Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Lung Cancer Home Page 2 NCI's gateway for information about lung cancer. Highlights from ASCO 2002 3 A collection of links to material summarizing some of the important clinical trial results announced at the 2002 annual meeting of the American Society of Clinical Oncology (ASCO).

Key Words: non-small cell lung cancer, carboplatin, paclitaxel. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary ⁴.)

A comparison of two approaches to the treatment of advanced non-small cell lung cancer (NSCLC) found that patients who received a two-drug combination therapy had a median survival that was two months longer than patients who received the single agent paclitaxel (brand name Taxol®), researchers reported at the annual meeting of the American Society of Clinical Oncology in Orlando, Fla., on May 20, 2002.

The study was a phase III randomized trial of 584 patients who had a median age of 63.5 and had either advanced stage IIIB or stage IV tumors. The trial compared the combination therapy of carboplatin plus paclitaxel versus paclitaxel alone, and examined survival, quality of life, and cost-effectiveness.

Patients in this study received treatment every three weeks for a maximum of six treatment cycles. The results showed that, after a median follow-up time of 12.5 months, there was a median survival of 6.5 months for paclitaxel alone versus 8.5 months for the combination therapy. One-year survival rates were similar for the two groups. Patients who could perform their daily activities with ease were more likely than sicker patients to benefit from the combination therapy, while patients in overall poor health did not appear to benefit from either therapy. Researchers found that patients on the combination regimen were also more likely to experience serious side effects, such as anemia and low white blood cell counts.

"Based on our findings, we recommend that treatment be individualized and that a patient's age and overall health be taken into consideration," said lead investigator Rogerio Lilenbaum, M.D., director, Thoracic Oncology Program, Mount Sinai Comprehensive Cancer Center, Fla.

Combination chemotherapy is the standard of care for patients with metastatic or recurrent NSCLC, but previous studies have not demonstrated that it provides a clear survival benefit compared to treatment with a single agent alone. As this study suggests, the survival benefit is still modest, but, according to ASCO President Larry Norton, M.D., it "opens the door a crack. When you look at the curative therapy of all diseases, it starts with a small advance where there is an impact and then that door gets opened a little wider."

This study also demonstrated that combination chemotherapy had no detrimental effect over single-agent chemotherapy on a patient's quality of life, and the cost of the two treatments was similar. "We believe that combination chemotherapy should be the standard of care for patients with non-small cell lung cancer," said Lilenbaum.

Paclitaxel is part of a group of drugs called taxanes, which have a unique way of preventing the growth of cancer cells and was originally isolated from the pacific yew tree. Taxanes affect certain cell structures called microtubules that play an important role in cell function. In normal cell growth, microtubules are formed when a cell starts dividing. Once the cell stops dividing, the microtubules are broken down or destroyed. Taxanes stop the microtubules from breaking down, and cancer cells become so clogged with microtubules that they cannot grow and divide.

Carboplatin belongs to the group of medicines known as alkylating agents. It acts by producing DNA cross-links between strands of DNA, which can lead to the cessation of cancer cell production.

The study was conducted by the NCI-sponsored cooperative group called Cancer and Leukemia Group B (CALGB) between October 1997 and January 2001. CALGB is a national clinical research group sponsored by the National Cancer Institute.

Glossary Terms

A condition in which the number of red blood cells is below normal.

A drug that is used to treat advanced ovarian cancer that has never been treated or symptoms of ovarian cancer that has come back after treatment with other anticancer drugs. It is also used together with other drugs to treat advanced, metastatic, or recurrent non-small cell lung cancer and is being studied in the treatment of other types of cancer. Carboplatin is a form of the anticancer drug cisplatin and causes fewer side effects in patients. It attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Paraplatin.

Treatment using more than one anticancer drug.

The time from either diagnosis or treatment at which half of the patients with a given disease are found to be, or expected to be, still alive. In a clinical trial, median survival time is one way to measure how effective a treatment is. Also called median overall survival and median survival.

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 drug used to treat breast cancer, ovarian cancer, and AIDS-related Kaposi sarcoma. It is also used together with another drug to treat non-small cell lung cancer. Paclitaxel is also being studied in the treatment of other types of cancer. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. Also called Taxol.

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.

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.

Stage III is divided into stages IIIA and IIIB. In stage IIIA, cancer has spread to lymph nodes on the same side of the chest as the tumor; the tumor may be any size and cancer may have spread to the main bronchus, the chest wall, the diaphragm, the pleura around the lungs, or the membrane around the heart, but cancer has not spread to the trachea; and part or all of the lung may have collapsed or developed pneumonitis (inflammation of the lung). In stage IIIB, the tumor may be any size and has spread to lymph nodes above the collarbone or in the opposite side of the chest from the tumor; AND/OR to any of the following places: the heart, major blood vessels that lead to or from the heart, the chest wall, the diaphragm, the trachea, the esophagus, the sternum (chest bone) or backbone, to more than one place in the same lobe of the lung, and/or into the fluid of the pleural cavity surrounding the lung.

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.

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.