Literature DB >> 35531104

Cardiotoxicity monitoring of pyrotinib in combination with nab-paclitaxel, doxorubicin, and cyclophosphamide in HER2-positive breast cancer: a single-armed clinical trial.

Wei Wang1,2, Lu Wang1, Jin-Yi Chang1,2, Fen Hu3, Jin-Yin Yan4, Juan Zhang1, Yong-Ping Liang5, Hui-Wen Zhang6, Hong-Peng Wu7, Hai-Feng Cai1.   

Abstract

Background: Human epidermal growth factor receptor 2 (HER2) inhibitors play a vital role in the treatment of HER2-positive breast cancer. Numerous studies have shown that traditional HER2 inhibitors and chemotherapeutics such as albumin-paclitaxel, liposomal doxorubicin, and cyclophosphamide (TAC regimen) have different degrees of cardiotoxicity. Pyrotinib is a novel small-molecule HER2 inhibitor and has no cardiotoxicity. Here, the purpose of this study was to investigate the cardiac safety of pyrotinib with TAC regimen for HER2-positive breast cancer.
Methods: In this study, 22 patients with stage I-IIIA HER2-positive breast cancer were screened, enrolled, and assigned to receive either neoadjuvant or postoperative adjuvant treatment with pyrotinib (320-400 mg, once daily) combined with TAC (albumin-paclitaxel 260 mg/m2, liposomal doxorubicin 20 mg/m2, cyclophosphamide 600 mg/m2) from December 2019 to May 2021. Patients' heart function was monitored using electrocardiogram, echocardiogram, and serological indicators. ST segment and T wave change, left ventricular ejection fraction (LVEF, %), N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), creatine kinase (CK), creatine kinase myoglobin band (CK-MB), together with patients' weight, white blood cells (WBC), red blood cells (RBC), platelets, plasma lipid, and glucose were recorded.
Results: Before and after the 2nd, 4th, and 6th cycles of treatment, the incidence of abnormal electrocardiogram of patients enrolled in the neoadjuvant treatment group was 36.4%, 27.3%, 27.3%, and 27.3%, respectively, while in the postoperative adjuvant treatment, the incidence was 45.5%, 36.4%, 36.4%, and 36.4%, respectively. LVEF before and after treatment in the neoadjuvant chemotherapy group was 65.36%±2.25% and 65.00%±2.15% (t=1.305, P=0.221), while in the postoperative adjuvant treatment group, LVEF was 66.27%±2.69% and 65.18%±1.89% (t=1.359, P=0.204). Pyrotinib combined with a TAC regimen may have induced a decrease in RBC. No obvious abnormality was found in the level of NT-pro-BNP, CK, CK-MB, patients' weight, WBC, platelets, plasma lipid, or glucose in all enrolled patients during the entire treatment process. Conclusions: Our findings indicated that neither neoadjuvant nor postoperative adjuvant treatment using pyrotinib combined with a TAC regimen to treat patients with HER2-positive breast cancer increased cardiotoxicity. However, the treatment may have induced a decrease in RBC and further research is needed. 2022 Gland Surgery. All rights reserved.

Entities:  

Keywords:  Cardiotoxicity; HER2-positive breast cancer; chemotherapy; pyrotinib

Year:  2022        PMID: 35531104      PMCID: PMC9068533          DOI: 10.21037/gs-22-161

Source DB:  PubMed          Journal:  Gland Surg        ISSN: 2227-684X


  23 in total

1.  Early Myocardial Strain Changes During Potentially Cardiotoxic Chemotherapy May Occur as a Result of Reductions in Left Ventricular End-Diastolic Volume: The Need to Interpret Left Ventricular Strain With Volumes.

Authors:  Jennifer H Jordan; Bunyapon Sukpraphrute; Giselle C Meléndez; Marie-Pierre Jolly; Ralph B D'Agostino; W Gregory Hundley
Journal:  Circulation       Date:  2017-06-20       Impact factor: 29.690

2.  Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer.

Authors:  Sara M Tolaney; William T Barry; Chau T Dang; Denise A Yardley; Beverly Moy; P Kelly Marcom; Kathy S Albain; Hope S Rugo; Matthew Ellis; Iuliana Shapira; Antonio C Wolff; Lisa A Carey; Beth A Overmoyer; Ann H Partridge; Hao Guo; Clifford A Hudis; Ian E Krop; Harold J Burstein; Eric P Winer
Journal:  N Engl J Med       Date:  2015-01-08       Impact factor: 91.245

3.  Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial.

Authors:  Miguel Martin; Frankie A Holmes; Bent Ejlertsen; Suzette Delaloge; Beverly Moy; Hiroji Iwata; Gunter von Minckwitz; Stephen K L Chia; Janine Mansi; Carlos H Barrios; Michael Gnant; Zorica Tomašević; Neelima Denduluri; Robert Šeparović; Erhan Gokmen; Anna Bashford; Manuel Ruiz Borrego; Sung-Bae Kim; Erik Hugger Jakobsen; Audrone Ciceniene; Kenichi Inoue; Friedrich Overkamp; Joan B Heijns; Anne C Armstrong; John S Link; Anil Abraham Joy; Richard Bryce; Alvin Wong; Susan Moran; Bin Yao; Feng Xu; Alan Auerbach; Marc Buyse; Arlene Chan
Journal:  Lancet Oncol       Date:  2017-11-13       Impact factor: 41.316

4.  Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer.

Authors:  Harold J Burstein; Yan Sun; Luc Y Dirix; Zefei Jiang; Robert Paridaens; Antoinette R Tan; Ahmad Awada; Anantbhushan Ranade; Shunchang Jiao; Gary Schwartz; Richat Abbas; Christine Powell; Kathleen Turnbull; Jennifer Vermette; Charles Zacharchuk; Rajendra Badwe
Journal:  J Clin Oncol       Date:  2010-02-08       Impact factor: 44.544

5.  Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

Authors:  Arlene Chan; Suzette Delaloge; Frankie A Holmes; Beverly Moy; Hiroji Iwata; Vernon J Harvey; Nicholas J Robert; Tajana Silovski; Erhan Gokmen; Gunter von Minckwitz; Bent Ejlertsen; Stephen K L Chia; Janine Mansi; Carlos H Barrios; Michael Gnant; Marc Buyse; Ira Gore; John Smith; Graydon Harker; Norikazu Masuda; Katarina Petrakova; Angel Guerrero Zotano; Nicholas Iannotti; Gladys Rodriguez; Pierfrancesco Tassone; Alvin Wong; Richard Bryce; Yining Ye; Bin Yao; Miguel Martin
Journal:  Lancet Oncol       Date:  2016-02-10       Impact factor: 41.316

6.  Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial.

Authors:  Luca Gianni; Tadeusz Pienkowski; Young-Hyuck Im; Laslo Roman; Ling-Ming Tseng; Mei-Ching Liu; Ana Lluch; Elżbieta Staroslawska; Juan de la Haba-Rodriguez; Seock-Ah Im; Jose Luiz Pedrini; Brigitte Poirier; Paolo Morandi; Vladimir Semiglazov; Vichien Srimuninnimit; Giulia Bianchi; Tania Szado; Jayantha Ratnayake; Graham Ross; Pinuccia Valagussa
Journal:  Lancet Oncol       Date:  2011-12-06       Impact factor: 41.316

7.  Left ventricular myocardial deformation and mechanical dyssynchrony in children with normal ventricular shortening fraction after anthracycline therapy.

Authors:  Yiu-fai Cheung; Wen-jing Hong; Godfrey C F Chan; Sophia J Wong; Shau-yin Ha
Journal:  Heart       Date:  2010-05-29       Impact factor: 5.994

8.  Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene.

Authors:  D J Slamon; G M Clark; S G Wong; W J Levin; A Ullrich; W L McGuire
Journal:  Science       Date:  1987-01-09       Impact factor: 47.728

9.  Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA).

Authors:  A Schneeweiss; S Chia; T Hickish; V Harvey; A Eniu; R Hegg; C Tausch; J H Seo; Y-F Tsai; J Ratnayake; V McNally; G Ross; J Cortés
Journal:  Ann Oncol       Date:  2013-05-22       Impact factor: 32.976

Review 10.  Trastuzumab-Induced Cardiomyopathy.

Authors:  Rachel Barish; Emily Gates; Ana Barac
Journal:  Cardiol Clin       Date:  2019-08-27       Impact factor: 2.213

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