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Chemotherapy-Free, De-escalated Neoadjuvent Therapy for HR-Positive/HER2-Positive Early Breast Cancer
5-Year Survival in the WSG-ADAPT-TP Trial
5-Year Survival in the WSG-ADAPT-TP Trial
According to 5-year results from the phase 2, WSG-ADAPT-TP trial, patients with HR-positive, HER2-positive early breast cancer who achieved a pathologic complete response (pCR) after 12 weeks of chemotherapy-free, de-escalated neoadjuvant therapy were more likely to have excellent survival without the need for further adjuvant chemotherapy.
The trial included 375 patients who were randomized to receive either 12 weeks of the antibody-drug conjugate trastuzumab-emtansine with or without endocrine therapy, or trastuzumab plus endocrine therapy once every 3 weeks. Patients who achieved a pCR were permitted to omit adjuvant chemotherapy.
All patients who received at least 1 dose of study treatment were included in the analysis. Results demonstrated that treatment with trastuzumab-emtansine, trastuzumab-emtansine plus endocrine therapy, and trastuzumab plus endocrine therapy all resulted in similar 5-year invasive disease-free survival (88.9%, 85.3%, 84.6%, respectively; Plog-rank = .608) and overall survival rates (97.2%, 96.4%, 96.3%, respectively; Plog-rank = .534). Patients who achieved pCR (n = 117) had a 5-year invasive disease-free survival rate of 92.7%, compared to 82.7% in those patients who did not achieve pCR (hazard ratio [HR], 0.40; 95% confidence interval [CI], 0.18 to 0.85). The 5-year invasive disease free survival rates between patients with pCR who did receive adjuvant chemotherapy (n = 76) and those who did not receive adjuvant chemotherapy (n = 41) were similar (93% vs92.1%; Plog-rank = .848).
The study authors concluded, “[The] WSG-ADAPT-TP [trial] demonstrated that such de-escalation trials in HER2[positive] [early breast cancer] are feasible and safe for patients.”
Source:
Harbeck N, Nitz U, Christgen M, et al. De-escalated neoadjuvant trastuzumab-emtansine with or without endocrine therapy versus trastuzumab with endocrine therapy in HR+/HER2+ early breast cancer: 5-year survival in the WSG-ADAPT-TP trial. J Clin Oncol. Published online February 21, 2023. doi: 10.1200/JCO.22.01816
