Bilici, AhmetÖlmez, Ömer FatihKaplan, Muhammed AliÖksüzoğlu, BernaSezer, AhmetKaradurmuş, NuriSendur, Mehmet Ali NahitAksoy, SercanErdem, DilekBaşaran, GülÇakar, BurcuShbair, Abdallah T. M.Arslan, ÇağataySümbül, Ahmet TanerSezgin Göksu, SemaKaradağ, IbrahimCicin, IrfanGümüş, MahmutSelçukbiricik, FatihHarputluoglu, HakanDemirci, Umut2024-12-042024-12-042023-04-200284-186Xhttps://doi.org/10.1080/0284186X.2023.2202330https://hdl.handle.net/11452/48845AimTo investigate the pathological complete response (pCR) achieved after neoadjuvant therapy with versus without adding pertuzumab (P) to trastuzumab (H) plus neoadjuvant chemotherapy (NCT) in HER2+ breast cancer (BC) patients in a real-life setting.MethodsA total of 1528 female HER2+ BC patients who received NCT plus H with or without P were included in this retrospective real-life study. Primary endpoint was pCR rate (ypT0/Tis ypN0). Clinicopathological characteristics, event-free survival (EFS) time, and relapse rates were evaluated with respect to HER2 blockade (NCT-H vs. NCT-HP) and pCR.ResultsOverall, 62.2% of patients received NCT-H and 37.8% received NCT-HP. NCT-HP was associated with a significantly higher pCR rate (66.4 vs. 56.8%, p < 0.001) and lower relapse (4.5 vs. 12.2%, p < 0.001) in comparison to NCT-H. Patients with pCR had a significantly lower relapse (5.6 vs. 14.9%, p < 0.001) and longer EFS time (mean(SE) 111.2(1.9) vs. 93.9(2.7) months, p < 0.001) compared to patients with non-pCR. Patients in the NCT-HP group were more likely to receive docetaxel (75.0 vs. 40.6%, p < 0.001), while those with pCR were more likely to receive paclitaxel (50.2 vs. 40.7%, p < 0.001) and NCT-HP (41.5 vs. 32.1%, p < 0.001). Hormone receptor status and breast conservation rates were similar in NCT-HP vs. NCT-H groups and in patients with vs. without pCR. Invasive ductal carcinoma (OR, 2.669, 95% CI 1.596 to 4.464, p < 0.001), lower histological grade of the tumor (OR, 4.052, 95% CI 2.446 to 6.713, p < 0.001 for grade 2 and OR, 3.496, 95% CI 2.020 to 6.053, p < 0.001 for grade 3), lower T stage (OR, 1.959, 95% CI 1.411 to 2.720, p < 0.001) and paclitaxel (vs. docetaxel, OR, 1.571, 95% CI 1.127 to 2.190, p = 0.008) significantly predicted the pCR.ConclusionsThis real-life study indicates that adding P to NCT-H enables higher pCR than NCT-H in HER2+ BC, while pCR was associated with lower relapse and better EFS time.eninfo:eu-repo/semantics/closedAccessPathological complete responseControlled superiority trialAdjuvant trastuzumabCardiac safetyOpen-labelNeosphereRegimensEfficacyHer2 protein positiveBreast cancerNeoadjuvant treatmentPertuzumabTrastuzumabEvent-free survivalRelapseReal-word evidenceScience & technologyLife sciences & biomedicineOncologyArticle00097168180000138139062410.1080/0284186X.2023.2202330