Document Type
Article
Publication Title
Breast cancer research and treatment
Abstract
BACKGROUND: The primary aim of this randomized neoadjuvant trial in operable, HER2-positive breast cancer, was to determine the efficacy on pathologic complete response (pCR) of substituting lapatinib (L) for trastuzumab (T) or adding L to T, in combination with weekly paclitaxel (WP) following AC. Results on pCR were previously reported. Here, we report data on planned secondary endpoints, recurrence-free interval (RFI) post-surgery, and overall survival (OS).
METHODS: All patients received standard AC q3 weeks × 4 cycles followed by WP (80 mg/m
RESULTS: RFI at 4.5 years was 87.2%, 79.4% (p = 0.34; HR = 1.37; 95% CI 0.80, 2.34), and 89.4% (p = 0.37; HR = 0.70; 0.37, 1.32) for arms T, L, and TL, respectively. The corresponding five-year OS was 94.8%, 89.1% (p = 0.34; HR = 1.46; 0.68, 3.11), and 95.8% (p = 0.25; HR = 0.58; 0.22, 1.51), respectively. Patients with pCR had a much better prognosis, especially in the ER-negative cohort: RFI (HR = 0.23, p < 0.001) and OS (HR = 0.28, p < 0.001).
CONCLUSIONS: Although pCR, RFI, and OS were numerically better with the dual combination and less with L, the differences were not statistically significant. However, achievement of pCR again correlated with improved outcomes, especially remarkable in the ER-negative subset.
CLINICAL TRIALS REGISTRATION: NCT00486668.
First Page
243
Last Page
252
DOI
10.1007/s10549-023-06881-8
Publication Date
6-1-2023
Recommended Citation
Rastogi, Priya; Tang, Gong; Hassan, Saima; Geyer, Charles E; Azar, Catherine A; Magrinat, Gustav C; Suga, J Marie; Bear, Harry D; Baez-Diaz, Luis; Sarwar, Shakir; Boileau, Jean-Francois; Brufsky, Adam M; Shibata, Henry R; Bandos, Hanna; Paik, Soonmyung; Yothers, Greg; Swain, Sandra M; Mamounas, Eleftherios P; and Wolmark, Norman, "Long-term outcomes of dual vs single HER2-directed neoadjuvant therapy in NSABP B-41." (2023). Oncology Articles. 3.
https://scholarlyworks.ohiohealth.com/oncology-articles/3