Pathological response and circulating tumor cell count identifies treated HER2+ inflammatory breast cancer patients with excellent prognosis: BEVERLY-2 survival data
Menée sur 52 patientes atteintes d'un cancer inflammatoire du sein HER2+ et incluses dans un essai évaluant l'efficacité et la toxicité d'une chimiothérapie néoadjuvante en combinaison avec le trastuzumab et le bévacizumab, cette étude française met en évidence l'intérêt de la réponse pathologique complète et de la mesure du nombre de cellules tumorales circulantes pour prédire la survie des patientes
Purpose : The BEVERLY-2 single-arm phase 2 trial assessed the efficacy and safety of combining neoadjuvant chemotherapy with bevacizumab and trastuzumab for the treatment of HER2-positive inflammatory breast cancer (IBC). Here we report the results of a pre-planned survival analysis at three years of follow-up, along with the association between outcome and circulating biomarkers and pathological complete response (pCR).
Experimental design : Patients received fluorouracil, epirubicin, cyclophosphamide and bevacizumab (cycles 1-4) and docetaxel, trastuzumab and bevacizumab (cycles 5-8) prior to surgery, followed by trastuzumab and bevacizumab for 30 weeks post-surgery. Circulating tumor (CTC) and endothelial cell (CEC) counts were assessed at baseline, cycle 5, pre-operative, post-operative and at one year.
Results : 52 patients were included. The 3-year disease-free survival (DFS) rate was 68% and overall survival (OS) rate was 90%. pCR (centrally reviewed) was strongly associated with 3-year DFS (80% and 53% in patients with/without pCR, respectively [p=0.03]). CTC detection also independently predicted 3-year DFS (81% vs. 43% for patients with <1 vs. ≥1 CTC/7.5 mL at baseline [p=0.01]). Patients with no CTC detected at baseline and with pCR had a high 3-year DFS (95%). CEC changes during treatment had no prognostic value.
Conclusions : Our study suggests that the prognosis of IBC relies on more than the achievement of pCR and highlights the role of early hematogenous tumor dissemination as assessed by CTCs. Combining these two prognostic factors isolates a subgroup of IBC with excellent survival when treated with bevacizumab and trastuzumab-containing regimens.
Clinical Cancer Research , résumé, 2014