFS) compared with placebo added to trastuzumab and chemotherapy overall and for patients with node (N)-positive disease (von Minckwitz et al. N Engl J Med 2017). This study investigated whether adding pertuzumab could benefit some N-negative subpopulations and whether to consider de-escalation for some N-positive subpopulations using Subpopulation Treatment Effect Pattern Plot (STEPP) analyses.
Conclusion: STEPP plots for N-negative cohort did not identify subpopulations clearly benefiting from adding pertuzumab, and those for N-positive cohort did not identify subpopulations warranting de-escalation. TILs percentage appeared to be more predictive of pertuzumab treatment effect than clinical composite risk score.
Gelber RD, Wang XV, Cole BF, et al. Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial. Eur J Cancer. 2022 May;166:219-228. doi: 10.1016/j.ejca.2022.01.031.