Study demonstrates longest reported survival rate for locally advanced lung cancer patients

05/13/05

Study regimen boosts five-year survival rate to 29 percent

(ORLANDO, Fla.) -- An investigational chemoradiation regimen has achieved the best long-term survival rates yet reported in patients with locally advanced non-small cell lung cancer, according to results of a Phase II Southwest Oncology Group study presented today at the 41st annual meeting of the American Society of Clinical Oncology.

The study, SWOG-9504, evaluated the use of the chemotherapy agent docetaxel (Taxotere) administered after two other chemotherapy drugs -- cisplatin and etoposide -- plus radiation therapy. Among patients treated with the regimen, 29 percent were still alive after five years versus 17 percent of patients from a previous study, SWOG-9019. Patients in the earlier study received the same chemoradiation without docetaxel. Median survival also increased from 15 months in SWOG-9019 to 26 months in SWOG-9504.

"The long-term survival data are particularly promising because they exceed the results of all other treatment approaches in this group of patients with locally advanced, Stage IIIB disease," said principal investigator David Gandara, professor of medicine and director of clinical research at UC Davis Cancer Center in Sacramento, Calif.

"The SWOG-9504 regimen can now be considered a standard of care for patients with unresectable, Stage III, non-small cell lung cancer," said Gandara, who is also chairman of the Southwest Oncology Group's Lung Cancer Committee.

Non-small cell lung cancer is the most common type of lung cancer, accounting for 87 percent of all lung cancers diagnosed in the United States. According to the American Cancer Society, the five-year survival rate for all stages of lung cancer combined is 15 percent, a rate that has improved only slightly in the last few years. Lung cancer is the leading cause of cancer death among both men and women: More people die of lung cancer than of colon, breast and prostate cancers combined.

Interim results of a follow-up Phase III trial were also reported at the meeting. Results of that study, S0023, confirm the SWOG-9504 findings.

Like SWOG-9504, S0023 evaluated concurrent chemoradiation followed by docetaxel in patients with unresectable, Stage III non-small cell lung cancer. But S0023 patients were then randomized to receive either a placebo or gefitinib (Iressa) as maintenance therapy. The study was designed to assess whether maintenance therapy with gefitinib improves overall survival and progression-free survival.

The interim analysis of 573 patients in S0023 showed a 19-month median survival overall. However, the trial was closed last month after review of the data indicated that gefitinib would not improve survival. Patients on the study are being encouraged to complete all of the planned chemotherapy, since results for those patients not receiving gefitinib were similar to those seen in the SWOG-9504 study.

"While we found that gefitinib did not improve survival in this patient population, we were pleased to see that consolidation docetaxel following chemoradiation still provided excellent survival for these patients," said Karen Kelly, lead investigator of the S0023 study. Kelly is professor of medicine at the University of Colorado Health Science Center.

Funded primarily by the National Cancer Institute, the Southwest Oncology Group is one of the largest cancer clinical trials cooperative groups in the United States. Its network of nearly 4,000 physician-scientists practicing throughout the U.S. work together to prevent cancer and to improve cancer treatment for adults. About 120 clinical trials are conducted by the Group at any given time.

Clinical trials are research studies conducted with people who volunteer to take part. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Most clinical research that involves the testing of a new drug progresses in a series of steps, called phases. Phase I trials evaluate how a new drug should be administered, how often, and what dose is safe. Phase II trials continue to test the safety of the drug, and evaluate how well it works. Phase III trials test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard treatment.

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