Please use this identifier to cite or link to this item: http://cmuir.cmu.ac.th/jspui/handle/6653943832/52240
Title: Randomized trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2–overexpressing metastatic breast cancer
Authors: Zhongzhen Guan
Binghe Xu
Michelle L. Desilvio
Zhenzhou Shen
Wichit Arpornwirat
Zhongsheng Tong
Vicharn Lorvidhaya
Zefei Jiang
Junlan Yang
Anatoly Makhson
Wai Lim Leung
Mark W. Russo
Beth Newstat
Li Wang
George Chen
Cristina Oliva
Henry Gomez
Keywords: Biochemistry, Genetics and Molecular Biology
Medicine
Issue Date: 1-Jun-2013
Abstract: © 2013 by American Society of Clinical Oncology. Purpose: Lapatinib is an oral small-molecule tyrosine kinase inhibitor of both epidermal growth factor receptor and human epidermal growth factor receptor 2 (HER2). This study is designed to test whether the addition of lapatinib to paclitaxel improves overall survival (OS) compared with placebo plus paclitaxel in patients with HER2-overexpressing metastatic breast cancer (MBC). Patients and Methods: This phase III, randomized, double-blind study assessed the efficacy and safety of lapatinib plus paclitaxel compared with placebo plus paclitaxel in patients with newly diagnosed HER2-positive MBC. The primary end point was OS. Secondary end points included progression-free survival (PFS), overall response rate (ORR), clinical benefit rate, and safety. Results: The addition of lapatinib to paclitaxel significantly improved OS versus paclitaxel (treatment hazard ratio [HR], 0.74; 95% CI, 0.58 to 0.94; P .0124); median OS was 27.8 versus 20.5 months, respectively. Median PFS was prolonged by 3.2 months, from 6.5 months with placebo plus paclitaxel to 9.7 months with lapatinib plus paclitaxel (HR, 0.52; 95% CI, 0.42 to 0.64; stratified log-rank P .001). ORR was significantly higher with lapatinib plus paclitaxel compared with placebo plus paclitaxel (69% v 50%, respectively; P .001). The incidence of grades 3 and 4 diarrhea and neutropenia was higher in the lapatinib plus paclitaxel arm. Only 4% of patients in this group reported febrile neutropenia. Cardiac events were low grade, asymptomatic, and mostly reversible. The incidence of hepatic events was similar in both arms. There were no fatal adverse events in the lapatinib plus paclitaxel arm. Conclusion: This trial demonstrated that lapatinib combined with paclitaxel offers a significant and clinically meaningful survival advantage over paclitaxel alone in patients with HER2-positive MBC.
URI: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84880452171&origin=inward
http://cmuir.cmu.ac.th/jspui/handle/6653943832/52240
ISSN: 15277755
0732183X
Appears in Collections:CMUL: Journal Articles

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