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.
Subject(s)
Antibodies, Monoclonal, Humanized , Antineoplastic Combined Chemotherapy Protocols , Breast Neoplasms , Neoadjuvant Therapy , Receptor, ErbB-2 , Trastuzumab , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Breast Neoplasms/metabolism , Trastuzumab/administration & dosage , Trastuzumab/adverse effects , Trastuzumab/therapeutic use , Neoadjuvant Therapy/methods , Middle Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/therapeutic use , Retrospective Studies , Receptor, ErbB-2/metabolism , Adult , Aged , Treatment Outcome , Neoplasm StagingABSTRACT
BACKGROUND: The implementation of BLS-D training courses in the school setting aims to increase the number of future citizens competent in the recognition and treatment of out-of-hospital cardiac arrest to increase overall survival. It is important to make teachers and students aware of their social responsibilities, consolidating collaboration with healthcare professionals. The present study investigates, through a cross-sectional cognitive survey, the perception of the importance of knowledge and diffusion of basic BLS manoeuvres and early defibrillation in the treatment of cardiac arrest. METHODS: An anonymous questionnaire was sent to secondary school teachers, divided into 14 questions: 12 items in closed form according to the Delphi method and the 5-point Likert rating scale, and the last two with different response methods. RESULTS: The total number of teachers who participated in the survey was 120. The majority of respondents believe that it is essential to know and transmit notions related to BLS-D to students, without the need to have an official certification as an instructor. Most of the teachers consider useful to have specific information on the placement and use of the defibrillator, to set reminder systems on life-saving manoeuvres and to share protocols on the management of cardiac arrest. CONCLUSIONS: The introduction of BLS-D training at school determines a constant increase in competent students and therefore the birth of a network of people educated in the management of out-of-hospital cardiac arrest. The teaching skills of teachers also allow them to identify the best strategies to make the learning method clear and valid for students. The autonomy of teachers in fulfilling the role of instructors is still poorly consolidated and shared, thus requiring the support of healthcare professionals.