Impact of 12 weeks nab-paclitaxel + carboplatin or gemcitabine followed by anthracycline administration according to pCR in triple-negative early breast cancer: Survival results of WSG-ADAPT-TN phase II trial.

Abstract

573Background: Optimal chemotherapy in TNBC EBC is unclear. ADAPT TN demonstrated higher pCR (46% vs. 29%) and better safety for only 12 weeks nab-paclitaxel/carboplatin vs nab-paclitaxel/gemcitabine (JNCI 2017). Methods: Patients with centrally confirmed TNBC (ER/PR < 1%, HER2-, cT1c-cT4c, cN0/+) were randomized to neoadjuvant A: 4x nab-paclitaxel 125 mg/m2/gemcitabine 1000 mg/m2 d1,8 q3w vs. B: 4x nab-paclitaxel 125 mg/m2/carboplatin AUC2 day 1/8 3-weekly (q3w). Primary endpoint was pCR (ypT0/is/ypN0) after 12 weeks of therapy. Event-free (EFS) -- defined as time from registration to any invasive relapse, secondary malignancy or death of any cause -- and overall survival (OS) were secondary endpoints. Adjuvant anthracycline-based chemotherapy (4xEC) was optional in patients with pCR. Here, we report the per-protocol interim survival analysis recommended by the DSMB after a median follow-up of 3 years. Results: 336 patients were enrolled (48 centers, arms A/B: n = 182/154). Median age was 50 years. At ba...