Related Pages Search for Clinical Trials 1 NCI's PDQ® registry of cancer clinical trials. Lung Cancer Home Page 2 NCI's gateway for information about lung cancer. Highlights from ASCO 2003 3 A collection of links to material summarizing some of the important clinical trial results announced at the 2003 annual meeting of the American Society of Clinical Oncology (ASCO).

Key Words: chemotherapy, lung cancer, radiation, surgery. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary ⁴.)

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.

Glossary Terms

Treatment with drugs that kill cancer cells.

A drug used to treat many types of cancer. Cisplatin contains the metal platinum. It kills cancer cells by damaging their DNA and stopping them from dividing. Cisplatin is a type of alkylating agent.

A drug used to treat testicular and small cell lung cancers. It is also being studied in the treatment of several other types of cancer. Etoposide blocks certain enzymes needed for cell division and DNA repair, and it may kill cancer cells. It is a type of podophyllotoxin derivative and a type of topoisomerase inhibitor. Also called Toposar and Vepesid.

A group of lung cancers that are named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Non-small cell lung cancer is the most common kind of lung cancer.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

The use of high-energy radiation from x-rays, gamma rays, neutrons, protons, and other sources to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external-beam radiation therapy), or it may come from radioactive material placed in the body near cancer cells (internal radiation therapy). Systemic radiation therapy uses a radioactive substance, such as a radiolabeled monoclonal antibody, that travels in the blood to tissues throughout the body. Also called irradiation and radiotherapy.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

In medicine, treatment that experts agree is appropriate, accepted, and widely used. Health care providers are obligated to provide patients with standard therapy. Also called best practice and standard of care.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.

A type of immune cell. Most white blood cells are made in the bone marrow and are found in the blood and lymph tissue. White blood cells help the body fight infections and other diseases. Granulocytes, monocytes, and lymphocytes are white blood cells. Also called leukocyte and WBC.