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39810: A Phase II trial of cancer and leukemia group B
Article first published online: 4 MAR 2005
Copyright © 2005 American Cancer Society
Volume 103, Issue 8, pages 1670–1675, 15 April 2005
How to Cite
Clamon, G., Herndon, J., Kern, J., Govindan, R., Garst, J., Watson, D. and Green, M. (2005), Lack of trastuzumab activity in nonsmall cell lung carcinoma with overexpression of erb-B2. Cancer, 103: 1670–1675. doi: 10.1002/cncr.20950
The following institutions participated in this study: CALGB Statistical Center, Durham, NC (Stephen George, Ph.D.; supported by grant CA336) Christiana Care Health Services, Inc. Community Cooperative Oncology Program (CCOP), Wilmington, DE (Stephen Grubbs, M.D; supported by grant CA45418); Dartmouth Medical School–Norris Cotton Cancer Center, Lebanon, NH (Marc S. Ernstoff, M.D.; supported by grant CA04326); Duke University Medical Center, Durham, NC (Jeffrey Crawford, M.D.; supported by grant CA47577); Greenville CCOP, Greenville, SC (Jeffrey Giguere, M.D.); Long Island Jewish Medical Center, Lake Success, NY (Marc Citron, M.D.; supported by grant CA11028); Rhode Island Hospital, Providence, RI (William Sikov, M.D.; supported by grant CA08025); Southeast Cancer Control Consortium Inc. CCOP, Goldsboro, NC (James N. Atkins, M.D.; supported by grant CA45808); State University of New York Upstate Medical University, Syracuse, NY (Stephen L. Graziano, M.D.; supported by grant CA21060); and Washington University School of Medicine, St. Louis, MO (Nancy Bartlett, M.D.; supported by grant CA77440).
The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.
- Issue published online: 4 APR 2005
- Article first published online: 4 MAR 2005
- Manuscript Accepted: 10 DEC 2004
- Manuscript Revised: 25 OCT 2004
- Manuscript Received: 18 AUG 2004
- National Cancer Institute. Grant Numbers: CA31946, CA47642, CA33601, CA77440, CA47577, CA03927
- nonsmall cell lung carcinoma
The overexpression of HER-2 occurs in a minority of patients with nonsmall cell lung carcinoma. Trastuzumab, which is a monoclonal antibody to HER-2, is an effective treatment in some women with breast carcinomas that overexpress HER-2, as demonstrated by immunohistochemistry. The objective of this Phase II study was to determine whether trastuzumab would effect responses in patients with nonsmall cell lung carcinoma who had tumors that overexpressed HER-2.
Patients were required to have Stage IIIB or Stage IV nonsmall cell lung carcinoma and tumors with 2+ or 3+ expression of HER-2, as determined with immunohistochemistry, and they may have received up to 1 prior chemotherapy regimen. Trastuzumab at a dose of 4 mg/kg was given intravenously on Week 1; then, weekly doses of 2 mg/kg were given. Response revaluation was performed every 8 weeks.
Among 209 screened patients, 24 patients (11%) had tumors with 2+ or 3+ expression of HER-2. One patient achieved a partial response, and one patient experienced a treatment-related death due to pulmonary toxicity.
Single-agent trastuzumab did not exhibit significant clinical activity against nonsmall cell lung carcinoma when HER-2 expression levels were measured by immunohistochemistry. Cancer 2005. © 2005 American Cancer Society.