M. D. Anderson researchers study drug showing promise in fighting lung cancer

Contact: Michael Courtney, (713) 792-0663; [email protected]

DENVER--Researchers at The University of Texas M. D. Anderson Cancer Center have found another anti-tumor drug that may prove useful in fighting lung cancer associated with smoking.

The clinical trial at the Houston cancer center indicates the drug, topotecan, shows promise as a new treatment option for patients suffering from advanced non-small cell lung cancer.

Results of the study are important because few drugs have been found to create a response from non-small cell lung cancer, one of the most common and lethal cancers in the United States, yet one for which there are no standard treatments.

The research, which focused on a particular type of non-small cell lung cancer, squamous cell carcinoma, was presented at the 33rd annual meeting of the American Association of Clinical Oncology in Denver, Colo., Monday, May 19.

In the study, topotecan produced a tumor response in 23 percent of the patients who participated, all of whom had advanced squamous cell lung cancer.

Lung cancer is the leading cause of cancer death among both men and women, resulting in more than 160,000 deaths in the United States each year. An estimated 180,000 individuals are diagnosed with the disease. Squamous cell carcinoma accounts for about 30 percent of all lung cancers and is the type of non-small cell lung cancer most associated with smoking.

"This result is encouraging since advanced non-small cell lung cancer is very difficult to treat and has proved to be extremely resistant to chemotherapy. In the past, few single agent therapies have achieved response rates greater than 15 percent," said Dr. Roman Perez-Soler, principal investigator of the study. Dr. Perez-Soler is chief of the Section of Experimental Therapy and deputy chairman of the Department of Thoracic/Head and Neck Medical Oncology at M. D. Anderson.

"Since there currently is no standard treatment and few options available for patients with non-small cell lung cancer, it is critical that we identify new drugs that can be used in the first-line treatment of this disease," he said. "Results of first-line studies with other drugs have been disappointing in terms of prolonging survival, either as single agents or in combination with other therapies."

In the non-comparative Phase II clinical trial, 30 patients (24 males and six females) with advanced squamous cell lung cancer were treated daily with 1.5 mg/m2 of the drug for five days. Patients received at least two of these five-day treatments every 21 days, with the total treatment regimen lasting two to 12 months. None of the patients had received prior chemotherapy.

The overall response rate was 23 percent. Seven patients (23.3 percent) achieved a partial remission (tumor shrinkage of greater than 50 percent) and two patients (6.7 percent) achieved a minor response. The overall median survival for all evaluable patients was 44 weeks, "which compares favorably with results from studies with other single or combination agents," Dr. Perez-Soler reported. "The improved response and median survival rates may be the result of the drug's unique qualities," Dr. Perez-Soler said. "Topotecan's mechanism of action is different from that of currently-used agents." This new class of drugs kills cancer cells by inhibiting the enzyme topoisomerase I, which is essential in the replication of DNA in human cells.

Topotecan is produced by SmithKline Beecham under the trademark of Hycamtin. In May 1996, it was the first "topoisomerase I" inhibitor to be cleared for marketing by the Food and Drug Administration.

Dr. Perez-Soler said the success of the study may lead to new studies at M. D. Anderson in which topotecan will be used with other chemotherapeutic agents or radiotherapy to possibly create an even better response from lung cancer patients with advanced squamous cell lung cancer.

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