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Encouraging Activity with Erlotinib (Tarceva) in Older New L

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http://www.docguide.com/news/content.ns ... AC0054FEE4

By Jill Stein

PARIS, FRANCE -- November 1, 2005 -- Erlotinib (Tarceva) appears to be relatively well tolerated and demonstrates promising activity and improved survival in older patients with previously untreated advanced non-small-cell lung cancer (NSCLC), investigators reported here at the 13th Annual Meeting of the European Cancer Conference (ECCO).

David Jackman, MD, Associate Professor of Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, United States, described results in 80 chemotherapy-naive patients who were treated with erlotinib, 150 mg PO once daily, until evidence of disease progression or toxicity.

Erlotinib is an orally available, potent, and highly selective inhibitor of human epidermal receptor 1/epidermal growth factor receptor (HER1/EGFR) tyrosine-kinase activity that has been shown to improves survival in patients with advanced, refractory NSCLC.

"Chemotherapy, the current standard of care for first-line NSCLC, appears to provide equal benefit for older and younger patients, but it is used less often in the elderly because of increased toxicity," Dr. Jackman noted.

One third of patients with NSCLC are over 70 years of age at the time of diagnosis. "More effective and less toxic therapies suitable for elderly patients are urgently needed," he added.

The study enrolled subjects who were 70 years of age or older and had histologically or cytologically confirmed stage III or IV NSCLC of any histological subtype, an ECOG performance status of 0 to 2, and adequate hematological, hepatic, and renal function. At least 3 weeks had elapsed since prior radiation or major surgery.

Median duration of treatment was 9 weeks. All patients were evaluated for survival and toxicity, and 69 patients were evaluated for best response.

Eight patients had a partial response, 33 had stable disease, and 28 had progressive disease. Median duration of response was 65 weeks, median duration of stable disease was 24 weeks, and median survival was 46 weeks.

The disease control rate (complete response plus partial response plus stable disease) was 51% of all patients enrolled and 59% of patients evaluated for best response.

Rash and diarrhea were the most common adverse effects, occurring in 74% and 60% of patients, respectively.

Ten patients dropped out of the study because of toxicity, and there was one treatment-related death from pneumonitis.

Based on the results, Dr. Jackman said that a phase 3 trial of first-line erlotinib versus vinorelbine in older NSCLC patients should be considered.

The study was sponsored by Genentech, Inc., OSI Pharmaceuticals, Inc., and F. Hoffmann-LaRoche Inc.

[Presentation title: A Phase II trial of Erlotinib (Tarceva) in Previously Untreated Elderly Patients (greater than or equal to 70 years) with Advanced Non-Small-Cell Lung Cancer. Abstract 1127]

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