Leading lung cancer researchers said two studies presented this week at the American Society of Clinical Oncology (ASCO) annual meeting in New Orleans may very well change the standard of care in the treatment of patients with early-stage non-small-cell lung cancer (NSCLC). Both studies involved the use of chemotherapy following surgery in patients with early stage NSCLC at high risk for recurrence and found that the approach provided a significant survival benefit when compared with surgery alone.

"Taken together, the results of these studies show conclusively that postsurgical chemotherapy does significantly improve survival," said Dr. Scott Saxman of the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI).

The first study, conducted by the National Cancer Institute of Canada (NCIC) Clinical Trials Group, in conjunction with clinical trials groups supported by the U.S. National Cancer Institute, compared postoperative observation versus a chemotherapy regimen of cisplatin and vinorelbine.

Overall survival in the postoperative chemotherapy group was 94 months compared with 73 months for those in the surgery-alone group; 69 percent of participants who received chemotherapy were alive after 5 years compared with 54 percent in the surgery-alone group. The second study compared chemotherapy with carboplatin and paclitaxel (Taxol) after surgery with no chemotherapy. This study - conducted by the Cancer and Leukemia Group B, one of NCI's cooperative clinical trials groups - was stopped earlier than planned when it became clear that the chemotherapy group had significantly better survival.

Chemotherapy reduced the risk of death from lung cancer by 49 percent, the researchers reported. After 4 years, 71 percent of the patients receiving chemotherapy were alive compared with 59 percent who had surgery alone.

Both study results offer "compelling data to move toward a new standard of care" in this patient group, said Dr. Timothy L. Winton, principal investigator of the NCIC-led study. They also show, he added, "that we have to treat this disease like a systemic disease and not expect local treatments like surgery to be curative on their own."

"The ASCO meeting also saw the release of new findings from a trial testing a new targeted therapy for the treatment of late-stage NSCLC. It compared the effects of erlotinib (Tarceva), an epidermal growth factor receptor (EGFR) inhibitor, with placebo in patients whose disease had progressed after one or two courses of chemotherapy. Patients given erlotinib showed improvements in progression-free survival and freedom from symptom deterioration. Median overall survival was 6.7 months with erlotinib versus 4.7 months with placebo.

The study "is the first EGFR-targeted therapy to show a significant survival benefit in this group of patients," said the trial's principal investigator, Dr. Frances Shepherd of Princess Margaret Hospital in Toronto.

"Since this study began, new information has emerged suggesting that mutations in the EGFR protein are important predictors of response to this class of drugs," noted Dr. Saxman, referring to two recent studies that showed NSCLC patients with EGFR mutations were more likely to respond to the EGFR inhibitor gefitinib (Iressa). "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."