August 06, 2009
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Maintenance erlotinib did not extend PFS in stage-III NSCLC

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13th World Congress on Lung Cancer

There was no statistically significant difference between PFS in patients with unresectable stage-III non–small cell lung cancer treated with placebo or erlotinib following concurrent chemoradiation, according to the results of a phase-3 trial presented at the 13th World Conference on Lung Cancer

Researchers conducted a randomized, placebo-controlled trial to determine the effectiveness of erlotinib (Tarceva, OSI Pharms) as maintenance therapy after treatment with concurrent chemoradiation therapy for patients with unresectable, stage-III NSCLC.

James R. Rigas, MD, medical director of the Comprehensive Thoracic Oncology Program at Dartmouth-Hitchcock Norris Cotton Cancer Center, in Lebanon, N.H., presented the trial findings.

Patients (n=243) were randomly assigned 150 mg per day erlotinib or placebo following concurrent radiation therapy.

In the intent-to-treat analysis, PFS was similar between patients in the two groups, according to researchers. However, the time to disease progression was longer in the erlotinib group (21.6 months) than in the placebo group (13.1 months).

An improvement in PFS and OS was seen in a retrospective, subset analysis of patients with “dispensed” erlotinib. PFS was 13.5 months in the erlotinib group and 10.4 months in the placebo group; OS was 30.4 months in the treatment group and only 25.1 months in the placebo group.

Eight percent of patients in the erlotinib therapy group discontinued treatment due to adverse reaction compared with only 1% of patients in the placebo group.

“While more research is needed, we are encouraged by these results and believe erlotinib could be a new maintenance therapy for high risk, stage-III patients,” Rigas said in a press release.

To determine the role of erlotinib as maintenance therapy in this setting, a larger prospective randomized trial is necessary, he said.

Rigas JR. #C6.1. Presented at: 13th World Conference on Lung Cancer: July 31-August 4, 2009; San Francisco.