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Key Words: chemotherapy, lung cancer, radiation, surgery. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary
Patients with non-small cell lung cancer (NSCLC) that has spread to surrounding lymph nodes who were treated with a three-pronged approach using chemotherapy, radiation, and surgery lived longer without progression of their disease than patients treated with just chemotherapy and radiation. However, it remains unclear whether three-pronged treatment extends patients’ overall survival compared to the two-pronged approach.

Source
American Society of Clinical Oncology (ASCO) annual meeting, Chicago, June 2, 2003.

Background
Non-small cell lung cancer (NSCLC) accounts for 80 percent of all lung cancer cases. In about one-quarter of patients with NSCLC, the disease has spread to the lymph nodes in the area between the lungs. Chemotherapy plus radiation is the current standard treatment for NSCLC that has reached this stage. The overall five-year survival rate for this group of patients is 10 to 15 percent.

Some studies have suggested that patients’ survival could be extended by adding surgery to standard treatment. However, the addition of surgery is controversial because it results in more patient deaths from post-operative complications. Also, the previous studies involved a small number of patients who were not assigned at random to receive either standard treatment or standard treatment plus surgery. Trials that are not randomized produce less-definitive results. The current study is the first randomized phase III clinical trial to compare standard treatment plus surgery with standard treatment alone.

The Study
Researchers randomly assigned 411 patients to receive either a standard two-pronged treatment regimen – chemotherapy (cisplatin and etoposide) plus full-dose radiation – or a three-pronged treatment consisting of the same chemotherapy regimen simultaneously with a lower dose of radiation, followed by surgery.

Results
Patients treated with chemotherapy, radiation, and surgery survived longer without progression of their disease. Twenty-nine percent of patients in the three-pronged treatment group had had no relapse of their cancer at three years, compared with 19 percent of those treated with chemotherapy and radiation alone.

There was no statistically significant difference, however, in how long patients in the two trial arms lived regardless of disease recurrence (that is, overall survival).

Fourteen patients (7 percent) in the three-pronged treatment group died as a result of complications from surgery. Three patients (2 percent) in the two-pronged, standard treatment group died from treatment complications. However, they had a higher incidence of low white blood cell counts, swallowing problems, nausea and vomiting, and pneumonia.

“Both treatment approaches produced better outcomes than we expected at three years,” said Kathy Albain, M.D., of Loyola University in Chicago, who was the lead investigator for the study. “We now have two viable treatment options for this group of patients [whose lung cancer has spread to the surrounding lymph nodes].”

Limitations
Longer-term follow-up is needed to determine whether patients who received chemotherapy, radiation, and surgery have improved overall survival compared with those who received chemotherapy and radiation alone. If after more follow-up, patients treated with the three-pronged approach do not appear to benefit from an improved overall survival rate, then patients and their physicians will need to consider whether the advantage in progression-free survival offsets the complications of surgery.

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