%0 Journal Article
%T Safety and efficacy analysis of neoadjuvant pertuzumab, trastuzumab and standard chemotherapy for HER2-positive early breast cancer: real-world data from NeoPowER study.
%A Canino F
%A Barbolini M
%A De Giorgi U
%A Fontana T
%A Gaspari V
%A Gianni C
%A Gianni L
%A Maestri A
%A Minichillo S
%A Moscetti L
%A Mura A
%A Nicoletti SVL
%A Omarini C
%A Pagani R
%A Sarti S
%A Toss A
%A Zamagni C
%A Cuoghi Costantini R
%A Caggia F
%A Antonelli G
%A Baglio F
%A Belluzzi L
%A Martinelli G
%A Natalizio S
%A Ponzoni O
%A Dominici M
%A Piacentini F
%J BMC Cancer
%V 24
%N 1
%D 2024 Jun 15
%M 38879498
%F 4.638
%R 10.1186/s12885-024-12506-0
%X <B>BACKGROUND: </B>The addition of pertuzumab (P) to trastuzumab (H) and standard chemotherapy (CT) as neoadjuvant treatment (NaT) for patients with HER2 + breast cancer (BC), has shown to increase the pathological complete response (pCR) rate, without main safety concerns. The aim of NeoPowER trial is to evaluate safety and efficacy of P + H + CT in a real-world population.<BR><B>METHODS: </B>We retrospectively reviewed the medical records of stage II-III, HER2 + BC patients treated with NaT: who received P + H + CT (neopower group) in 5 Emilia Romagna institutions were compared with an historical group who received H + CT (control group). The primary endpoint was the safety, secondary endpoints were pCR rate, DRFS and OS and their correlation to NaT and other potential variables.<BR><B>RESULTS: </B>260 patients were included, 48% received P + H + CT, of whom 44% was given anthraciclynes as part of CT, compared to 83% in the control group. The toxicity profile was similar, excluding diarrhea more frequent in the neopower group (20% vs. 9%). Three patients experienced significant reductions in left ventricular ejection fraction (LVEF), all receiving anthracyclines. The pCR rate was 46% (P + H + CT) and 40% (H + CT) (p = 0.39). The addition of P had statistically correlation with pCR only in the patients receiving anthra-free regimens (OR = 3.05,p = 0.047). Preoperative use of anthracyclines (OR = 1.81,p = 0.03) and duration of NaT (OR = 1.18,p = 0.02) were statistically related to pCR. 12/21 distant-relapse events and 14/17 deaths occurred in the control group. Patients who achieve pCR had a significant increase in DRFS (HR = 0.23,p = 0.009).<BR><B>CONCLUSIONS: </B>Adding neoadjuvant P to H and CT is safe. With the exception of diarrhea, rate of adverse events of grade > 2 did not differ between the two groups. P did not increase the cardiotoxicity when added to H + CT, nevertheless in our population all cardiac events occurred in patients who received anthracycline-containing regimens. Not statistically significant, higher pCR rate is achievable in patients receiving neoadjuvant P + H + CT. The study did not show a statistically significant correlation between the addition of P and long-term outcomes.