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

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.

Índice de sobrecarga vascular e pressäo arterial como indicadores de variaçäo tensional sistólica após induçäo anestésica com propofol em pacientes normotensos e hipertensos / Vascular overload index and blood pressure as predictors of systolic blood pressure changes following anesthestic induction with propofol in normotensive and hypertensive patients

Justificativa e objetivos: o índice de sobrecarga vascular (IV=1,33 PAS - 0,33 PAD -133) é um indicador do risco hipertensivo cardiovascular, que se correlaciona com a ocorrência de episódios hipotensivos durante a anestesia. Este estudo avaliou as pressöes arteriais sistológica, diastológica e média e o ISV como indicadores da magnitude da variaçäo tensional sistólica, após a administraçäo de propofol. Método: foram estudados prospectivamente 100 pacientes, estado físico ASA I e II, divididos em dois grupos: grupo N, normotensos e grupo H, hipertensos tratados. A anestesia foi induzida com propofol (2mg.kg(elevado a menos 1)). A frequencia cardíaca (FC) e as pressöes arteriais sistólica (PAS), diastólica (PAD) e média (PAM) foram medidas, antes (M1) e após (M2) a administraçäo de propofol. O ISV e a pressäo de pulso (PP) foram calculados a partir da pressäo arterial obtida em M1. A variaçäo tensional sistólica foi calculada pela fórmula (VTS=PAS(M2) -PAS)m1)). Resultados: ocorreu significativa diminuiçäo da PAS em ambos os grupos, sendo maior no grupo H. No grupo H os coeficientes de correlaçäo entre a VTS e os parâmetros PAS, PP e ISV foram -0,84, -0,82 e -0,86, respectivamente. Os coeficientes de correlaçäo para PAD e PAM näo foram significativos. No grupo N os coeficientes de correlaçäo entre a VTS e os parâmetros PAS, PAD, PP, PAM e ISV foram respectivamente -0,34, -0,23, -0,27, -0,36 e -0,35 (p<0,05). Conclusöes: a pressäo arterial sistólica, a pressäo de pulso e o índice de sobrecarga vascular prévios à induçäo correlacionam-se fortemente com a magnitude da reduçäo tensional sistólica em pacientes hipertensos tratados