BMC Cancer (Jun 2024)

Safety and efficacy analysis of neoadjuvant pertuzumab, trastuzumab and standard chemotherapy for HER2–positive early breast cancer: real–world data from NeoPowER study

  • Fabio Canino,
  • Monica Barbolini,
  • Ugo De Giorgi,
  • Tommaso Fontana,
  • Valeria Gaspari,
  • Caterina Gianni,
  • Lorenzo Gianni,
  • Antonio Maestri,
  • Santino Minichillo,
  • Luca Moscetti,
  • Antonella Mura,
  • Stefania Vittoria Luisa Nicoletti,
  • Claudia Omarini,
  • Rachele Pagani,
  • Samanta Sarti,
  • Angela Toss,
  • Claudio Zamagni,
  • Riccardo Cuoghi Costantini,
  • Federica Caggia,
  • Giuseppina Antonelli,
  • Federica Baglio,
  • Lorenzo Belluzzi,
  • Giulio Martinelli,
  • Salvatore Natalizio,
  • Ornella Ponzoni,
  • Massimo Dominici,
  • Federico Piacentini

DOI
https://doi.org/10.1186/s12885-024-12506-0
Journal volume & issue
Vol. 24, no. 1
pp. 1 – 18

Abstract

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Abstract Background 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. Methods 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. Results 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). Conclusions 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.

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