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Key Words

Lung cancer, non-small cell lung cancer, erlotinib ( Tarceva®). (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary

Erlotinib (Tarceva®) prolonged survival in patients with advanced non-small cell lung cancer who had progressed after standard chemotherapy.

Source

American Society of Clinical Oncology (ASCO) annual meeting, New Orleans, June 5, 2004.

Background

Up to now, patients with advanced non-small cell lung cancer who have relapsed after standard therapy have had few treatment options. Erlotinib is a targeted drug taken by mouth that works by interfering with cell signals controlled by a protein called the epidermal growth factor receptor (EGFR). This protein, also called HER1, is found on the surface of many tumor cells and affects tumor growth. Erlotinib is not yet approved by the U.S. Food and Drug Administration.

The Study

The trial included 731 patients with advanced non-small cell lung cancer whose disease had progressed after one or two courses of chemotherapy. The patients were divided randomly into two groups. One group received erlotinib and the other group received a placebo.

The trial’s principal investigator was Frances A. Shepherd, M.D., of Princess Margaret Hospital in Toronto. It was coordinated by the National Cancer Institute of Canada Clinical Trials Group.

Results

The median survival among patients who took erlotinib was 6.7 months compared to 4.7 months for those on placebo. At one year, 31 percent of the patients taking erlotinib were still alive compared to 22 percent of those taking the placebo. The time it took before the cancer progressed was also longer in the erlotinib group – 2.23 months compared to 1.84 months in the placebo group. These findings were statistically significant.

In addition, patients receiving erlotinib reported longer periods of time before the worsening of cough, shortness of breath, and pain. They also experienced fewer side effects; rash and diarrhea were the most common.

Limitations

Since the study began, notes Scott Saxman, M.D., of the National Cancer Institute’s Cancer Therapy Evaluation Program, new information has emerged suggesting that mutations in the EGFR protein are important predictors of response to this class of drugs. Analysis of the tissues of patients who participated in this trial will be important to determine whether those most likely to benefit can be identified.

Comments

This is an important study because “it is the first EGFR-targeted therapy to show a significant survival benefit” in this group of patients, said Shepherd. These patients “now have an option to improve survival with minimal toxicity.”

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