Safety and efficacy analysis of neoadjuvant pertuzumab, trastuzumab and standard chemotherapy for HER2-positive early breast cancer: real-world data from NeoPowER study.
In: BMC cancer, Jg. 24 (2024-06-15), Heft 1, S. 735
academicJournal
Zugriff:
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).)
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Safety and efficacy analysis of neoadjuvant pertuzumab, trastuzumab and standard chemotherapy for HER2-positive early breast cancer: real-world data from NeoPowER study.
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Autor/in / Beteiligte Person: | Canino, F ; Barbolini, M ; De Giorgi, U ; Fontana, T ; Gaspari, V ; Gianni, C ; Gianni, L ; Maestri, A ; Minichillo, S ; Moscetti, L ; Mura, A ; Nicoletti, SVL ; Omarini, C ; Pagani, R ; Sarti, S ; Toss, A ; Zamagni, C ; Cuoghi Costantini, R ; Caggia, F ; Antonelli, G ; Baglio, F ; Belluzzi, L ; Martinelli, G ; Natalizio, S ; Ponzoni, O ; Dominici, M ; Piacentini, F |
Zeitschrift: | BMC cancer, Jg. 24 (2024-06-15), Heft 1, S. 735 |
Veröffentlichung: | London : BioMed Central, [2001-, 2024 |
Medientyp: | academicJournal |
ISSN: | 1471-2407 (electronic) |
DOI: | 10.1186/s12885-024-12506-0 |
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