Abstract P6-14-02: An anti-PD1 antibody-based therapy results in dramatic reduction of TNBC PDX tumors in humanized mice models

Background:The multicenter, open-label Phase II TRYPHAENA study (NCT00976989) showed that neoadjuvant pertuzumab (P) + trastuzumab (H) + chemotherapy (anthracycline-containing or anthracycline-free) was generally well tolerated with low rates of symptomatic left ventricular systolic dysfunction (LVSD, the primary endpoint), in patients (pts) with HER2-positive, operable, locally advanced or inflammatory breast cancer. All three arms were highly clinically active: total pathologic complete response in the breast and axilla (tpCR; ypT0/is, ypN0) rates were 55–64%. We now report long-term disease-free survival (DFS), progression-free survival (PFS), overall survival (OS), and cardiac safety.Methods:Pts were randomized 1:1:1 to six 3-weekly neoadjuvant treatment cycles. Arm A: H + P (cycles 1–6) + fluorouracil, epirubicin, cyclophosphamide (FEC, cycles 1–3) + docetaxel (T) (cycles 4–6), Arm B: FEC (cycles 1–3) followed by T + H + P (cycles 4–6), Arm C: T + H + P + carboplatin (cycles 1–6). Adjuvant H was then given to complete 1 year of treatment. Doses: P 840mg loading and 420mg maintenance; H 8mg/kg loading and 6mg/kg maintenance; T 75mg/m2, up to 100mg/m2 if tolerated (Arms A and B); fluorouracil 500mg/m2; epirubicin 100mg/m2; cyclophosphamide 600mg/m2; carboplatin area under the plasma concentration–time curve 6. A preplanned descriptive analysis of DFS (time from surgery until disease progression or death), PFS (time from randomization until disease progressi...
Source: Cancer Research - Category: Cancer & Oncology Authors: Tags: Poster Session Abstracts Source Type: research