In the current work, researchers evaluated 216 patients with recurrent non-small-cell lung cancer who had undergone two or more rounds of chemotherapy. One group of patients received 250 mg of ZD 1839 daily, whereas the second group received 500 mg daily until the disease progressed. Investigators found that lung cancer symptoms such as cough, shortness of breath, chest pain or tightness, poor appetite, and fatigue were greatly improved in about 40 percent of patients. Furthermore, symptom improvement was associated with a longer survival.

"Our results show that patients who felt better after taking ZD 1839 actually lived longer than those whose symptoms did not improve," said Ronald B. Natale, M.D., lead author and presenter. "This is important because it shows that a daily pill reduced symptoms such to the extent that many of our patients were able to resume their normal activities and enjoy life for longer."

"The challenge for those of us treating patients with advanced lung cancer today, is how we can manage our patients care so that the side effects from these treatments aren't worse than the symptoms," commented Dr. Natale.

To explore whether ZD 1839 could reduce symptoms associated with non-small-cell lung cancer, investigators evaluated 216 patients whose disease had progressed after at least two prior rounds of chemotherapy. Among these patients, 102 were randomized to receive 250 mg of ZD 1839 each day, whereas 114 were randomized to 500 mg daily.

Symptoms of the disease were monitored weekly using a specially developed seven-item questionnaire, in which patients rated symptom severity on a scale of 0 to 4. Quality of life was measured monthly using a similar self-administered questionnaire. Both questionnaires had been extensively tested and validated in previous lung cancer trials and had been shown to measure meaningful improvements in lung cancer symptoms and patient quality of life. Symptoms were considered to be reduced if the total score on the symptom scale improved by at least two points for greater than a month.

The investigators found that symptoms were significantly reduced in 43 percent of patients receiving the lower dose of ZD 1839, while 34 percent of those receiving the higher dose experienced fewer symptoms. Side effects were minimal and included mild skin reactions and diarrhea. Quality of life was improved in 34 percent of patients who responded to the lower dose of ZD 1839 compared with improved quality of life in 23 percent of patients receiving the higher dose.

"Although patients at both dose levels tolerated ZD 1839 reasonably well, there were fewer and less severe side effects at the 250 mg dose compared to the 500 mg dose level," said Dr. Natale. "Since there were no significant differences between dose levels in these patients' quality of life or symptom improvement, the recommended dose will be 250 mg."

In addition, roughly 11 percent of patients had significant tumor regression as measured by tomographic scans and another 30 percent had disease stabilization for at least two months. Interestingly, symptoms were improved in 95 percent of patients whose tumors shrank in response to treatment. In contrast, 71 percent with stable disease experienced fewer symptoms. Quality of life was also improved in 86 percent of the patients who responded to treatment and in 52 percent of patients with stable disease. Further, the investigators observed that patients with reduced symptoms lived almost five months longer than those whose symptoms did not improve.

"The truly surprising findings from this study were not only that patients with fewer symptoms lived longer, but that patients felt better and had fewer symptoms despite whether or not their tumors responded to treatment with ZD 1839," said Dr. Natale. "This represents a significant step forward for patients battling this disease."