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Breast Cancer treatment details. Biologic therapy. Sarah Cannon Research Institute, Nashville, TN, United States

Survival: ?
Toxicity Grade: 3
Treatments: Biologic therapy
Country: United States
City/State/Province: Nashville, TN
Hospital: Sarah Cannon Research Institute
Journal: Link
Date: 8/2005

Patients: This Phase I study involved 67 patients with metastatic solid tumors including: 30 with breast cancer, 10 lung cancer, 7 colorectal cancer, 5 adenocarcinoma, 5 head and neck cancer, and 4 ovarian cancer. Eighteen patients were men, and forty-nine were women. All but one patient had received chemotherapy before this study. The patients were randomized into six dosage groups, and the median age was approximately 56 years.

Treatment: The treatment consisted of one biological therapy, lapatinib which is an inhibitor of epidermal growth factor receptor tyrosine kinases.

Toxicity: No Grade 4 toxicities were reported. Grade 3 toxicities included skin rash, diarrhea, gastrointestinal reflux, and abdominal pain.

Results: No median overall survival was reported. Partial responses were observed in four women with trastuzumab-resistant metastatic breast cancer, and stable disease was observed with 24 other patients, ten of whom were treated beyond six months. The authors concluded that lapatinib was well tolerated in these patients at daily doses up to 1,600 mg.

Support: GlaxoSmithKline financially supported this study, and many of the authors have been employees, consultants, or stockholders. In addition, some of the authors have previously received research funds and honoraria from GlaxoSmithKline. GlaxoSmithKline develops, manufactures, and markets lapatinib.

Correspondence: Howard A. Burris III, MD

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