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Erlotinib Is ‘Active, Well Tolerated’ in Pretreated NSCLC

Erlotinib Is ‘Active, Well Tolerated’ in Pretreated NSCLC

NEW YORK—The investigational epidermal growth factor receptor (EGFR)
tyrosine kinase inhibitor erlotinib (Tarceva, also known as OSI-774) produced
objective remissions and mild toxicity in stage IV non-small-cell lung cancer
(NSCLC) patients who had undergone a number of prior chemotherapy regimens,
according to results of a phase II study.

"There is no question that Tarceva is active and well tolerated in heavily
pretreated NSCLC patients, all of whom had received previous platinum-based
chemotherapy," said Philip Bonomi, MD, director of oncology, Rush Medical
College, Chicago. "The responses are relatively durable, and survival is
certainly very encouraging."

Rash and diarrhea were common but rarely severe; only a few patients
required dose reductions due to adverse events, Dr. Bonomi said at the Mount
Sinai School of Medicine Chemotherapy Foundation Symposium XX.

Response to erlo-tinib therapy appeared to correlate with rash; almost
every responder developed rash vs only about half of nonresponders. "It may
be that the rash has some predictive value in terms of response," he said.

The phase II NSCLC trial was based on preclinical studies showing that
inhibiting the EGFR pathway reduces malignant cell proliferation. A high
percentage (40% to 80%) of NSCLC tumors express EGFR. "When it first came
out, people thought it would be a cytostatic drug, but this agent actually
causes tumor regression," Dr. Bonomi said.

To determine the response rate in NSCLC after treatment with a
platinum-containing chemotherapy regimen, investigators enrolled 57 patients
with at least a low level of EGFR expression and relatively good performance
status. Patients received erlotinib 150 mg/d orally, with an opportunity for
dose reduction or escalation depending on toxicity. Response was confirmed at
6 weeks, and disease was assessed every 8 weeks.

The 57 study subjects included 23 men and 34 women (mean age, 62 years)
who had received at least one prior chemotherapy regimen; all but 10 had
received two or more regimens, and all but 2 had received a prior platinum.
Median duration of treatment was 63 days (range, 12 to 843) and dose
decreases were required in only three patients (5%).

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