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Title of Journal: Breast Cancer Res Treat

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Abbravation: Breast Cancer Research and Treatment

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Springer US

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DOI

10.1002/tee.20486

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ISSN

1573-7217

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RC0639 phase II study of paclitaxel trastuzumab

Authors: Alvaro MorenoAspitia Amylou C Dueck Ismael GhanemCañete Tejal Patel Shaker Dakhil David Johnson Sandra Franco Stephen Kahanic Gerardo ColonOtero Kathleen S Tenner Richard Rodeheffer Ann E McCullough Robert B Jenkins Frances M Palmieri Donald Northfelt Edith A Perez
Publish Date: 2013/03/12
Volume: 138, Issue: 2, Pages: 427-435
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Abstract

Lapatinib adds to the efficacy of trastuzumab in preclinical models and also in the neoadjuvant setting This study assesses the safety and feasibility of adding lapatinib to paclitaxel and trastuzumab THL as part of the adjuvant therapy for HER2positive breast cancer HER2+ BC In this singlearm phase II study patients with stages I–III HER2+ BC received standard anthracyclinebased chemotherapy followed by weekly taxane with concurrent standard trastuzumab plus daily lapatinib for a total of 12 months The primary endpoint was symptomatic congestive heart failure secondary endpoints included overall safety A total of 109 eligible patients were enrolled Median followup is 43 years No patients experienced congestive heart failure while on treatment Mean left ventricular ejection fraction at baseline and at the end of THL were 636  N = 109 SD = 57 and 598  N = 98 SD = 81 respectively mean change −395  N = 98 SD = 83 p  0001 One hundred and two patients initiated postAC treatment of them 31  experienced grade 3 no G4 diarrhea with lapatinib at 750 mg/day The addition of lapatinib to paclitaxel and trastuzumab following AC does not add cardiac toxicity Lapatinib dose of 750 mg/day in combination with standard chemotherapy plus trastuzumab has acceptable overall tolerability

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