SAFE trial: an ongoing randomized clinical study to assess the role of cardiotoxicity prevention in breast cancer patients treated with anthracyclines with or without trastuzumab

被引：22

作者：

Meattini, Icro ^{[1
]}

Curigliano, Giuseppe ^{[2
]}

Terziani, Francesca ^{[1
]}

Becherini, Carlotta ^{[1
]}

Airoldi, Mario ^{[3
]}

Allegrini, Giacomo ^{[4
]}

Amoroso, Domenico ^{[5
]}

Barni, Sandro ^{[6
]}

Bengala, Carmelo ^{[7
]}

Guarneri, Valentina ^{[8
]}

Marchetti, Paolo ^{[9
]}

Martella, Francesca ^{[10
]}

Piovano, Pierluigi ^{[11
]}

Vannini, Agnese ^{[1
]}

Desideri, Isacco ^{[1
]}

Tarquini, Roberto ^{[12
]}

Galanti, Giorgio ^{[1
]}

Barletta, Giuseppe ^{[1
]}

Livi, Lorenzo ^{[1
]}

机构：

[1] Univ Florence, Azienda Osped Univ Careggi, Largo GA Brambilla 3, I-50134 Florence, Italy

[2] European Inst Oncol, Early Drug Dev Innovat Therapies Div, Milan, Italy

[3] Azienda Osped Univ Citta Salute & Sci, Breast Unit, Turin, Italy

[4] Presidio Osped Felice Lotti, Med Oncol Unit, Pontedera, Italy

[5] Osped Versilia, UOC Oncol, Ist Toscano Tumori, Lido Di Camaiore, Italy

[6] Dipartimento Oncol ASST Bergamo Ovest, Treviglio, Italy

[7] Osped Misericordia, Med Oncol Unit, Grosseto, Italy

[8] Ist Oncol Veneto, Div Med Oncol 2, Padua, Italy

[9] Azienda Osped St Andrea, Med Oncol Unit, Rome, Italy

[10] Santa Maria Annunziata Hosp, Breast Unit, Florence, Italy

[11] Osped Ss Antonio & Biagio & C Arrigo, SC Oncol, Alessandria, Italy

[12] Osped San Giuseppe, Med Interna 1, Empoli, Italy

来源：

MEDICAL ONCOLOGY | 2017年 / 34卷 / 05期

关键词：

Breast cancer; Adjuvant anthracyclines; Trastuzumab; Beta-blockers; Cardiotoxicity prevention; ADJUVANT TRASTUZUMAB; FOLLOW-UP; CHEMOTHERAPY; CYCLOPHOSPHAMIDE; DYSFUNCTION; DOXORUBICIN; THERAPY;

D O I：

10.1007/s12032-017-0938-x

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Over the years, thanks to the addition of new generation systemic agents, as well as the use of more advanced and precise radiotherapy techniques, it was able to obtain a high curability rate for breast cancer. Anthracyclines play a key role in the treatment of breast disease, with a well-known benefit on disease-free survival of patients with positive nodal status. Trastuzumab have shown a significant outcome advantage after 1-year administration in case of HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has been observed after anthracyclines and trastuzumab therapies. Even though the cardiology and oncology community strongly recommend a cardiotoxicity prevention strategy for this subset of patients, there is still no consensus on the optimal patient's approach. We aimed to review the published and ongoing researches on cardioprevention strategies and to present the SAFE trial (CT registry ID: NCT2236806; EudraCT number: 2015-000914-23). It is a randomized phase 3, four-arm, single-blind, placebo-controlled study that aims to evaluate the effect of bisoprolol, ramipril or both drugs, compared to placebo, on subclinical heart damage evaluated by speckle tracking cardiac ultrasound in non-metastatic breast cancer patients.

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