Originally published as JCO Early Release 10.1200/JCO.2005.16.584 on June 13 2005
Journal of Clinical Oncology, Vol 23, No 23 (August 10), 2005: pp. 5305-5313
© 2005 American Society of Clinical Oncology.
Phase I Safety, Pharmacokinetics, and Clinical Activity Study of Lapatinib (GW572016), a Reversible Dual Inhibitor of Epidermal Growth Factor Receptor Tyrosine Kinases, in Heavily Pretreated Patients With Metastatic Carcinomas
Howard A. Burris, III,
Herbert I. Hurwitz,
E. Claire Dees,
Afshin Dowlati,
Kimberly L. Blackwell,
Bert O'Neil,
Paul K. Marcom,
Matthew J. Ellis,
Beth Overmoyer,
Suzanne F. Jones,
Jennifer L. Harris,
Deborah A. Smith,
Kevin M. Koch,
Andrew Stead,
Steve Mangum,
Neil L. Spector
From the Sarah Cannon Research Institute, Nashville, TN; Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill; Duke University Medical Center, Durham; GlaxoSmithKline Inc, Research Triangle Park, NC; and Case Western Reserve University, Cleveland, OH
Address reprint requests to Howard A. Burris III, The Sarah Cannon Research Institute, 250 25th Avenue N, Suite 110, Nashville, TN 37203; e-mail: hburris{at}tnonc.com.
PURPOSE: This study (EGF10004 assessed the safety/tolerability, pharmacokinetics, and clinical activity of daily oral dosing with lapatinib (GW572016) in patients with ErbB1-expressing and/or ErbB2-overexpressing advanced-stage refractory solid tumors.
PATIENTS AND METHODS: Heavily pretreated patients with ErbB1-expressing and/or ErbB2-overexpressing metastatic cancers were randomly assigned to one of five dose cohorts of lapatinib administered once daily. Pharmacokinetic samples were obtained on days 1 and 20. Clinical response was assessed every 8 weeks.
RESULTS: Sixty-seven patients with metastatic solid tumors were treated with lapatinib. The most frequently reported drug-related adverse events were diarrhea (42%) and rash (31%). No grade 4 drug-related adverse events were reported. Five grade 3 drug-related toxicities (gastrointestinal events and rash) were experienced by four patients. Drug-related interstitial pneumonitis or cardiac dysfunction associated with other ErbB-targeted therapies was not reported. Four patients with trastuzumab-resistant metastatic breast cancer—two of whom were classified as having inflammatory breast cancer—had partial responses (PRs). Twenty-four patients with various other carcinomas experienced stable disease, of whom 10 received lapatinib for  6 months. The relationships between lapatinib dose or serum concentration and clinical response could not be adequately characterized due to the limited response data. The incidence of diarrhea increased with increasing dose, whereas the incidence of rash was not related to dose.
CONCLUSION: Lapatinib was well tolerated at doses ranging from 500 to 1,600 mg once daily. Clinical activity was observed in heavily pretreated patients with ErbB1-expressing and/or ErbB2-overexpressing metastatic cancers, including four PRs in patients with trastuzumab-resistant breast cancers and prolonged stable disease in 10 patients.
Supported by a grant from GlaxoSmithKline.
Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.
Terms in blue are defined in the glossary, found at the end of this issue and online at www.jco.org.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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