Patients (pts) with TNBC involved in the GeparSixto study showed an improved pCR rate (ypT0 ypN0) with the addition of carboplatin (Cb) to anthracycline/taxane-based neoadjuvant chemotherapy, which translated in an improved early disease-free survival (DFS). No difference was observed in the HER2+ subgroup for pCR and DFS by adding Cb. Here, we present the results on the long-term survival analysis.
In the GeparSixto trial, pts were treated for 18 weeks with paclitaxel 80mg/m2 q1w and non-pegylated-liposomal doxorubicin (NPLD) 20mg/m2 q1w (PM), concurrently with bevacizumab 15mg/kg q3w if TNBC or trastuzumab 6(8)mg/kg q3w and lapatinib 750mg daily if HER2+. 595 pts were randomised 1:1 to receive concurrently Cb AUC 1.5-2.0 q1w (reduced to 1.5 by an amendment after 330 pts) vs no Cb, stratified by subtype (HER+ vs TNBC), 588 pts started treatment. Primary objective was pCR (ypT0 ypN0). DFS, distant (DDFS), loco regional recurrence-free (LRRFS) and overall survival (OS) were secondary objectives.
After a median follow-up of 47.3 months (range 1.7-62.8) overall no significant difference in DFS was seen with PMCb vs PM (HR = 0.83 [95%CI 0.58-1.20]; p = 0.327). However, Pts with TNBC had a significantly better DFS (HR = 0.56 [95%CI 0.34-0.93]; p = 0.024) and DDFS (HR = 0.50 [95%CI 0.29-0.86]; p = 0.013) when treated with PMCb. No difference was seen in pts with HER2+ disease (DFS HR = 1.34 [95%CI 0.77-2.34]; p = 0.295; interaction test p = 0.022 and DDFS HR = 1.56 [95% CI 0.86-2.83]; p = 0.145; interaction test p = 0.006). A trend towards a better OS was observed in pts with TNBC (HR = 0.60 [95%CI 0.32-1.12]; p = 0.110). OS was not different between the two arms, neither overall (HR = 0.72 [95%CI 0.43-1.21]; p = 0.223) nor in HER2+ disease (HR = 1.13 [95%CI 0.44-2.93]; p = 0.800). Multivariable analysis comfirms that pCR (pCR vs no pCR) independently predicted DFS (HR = 0.23, p
Long-term survival analysis supports the neoadjuvant use of Cb in TNBC. The value of pCR as a strong predictor of DFS and OS was confirmed.
Clinical trial identification
Legal entity responsible for the study
German Breast Group
Teva, GSK, Roche, Hexal
G. von Minckwitz, S. Loibl: Research grant to the institution from Teva. All other authors have declared no conflicts of interest.