Gene therapy approved for lung cancer.

A National Institutes of Health panel last week approved the first use of gene therapy against the leading cancerous killer in the United States: non-small-cell lung cancer.

The panel voted to permit a team led by Jack A. Roth of the University of Texas' M.D. Anderson Cancer Center in Houston to inactivate a cancer-causing gene called K-ras in the tumors of lung cancer patients and to insert into the tumors a normal copy of a cancer-suppressing gene called p53. When mutated, p53 contributes to the chain of events that causes many types of cancer.

Roth and his colleagues received approval from the NIH Recombinant DNA Advisory Committee to use the new gene-therapy procedure to treat 14 patients with advanced lung cancer. After surgically removing as many of the patients' lung tumors as possible, the researchers plan to inject the remaining tumors with genetically engineered viruses containing two foreign genes. The first gene will direct the cancer cells to produce so-called antisense genetic material designed to shut down the action of K-ras (SN: 2/16/91, p.108). The second gene will replace a defective p53 gene in the tumors.

The researchers hope the procedure will arrest the growth of the patients' tumors and perhaps prolong their lives. Because non-small-cell lung cancer does not respond readily to surgery, radiation, or chemotherapy, many patients with the disease die within a year. In contrast, chemotherapy cures roughly 80 percent of patients with the less common small-cell lung cancer.

Barbara E. Murray of the University of Texas Medical School in Houston, who chaired the NIH panel, says the gene-therapy procedure "is a novel approach that offers a long shot for a group of patients with few other options."

Before beginning the treatment, Roth and his colleagues must also receive approval from the Food and Drug Administration. They met with FDA officials to apply for this approval last week.