A new study adds to growing evidence that patients with non-small-cell lung cancer (NSCLC) may benefit from a course of chemotherapy after their tumors have been removed surgically.

Patients who received chemotherapy as early as possible following surgery lived significantly longer than similar patients who had surgery alone, according to findings in the June 23 New England Journal of Medicine (NEJM).

After 5 years, 69 percent of the patients who had surgery and chemotherapy were alive, as compared to 54 percent of the surgery-alone group. Overall, the median survival for the chemotherapy and surgery group was 94 months as compared to 73 months for patients in the surgery-alone group.

"These results are extremely good news for lung cancer patients," says Dr. Timothy Winton of the University of Alberta, who led the study. "We thought that intervening with an effective chemotherapy regimen after surgery might have long-term benefits for relatively healthy patients, but the findings far exceeded our expectations."

The randomized trial included 482 patients with early stage NSCLC in Canada and the United States. The chemotherapy, which began about 6 weeks after surgery, consisted of two drugs, vinorelbine and cisplatin, given intravenously over 4 to 6 months. Chemotherapy after surgery is common in treating breast and colon cancers, but early lung cancer trials failed to show that chemotherapy helped patients, and its use has been controversial until now.

Unlike those trials, this one included only patients with minimal symptoms who were likely to tolerate the chemotherapy. The trial also used a more active chemotherapy regimen than some of the older studies, and postoperative radiation was not given.

"We believe the strategy of focusing on a select patient group shortly after surgery was critical to achieving the results," says Dr. Winton, who first presented findings from the study at the 2004 American Society of Clinical Oncology (ASCO) annual meeting.

Dr. Katherine M.W. Pisters of the University of Texas M.D. Anderson Cancer Center attended the ASCO presentation, and she initially had trouble believing the results. The study's 31 percent reduction in the risk of death for the chemotherapy group "is unheard of in lung cancer," she explains.

Dr. Pisters wrote a commentary in NEJM entitled "Adjuvant Chemotherapy for Non-Small-Cell Lung Cancer - The Smoke Clears," a reference to the controversy that she argues is now over based on the results of this and at least two other trials.

"There is no longer any question that postoperative chemotherapy improves survival for these patients," says Dr. Pisters. "This really does work, and it's not controversial anymore."

Both Dr. Pisters and Dr. Winton say that more patients with early-stage NSCLC are receiving chemotherapy because of these clinical trials, though no statistics are available.

With the results published in a high-profile journal read by many physicians, the trend is likely to continue. It will help that two professional organizations, the American College of Chest Physicians and ASCO, are revising their treatment guidelines for physicians to make this the new standard of care for patients with early-stage NSCLC.

"The preponderance of evidence from the relevant clinical trials supports the consideration of chemotherapy following surgery" for these patients, notes Dr. Janet Dancey of NCI's Cancer Therapy Evaluation Program.

By Edward R. Winstead