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

Autor: Canino F; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy. fabio.canino@unimore.it., Barbolini M; Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., De Giorgi U; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy., Fontana T; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Gaspari V; Department of Medical Oncology, Infermi Hospital, AUSL della Romagna, Rimini, Italy., Gianni C; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy., Gianni L; Department of Medical Oncology, Infermi Hospital, AUSL della Romagna, Rimini, Italy., Maestri A; Department of Medical Oncology, AUSL di Bologna, Bologna, Italy., Minichillo S; Department of Medical Oncology, AUSL di Bologna, Bologna, Italy., Moscetti L; Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Mura A; Department of Medical Oncology, AUSL di Bologna, Bologna, Italy., Nicoletti SVL; Department of Medical Oncology, Infermi Hospital, AUSL della Romagna, Rimini, Italy., Omarini C; Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Pagani R; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Sarti S; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) 'Dino Amadori', Meldola, Italy., Toss A; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy.; Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Zamagni C; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Cuoghi Costantini R; Unit of Clinical Statistics, University Hospital of Modena, Modena, Italy., Caggia F; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy., Antonelli G; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy., Baglio F; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy., Belluzzi L; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy., Martinelli G; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy., Natalizio S; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy., Ponzoni O; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy., Dominici M; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy.; Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy., Piacentini F; Division of Medical Oncology, Department of Medical and Surgical Sciences for Children and Adults, University Hospital of Modena, Largo del Pozzo 71, Modena, 41124, Italy.; Division of Medical Oncology, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2024 Jun 15; Vol. 24 (1), pp. 735. Date of Electronic Publication: 2024 Jun 15.
DOI: 10.1186/s12885-024-12506-0
Abstrakt: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
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